The drive to expand vaccine manufacturing in Africa is gaining momentum with several new partnership agreements including technology transfer for the production of both malaria and COVID-19 vaccines as the continent strives to produce at least 60% of its vaccines requirements by 2040 under the region’s African Vaccine Manufacturing initiative (AVMI).

New partnership agreements for Africa to produce its vaccine requirements

• GSK partnered with PATH for transfer of the RTS, S antigen manufacturing

Belgium-based researcher, developer and manufacturer of medical products, GlaxoSmithKline (GSK) Biologicals SA earlier this year partnered with PATH, and Bharat Biotech International Ltd (BBIL) in sighing a product transfer agreement for the malaria vaccine, RTS,S/AS01E targeting the African market, a region that accounted for 94% of the 409,000 malaria-related deaths in 2019. (1)

The agreement entails the transfer of manufacturing of the RTS,S antigen part of the vaccine and the grant of a license on all rights pertaining to the RTS,S/AS01 malaria vaccine to BBIL, an Indian multinational biotechnology company. (2)

However, GSK, which has developed various adjuvant systems or formulations of classical adjuvants mixed with biological response modifiers (BRM) for the development of both prophylactic and therapeutic vaccines, will retain the production of the adjuvant of the vaccine (AS01E) which it will then supply to BBIL. GSK’s other adjuvant systems include the AS04, AS02 and AS01.

“RTS,S, which was developed in partnership with the PATH Malaria Vaccine Initiative (MVI), is the first candidate vaccine for the prevention of malaria to reach this milestone,” PATH said in a statement. (3)

The vaccine has already been approved by the European Medicines Agency (EMA) and sanctioned for use in Kenya, Ghana and Malawi as part of the countries’ respective national immunization programmes.

• BioNTech SE work with Biovac in the manufacture of finished doses of the COVID-19 vaccine

Separately, American multinational pharmaceutical and biotechnology corporation Pfizer Inc in partnership with Germany biotechnology firm BioNTech SE announced in July 2021 a new deal to work with South Africa-based The Biovac Institute (Pty) Ltd in the manufacture of 100 million finished doses annually of the Pfizer-BioNTech COVID-19 vaccine targeting the African market.

Biovac will carry out the actual manufacture and distribution of the vaccine utilizing the existing global supply chains of Pfizer and BioNTech.

“Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished dosage will commence in 2022,” said Pfizer chairman and CEO Albert Bourla.

Africa’s manufacturer of human vaccines likely leads consumeing of vaccine adjuvants

The vaccine manufacturing agreements are a response to Africa’s increasing incidences of epidemic outbreaks and persistent prevalence of infectious diseases and in support of AVMI that in the end will boost the security of the region’s vaccine supply and open new growth opportunities for the global vaccine adjuvant market that is projected to reach USD 769.4 Million by end of 2021 from the 2016 estimates of USD 467.0 Million. (4)

Although Africa’s population is nearly 14% of the world’s total, it has less than 0.1% of the global vaccine production that could mean low adjuvant uptake and hence the AU initiative to scale up the continent’s vaccine manufacture levels. (5)

But despite the low vaccine production levels in Africa, the region still records substantial cases of infectious diseases such as malaria, pneumonia, common cold, diphtheria, HIV/AIDS, Measles, sexually transmitted diseases and now COVID-19. Africa is still a hotspot for epidemic outbreaks such as cholera, malaria, dysentery and hemorrhagic fevers such as Ebola and Rift Valley fever.

Currently, Africa’s manufacturers of human vaccines, and likely leading consumers of vaccine adjuvants in the region include South Africa, Tunisia, Senegal, Egypt and Ethiopia.

A number of other additional agreements have recently been reached between some African governments and international vaccine makers or development partners for the expansion of Africa’s vaccine production capacity that in turn would catalyze growth of the global vaccine adjuvants market. (6)

For example, Senegal, the European Union, the US, several European governments, and other partners, reached an agreement to finance vaccine production at the Institut Pasteur of Dakar.

Elsewhere, Morocco also signed in July 2021 a Memorandum of Understanding with the Swedish company “Recipharm” to establish and scale-up COVID-19 vaccine manufacturing capacity in the North Africa country.

Earlier, South Africa struck a deal with Biovac, Afrigen Biologics & Vaccines, a network of universities, WHO, COVAX, and Africa CDC to set up the first COVID-19 mRNA vaccine technology transfer hub in Africa.

Meanwhile, Egypt had in April 2021, signed two agreements between Holding Company for Biological Products and Vaccines (VACSERA) and Sinovac for COVID-19 vaccine manufacturing in the country.

Similar agreement was signed between Algeria and Russia for a partnership in the production of the Sputnik V COVID-19 vaