VacSafe Africa Brief

This brief is available to download with full appendix and references here: VacSafe Africa Brief Vol.1 No.8.

Summary: This report is a product of the VacSafe Working Group, a group of leading scientists, vaccine and public health experts, and policymakers. Its purpose is to provide an informed overview on the state of SARS-CoV-2 vaccines in Africa (54 countries and 2 disputed territories) with a view to inform US legislators. This briefing comes as the Omicron variant surge appears to be receding in many countries, but as cases still remain high particularly through northern Africa. Africa continues to face vaccine shortages and distribution challenges. Information included in this briefing is drawn from private and public sources. For broader context, refer to earlier installments of the Vaccines in Africa Brief.

Contributing Authors: Dr. Lawrence R. Stanberry, Dr. Shabir Madhi, Dr. Wilmot James, Mr. Joshua Nott, Mr. Jeffray Tsai, Ms. Isabell Ventouris, and Mr. Ayush Baral. Editor: Mrs. Harlowe Zefting.

Vaccines in Africa (54 countries and two disputed territories)

1. SARS-CoV-2 Vaccination Status in Africa

The Our World in Data vaccine tracker reported that as of February 4, 2022, a total of 357.57 million vaccine doses have been administered across the entire African continent, constituting 3.5% of the total of 10.15 billion doses administered globally. Furthermore, only 10.92% of the population in Africa has been vaccinated, with 16.12% given at least one dose.

According to Our World in Data vaccine tracker as of January 28, 2022, the three African countries with the highest rates of people vaccinated are Seychelles (84%), Maldives (73%) and Morocco (66%). The three lowest are Burundi (0.053%), DR Congo (0.4%) and Chad (1.5%).

2. Vaccine Efficacy, Safety, and Approval

• Moderna (Spikevax) - WHO Emergency Use Listing and approved in Botswana, Congo, Egypt, Ghana, Kenya, Libya, Malawi, Nigeria, Rwanda and Seychelles.
• Oxford-AstraZeneca (Vaxzevria) - Africa Regulatory Taskforce approved, WHO Emergency Use Listing and approved in 40 African countries. 
• Serum Institute of India (licensed to produce and sell the Oxford-Astra-Zenca Covishield vaccine) - Africa Regulatory Taskforce (ART) approved, WHO Emergency Use Listing and approved in 14 African countries.
• Pfizer-BioNTech (Comirnaty) - WHO Emergency Use Listing, FDA approval and approved in 21 African Countries.
• Sinopharm (Covilo or BBIBP-CorV) - WHO Emergency Use Listing and approved in 35 African countries. 
• Sinovac (CoronaVac) - WHO Emergency Use Listing and approved in Algeria, Benin, Botswana, Djibouti, Egypt, Libya, Malawi, South Africa, Tanzania, Togo, Tunisia, Uganda, and Zimbabwe. 
• Bharat Biotech (Covaxin) - approved in Botswana, Mauritius, and Zimbabwe.  
• Gamaleya Institute (Sputnik V) - approved in 19 African countries. 
• Gamaleya Institute (Sputnik Light) – approved in Angola, Egypt, Mauritius, Republic of Congo, Tunisia and Tanzania.
• Janssen/Johnson & Johnson (Ad26.COV2.S) - WHO Emergency Use Listing, Africa Regulatory Taskforce approved and approved in 33 African countries.

3. Continental Vaccine Acquisition

Pfizer-BioNTech and Moderna have begun testing for vaccine 3^rd and 4^th doses that are able to combat the Omicron variant infections. These mRNA vaccines are easier to tweak through a simple revision of the Sars-CoV-2 spike sequence.

Dr. Nkengasong has said that Johnson and Johnson vaccines that were purchased throught AVAT’s Task Team have expired, which is due to the fact that many vaccine donations to African states contain near-expired vaccines. Countries have been refusing vaccines that only have a shelf life of one or two months.

Kenya and South Africa will soon start producing generic versions of Merck’s pill, Molnupiravir. It has been known to be able to cut hospitalization rates in half for patients with signs of COVID-19. The EU, UK, and US have authorized its use in recent months. The deal was negotiated by UN backed Medicines Patent Pool.

Africa only received around six percent of all COVID vaccines and administered roughly 60 percent of it, despite having 17 percent of the world’s population.

The US announced they will send roughly 1.6 million doses of Pfizer Covid-19 vaccines to Uganda.

4. Vaccine Distribution

The World Health Organization had an aim for all countries to reach a goal of getting 40% of the population vaccinated by the end of 2021, while getting 70% of the population vaccinated by June 2022. However, only seven African countries: Seychelles, Mauritius, Morocco, Tunisia, Cabo Verde, Botswana, and Rwanda, were able to reach this goal. The target of getting 70% of the population will be missed by almost all African countries.

African countries that performed best with vaccinating their populations finalized vaccine deployment plans before the vaccines arrived. Dr. Nkengasong stated that African countries need to increase investment in health, which will not only help with COVID-19 control, but also in other diseases.

The slow vaccination rates have detrimental economic effects as most recent estimates for sub-Saharan Africa show: They will most likely lose three percent of their GDP from 2022 to 2025.

The latest developments in the Western Covid-19 vaccine production sector imply that the big issue will no longer be the supply of vaccines, but rather its unequal distribution and deployment once in country. With a steady global vaccine production of 1.5 billion doses per month and an outlook of over 1.2 billion vaccine doses for donation by the G7 alone, African officials request Western countries to transfer their large stockpile of unused vaccines to COVAX and COVAX to work together with AVATT and national governments for a fair and efficient allocation and distribution.

Nigerian health authorities had destroyed over one million expired Covid-19 doses last month in an effort to boost public confidence, in a presumed demonstration of not inflicting expired medicines on their publics.

Tech insurer Parsyl partners announced on January 24th that they will distribute 10,000 vaccine monitoring devices in partnership with the CDC. This should further help Africa’s vaccine distribution effort. The platform and its various monitoring devices help enable frontline workers and vaccinators to monitor and track the different usage requirements of Ultra Cold Chain (UCC) Covid-19 vaccines.

5. Vaccine Fill & Manufacturing

Although challenges in infrastructure, regulation, and expertise are hard on the development of the African pharmaceutical sector, it is expected to grow from 19 billion US-Dollar in 2012 to 66 billion US-Dollar by 2022. One of the fastest growing in the world.

Growing efforts for making African countries more independent from COVAX and increasing vaccine fill and manufacturing, that is currently at roughly one percent, make it ever more clear of how crucial a strong regulatory system and a well-functioning health ecosystem are for success.

South Africa and Nigeria have facilities for vaccine manufacturing, research innovation, and development. South Africa has achieved tremendous milestones in its Covid-19 response, including mobilizing financing for local vaccine manufacturing through the newly established Pfizer-COVAX partnership. Rwanda, which was notably the first country to sign the treaty in June 2019, has entered into an agreement with the International Finance Corporation (IFC) to develop vaccine manufacturing capacity in the country.  

The African Medicines Agency (AMA) that launched in September 2021 is the second continental health agency (after Africa CDC) and has the mandate to enhance regulatory oversight across the continent and enabling quality, safe, and efficacious medicines. It is partnering with other key Africa programs (African Continental Free Trade Area, Partnerships for African Vaccine Manufacturing, and African Medicines Regulatory Harmonization/ African Vaccine Regulatory Forum) to further strengthen continental research and development capacity, harmonize drug registration regulations, and help African countries comply with best practices and international standards. This is believed to help spurring local pharmaceutical production by establishing a supportive structure in which all member states can work together to respond to current and future emergency health crises such as Covid-19. As at 1 December 2021, a total of 18 member states have ratified the AMA and submitted instruments of ratification to the African Union Commission (AUC).

Even though the African Union has already started to become more independent with AVAT in 2020, it needs to increase its supply times seven if it wants to make sure that by September 2022 at last 70 percent of its eligible population is vaccinated.

6. Vaccination Licensing Issues/IP/tech transfer

Afrigen Biologics and Vaccines, says it has created a copy of Moderna’s mRNA COVID-19 without Moderna’s involvement, in under 2 months. Advocates were quick to point how this fly into the face of the narrative on complexity of mRNA vaccine manufacturing and the lack of corresponding expertise in the developing world. Many steps remain before Afrigen’s mRNA vaccine could be ready for distribution but the WHO hopes that the process of creating it will lay the foundation for a more globally distributed mRNA vaccine industry in the future. Once the researchers confirm the copy is reliable, they will work with other global south companies on scaling up production. Then, the vaccine will be tested in rodents.

PhRMA has told the USTR that the WHO and other agencies, including the WTO, were no longer reliable stewards of intellectual property rights. The industry lobbying group accused the WHO of promoting “harmful policies” that it says would hurt incentives for drug and vaccine makers. The message comes as the US Trade Representative is preparing its 301 Watch List, which the industry uses to identify countries that do not sufficiently protect IPR.

After officials at the World Trade Organization missed a December deadline on a potential IP waiver, discussions on the topic are ramping back up. Last week, WTO Okonjo-Iweala called on members to reach a consensus on an IP waiver by the end of February.

7. Emerging Variants

Multiple variants of the virus that causes COVID-19 are circulating globally. In collaboration with a SARS-CoV-2 Interagency Group (SIG), US CDC established three classifications for the SARS-CoV-2 variants being monitored: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC).

The US Centers for Disease and Prevention (CDC) Global Variants Report is tracking the worldwide distribution of five variants; as of January 25, 2022, all five variants are reported to be circulating in Africa:

• Alpha (B.1.1.7): (VOC) initially detected in the UK, December 2020
  • Verified in all African countries except: not reported in Eritrea, and unverified in Botswana.
• Beta (B.1.351): (VOC) initially detected in South Africa, December 2020
  • Verified in all African countries except: not reported in Algeria, Egypt, Eritrea, and Niger.
• Delta (B.1.617.2): (VOC) initially detected in India, December 2020
  • Verified in all African countries except: not reported in Eritrea, Libya, Madagascar, Sudan and unverified in Cote d’Ivoire. 
• Gamma (P.1): (VOC) initially identified in travelers from Brazil, January, 2021
  • Verified in Sudan, Kenya, United Republic of Tanzania, South Africa, Namibia, Angola, Gabon, Congo, Equatorial Guinea, Cameroon, Benin, Togo, Ghana, Cote d’Ivoire and not reported in Madagascar, Ethiopia.
• Omicron (B.1.1.529), initially identified in South Africa, was designated a VOC on November 26, 2021.
  • As of January 27, 2022, it is still unverified in Mali, Cote d’Ivoire, Gabon, Congo, United Republic of Tanzania and not reported in Guinea-Bissau, Liberia, Benin, Libya, Chad, Sudan, Central African Republic, Cameroon, Equatorial Guinea, Eritrea, Ethiopia, Somalia, Burundi, Madagascar and Lesotho.

The World Health Organization has currently designated two Variants of Interest (VOI).

• Lambda (C.37). initially detected in Peru, August 2020:
  • Verified in South Africa
• Mu (B.1.621), initially detected in Colombia, August 2021
  • Currently the MU variant in not verified to be circulating in Africa

The category, Variant of High Consequence, is reserved for variants that have clear evidence that prevention measures or medical countermeasures have significantly reduced effectiveness relative to previously circulating variants.

• Currently, there are no SARS-CoV-2 variants that rise to the level of high consequence.

This brief is available to download with full appendix and references here: VacSafe Africa Brief Vol.1 No.8.

This brief is available to download with full appendix and references here: VacSafe Africa Brief Vol.1 No.7.

Summary: This report is a product of the VacSafe Working Group, a group of leading scientists, vaccine and public health experts, and policymakers. Its purpose is to provide an informed overview on the state of SARS-CoV-2 vaccines in Africa (54 countries and 2 disputed territories) with a view to inform US legislators. This briefing comes as the Omicron variant has arisen and become dominant in southern Africa, bringing the region into global attention. Africa continues to face vaccine shortages and distribution challenges. Information included in this briefing is drawn from private and public sources. For broader context, refer to earlier installments of the Vaccines in Africa Brief.

Contributing Authors: Dr. Lawrence R. Stanberry, Dr. Shabir Madhi, Dr. Wilmot James, Mr. Joshua Nott, Mr. Jeffray Tsai, and Ms. Isabell Ventouris Editor: Mrs. Harlowe Zefting.

Vaccines in Africa (54 countries and two disputed territories)

1. SARS-CoV-2 Vaccination Status in Africa

The Our World in Data vaccine tracker reported that as of December 4, 2021, a total of 246.25million vaccine doses have been administered across the entire African continent. 7.48% of the population has been fully vaccinated, with 3.82% given at least one dose. This brings to a total of a total of 11.30% share of people vaccinated against COVID-19.

According to Our World in Data vaccine tracker as of December 4, 2021, the three best countries by share of people vaccinated are Seychelles (83%), Mauritius (72%) and Morocco (66%). The three lowest are Burundi (0.01%), DR Congo (0.15%) and Chad (1.1%).

The B.1.1.529 Omicron variant has raised attention as it overtakes the Delta variant in southern Africa, and is now in at least 23 countries and continues to appear in different parts of the world.  The Omicron variant has more mutations than the Delta variant, leading to higher transmissibility and vaccine-induced antibody evasiveness. However, there is still more information that needs to be gathered to determine severity of illness, particularly in individuals who have developed immunity either from vaccines or past infections.  

2. Vaccine Efficacy, Safety, and Approval (as of November 29, 2021)

• Moderna - WHO Emergency Use Listing and approved in Botswana, Egypt, Ghana, Kenya, Libya, Nigeria, Rwanda and Seychelles.
• Oxford-AstraZeneca (Covishield) - Africa Regulatory Taskforce approved, WHO Emergency Use Listing and approved in 35 African countries. 
• Serum Institute of India (licensed to produce and sell the Oxford-Astra-Zenca Covishield vaccine) - Africa Regulatory Taskforce (ART) approved, WHO Emergency Use Listing and approved in 14 African countries.
• Pfizer-BioNTech - WHO Emergency Use Listing, FDA approval and approved in Botswana, Cabo Verde, Egypt, Gabon, Kenya, Libya, Nigeria, Rwanda, South Africa and Tunisia.
• Sinopharm - BBIBP-CorV - WHO Emergency Use Listing and approved in 24 African countries. 
• Sinovac (CoronaVac) - WHO Emergency Use Listing and approved in Algeria, Benin, Egypt, South Africa, Tanzania, Togo, Tunisia and Zimbabwe. 
• Bharat Biotech (Covaxin) - approved in Mauritius and Zimbabwe. 
• Gamaleya Institute (Sputnik V) - approved in 19 African countries. 
• Gamaleya Institute (Sputnik Light) – approved in Angola, Egypt, Mauritius, Republic of Congo, and Tanzania.
• Janssen/Johnson & Johnson (Ad26.COV2.S) - WHO Emergency Use Listing, Africa Regulatory Taskforce approved and approved in Egypt, Gabon, Ghana, Kenya, Liberia, Libya, Madagascar, Malawi, Nigeria, Senegal, South Africa, Sudan, Tanzania, Tunisia, Zambia and Zimbabwe.

3. Continental Vaccine Acquisition

Africa CDC and the Mastercard Foundation announced that 15.2 million vaccines purchased under the Saving Lives and Livelihoods initiative are being distributed across Africa. Over 3.3 millions of J&J doses arrived in Nigeria. This is the first batch of vaccines to be delivered under the initiative, and the vaccines will be distributed by UNICEF. Under this initiative and negotiated by AVAT, there was a purchase of 400 million Johnson & Johnson vaccines, and also a recent purchase of 50 million Moderna vaccines from earlier this year.

With the new emerging B.1.1.529 Omicron variant, BioNTech has said that it would be testing and tweaking the current vaccine. Candidates with three existing doses would be tested against the Omicron variant, and a new variant-specific booster would be developed as needed. Scientists are concerned if this version of the virus would be the “escape variant.”

Chinese president Xi Jinping pledged to donate 1 billion vaccine doses to Africa, and encouraged Chinese companies to invest no less than $10 billion to Africa over the next three years. In the US, President Biden made a statement saying that the US mas made more vaccine donations than every other country combined, and calls for everyone to be donating.

In light of China pledging to donate another billion doses, African countries say they no longer want “ad hoc donations with little notice and short shelf lives”, demanding that donated doses should have a minimum of 10 weeks shelf life when they arrive. In a joint statement issued by the AU member states, it says that the short shelf lives of donations so far have “[...] made it extremely challenging for countries to plan vaccination campaigns and increase absorptive capacity.”

These claims have not been made for the first time: In June 2021, Zimbabwe turned down three million doses of the J&J single-dose vaccine due to lacking storage capacities.

4. Vaccine Distribution

South Sudan has struggled to improve COVID-19 vaccine distribution. South Sudan’s people  believe that flooding, hunger and malaria are the biggest problem they face. There is acknowledgement that the pandemic exists, however, COVID-19 related deaths are simply not visible. As a result, vaccine information communicated to the population has little effect if the population does not believe that the pandemic is a major problem in their lives.

The national government of Kenya announced that residents need to bring proof of COVID-19 vaccination to access services by December 21. Although this has been welcomed by some businesses, due to the low vaccination rates, this may seem unrealistic. 

As South Africa faces the fourth wave of COVID-19 with the Omicron variant, there are still struggles with the vaccine access in southern Africa, which South African president Cyril Ramaphosa says is “vaccine apartheid.”

5. Vaccine Fill and Manufacturing

The African continent has been let down by the unequal international Covid-19 vaccine distribution system. The rise of the Omicron variant shows again that Africa has to take matters into their own hands. Although vastly under-reported by the media, a critical agenda has been taking shape for African countries to become independent in their vaccine development and -manufacturing abilities. On December 6^th and 7^th, Rwanda’s President Kagame hosted the Partnership for Africa Vaccine Manufacturing meeting in Kigali. In the meeting the two key elements were pointed out: Self-reliance in development and manufacturing of life-saving technologies, and the importance of pan-African collaboration.

With their $500 million US Dollar investment plan, the Moderna factory is just one of the U.S.-backed vaccine manufacturing initiatives in Africa. In partnership with France and Germany, the U.S. government in June announced a 600 million euro investment enabling the South African firm Aspen Pharmacare Holdings Limited to produce Johnson & Johnson vaccine. The U.S. government, along with African and European development partners, also aids the Institut Pasteur de Dakar to increase production of vaccines in Senegal.

Pfizer confirmed their “fill and finish” deal with South Africa’s Biovac Institute on Monday December 6^th. Receiving the drug substance from Europe, production for the Pfizer-BioNTech COVID-19 vaccine is set to start in early 2022.

WHO Director-General Ghebreyesus addressed the situation at the Stakeholder Engagement Event and acknowledged the progress that had been made so far on implementing the partnerships for vaccine manufacturing in Africa. He specifically cited the following developments:

• The start of the Africa Medicines Agency treaty.
• The formal commitment of Egypt, Morocco, Rwanda, Senegal, and Algeria to COVID-19 vaccine manufacturing.
• The WHO-led establishment of an mRNA technology transfer hub in South Africa and a vaccine industry talent development program
• The coordinated development of local manufacturing capacity on the continent in partnership with the Team Europe Initiative on manufacturing and access to medicines, vaccines and health technologies.

Ghebreyesus ends his speech by pointing out the supply increase of skilled workforce with training in biomanufacturing as the biggest challenge.

On Tuesday October 22nd, BioNTech signed an agreement with the Rwandan government and Institut Pasteur de Dakar in Senegal on the construction of the first mRNA vaccine manufacturing facility in Africa starting in mid-2022. That timing sets the Pfizer partner up to potentially beat Moderna in building the first mRNA vaccine manufacturing site on the continent. Although information on the location have not been revealed, experts expect the plant to be located in either Rwanda or Senegal.

6. Vaccination Licensing Issues/IP/Tech Transfer

The WHO COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) announced the first global, non-exclusive and transparent voluntary license for a COVID-19 diagnostic test. The technology, offered by the Spanish National Research Council (CSIC), is an antibody test capable of quantifying three different types of antibodies, and can differentiate vaccinated people from natural COVID-19 infections for public health surveillance. This has the potential to boost testing capacity for poor countries with limited COVID-19 surveillance. 

After negotiations stalled on waiving the intellectual property around Covid19 Vx ahead of a December deadline, the European Commission has now gone from threatening to veto any IP waiver to calling for a “targeted” waiver on compulsory licenses only - a move advocates call meaningless and merely a PR stunt (not that there aren’t important barriers created by certain Art. 31 and especially Art. 31bis provisions, but that there are many other important barriers that must be addressed in addition).  

South Africa’s Aspen Pharmacare and J&J are expanding their existing manufacturing by granting Aspen the rights to manufacture finished SARS-CoV-2 Covid-19 vaccine product from drug substance supplied by J&J. Aspen will sell the finished form vaccine under its own branding to public sector markets in Africa through transactions with designated multilateral organizations and with national governments of Member States of the AU.

A federal appeals court on Wednesday dismissed two patent challenges from Moderna over key components (LNPs) involved in making its COVID-19 vaccine. The court's decision to side with Arbutus Biopharma means it could potentially sue Moderna for patent infringement and demand royalties from Moderna’s COVID-19 vaccine. Even more interesting, Arbutus could also seek invalidation of Moderna’s patent, to which NIH had been demanding recognition of co-inventorship. 

7. Emerging Variants

Multiple variants of the virus that causes COVID-19 are circulating globally. In collaboration with a SARS-CoV-2 Interagency Group (SIG), US CDC established three classifications for the SARS-CoV-2 variants being monitored: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC). 

The US Centers for Disease and Prevention (CDC) Global Variants Report is tracking the worldwide distribution of four variants; as of November 24, 2021, all four variants are reported to be circulating in Africa and a new fifth variant has been detected in five African countries:

• Alpha (B.1.1.7): (VOC) initially detected in the UK, December 2020
  • Verified in all African countries except: not reported in Comoros, Eritrea, Lesotho, Mali, Sierra Leone, Tanzania, and Western Sahara (a disputed territory) and unverified in Botswana and Eswatini.
• Beta (B.1.351): (VOC) initially detected in South Africa, December 2020
  • Verified in all African countries except: not reported in Algeria, Burkina Faso, Cabo Verde, Chad, Egypt, Eritrea, Gambia, Mali, Niger, Western Sahara, and unverified in Congo.
• Delta (B.1.617.2): (VOC) initially detected in India, December 2020
  • Verified in all African countries except: not reported in Chad, Djibouti, Eritrea, Libya, and Sudan and unverified in Comoros, Cote d”Ivoire, Lesotho and Reunion. 
• Gamma (P.1): (VOC) initially identified in travelers from Brazil, January, 2021
  • Verified in Angola, Benin, Congo, Ghana, Reunion, Sudan, and Togo
• Omicron (B.1.1.529), initially identified in Botswana and South Africa, was designated a VOC on November 26, 2021.
  • As of December 1, 2021, it had been verified in Botswana, Ghana, Nigeria, Reunion and South Africa.

The World Health Organization has currently designated two Variants of Interest (VOI).

• Lambda (C.37). initially detected in Peru, August 2020:
  • Verified in South Africa
• Mu (B.1.621), initially detected in Colombia, August 2021
  • Currently the MU variant in not verified to be circulating in Africa

The category, Variant of High Consequence, is reserved for variants that have clear evidence that prevention measures or medical countermeasures have significantly reduced effectiveness relative to previously circulating variants.

Currently, there are no SARS-CoV-2 variants that rise to the level of high consequence.

A PDF version of this brief with full appendix and reference is available for download here: VacSafe Africa Brief Vol.1 No.7.

A PDF version of this brief, with the appendix and references, is available for download here: VacSafe Africa Brief Vol.1 No.6

Summary: This report is a product of the VacSafe Working Group, a group of leading scientists, vaccine and public health experts, and policymakers. Its purpose is to provide an up-to-date overview of the state of SARS-CoV-2 vaccines in Africa (54 countries and two disputed territories). This briefing comes as Africa continues to face major vaccine shortages, amid a high level of community transmission due to the Delta variant. Information included in this briefing is drawn from private and public sources. For broader context, refer to earlier installments of the Vaccines in Africa Brief.

Contributing Authors: Dr. Lawrence R. Stanberry, Dr. Shabir Madhi, Dr. Wilmot James, Mr. Joshua Nott, Mr. Jeffray Tsai (Editor) and Ms. Isabell Ventouris (Co-Editor). Design: Ms. Harlowe Wang.

Vaccines in Africa (54 countries and two disputed territories)

1. SARS-CoV-2 Vaccination Status in Africa

The Our World in Data vaccine tracker reported that as of October 30, 2021, a total of 119.99 million vaccine doses had been administered across the entire African continent. 5.77% of the population has been fully vaccinated, with 2.96% given at least one dose.

According to Our World in Data vaccine tracker as of October 30, 2021, the three best countries by share of people vaccinated are Seychelles (82%), Mauritius (71%) and Morocco (64%). The three lowest are Tanzania (1.4%), Madagascar (1.3%), and Chad (0.97%).

Five countries on the African continent will be able to hit the 40% target by the end of this year: Seychelles, Mauritius, Morocco, Tunisia, and Cape Verde.

2. Vaccine Efficacy, Safety, and Approval

• Moderna has WHO Emergency Use Listing and is approved in Botswana, Ghana, Kenya, Libya, Nigeria, Rwanda and Seychelles.
• Oxford-AstraZeneca (Covidshield) – Africa Regulatory Taskforce (ART) approved. WHO Emergency Use Listing and approved in 32 African countries.
• Serum Institute of India, which is licensed to produce and sell Oxford-Astra Zeneca, has ART and WHO Emergency Use Listing approvals and approved in 14 African countries.
• Pfizer-BioNTech – WHO Emergency Use Listing, FDA approval, and approved in Botswana, Cabo Verde, Kenya, Libya, Nigeria, Rwanda, South Africa and Tunisia.
• Sinopharm – BBIBP-CorV – WHO Emergency Use listing and approved in 24 African countries.
• Sinovac (CoronaVac) – WHO Emergency Use Listing and approved in Algeria, Benin, Egypt, South Africa, Tanzania, Togo, Tunisia, and Zimbabwe.
• Bharat Biotech (Covaxin) – approved in Mauritius and Zimbabwe.
• Gamaleya Institute (Sputnik V) – approved in 19 African countries.
• Gamaleya Institute (Sputnik Light) – approved in Angola, Egypt, Mauritius, and Republic of Congo.
• Janssen/Johnson & Johnson (Ad26.COV2.S) – WHO Emergency Use Listing, ART approved and approved in Egypt, Ghana, Kenya, Liberia, Libya, Madagascar, Malawi, Nigeria, Senegal, South Africa, Tanzania, Tunisia, Zambia and Zimbabwe.

3. Continental Vaccine Acquisition

Seth Berkley from the Global Alliance for Vaccines and Immunizations (GAVI) informed the World Health Summit (WHS) that less than 10% of vaccine dose donations promised to COVAX had been delivered. The People’s Vaccine Alliance (PVA) found that 1 out of 7 vaccines pledge by HIC have reached LIC.

On October 15, 2021, President Biden from the US told President Kenyatta from Kenya that the US will make a donation of 17-million doses of the Johnson & Johnson vaccine to the African Union.

Moderna announced that they established a Memorandum of Understanding to sell up to 110 million doses to African Union (AU) states. This would be in addition to the agreement made with COVAX to supply 500 million vaccine doses from the end of Q4 of 2021 through 2022.

4. Vaccine Distribution

South Africa declined to approve Sputnik V vaccine over concerns regarding the increase risk of HIV infection. The vaccine contains a modified form of adenovirus, which officials say was used in HIV vaccine research that failed as it increased the chance of being infected (with HIV) among vaccinated men. This further implies the need of African involvement in drug development. In addition, Namibia also decided to suspend the use of Sputnik days after the drug regulator in South Africa flagged concerns about its safety for people at risk of HIV.

Institut Pasteur of Morocco and Rwanda Biomedical Centre have shown efficiency in rolling out vaccinations in their countries. Morocco has vaccinated more than 80% of its target population, while Rwanda has 25% of its eligible population vaccinated, with a goal of 40% of the population vaccinated by the end of 2021.

5. Vaccine Fill & Manufacturing

Rwanda and Senegal are setting up mRNA manufacturing facilities in an agreement with BioNTech. Construction will begin mid-2022 with each production line producing around 50 million doses a year.

Canada will donate $15 million to the new technology transfer hub being built in South Africa that will help manufacture mRNA vaccines.

South Africa’s Aspen Pharmacare is planning to increase COVID-19 vaccine manufacturing capacity to 1.3 billion doses a year by 2024. Aspen is responsible for the final stages of manufacturing the Johnson & Johnson vaccine. In addition, Afrigen Biologics and Vaccines have scientists reverse-engineering the Moderna vaccine, in hopes of creating vaccine access in Africa. This is backed by WHO, which is coordinating vaccine research and making a training and production hub in South Africa.

Moderna Therapeutics CEO Stéphane Bancel announced that the pharma- and biotech giant is in the process of planning its first African vaccine plant. This new state of the art vaccine manufacturing facility will receive investments for up to $500 million US Dollar and is expected to produce up to 500 million doses of Moderna’s mRNA vaccine. The plant is also expected to produce other Moderna vaccines and will be mostly staffed with local workers. Moderna is currently in the process of identifying which country will be the location of the vaccine plant, with South Africa, Rwanda, and the Senegal being the top candidates.

The four main factors for successful vaccine manufacturing are large scale financing, enhanced research capacity, the commitment from governments to purchase vaccines, and regulatory bodies that meet international standards. Due to the inherent difficulty of biological processes, one of the biggest hurdles to capacity expansion is definitely the manufacture of vaccine batches with consistent characteristics and quality. The transfer of technologies and production processes to facilities in Africa will therefore be particularly difficult. There are specific challenges involved in vaccine production, including process development, process maintenance, lead time, production facilities, equipment, life cycle management, and product portfolio management. A robust and stable manufacturing process and consistent component supplies over decades are key to ensure long life cycle of a vaccine in a market. Failure to manage these risks can result in costly product recalls, suspensions from the market and penalties.

Brazil and Cuba are good learning examples for vaccine production setup by public institutions, while India is an example for private manufacturers. These countries committed to build or shape their own biopharmaceutical manufacturing capacity, initially focused on domestic needs and later expanded to supply international markets through the United Nations Children's Fund (UNICEF) and the Pan American Health Organization (PAHO). Another hurdle are issues with regulatory bodies: A weak National Regulatory Authority (NRA) can create serious difficulties for the national and global business of a vaccine manufacturer. Since 2010, after the World Health Organization (WHO) assessed NRAs in Africa, there have been great development in African NRAs with some becoming fully functional, though, usually for oversight of pharmaceuticals only and not yet for biopharmaceuticals like vaccines. For vaccines, they depend on WHO pre-qualification program (WHO-PQ) or other competent NRA licensure before local marketing authorization. These aspects must be keenly thought through and covered in the implementation plan of facility establishment and maintenance in Africa. African governments are interested in the establishment of vaccine manufacturing capacity in their countries. However, they would do this only with an external financial and/or technical capacity building support. Thus, they are willing to support an investor at varying levels, such as land, tax incentives, infrastructure provision, and monetary support as a private public partnership. They are also willing to facilitate necessary extra capacity building in their NRA in a form of training or to support collaboration with competent authorities of other countries and the WHO. The latter would help them during an interim phase to cover all regulatory aspects around vaccine manufacturing facility establishment and at the initial stage of product life cycle. All responders expect access to a vaccine at an affordable price and establishment of employment for native experts.

6. Vaccine Licensing/Intellectual Property

The US restated its support for a TRIPS waiver this week, with Dep. Press Secretary Karine Jean-Pierre saying WTO members must “step up […] and support an intellectual property waiver, and every company must act ambitiously and urgently toe expand manufacturing now” according to a White House transcript. “[I]t’s clear that the world must do more in our global COVID-19 response. Other countries must step up, like the United States, and act with more urgency to stamp out … the virus everywhere,” she added.

Germany’s BioNTech signed an agreement with Senegal and Rwanda to build mRNA vaccine factories in Africa, working with the Institut Pasteur Dakar and the Rwandan government. BioNTech said construction is set to start in mid-2022, and it ultimately plans to transfer manufacturing capacities and know-how to local partners. No dates were specified, and it is unclear how this effort will articulate itself with the WHO-sponsored SA hub (with some worrying the two efforts, if not coordinated, may undermine each other).

7. Emerging Variants

Multiple variants of the virus that causes COVID-19 are circulating globally. In collaboration with a SARS-CoV-2 Interagency Group (SIG), US CDC established three classifications for SARS-CoV-2 variants being monitored: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC). The US CDC Global Variants Report is tracking the worldwide distribution of four variants, three variants are reported to be circulating in Africa:

• Alpha (B.1.1.7): (VOC) initially detected in the UK, December 2020. Verified in all African countries except: not reported in Comoros, Eritrea, Lesotho, Mali, Sierra Leone, Tanzania, Western Sahara (a disputed territory), Zimbabwe and unverified in Botswana and eSwatini.
• Beta (B.1.351): (VOC) initially detected in South Africa, December 2020. Verified in 43 African countries.
• Delta (B.1.617.2): (VOC) initially detected in India, December 2020. Verified in 41 African countries.
• Gamma (P.1): (VOC) initially identified in travelers from Brazil, January 2021.

The World Health Organization has currently two Variants of Interest (VOI).

• Lambda (C.37), initially detected in Peru, August 2020. Verified in South Africa.
• Mu (B.1.621), initially detected in Colombia, August 2021. Currently, the Mu variant has not been verified to be circulating in Africa.

The category Variant of High Consequence is reserved for variants that have clear evidence that prevention measures or medical countermeasures have significantly reduced effectiveness relative to previously circulating variants. There are currently no variants that rise to the level of high consequence.

There are currently 14 designated Variants Under Monitoring, including C.1.2, first detected in South Africa, September 1, 2021.

Read the full brief, with appendix and references, in PDF form here: VacSafe Africa Brief Vol.1 No.6.

A PDF version of this brief, with the appendix and references, is available for download here: VacSafe Africa Brief Vol.1 No.5

Summary: This report is a product of the VacSafe Working Group, a group of leading scientists, vaccine and public health experts, and policymakers. Its purpose is to provide an up-to-date overview of the state of SARS-CoV-2 vaccines in Africa (54 countries and two disputed territories). This briefing comes as Africa continues to face major vaccine shortages, amid a high level of community transmission during its third wave of the COVID-19 pandemic. Information included in this briefing is drawn from private and public sources. For broader context, refer to earlier installments of the Vaccines in Africa Brief.

Contributing Authors: Dr. Lawrence R. Stanberry, Dr. Shabir Madhi, Dr. Wilmot James, Mr. Joshua Nott, Ms. Harlowe Wang (Editor). 

Vaccines in Africa (54 countries and two disputed territories)

1. SARS-CoV-2 Vaccination Status in Africa

• The Our World in Data vaccine tracker reported that as of August 29, 2021, a total of 99.57 million (of 5.31 billion globally) vaccine doses have been administered across the African continent, which has 17 per cent of the globe’s population living there. 2.68% of the population has been fully vaccinated, with 4.79% given at least one dose.
• South Africa and Morocco are the only African countries on track to vaccinate at least 60% of their population by mid-2022, a timeline that an Economist Intelligence Unit (EIU) report states may prevent GDP losses totaling $2.3 trillion between 2022 and 2025. Other countries in Africa are not expected to meet that goal until 2023 and beyond.

2. Emerging Variants

• Special Announcement: An article, not yet peer-reviewed, was posted 26 August 2021. The article reports the identification, in South Africa and seven other countries, of a potential variant of interest (VOIs) assigned to the PANGO lineage C.1.2. C.1.2 contains multiple mutations within the spike protein, which have been observed in other variants of concern (VOCs) and are associated with increased transmissibility and reduced neutralization sensitivity. We will continue to monitor this variant and will report further developments.
• Multiple variants of the virus that causes COVID-19 are circulating globally. In collaboration with a SARS-CoV-2 Interagency Group (SIG), US CDC established three classifications for the SARS-CoV-2 variants being monitored: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC). 
• The US Centers for Disease and Prevention (CDC) Global Variants Report is tracking the worldwide distribution of four variants; as of July 23, 2021, three variants are reported to be circulating in Africa:
  • Alpha (B.1.1.7): (VOC) initially detected in the UK, December 2020.
    • Verified in all African countries except: not reported in Eswatini, Lesotho, Madagascar, Mali, Tanzania and unverified in Botswana.
  • Beta (B.1.351): (VOC) initially detected in South Africa, December 2020
    • Verified in 37 African countries.
  • Delta (B.1.617.2): (VOC) initially detected in India, December 2020.
    • Verified in 27 African countries.
  • Gamma (P.1): (VOC) initially identified in travelers from Brazil, January, 2021.
    • Not verified to be circulating in Africa.
• The World Health Organization has designated four Variants of Interest (VOI). Currently, none of the VOI have been verified to be circulating in Africa.
  • Eta (B.1.525), initially detected in multiple countries, December 2020.
  • Iota (B.1.617.1), initially detected in USA, November 2020.
  • Kappa initially detected in India, October 2020.
  • Lambda (C.37). initially detected in Peru, August 2020.
• The category, Variant of High Consequence, is reserved for variants that have clear evidence that prevention measures or medical countermeasures have significantly reduced effectiveness relative to previously circulating variants.
  • Currently, there are no SARS-CoV-2 variants that rise to the level of high consequence.

3. Vaccine Efficacy, Safety, and Approval

• Moderna - WHO Emergency Use Listing and approved in Botswana, Libya, Nigeria, Rwanda and Seychelles.
• Oxford-AstraZeneca (Covishield) - Africa Regulatory Taskforce approved, WHO Emergency Use Listing and approved in 37 African countries. 
• Serum Institute of India (licensed to produce and sell the Oxford-Astra-Zenca Covishield vaccine) - Africa Regulatory Taskforce (ART) approved, WHO Emergency Use Listing and approved in 13 African countries.
• Pfizer-BioNTech - WHO Emergency Use Listing, FDA approval and approved in Botswana, Cabo Verde, Libya, Nigeria, Rwanda, Tunisia and South Africa. 
• Sinopharm - BBIBP-CorV - WHO Emergency Use Listing and approved in 20 African countries. 
• Sinovac (CoronaVac) - WHO Emergency Use Listing and approved in Benin, Egypt, South Africa, Tanzania, Togo, Tunisia and Zimbabwe. 
• Bharat Biotech (Covaxin) - approved in Mauritius and Zimbabwe. 
• Gamaleya Institute (Sputnik V) - approved in 19 African countries. 
• Gamaleya Institute (Sputnik Light) – approved in Angola, Congo and Mauritius.
• Janssen/Johnson & Johnson (Ad26.COV2.S) - WHO Emergency Use Listing, Africa Regulatory Taskforce approved and approved in Libya, Nigeria, South Africa, Tunisia, Zambia and Zimbabwe.

4. Continental Vaccine Acquisition

With a population of 1.24 billion, Africa is dependent on three vaccine sources: (1) the WHO’s COVAX scheme (co-led by The GAVI Alliance and The Coalition for Epidemic Preparedness Innovations (CEPI)); (2) the African Union (AU) via the African Vaccine Acquisition Trust (AVAT); and (3) bilateral agreements with pharmaceutical companies and/or vaccine-producing countries and donation agreements.

• COVAX:
  • With 620 million COVID-19 vaccine doses set to arrive in Africa through COVAX alone by the end of 2021, African countries are set to roll out a range of different vaccines, each with their own unique storage, transport and administration requirements.
  • Through COVAX, the United States shipped 488,370 doses of Pfizer to Rwanda on August 17, the first shipment of the 500 million doses in international donations pledged by President Joseph Biden at the G7 summit.
  • The United States has shipped more than 2.2 million doses of Pfizer/BioNTech's Covid-19 vaccine to South Africa destined to arrive there on 29 August, according to a White House official. The 2,217,150 doses are donated through the global vaccination program Covid-19 Vaccines Global Access, or COVAX, the official said. Cumulatively, the US will have donated nearly 8 million COVID-19 vaccine doses to South Africa.
  • COVAX plans to ship 100 million doses of the Sinovac and Sinopharm vaccines (50 million each), mostly to Africa and Asia, in its first global delivery of Chinese vaccines. As of July 29, deliveries are planned for ‘July to September 2021.’
    • South Africa is listed by COVAX as one of Africa's largest recipients of Sinovac shipments with an allocation of 2.5 million doses, but a senior health official said the country was currently unable to accept the vaccines: ‘There is not enough information on effectiveness against the Delta variant and there is no data on Sinovac in populations with HIV.’
    • Nigeria, the main recipient of Chinese shots in Africa under COVAX with an allocation of nearly 8 million Sinopharm doses, has approved the vaccines but has called it a ‘potential’ option for the country's inoculation campaign. 
    • Officials from Kenya, Rwanda, Togo and Somalia, which are entitled to smaller shipments, said they had no concerns about the Chinese vaccines because they had been vetted by the WHO.
  • Vaccine shipments to Africa have picked up with the COVAX Facility delivering almost 10 million doses to Africa so far in August i.e. nine times what was delivered in the same period in July. The African Union has so far delivered 1.5 million doses to nine countries. Since June, the number of doses administered per 100 people in sub-Saharan Africa has increased marginally from 1.2 per 100 people to 3.4 per 100 people.
  • In late June alone, COVAX sent 530,000 doses to the UK, more than double the amount sent that month to the entire continent of Africa. Other wealthy countries to receive doses from COVAX include Australia, Canada, New Zealand, and Qatar. In the meantime, COVAX has only been able to deliver 25 million of the 700 million doses the AU expects this year.
• African Union via AVAT:
  • UNICEF will obtain and deliver COVID-19 vaccines on behalf of AVAT.
  • COVID-19 vaccine deliveries from the African Union’s Africa Vaccine Acquisition Trust (AVAT) are picking up, with a projected rise to 10 million each month from September. Around 45 million doses are expected from AVAT by the year’s end.
  • France will donate 10 million doses of AstraZeneca and Pfizer COVID-19 vaccines to African Union Member States over the next three months. The vaccines will be allocated and distributed by the initiative known as the Africa Vaccine Acquisition Trust (AVAT) and the COVAX global vaccine initiative.
• Significant Bilateral Vaccine Purchases & Vaccine Diplomacy:
  • China (to date): In addition to COVAX contributions, approximately 9 million doses have been donated to Africa and 47 million doses purchased by African countries.
    • 41 African countries have been receiving sales and donations of vaccines from China.
  • Germany will make up to 70 million doses of COVID-19 vaccine available to African countries this year. "Germany will make available not only 30 million doses of vaccines but it will be as much as 70 million doses," Chancellor Angela Merkel told a news conference after a summit with African leaders on the G20's Compact with Africa initiative.
  • The United Kingdom delivered 249,000 doses of AstraZeneca to Ghana, part of a pledge to donate 100 million doses internationally, of which 80% will be through COVAX.  Nigeria, the Democratic Republic of the Congo (DRC) and Ethiopia have also received doses.
• High-income countries have ignored WHO guidelines to delay booster shots. WHO regional director for Africa, Dr. Matshidiso Moeti, warned that moves by some wealthy countries to introduce booster shots threaten the African continent’s ability to fight the devastating pandemic. African countries continue to lag far behind those on other continents in inoculations, with less than 3 percent of Africa’s 1.3 billion people fully vaccinated against the virus.
  • Dr. Moeti said richer countries hoarding vaccinations “make a mockery of vaccine equity.” The comment comes after wealthy nations plan COVID booster shots even as much of the world is yet to receive a first dose.
  • WHO Director-General Dr. Tedros lamented “the fundamental weakness at the root of the pandemic,” i.e. a broadly hesitant approach to sharing vaccines information, tech and tools.
  • In response to criticism, President Biden said: “We’re providing more to the rest of the world than all the rest of the world combined… We’re keeping our part of the bargain.”

5. Vaccine Fill & Manufacturing

• Up to 10 million J&J doses partially produced by South African manufacturer Aspen are being exported to Europe in August and September, and millions more were exported in recent months. Meanwhile, South Africa is yet to receive the overwhelming majority of the 31 million doses it ordered from J&J, one of the reasons why only 9.7% of its population is fully vaccinated. The government was reportedly forced to waive its right to impose vaccine export restrictions in the confidential contract it signed with the company. Facing backlash, the EU says import of J&J vaccines from South Africa is temporary. The EC explained it had reached such an agreement after criticism of the scheme.
• The team behind Sputnik V. has said that plans have already been put in place to adapt the fomula based on genetic sequencing from the new Delta varian. Alexander Gintzburg, who heads up Moscow's Gamaleya Institute stated that a modified version of Sputnik V had already been created. Morocco has established manufacturing agreements with several leading vaccine contenders including Russian ones.

6. Vaccine Distribution

• COVAX has initiated five rounds of vaccine allocation to participant countries:
  • Tanzania has received one million doses of the Johnson & Johnson vaccine sent from the US under COVAX. Doses are being distributed at 550 vaccination centers nationwide. Tanzania has placed another order for the vaccine through the African Union as part of its plan to initially target more than 60% of the population.
  • Nigeria approved the Sinopharm COVID-19 vaccine and expects to receive 7.7 million doses via COVAX.
• AVAT
  • President Cyril Ramaphosa of South Africa announced the start of monthly shipments of vaccines acquired by the AU / African Vaccine Acquisition Trust (AVAT) to the AU Member States on. An initiative by the AU Member States to pool their purchasing power, the AVAT, on 28 March 2021, had signed the historic agreement for the purchase of 220 million doses of the Johnson & Johnson single-shot COVID-19 vaccine, with the potential to order an additional 180 million doses.
    • The Johnson & Johnson vaccine was selected because: (1) as a single-shot vaccine it is easier and cheaper to administer; (2) the vaccine has a long shelf-life and favourable storage conditions; (3) the vaccine is partly manufactured on the African continent, with fill-finish activities taking place in South Africa.
    • 6.4m doses shipped in August to several AU Member States. Monthly shipments will continue and be continually ramped up, with a target of delivering almost 50m vaccines before the end of December. By January, the number of vaccines being released will be in excess of 25m per month. In collaboration with the Africa Medical Supplies Platform (AMSP), UNICEF is providing logistical and delivery services to the Member States.
• West Africa has to date received around 29 million vaccine doses—almost the same amount as East and Southern Africa. However, the rollout has been slow, with 38% of the doses administered compared with 76% in East and Southern Africa and 95% in North Africa. West Africa has delivered 2.4 doses per 100 people. In East and Southern Africa, the figure stands at 4.8 doses per 100 people.

7. Vaccine Licensing/Intellectual Property

See appendix in the PDF version of this brief for a diagram of vaccine patent architecture (Figure 1). 

• The Medicines Patent Pool (MPP), WHO, Afrigen Biologics, Biovac, the South African Medical Research Council (SAMRC) and Africa CDC have signed a letter of intent to address the global imbalance of manufacturing capacity for COVID-19 vaccines. The letter sets out the terms of the collaboration and responsibilities between the organizations for the development of a tech transfer hub. To get the hub up and running in a year, its partners still need help from the pharmaceutical sector  - but neither Moderna nor Pfizer has signaled interest in working with the facility. The due diligence, which was conducted by both by the MPP and by WHO indicates at this moment that there is no IP barrier in South Africa for the production of mRNA vaccines (i.e., there is currently no patent application for an mRNA vaccine in the country, even though a patent application could still emerge). So other companies could go ahead and produce mRNA in South Africa - but of course time is of the essence and this would take longer than if the originators shared the technology.
• Through public investment in development of the NIH-Moderna COVID-19 vaccine, the US government has the vaccine recipe in its possession and has rights under contract to share key information with the rest of the world to facilitate increased vaccine production, according to a new report by Public Citizen. The US has so far chosen not to exercise these rights. The action or inaction of the US in this respect would have considerable implications for end-to-end vaccine manufacturing in the developing world including Africa.
• BioNTech also hopes it can follow up its global COVID-19 success with the world’s first mRNA vaccines against malaria and tuberculosis. While still under development, the German biotech is already eyeing Rwanda and Senegal to support future production of the two vaccine hopefuls, the company said on August 27. The sites would provide ‘end-to-end vaccine supply solutions on the African continent.’  This is striking to read as similar deals have been excluded for Covid vaccines.
• In Senegal, the Institut de Pasteur in Dakar is building a manufacturing plant in the hopes of starting production of COVID-19 vaccines later this year. Its goal is to produce 25 million doses per month by the end of 2022. The facility received 6.75 million euros from EU countries and institutions, and the USG’s International Development Finance Corporation (DFC) has also committed $3.3 million towards it. So far DFC has struck deals with India’s Biological E, South Africa’s Aspen and Senegal as part of its aim to help Vx producers in poorer countries.

A PDF version of this brief, with the appendix and references, is available for download here: VacSafe Africa Brief Vol.1 No.4

Summary: This report is a product of the VacSafe Working Group, a group of leading scientists, vaccine and public health experts, and policymakers. Its purpose is to provide an up-to-date overview of the state of SARS-CoV-2 vaccines in Africa (54 countries and two disputed territories). This briefing comes as Africa is experiencing its third and potentially deadliest wave of the COVID-19 pandemic, pressing the need for acceleration of vaccine allocation and distribution to the continent. Information included in this briefing is drawn from private and public sources. For broader context, refer to earlier installments of the Vaccines in Africa Brief.

Contributing Authors: Dr. Lawrence R. Stanberry, Dr. Shabir Madhi, Dr. Wilmot James, Mr. Joshua Nott, Ms. Abigail Pyne, Ms. Alexandra Castro, and Mr. Lewis Rubin-Thompson (Editor).

Vaccines in Africa (54 countries and two disputed territories)

1. SARS-CoV-2 Vaccination Status in Africa

• The Economist reported that as of July 31, 2021, 32.1 million doses of COVID-19 vaccines had been distributed in sub-Saharan Africa, with 3.3% of its population above the age of 12 having received at least one dose and 1.3% having received a second.
• The Our World in Data vaccine tracker reported that as of July 31, 2021, a total of 68.53 million vaccine doses had been administered across the entire African continent, with 3.6% of the population having received at least one dose.

2. Emerging Variants 

• Multiple variants of the virus which causes COVID-19 are circulating globally. In collaboration with the SARS-CoV-2 Interagency Group (SIG), the US Centers for Disease Control and Prevention (CDC) have established three classifications for the SARS-CoV-2 variants being monitored: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC). 
• The CDC Global Variants Report, which is tracking the worldwide distribution of four variants, reports that as of July 24, 2021, three of those variants were circulating in Africa:
  • Alpha (B.1.1.7) (VOC): initially detected December 2020 in the United Kingdom; verified in 35 African countries.
  • Beta (B.1.351) (VOC): initially detected December 2020 in South Africa; verified in 28 African countries.
  • Delta (B.1.617.2) (VOC): initially detected December 2020 in India; verified in 22 African countries.
  • Gamma (P.1) (VOC): initially identified January 2021 in travelers from Brazil; not detected in Africa at time of publication.
• The World Health Organization (WHO) has identified seven VOI:
  • Epsilon (B.1.427/B.1.429); initially detected March 2020 in the US.
  • Zeta (P.2); initially detected April 2020 in Brazil.
  • Eta (B.1.525); initially detected December 2020 in multiple countries.
  • Theta (P.3); initially detected January 2021 in the Philippines.
  • Iota (B.1.617.1); initially detected November 2020 in the US.
  • Kappa; Initially detected October 2020 in India.
  • Lambda (C.37); initially detected August 2020 in Peru.

3. Vaccine Efficacy, Safety, and Approval 

• Moderna – Received WHO Emergency Use Listing status and approved for use in Rwanda. 
• Oxford–AstraZeneca (Covishield) – Approved by Africa Regulatory Taskforce (ART), received WHO Emergency Use Listing status and approved for use in 25 African countries.
• Pfizer-BioNTech – Received WHO Emergency Use Listing status and approved for use in Botswana, Rwanda, South Africa, and Tunisia. 
• Sinopharm (BBIBP-CorV) – Received WHO Emergency Use Listing status and approved for use in 15 African countries. 
• Sinovac (CoronaVac) – Received WHO Emergency Use Listing status and approved for use in Egypt, Tunisia, and Zimbabwe. 
• Bharat Biotech (COVAXIN) – Approved for use in Botswana and Zimbabwe.
• Gamaleya Research Institute of Epidemiology and Microbiology (Sputnik V) – Approved for use in 12 African countries.
• Johnson & Johnson (Ad26.COV2.S) – Received WHO Emergency Use Listing status and approved in Tunisia, South Africa, and Zambia.

4. Continental Vaccine Acquisition

With a population of 1.24 billion, Africa is dependent on three vaccine sources: (1) the WHO’s COVAX scheme (co-led by the Global Alliance for Vaccines and Immunization (GAVI) and The Coalition for Epidemic Preparedness Innovations (CEPI)), a worldwide initiative aimed at distributing vaccines to countries regardless of wealth; (2) the African Union (AU) via the African Vaccine Acquisition Trust (AVAT); and (3) bilateral agreements with pharmaceutical companies and/or vaccine-producing countries and donation agreements. 

• COVAX: 
  • On June 3, the US pledged 80 million vaccine doses to poorer countries, of which Africa is to receive five million via COVAX. At the Carbis Bay G7 Summit, the US pledged a further 500 million Pfizer-BioNTech doses (200 million in 2021 and 300 million in 2022) to 92 poorer nations and the African Union — the exact details of the apportionments are undisclosed. In mid-July, the U.S. began sending the first donation of what is projected to be 25 million doses to member states of the African Union.  The United Kingdom pledged the donation of 100 million doses of COVID-19 vaccine, 5 million of which will be made available to poorer nations. Similar to the US declaration, little detail on process and timing is available.
  • On July 13th, COVAX signed agreements with two Chinese pharmaceutical companies (Sinopharm and Sinovac) to buy 550 million of their COVID-19 vaccines by the first half of next year. GAVI has the option to purchase a total of 170 Sinopharm vaccines and 380 million Sinovac vaccines.
    • Under the agreements, Chinese vaccine makers Sinopharm and Sinovac will begin to make 110 million doses immediately available, according to a news release from GAVI.
• Additional financing will be needed this year for COVAX to exercise its options to purchase vaccines for 2022. COVAX and the World Bank have announced a new financing mechanism that builds on GAVI’s newly designed Advanced Market Commitment (AMC) cost-sharing arrangement. This should allow AMC countries to purchase doses beyond the fully donor-subsidized doses that they are already receiving from COVAX. COVAX will now be able to make advance purchases from manufacturers based on aggregated demand across countries, using financing from the World Bank and other multilateral development banks. Bolstered by the new finance, COVAX says it should be able to make available up to 430 million additional COVID vaccine doses, or enough to fully vaccinate 250 million people, for delivery between late 2021 and mid-2022. 
• The African continent is turning to other sources/mechanisms to slowly begin chipping away at the dire situation. The African Union (AU) shipped 6 million doses of the J&J vaccine during the week of July 26. This is the first shipment of doses available for purchase through the African Vaccine Acquisition Task Team (AVATT). Following the breakdown in vaccine supplies from COVAX in March, the AU signed a deal with J&J for 400 million doses, to be provided over 18 months. Next week, the 27 countries that have already paid for doses will begin to receive them. Another 18 countries are in the process of finalizing loans from the World Bank. An additional 1 million J&J doses – part of approximately 25 million doses donated by the USG to Africa – were delivered this week, with doses destined to Burkina Faso, Djibouti, Ethiopia, the Gambia and Senegal.
• African Union via AVAT:
  • UNICEF will obtain and deliver COVID-19 vaccines on behalf of AVAT.
  • Johnson & Johnson: 220 million doses by the end of 2022 with option of extending to purchase a further 180 million (~$10 per dose).
    • Afreximbank has provided $330 million to J&J as a non-refundable down payment for the doses. Countries can secure doses through the Africa Medical Supplies Platform and can participate in a payment plan of up to five years with the bank, with a subsidized interest rate between 3% and 5%.
      • The first shipment of J&J (6 million doses) vaccines began the last week of July. 35 million doses are expected to be delivered by the end of 2021.
      • 27 African countries have paid for AVAT doses and will begin to receive them in the coming weeks. 18 additional countries are finalizing World Bank loans. A Special Envoy for the African Union stated that he expects 45 member states will receive shipments by the end of August.
• Significant Bilateral Vaccine Purchases & Vaccine Diplomacy:
  • Egypt: 50 million doses of Sputnik V. 
  • South Africa: 31million J&J and 30 million Pfizer BioNTech.
  • China (to date): Approximately 7.16 million doses donated to Africa and 59.55 million doses purchased by African countries. 36 African countries have been receiving sales and donations of vaccines from China.
  • Russia Vaccine Donations: >1 million doses of Sputnik V to 3 African countries (Algeria, Guinea, and Zimbabwe).

5. Vaccine Manufacturing

• In late July, Pfizer and BioNTech announced the signing of a letter of intent with the South African biopharmaceutical company, The Biovac Institute (Biovac). Through this collaboration, Biovac will conduct the final steps of vaccine manufacturing, namely the ‘fill and finish’ stage, and distribute the Pfizer vaccine. Manufacturing components will be supplied from European facilities. By the end of 2021, Biovac will be incorporated into the vaccine supply chain. The production of finished doses will begin in 2022. When utilized fully, the Cape Town Biovac facility will be capable of producing over 100 million doses per year. All doses will go to members of the African Union. 
• On July 26, Aspen Pharmacare, a pharmaceutical company based in South Africa, supplied its first batch of Johnson & Johnson vaccine doses to South Africa. The late stage of manufacturing was conducted locally, with drug components sourced from Europe. Vaccine doses will be distributed to other African member states through the Africa Vaccine Acquisition Task Team/African Union platform.
• As of July 12, the Prime Minister of Egypt stated that the Egyptian Holding Company for Biological Products and Vaccines (VACSERA) produced 1 million doses of the Sinovac vaccine using imported raw materials. Egypt expects to locally produce 5 million doses by August and 40 million doses of Sinovac within a year. These doses will be distributed to Africa and the Middle East. Additionally, in April, Egypt’s Minapharm entered into an agreement with the Russian Direct Investment Fund to locally produce over 40 million doses of Sputnik V per year for global distribution.
• On July 26, Algeria announced that it will begin producing the Sinovac vaccine locally. Algeria already has an agreement to locally produce the Sputnik V vaccine, with production commencing in September.
• On July 6, pharmaceutical firm Sothema of Morocco announced they will begin locally producing 5 million Sinopharm vaccine doses per month. Additionally, the Moroccan government signed a deal with the Swedish pharmaceutical company Recipharm to construct a Morocco-based plant to produce other essential vaccines.
• The WHO and COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities, and the Africa CDC to establish Africa's first COVID mRNA vaccine technology transfer hub.
• WTO’s ED Ngozi Okonjo-Iweala said Africa was also working with the EU and other partners to help create regional vaccine manufacturing hubs in South Africa, Senegal and Rwanda, with Nigeria under consideration.
• Uganda’s President Museveni announced a vaccine-making facility that is set to begin production in six months. Museveni’s decision to commission the Biological Drugs and mRNA vaccine facility comes at a time when African countries are being hit the hardest and Uganda struggles to find a COVID-19 vaccine supplier.
• Momentum is building for the African Medicines Agency (AMA), which could boost local manufacturing of health products and protect consumers against counterfeits. The Treaty for the Establishment of the AMA requires ratification from 15 member states to go into effect.  In June, Algeria became the 9th state to ratify the treaty. In mid-July, Egypt signed on to the AMA and expressed desire to be the home base for the agency’s headquarters. The AMA is expected to be approved in the upcoming 35th African Union Summit, to take place in early 2022.  
• Africa uses roughly 25% of the annual global vaccine supply (representing approximately 1.3 billion doses). 99% of those doses are imported. 

6. Vaccine Distribution

• COVAX has initiated five rounds of vaccine allocation to participant countries (See Appendix Table 1 for country-level vaccine allocation and doses received in the AFRO region).
  • The first round of allocation was announced in early February and outlined an exceptional distribution of 1.2 million doses of the Pfizer/BioNTech vaccine to healthcare workers and high-risk populations; distribution of these doses took place during Q1 of 2021.
  • The second round of allocation covered 237 million doses of the Oxford AstraZeneca (Covishield) vaccine. Many of these doses are being manufactured by the Serum Institute in India. Distribution was intended to be completed in May, but rising COVID-19 cases in India and bans on the export of the Oxford–AstraZeneca vaccine have caused significant delays.
  • The third round of allocation covered 14.1 million doses of the Pfizer-BioNTech vaccine. Distribution took place between April and June 2021.
  • The fourth round of allocation covered 17,366,400 doses of the Oxford AstraZeneca vaccine. This round is focused on participants that have experienced delays due to Round 2 disruptions in supply.
  • The fifth round of allocation provides 72,190,170 doses of the Pfizer-BioNTech vaccine. Distribution will take place between July and September 2021.
• COVAX has met only 7.67% of its goal to deliver two billion doses by the end of 2021, though a significant increase in supplies is expected by early 2022. Thus far, 153.4 million doses have been distributed to 137 participating countries. Managing Director of the COVAX office, Aurelia Nguyen, recently stated that deliveries will continue to be “very lean through July and August.”
• A temporary pause on exports of the AstraZeneca vaccine from India and stockpiling of vaccine doses in wealthy countries have significantly delayed vaccination timelines in Africa. 
• Based on current projections, COVAX will make delivery of 200 million vaccination doses by October 2021. About three-quarters of the 70 million doses African countries have received have already been administered, according to the WHO. 
  • 200 million vaccine doses would be enough to fully vaccinate only 7% of the population.
• Beyond COVAX, other sources are also beginning to accelerate their delivery timelines: 
  • Vaccine deliveries from the AU Africa Vaccine Acquisition Trust (AVAT) have started this month (6 million doses), with a projected rise to 10M each month from September. Around 45 million doses are expected from AVAT by the year’s end. 
  • Tanzania has finally started to administer COVID-19 vaccines. Tanzania’s vaccine rollout is the result of a donation of 1,058,000 doses of the J&J vaccine from the USG. President Samia Suluhu publicly received the vaccine on Wednesday, a sharp contrast to her predecessor, John Magufuli, who died in March after months of denying the existence of COVID in the country. Burundi and Eritrea are now the two African countries that have not started to vaccinate their citizens against COVID-19, though Burundi did say on Wednesday that it will accept vaccine donations with support from the World Bank. 
  • With doses making their way to the African continent in the coming weeks, the WHO AFRO’s Dr. Moeti has expressed concerns about fast-approaching expiration dates, which could place governments under pressure to administer shots before time runs out. The bulk of doses that the UK is now sending to lower-income countries will expire in September.
• As of July 26, 2021, Bridge Consulting in Beijing recorded that approximately 41 million of 66 million pledged Chinese vaccines have been delivered in Africa.

7. Vaccine Licensing/Intellectual Property

See appendix in the PDF version of this brief for a diagram of vaccine patent architecture (Figure 1).

• A World Trade Organization (WTO) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) meeting took place on July 20th. Members remained divided on fundamental issues but agreed to continue discussion on a potential temporary waiver of particular TRIPS provisions in efforts to better respond to COVID-19. This proposed waiver has been co-sponsored by many countries and groups, including Kenya, Eswatini, Mozambique, Zimbabwe, Egypt, and the African Group. The next TRIPS Council informal meeting will take place in September with the next formal meeting scheduled to take place in October. 
• The move was the latest in a series of incremental advances on the initiative by India and South Africa. The UK parliament came out in support of the waiver, but the UK is still opposed. Same for the EU as a bloc. France, Japan, China came out in support. The EU proposal – which has proposed alternative measures to expand medicines and vaccines production – will remain on the table side by side with the waiver proposal as part of the overall negotiations. The EU alternative, under heavy fire from medicines access groups since it was published in early June, calls for the better use of existing WTO measures permitting countries to issue compulsory licenses. It also calls upon IP holders to step up their issuance of voluntary licenses for COVID-related health products in short supply.
• WTO General Council Chair Dacio Castillo of Honduras has selected Ambassador David Walker of New Zealand to be the facilitator responsible for leading WTO members in finding a multilateral response to the COVID-19 pandemic. According to some of those pushing for the waiver, the WTO's future now rests on what happens next: “The credibility of the WTO will depend on its ability to find a meaningful outcome on this issue that truly ramps-up and diversifies production," says Ms. X. Mlumbi-Peter, South Africa's ambassador to the WTO. Meanwhile, the EU continues to push for a declaration at WTO, in parallel with waiver efforts.
• The Medicines Patent Pool (MPP) launched a new patents database devoted to COVID-19 vaccines. VaxPaL builds on MPP’s 10-year experience in mapping patents on key health technologies. As of now, VaxPaL provides patent information on COVID-19 vaccines compiled into an Excel workbook. In the coming months, VaxPaL will be turned into a fully searchable online database.
• Gayle Smith, President Biden’s head of global Covid-19 response, has called on pharmaceutical companies to share vaccine technology so the US can help create regional manufacturing hubs in the global south.
• The UN Special Rapporteur on health, Dr Ttaleng Mofokeng, weighed in on the status of collaboration to produce Vaccines on the continent: “We’re filling vials. Not manufacturing… There’s no scientific knowledge sharing. There’s no Intellectual Property transfer. Just getting product to fill in vials and label.” 
• The People’s Vaccine Alliance, which includes Oxfam, Amnesty International, and dozens of other organizations, say Modena and Pfizer/BioNtech have reaped massive profits by charging up to $41 billion over the estimated cost of producing the vaccines. The 2 companies have sold over 90% of their vaccines to wealthy countries so far, garnering up to 24 times the potential cost of production.

A PDF version of this brief, with the appendix and references, is available for download here: VacSafe Africa Brief Vol.1 No.3.

Summary: This report is a product of the VacSafe Working Group, a group of leading scientists, vaccine and public health experts, and policymakers. Its purpose is to provide an up-to-date overview of the state of SARS-CoV-2 vaccines in Africa (54 countries and two disputed territories). This briefing comes as Africa is experiencing its third and potentially deadliest wave of the COVID-19 pandemic, pressing the need for acceleration of vaccine allocation and distribution to the continent. Information included in this briefing is drawn from public sources. For broader context, refer to earlier installments of the Vaccines in Africa Brief.

Contributing Authors: Dr. Lawrence R. Stanberry, Dr. Shabir Madhi, Dr. Wilmot James, Mr. Joshua Nott, Ms. Abigail Pyne, and Mr. Lewis Rubin-Thompson (Editor). 

Vaccines in Africa (54 countries and two disputed territories)

1. SARS-CoV-2 Vaccination Status in Africa

• The Economist reported that as of June 30, 2021, 21.5 million doses of COVID-19 vaccines had been distributed in sub-Saharan Africa, with 2.4% of its population above the age of 12 having received at least one dose and 0.6% having received a second.
• The Our World in Data vaccine tracker reported that as of June 29, 2021, a total of 50.48 million vaccine doses had been administered across the entire African continent.

2. Emerging Variants

• Multiple variants of the virus which causes COVID-19 are circulating globally. In collaboration with the SARS-CoV-2 Inter-agency Group (SIG), US Centers for Disease Control and Prevention (CDC) have established three classifications for the SARS-CoV-2 variants being monitored: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC). 
• The CDC Global Variants Report, which is tracking the worldwide distribution of four variants, reports that as of June 21, 2021, three of those variants were circulating in Africa:
  • Alpha (B.1.1.7) (VOC): initially detected December 2020 in the United Kingdom; verified in 27 African countries.
  • Beta (B.1.351) (VOC): initially detected December 2020 in South Africa; verified in 23 African countries.
  • Delta (B.1.617.2) (VOC): initially detected December 2020 in India; verified in two African countries
  • Gamma (P.1) (VOC): initially identified January 2021 in travelers from Brazil; not detected in Africa at time of publication.
• The World Health Organization (WHO) has identified seven VOI:
  • Epsilon (B.1.427/B.1.429); initially detected March 2020 in the US.
  • Zeta (P.2); initially detected April 2020 in Brazil.
  • Eta (B.1.525); initially detected December 2020 in multiple countries.
  • Theta (P.3); initially detected January 2021 in the Philippines.
  • Iota (B.1.617.1); initially detected November 2020 in the US.
  • Kappa; Initially detected October 2020 in India.
  • Lambda (C.37); initially detected August 2020 in Peru.

3. Vaccine Efficacy, Safety, and Approval 

• Moderna – Received WHO Emergency Use Listing status and approved for use in Rwanda. 
• Oxford–AstraZeneca (Covishield) – Approved by Africa Regulatory Taskforce (ART), received WHO Emergency Use Listing status and approved for use in 25 African countries.
• Pfizer-BioNTech – Received WHO Emergency Use Listing status and approved for use in Botswana, Rwanda, South Africa, and Tunisia. 
• Sinopharm (BBIBP-CorV) – Received WHO Emergency Use Listing status and approved for use in 15 African countries. 
• Sinovac (CoronaVac) – Approved for use in Egypt, Tunisia, and Zimbabwe. 
• Bharat Biotech (COVAXIN) – Approved for use in Botswana and Zimbabwe.
• Gamaleya Research Institute of Epidemiology and Microbiology (Sputnik V) – Approved for use in 12 African countries.
• Johnson & Johnson (Ad26.COV2.S) – Received WHO Emergency Use Listing status and approved in Tunisia, South Africa, and Zambia.

4. Continental Vaccine Acquisition

With a population of 1.24 billion, Africa is dependent on three vaccine sources: (1) the WHO’s COVAX scheme (co-led by the GAVI Alliance and The Coalition for Epidemic Preparedness Innovations (CEPI)); (2) the African Union (AU) via the African Vaccine Acquisition Trust (AVAT); and (3) bilateral agreements with pharmaceutical companies and/or vaccine-producing countries and donation agreements. 

• COVAX:
  • COVAX has met only 4% of its goal to deliver two billion doses by the end of 2021, though a significant increase in supplies is expected by early 2022. Thus far, 80 million doses have been distributed to 129 participating countries. Managing Director of the COVAX office, Aurelia Nguyen, recently stated that deliveries will continue to be “very lean through July and August.” 
  • On June 3, the US pledged 80 million vaccine doses to poorer countries, of which Africa is to receive five million via COVAX. At the Carbis Bay G7 Summit, the US pledged a further 500 million Pfizer-BioNTech doses (200 million in 2021 and 300 million in 2022) to 92 poorer nations and the African Union — the exact details of the apportionments are undisclosed. The United Kingdom pledged the donation of 100 million doses of COVID-19 vaccine, 5 million of which will be made available to poorer nations. Similar to the US declaration, little detail on process and timing is available.

• A COVAX shake up now underway was discussed at the GAVI board held on Friday, June 25.
  • In the run up to the meeting, some board documents indicated that the overhaul was meant to reduce COVAX's financial risks, increase its focus on the countries most in need, and reduce the participation of richer countries as recipients.
  • About 190 countries are currently part of COVAX; one third do not use its vaccines and about 40 have launched their vaccine drives with doses from COVAX. In a separate internal document, Gavi estimates that membership may shrink to 120-130 countries next year. Many rich nations are expected to step aside voluntarily. 
  • The planned policy change may also make it costlier for middle income countries (MICs) to take part. From next year, MICs that still need COVAX vaccines may have to pay/co-pay for them in advance. This means that countries like South Africa, Nigeria and Egypt may face higher costs and need to borrow money to secure doses.
  • According to a statement published by GAVI after the Board meeting, the Board approved “an evolution in the model of participation for self-financing participants (SFPs) of the COVAX Facility. Starting in 2022, the model will enable SFPs that rely on the Facility to access doses to continue procuring vaccines through COVAX under revised terms and conditions. The move, based on lessons learned over the past year, will enable simplified operations and reduce financial risks to Gavi and COVAX.” 

• African Union via AVAT: 
  • Oxford–AstraZeneca: procurement paused as of April 8^th, 2021.
  • Johnson & Johnson: 220mn doses with option of extending to purchase a further 180mn (~$10 per dose). As of May 10:
    • Afreximbank has provided $330 million to J&J as a non-refundable down payment for the doses. Countries can secure doses through the Africa Medical Supplies Platform and can participate in a payment plan of up to five years with the bank, with a subsidized interest rate between 3% and 5%. 
    • Only Botswana, Cameroon, Tunisia, Togo, and Mauritius have completed orders and submitted a 15% deposit as a down payment for the doses. 
    • Another 13 have signed commitment letters, but not given deposits, and another 17 have expressed interests in pre-orders but not taken further action. Twenty-one countries have not taken any action toward securing these doses.
  • Oxford–AstraZeneca, Johnson & Johnson, Pfizer-BioNTech: in January AU agreed to purchase a combined total of 270 million doses of these three vaccines.  Gamaleya Institute (Sputnik V): 300 million doses at $9.75 price per dose.
• Significant Bilateral Vaccine Purchases & Vaccine Diplomacy:
  • Egypt: 50mn doses of Sputnik V. 
  • South Africa: 31mn J&J and 30mn Pfizer BioNTech
  • China (to date): Approximately 6.59 million doses donated to Africa and 44.7mn doses purchased by African countries. 33 African countries have been receiving sales and donations of vaccines from China
  • Russia Vaccine Donations: >1mn doses of Sputnik V to 3 African countries (Algeria, Guinea, and Zimbabwe).

5. Vaccine Fill & Manufacturing

• Only 30% of medicines used in Sub-Saharan Africa are locally produced. EU Commissioner Jutta Urpilainen said Team Europe aims to work with partners in Africa to develop and strengthen pharmaceutical production in the continent. The issue is high on the agenda of the first World Local Production Forum this week.
• Mastercard Foundation pledges $1.3 billion to Africa vaccine efforts. On June 8 the Mastercard Foundation announced that it will donate $1.3 billion to boost vaccine manufacturing and distribution in Africa in partnership with the continent’s Africa Centers for Disease Control and Prevention. 
• The WHO and COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the A-CDC to establish Africa's first COVID mRNA vaccine technology transfer hub. 
• WTO’s ED Ngozi Okonjo-Iweala said Africa was also working with the EU and other partners to help create regional vaccine manufacturing hubs in South Africa, Senegal and Rwanda, with Nigeria under consideration.
• AMA - Momentum is building for the African Medicines Agency, which could boost local manufacturing of health products and protect consumers against counterfeits. Algeria this week ratified the treaty that will create the agency — once at least six more countries sign on.
• Africa uses roughly 25% of the annual global vaccine supply (representing approximately 1.3 billion doses). 99% of those doses are imported. 
• Current vaccine manufacturing capacity in the continent is limited and focused on internal markets; there is an absence of large-scale production at present and limited export of vaccine products. 
• UK AID listed 10 players in vaccine manufacturing on the continent. These manufacturers collectively produce about 12 million doses per annum. The majority of Africa’s vaccine manufacturing capacity is concentrated on fill-finish, and packaging and labeling. 
• Recognizing that there are no facilities in Africa that have capacity to produce RNA or vector-based vaccines, and following the launch of the African Union/Africa CDC Partnership for African Manufacturing Framework, CEPI is concluding an MOU with the Africa CDC to help push Africa’s manufacturing capacity.
• On May 21 2021, the European Union (EU) President Ursula von der Leyen announced that the EU would commit US$1.2 billion towards the establishment of vaccine manufacturing hubs in Africa. China has also signaled its intention to support vaccine manufacturing on the continent. 
• The Biden-Harris Administration’s support of the proposed TRIPS waiver in relation to COVID-19 vaccines has also been recognized as a significant step towards greater global vaccine equity, which could ultimately include enhancing vaccine manufacturing capacity in developing countries. At the World Health Assembly (24 May to 1 June) the US reaffirmed its support for COVID19 vaccine IP waiver when delegates discussed local production in lower to middle income countries.  
• At the WHA Ethiopia led a resolution to strengthen ‘local production of medicines and other health technologies to improve access.’ The resolution has support from the WHO Africa Region, the EU, the US, China, Brazil and other nations. The resolution seeks to ‘strengthen local production and know-how’ and ‘promotes technology transfer and innovation.’ Costa Rica and the WHO called on countries to support WHO’s COVID-19 Technology Access Pool (C-TAP).
• There is an increased role of the private sector in bolstering the continent’s vaccine manufacturing capacity.
  • Following the contamination of a key J&J ingredient at U.S.-based Emergent BioSolutions, 2 million doses produced in South Africa had to be discarded. South African based Aspen Pharmacare expects the first locally produced J&J doses to be ready for use by the last week of June. Aspen Pharmacare has committed to supplying 300 million doses of J&J vaccines.
  • Egypt’s Minapharm has entered into an agreement with the Russian Direct Investment Fund to locally produce over 40 million doses of Sputnik V per year for global distribution 
• Sputnik V is said to be ready for manufacturing in Algeria come September 2021. The vaccine will be produced in partnership with state pharmaceutical product’s firm Saidai in the eastern city of Constantine, in a tie-up with what is described as ‘a leading Indian laboratory.’ It is unclear what will be involved in the Russia-sponsored technology transfer. 
• In late May, Egypt received raw materials for the production of 2 million Sinovac doses. These materials are expected to be manufactured into vaccines by the end of June. Egypt expects to locally produce 5 million doses by August and 40 million doses of Sinovac by the end of 2021. These doses will go to Egypt as well as other African countries.

6. Vaccine Distribution

• COVAX has initiated three rounds of vaccine allocation to participant countries (See Appendix Table 1 for country-level allocation in the AFRO region). 
  • The first round of allocation was announced in early February and outlined an exceptional distribution of 1.2 million doses of the Pfizer/BioNTech vaccine; distribution of these doses took place during Q1 of 2021.
  • The second round of allocation covered 237 million doses of the Oxford AstraZeneca (Covishield) vaccine. Many of these doses are being manufactured by the Serum Institute in India. Distribution was intended to be completed in May, but rising COVID-19 cases in India and bans on the export of the Oxford–AstraZeneca vaccine have caused significant delays.
  • The third round of allocation covered 14.1 million doses of the Pfizer-BioNTech vaccine. Distribution will take place between April and June 2021. 
• Seven countries in Africa have used almost 100% of the allotted COVAX doses including Botswana, Ghana, Rwanda and Senegal. In addition to these states, there is some partial use and discarding:
  • Kenya and Malawi have used nearly 90% of their COVAX doses.
  • Cabo Verde and the Gambia have used 60% of their COVAX doses.
  • 1.3 million doses have been redistributed from Democratic Republic of Congo to other parts of Africa because the country will not be able to use them all before their expiry date in June.
  • South Sudan plans to discard 59,000 doses and Malawi has already destroyed 20,000 doses of the vaccines. This is largely due to the very late stage at which the vaccine doses were received by the countries and speaks to challenges of both delays in acquisition and country preparedness to distribute and administer vaccines. 

7. Vaccine Licensing/Intellectual Property

See appendix in the PDF version of this brief for a diagram of vaccine patent architecture (Figure 1)

Vaccine Licensing and Intellectual Property: 

• An informal WTO TRIPS meeting that kicked-off text-based negotiations over the waiver took place the week of 14 June. Members remained divided on fundamental issues, but agreed to schedule meetings over the next 6 weeks to discuss waiver proposals. This suggests that there lies a long road ahead. The WTO’s TRIPS Council agreed on Wed to move ahead with a “text-based process,” effectively green-lighting negotiations over the proposal to waive IP associated with COVID Dx, Tx and vaccines. The chair said that he foresees an intensive schedule of meetings and consultations, beginning immediately after the TRIPS Council meeting. The chair intends to consult members urgently on how the process can be arranged in practical terms, aiming at agreement on a report to the next General Council meeting scheduled for 21-22 July.
• The move was the latest in a series of incremental advances on the initiative by India and South Africa. The UK parliament came out in support of the waiver, but the UK is still opposed. Same for the EU as a bloc. France, Japan, China came out in support. The EU proposal – which has proposed alternative measures to expand medicines and vaccines production – will remain on the table side by side with the waiver proposal as part of the overall negotiations. The EU alternative, under heavy fire from medicines access groups since it was published in early June, calls for the better use of existing WTO measures permitting countries to issue compulsory licenses. It also calls upon IP holders to step up their issuance of voluntary licenses for COVID-related health products in short supply.
• WTO General Council Chair Dacio Castillo of Honduras has selected Ambassador David Walker of New Zealand to be the facilitator responsible for leading WTO members in finding a multilateral response to the COVID-19 pandemic. According to some of those pushing for the waiver, the WTO's future now rests on what happens next: “The credibility of the WTO will depend on its ability to find a meaningful outcome on this issue that truly ramps-up and diversifies production," says Mlumbi-Peter, South Africa's ambassador to the WTO. Meanwhile, the EU continues to push for a declaration at WTO, in parallel with waiver efforts.
• The Medicines Patent Pool (MPP) launched a new patents database devoted to COVID-19 vaccines. VaxPaL builds on MPP’s 10-year experience in mapping patents on key health technologies. As of now, VaxPaL provides patent information on COVID-19 vaccines compiled into an Excel workbook. In the coming months, VaxPaL will be turned into a fully searchable online database.

The full PDF of this memo, with the appendix and references, is available for viewing and download here: VacSafe Africa Brief Vol.1 No.2.

Summary: This report is a product of the VacSafe Working Group, a group of leading scientists, vaccine and public health experts, and policymakers. Its purpose is to provide an informed overview on the state of SARS-CoV-2 vaccines in Africa (54 countries and 1 disputed territory) with a view to inform legislators. Data and information sourced for this briefing are drawn from reputable private and public sources.

Contributing Authors: Dr. Lawrence R. Stanberry, Dr. Shabir Madhi, Dr. Wilmot James, Mr. Joshua Nott, Dr. Heinrich Volmink, and Mr. Lewis Rubin-Thompson (Editor).

Vaccines in Africa (54 countries 2 disputed territories)

1. SARS-CoV-2 Vaccination Status in Africa

• As of May 30, 2021, the Economist reported that 13.5 million doses of COVID-19 vaccines had been distributed in Sub-Saharan Africa, with 2.4% of adults in the region having received at least one vaccine dose, and 0.2% of adults having received a second dose.
• As of May 29, 2021, the Our World in Data vaccine tracker reported that a total of 31.04 million vaccine doses had been administered across the entire African continent, accounting for 1.77% of doses administered globally.

2. Emerging Variants

• Multiple variants of the virus that causes COVID-19 are circulating globally. In collaboration with a SARS-CoV-2 Interagency Group (SIG), US CDC established three classifications for the SARS-CoV-2 variants being monitored: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC).
• The WHO Virus Evolution Working Group recently convened and recommended labeling variants using letters of the Greek alphabet.
• The US Centers for Disease and Prevention (CDC) Global Variants Report is tracking the world-wide distribution of six variants; as of May 20, 2021, three variants are reported to be circulating in Africa:
  • B.1.1.7 (α): (VOC) initially detected in the UK, December 2020.
    • Verified in 17 African countries.
  • B.1.351 (β): (VOC) initially detected in South Africa, December 2020.
    • Verified in 16 African countries.
  • P.1 (γ): (VOI) initially identified in travelers from Brazil, January 2021.
    • Not verified to be circulating in Africa.
  • B.1.617.1 (κ): (VOI) initially detected in India, December 2020.
    • Not verified to be circulating in Africa.
  • B.1.617.2 (δ): (VOI) initially detected in India, December 2020.
    • Verified in two African countries.
  • B.1.617.3 (Unlabeled): (VOI) initially detected in India, October 2020.
    • Not verified to be circulating in Africa.

3. Vaccine Efficacy, Safety, and Approval

• Moderna - WHO Emergency Use Listing and approved in Rwanda. 
• Oxford-AstraZeneca (Covishield) - Africa Regulatory Taskforce (ART) approved, WHO Emergency Use Listing and approved in 25 African countries.
• Serum Institute of India (licensed to produce and sell the Oxford-Astra-Zeneca Covishield vaccine) - Africa Regulatory Taskforce (ART) approved, WHO Emergency Use Listing and approved in 10 African countries.
• Pfizer-BioNTech - WHO Emergency Use Listing and approved in Botswana, Rwanda, Tunisia, and South Africa. 
• Sinopharm (BBIBP-CorV) - WHO Emergency Use Listing and approved in 15 African countries. 
• Sinovac (CoronaVac) - approved in Egypt, Tunisia, and Zimbabwe. 
• Bharat Biotech (Covaxin) - approved in Botswana and Zimbabwe. 
• Gamaleya Institute (Sputnik V) - approved in 12 African countries.
•  Janssen/Johnson & Johnson (Ad26.COV2.S) - WHO Emergency Use Listing and  approved in Tunisia, South Africa, and Zambia.

4. Continental Vaccine Acquisition

• With a population of 1.24 billion people, Africa is dependent on three vaccine sources: (1) the WHO’s COVAX scheme (co-led with the Global Alliance for Vaccines and Immunization (GAVI) and Coalition for Epidemic Preparedness Innovations (CEPI)); (2) the African Union (AU) via the African Vaccine Acquisition Trust (AVAT); and (3) bilateral agreements with pharmaceutical companies and/or vaccine producing countries and donation agreements.
• COVAX:
  • 600 million doses have been secured for 36 African countries. The timeline for delivery of these vaccines remains uncertain. 
  • As of May 21, 2021, leaders of the G20 and other states made a series of declarations at the Global Health Summit — The Rome Declaration. Sixteen key principles were adopted as pillars to upscale current efforts to confront COVID-19 and to build greater resilience in health systems in preparation for the next pandemic. G20 leaders recognized the role of “extensive COVID-19 immunization as a global public good” and affirmed their “support for all collaborative efforts, especially to Access to COVID-19 Tools Accelerator (ACT-A).” Leaders also underscored the importance of addressing the ACT-A funding gap.
  • In 20 countries across Africa, 20 million people are due for their second AstraZeneca shot in June — but their expected doses have not come through. Fifty million people in Africa who were supposed to get their first doses of AstraZeneca in April and May did not either. Compared with 1.5 billion vaccine doses already administered globally, Africa has to date administered 28 million doses.
  • With vaccine doses deliveries delayed, the Africa CDC suggested that COVID-19 could become endemic on the continent. “If we keep vaccinating at this pace, we are not going to achieve our target. And that will delay our ability to eliminate the virus from our population — and my greatest concern is that we may actually begin to move towards the endemicity of this virus,” Africa CDC Director John Nkengasong said at the World Health Assembly (WHA).
  • India’s export ban of the Oxford-AstraZeneca vaccine and delays in production at the Serum Institute in India (SII) has been a setback for vaccination efforts. The SII was due to supply around half of the two billion vaccines for COVAX this year but there were no shipments for March, April, or May. The shortfall is expected to rise to 190 million doses by the end of June.
• African Union via AVAT:
  • Oxford-AstraZeneca: procurement paused as of April 8^th, 2021.  
  • Johnson & Johnson (J&J): 220 million doses with option of extending to purchase a further 180 million (~$10 per dose). As of May 10:
    • Afreximbank has provided a non-refundable US$330 million upfront to J&J as down payment for the doses. Countries can secure doses through the Africa Medical Supplies Platform and can participate in a payment plan of up to five years with the bank, with a subsidized interest rate between 3% and 5%. 
    • Only Botswana, Cameroon, Tunisia, Togo, and Mauritius have completed orders and submitted a 15% deposit as a down payment for the doses. 
    • Another 13 countries have signed commitment letters, but not given deposits, and another 17 have expressed interests in pre-orders but not taken further action. Twenty-one countries have not taken any action toward securing these doses.
  • Oxford-AstraZeneca, J&J, Pfizer-BioNTech: in January the AU agreed to purchase a combined total of 270 million doses of these three vaccines.
  • Gamaleya Institute (Sputnik V): 300 million doses at US$9.75 price per dose.
• Significant Bilateral Vaccine Purchases & Vaccine Diplomacy:
  • Egypt: 50 million doses of Sputnik V. 
  • South Africa: 31 million J&J and 30 million Pfizer-BioNTech. 
  • China Vaccine Donations to African States (to date): ~5.8 million doses to eight African countries. 
  • Russia Vaccine Donations: >1 million doses of Sputnik V to three African countries (Algeria, Guinea, and Zimbabwe).

5. Vaccine Fill & Manufacturing

• Africa uses roughly 25% of the annual global vaccine supply (representing approximately 1.3 billion doses). 99% of those doses are imported.
• Current vaccine manufacturing capacity in the continent is limited and focused on internal markets; there is an absence of large-scale production at present and limited export of vaccine products.
• UK AID listed 10 players in vaccine manufacturing on the continent. These manufacturers collectively produce about 12 million doses per annum. The majority of Africa’s vaccine manufacturing capacity is concentrated on fill-finish and packaging and labeling.
• On May 21, 2021, the European Union (EU) President Ursula von der Leyen announced that the EU would commit $1.2 billion towards the establishment of vaccine manufacturing hubs in Africa. China has also signaled its intention to support vaccine manufacturing on the continent.
• The Biden-Harris Administration’s support of the proposed Trade-Related Aspects of Intellectual Property (TRIPS) waiver in relation to COVID-19 vaccines has also been recognized as a significant step towards greater global vaccine equity, which could ultimately include enhancing vaccine manufacturing capacity in developing countries. At the World Health Assembly (May 24 to June 1) the US reaffirmed its support for COVID-19 vaccine IP waiver when delegates discussed local production in lower to middle income countries.
• At the WHA Ethiopia led a resolution to strengthen “local production of medicines and other health technologies to improve access. The resolution has support from the WHO Africa Region, the EU, the US, China, Brazil and other nations. The resolution seeks to “strengthen local production and know-how” and “promotes technology transfer and innovation.” Costa Rica and the WHO called on countries to support WHO’s COVID-19 Technology Access Pool (C-TAP).
• There is an increased role of the private sector in bolstering the continent’s vaccine manufacturing capacity. In South Africa, for example, Aspen Pharmacare was recently able to contribute, locally, to the manufacturing process (notably fill-finish) of 1.1 million doses of the J&J vaccine.
• Sputnik V is said to be ready for manufacturing in Algeria come September 2021. The vaccine will be produced in partnership with state pharmaceutical product’s firm Saidai in the eastern city of Constantine, in a tie-up with what is described as “a leading” but unnamed Indian laboratory. It is unclear what will be involved in the Russia-sponsored technology transfer.
• South African-United States billionaire, Patrick Soon-Shiong, committed an initial US$ 213 million to a collaboration between his company ImmunityBio and Cape Town’s Biovac to build capability to produce active pharmaceutical ingredient manufacturing for his hAd5 T-cell SARS-CoV-2 vaccine. Dr. Soon-Shiong remarked that “Biovac’s Private Public Partnership model also demonstrates that the private sector can partner with the government in the quest for a common health response.”

6. Vaccine Distribution

• COVAX has initiated three rounds of vaccine allocation to participant countries (See Appendix Table 1 for country-level allocation in the AFRO region).
  • The first round of allocation was announced in early February and outlined an exceptional distribution of 1.2 million doses of the Pfizer-BioNTech vaccine; distribution of these doses took place during Q1 of 2021;
  • The second round of allocation covered 237 million doses of the Oxford AstraZeneca (Covishield) vaccine. Many of these doses are being manufactured by the Serum Institute in India. Distribution was intended to be completed in May, but rising COVID-19 cases in India and bans on the export of the Oxford-AstraZeneca vaccine have caused significant delays; and  
  • The third round of allocation covered 14.1 million doses of the Pfizer-BioNTech vaccine. Distribution will take place between April and June 2021.
• Seven countries in Africa have used almost 100% of the allotted COVAX doses including Botswana, Ghana, Rwanda, and Senegal. In addition to these states,
  • Kenya and Malawi have used nearly 90% of their COVAX doses;
  • Cabo Verde and the Gambia have used 60% of their COVAX doses;
  • 1.3 million doses have been redistributed from Democratic Republic of Congo to other parts of Africa because the country will not be able to use them all before their expiry date in June; and
  • South Sudan plans to discard 59,000 doses and Malawi has already destroyed 20,000 doses of the vaccines. This is largely due to the very late stage at which the vaccine doses were received by the countries (with the stocks expiring on April 13) and speaks to challenges of both delays in acquisition and country preparedness to distribute and administer vaccines.
• Cold-chain storage requirements remain a significant challenge in distributing the Pfizer-BioNTech vaccine.
• Distribution of 220 million single-dose J&J vaccines secured by the AU through the African Vaccine Acquisition Task Team (AVATT) will take place across 18 months, with delivery expected to begin in Q3 of 2021. Distribution will be facilitated by the African Medical Supplies Platform (AMSP). The contract includes an option to purchase an additional 180 million doses (see section 4).
  • The J&J agreement would bring the continent to around half of its requirements for herd immunity.
  • The J&J vaccine is viewed as an ideal option for the continent due to its single dose, which reduces logistics and administration costs such as reliance on cold-chain storage.
  • Despite the promise of this deal, finalizing orders for individual countries has been a challenge.
• The US government could speed global vaccination efforts by requiring J&J to share its vaccine patent rights and formulation guide with third-party manufacturers. Barriers posed by patent laws can be overridden by invoking the Government Patent Use law, and the Defense Production Act can be invoked to facilitate technology transfer between manufacturers.
  • The single-dose and low reliance on cold-chain advantages of the J&J vaccine make it an ideal candidate for patent waivers and international technology transfer in order to increase global production.
  • There is precedent for technology sharing of this nature, as the Defense Production Act helped facilitate cooperation between J&J and rival firm Merck & Co. to increase production of the J&J vaccine in the US.
• UNICEF is partnered with GAVI to aid in vaccine distribution and procurement. As the single largest buyer of vaccines in the world, UNICEF is leveraging its experience and partnerships to help with procurement, shipping, and storage of COVID-19 vaccines. UNICEF has signed an agreement with Human Vaccine, a subsidiary of the Russian Direct Investment Fund, for supply of Sputnik V. The agreement allows UNICEF to access up to 220 million doses of the vaccine for 2021. The procurement depends on a WHO Emergency Use License and an advance purchase agreement with GAVI for COVAX.
• GAVI, partnered with UNICEF, leads the procurement and delivery arm of COVAX.
• China told the WHA on May 26 that it will support developing countries’ access to affordable COVID-19 vaccines, but stopped short of any commitment to supply its recently approved Sinopharm vaccine to COVAX. The Chinese delegate said that the country already provided bilateral vaccine assistance to more than 80 countries, along with exports to 43 more nations for a total of 300 million doses.
• CEPI works on the R&D front of COVID-19 vaccines. CEPI has made significant investments in vaccine manufacturing capacity and is investing in the next generation of COVID-19 vaccines,
• which have the potential to minimize reliance on cold-chain storage. Reducing reliance on cold-chain storage will make delivery and distribution of future vaccine candidates in Africa significantly easier.

7. Vaccine Licensing/Intellectual Property/Tech Transfer

• See appendix in the PDF brief for key upcoming conventions relevant to vaccine licensing, intellectual property, and tech transfer, as well as a diagram of vaccine patent architecture (Figure 1).
• Vaccine Licensing and Intellectual Property:
  • The Biden Administration announced that the US support for a waiver on COVID-19 vaccines is the first step in what could be a lengthy process. In its announcement the US broke from, amongst others, Switzerland's opposition to India’s and South Africa’s petition to the World Trade Organization to remove patent and trade-secret protections for all COVID-related products, including therapeutics and diagnostics. US Trade Representative Katherine Tai mentioned waiving intellectual-property protections, but only for vaccines.
  • Director-General Okonjo-Iweala on May 10 said she hopes that by December 2021 World Trade Organization (WTO) members will have reached a “pragmatic” solution over whether to go with a COVID-19 vaccine waiver. She understood that waiver advocates were preparing a revised proposal which she hoped would be presented to the WTO “as soon as possible.” China’s Commerce Ministry Spokesman Gao said on May 13 that Beijing supported a proposal to enter into text-based negotiations.
  • New research highlights the complex nature of the IP surrounding mRNA Vaccines. Authors identified patents that were relevant to various Vaccine tech platforms and used US Securities and Exchange Commission (SEC) filings to highlight pertinent licensing deals.
  • In a Foreign Affairs article Peter Hotez, Maria Bottazzi, and Prashant Yadav point out that producing technology as complex as messenger RNA (mRNA) inoculations against COVID-19 requires not only patents but an entire infrastructure that cannot be transferred overnight. They made the sobering observation that sharing of patents is an important and welcome development for the long term, but it may not even be the most pressing first step.
• Technological Transfer:
  • The World Health Organization (WHO) has received 42 expressions of interest from countries, institutions, and biotechnology companies interested in the creation of a technology transfer hub. The hub and training center are expected to launch by 2022, according to WHO, Gavi, and CEPI, who are urging “realism” against the calls from LMICs to expand manufacturing capacity more rapidly. At the WHA (May 24 to June 1), Costa Rica and the WHO called again on countries to support WHO’s COVID-19 Technology Access Pool (C-TAP).

A PDF version of this brief, with the appendix and references, is available for download here: VacSafe Africa Brief Vol.1 No.1.

Summary: This memo is a product of the VacSafe Working Group, a group of leading scientists, vaccine and public health experts, and policymakers. Its purpose is to provide an informed overview on the state of SARS-CoV-2 vaccines in Africa (54 countries and 2 disputed territories) for use and reference by legislators. Data and information sourced for this briefing are drawn from reputable public sources.

Contributing Authors: Dr. Lawrence R. Stanberry, Dr. Shabir Madhi, Dr. Wilmot James, Mr. Joshua Nott, Mr. Andrew Choi, Dr. Heinrich Volmink, and Mr. Lewis Rubin-Thompson (Editor).

Vaccines in Africa (54 countries 2 disputed territories)

1. SARS-CoV-2 Vaccination Status in Africa

• As of May 3, 2021, the Our World in Data vaccine tracker has reported that approximately 18 million doses of COVID-19 vaccines have been administered in Africa.
• The editorial team is in the process of creating an interactive map that cross-references several datasets to produce meaningful indices about vaccine manufacturing, acquisition, distribution, and take-up in Africa. Please see the Appendix (Fig. 1) below to find a static picture of what this will look like, with South Africa as an example. The Appendix also includes an annotated list of referenced data sets.

2. Emerging Variants

• Multiple variants of the virus that causes COVID-19 are circulating globally. In collaboration with a SARS-CoV-2 Interagency Group (SIG), US CDC established three classifications for the SARS-CoV-2 variants being monitored: Variant of Interest (VOI), Variant of Concern (VOC), and Variant of High Consequence (VOHC).
• There are currently five VOCs in the United States
  • B.1.1.7: initially detected in the UK.
  • B.1.351: initially detected in South Africa in December 2020.
  • P.1: initially identified in travelers from Brazil, in early January 2021.
  • B.1.427 and B.1.429: first identified in California in February 2021 and classified as VOCs in March 2021.
• As of April 28^th, 2021 there were two VOCs known to be circulating in Africa – B.1.1.7 and B.1.351.

3. Vaccine Efficacy, Safety, and Approval

• Moderna - WHO Emergency Use Listing.
• Oxford-AstraZeneca (Covishield) - Africa Regulatory Taskforce (ART) approved, WHO Emergency Use Listing – approved in 25 African countries.
• Pfizer-BioNTech - WHO Emergency Use Listing – approved in Rwanda, Tunisia and South Africa.
• Sinopharm - BBIBP-CorV - approved in 15 African countries.
• Sinovac (CoronaVac) - approved in Egypt, Tunisia and Zimbabwe.
• Bharat Biotech (Covaxin) - approved in Botswana and Zimbabwe.
• Gamaleya Institute (Sputnik V) - approved in 10 African countries.
• Janssen/Johnson & Johnson (Ad26.COV2.S) - WHO Emergency Use Listing and approval in Tunisia, South Africa, and Zambia.

4. Continental Vaccine Acquisition

• With a population of 1.24B, Africa is dependent on three vaccine sources: (1) the WHO’s COVAX scheme (co-led with the Global Alliance for Vaccines and Immunization (GAVI) and Coalition for Epidemic Preparedness Innovations (CEPI)); (2) the African Union (AU) via the African Vaccine Acquisition Trust (AVAT); and (3) bilateral agreements with pharmaceutical companies and/or vaccine producing countries and donation agreements.
• COVAX:
  • 600M doses have been secured for 36 African countries.  The timeline for delivery of these vaccines remains uncertain. Bans on the export of the Oxford-AstraZeneca vaccine, delays in production at the Serum Institute in India, and cold-chain storage challenges have already contributed to delays.
• African Union via AVAT:
  • Oxford-AstraZeneca: procurement paused as of April 8^th, 2021.
  • Johnson & Johnson: 220M doses with option of extending to purchase a further 180M (~$10 per dose).
  • Oxford-AstraZeneca, Johnson & Johnson, Pfizer-BioNTech: in January AU agreed to purchase a combined total of 270M doses of these three vaccines.
  • Gamaleya Institute (Sputnik V): 300M doses at $9.75 price per dose.
• Significant Bilateral Vaccine Purchases & Vaccine Diplomacy:
  • Egypt: 50M doses of Sputnik V.
  • South Africa: 31M J&J and 30M Pfizer-BioNTech.
  • China Vaccine Donations to African States (to date): ~1M doses to ~8 African countries.
  • Russia Vaccine Donations: >1M doses of Sputnik V to 3 African countries (Algeria, Guinea, and Zimbabwe).

5. Vaccine Fill & Manufacturing

• Current vaccine manufacturing capacity in Africa is limited and focused on internal markets; there is an absence of large-scale production at present and limited export of vaccine products.
• The continent uses roughly 25% of the annual global vaccine supply (representing approximately 1.3B doses). 99% of those doses are imported.
• The African Union and Africa CDC launched the Partnership for African Manufacturing Framework. This framework, which includes a partnership with CEPI, could see Africa’s manufacturing increase from meeting the vaccine needs of less than 1% of the continent’s population to 60% by 2040.
• According to a recent UK AID report, there are currently only 10 players in vaccine manufacturing on the continent. These manufacturers collectively produce about 12M doses per annum. Appendix Figure 2 gives more detail on the vaccine profile covered as well as actual and planned activities in key areas of the vaccine value chain, based on the information contained in the report.
• The majority of Africa’s vaccine manufacturing capacity is concentrated on fill-finish and packaging and labeling. South Africa’s Biovac is currently developing its manufacturing capacity. However, at the current rate, Biovac’s vaccine production will not begin for 12-24 months and will be limited to approximately 30M doses per year.
• At present, there are no facilities in Africa that have capacity to produce RNA or vector-based vaccines.

6. Vaccine Distribution

• COVAX has initiated three rounds of vaccine allocation to participant countries (See Appendix Table 1 for country-level allocation in the AFRO region).
  • The first round of allocation was announced in early February and outlined an exceptional distribution of 1.2M doses of the Pfizer-BioNTech vaccine; distribution of these doses took place during Q1 of 2021.
  • The second round of allocation covered 237M doses of the Oxford-AstraZeneca (COVISHIELD) vaccine. Many of these doses are being manufactured by the Serum Institute in India. Distribution was intended to be completed in May, but rising COVID-19 cases in India and bans on the export of the Oxford-AstraZeneca vaccine have caused significant delays.
  • The third round of allocation covered 14.1M doses of the Pfizer-BioNTech vaccine. Distribution will take place between April and June 2021.
• Cold-chain storage requirements remain a significant challenge in distributing the Pfizer-BioNTech vaccine.
• Distribution of 220 million single-dose Johnson & Johnson vaccines secured by the AU through the African Vaccine Acquisition Task Team (AVATT) will take place across 18 months. Distribution will be facilitated by the African Medical Supplies Platform (AMSP) The contract includes an option to purchase an additional 180M doses (see section 4).
• UNICEF is partnered with GAVI to aid in vaccine distribution and procurement. As the single largest buyer of vaccines in the world, UNICEF is leveraging its experience and partnerships to help with procurement, shipping, and storage of COVID-19 vaccines.
• GAVI, partnered with UNICEF, leads the procurement and delivery arm of COVAX.
• CEPI works on the R&D front of COVID-19 vaccines. CEPI has made significant investments in vaccine manufacturing capacity and is investing in the next generation of COVID-19 vaccines, which have the potential to minimize reliance on cold-chain storage. Reducing reliance on cold-chain storage will make delivery and distribution of future vaccine candidates in Africa significantly easier.

7. Vaccination Licensing Issues/IP/tech transfer

• Vaccine Intellectual Property
  • As of June 2020, AstraZeneca, CEPI, and GAVI have entered into a voluntary licensing agreement with the Serum Institute of India (SII) facilitating IP transfers and the production of a not-for-profit vaccine.
  • On October 16, 2020, South Africa and India launched proceedings with the World Trade Organization’s Trade-Related Aspects of Intellectual Property to temporarily suspend IP rights for COVID-19 vaccinations. Europe, Britain and Japan oppose the petition. Proceedings are ongoing.
  • The newly appointed Director-General of the WTO, Dr Ngozi Okonjo-Iweala, endorsed voluntary pharmaceutical licensing in April. "There is some capacity in developing countries unused now. Let's have the same kind of arrangement that AstraZeneca has with the Serum Institute of India … Novavax, J&J and all the others should follow suit" she said to the BBC.
• Technological Transfer
  • There are currently nine technology platforms for designing and making COVID 19 vaccines: (1) live attenuated virus; (2) inactivated virus; (3) non-replicating viral vector; (4) replicating viral vector; (5) recombinant protein; (6) peptide based; (7) virus-like particle; (8) DNA; and (9) RNA. The COVID-19 vaccines currently approved for use are based on technologies 2, 3, 6 and 9 as listed previously.
  • South Africa’s Aspen Pharmacare signed an agreement to transfer J&J vaccine technology for the final stage of production, fill and finish, at their Nelson Mandela Bay plant in the Eastern Cape. The J&J vaccine is made using a non-replicating adenovirus vector.
  • Algeria announced that the country will be producing the Russian vaccine Sputnik V as of September 2021. Sputnik V uses a method very similar to J&J where genetic information is ferried to its destination by a non-replicating adenovirus. It is not clear what the extent of technology transfer is.
  • No African country is yet producing RNA vaccines. The leap in technology required to scale Africa’s vaccine manufacturing capacity to accommodate RNA-based technologies will require significant investment in technology and expertise.
  • At the recent Partnership for African Manufacturing Framework meeting, the Africa CDC laid out plans to establish vaccine manufacturing hubs in each of its five regions. In each instance, major barriers to technology transfer—particularly investment, technical skills, and infrastructure—must be overcome.
  • In a recent Foreign Affairs article, the authors argue that major international organizations like GAVI and CEPI, national governments, and private companies must work collectively to take advantage of the “medical miracle” RNA vaccines provide.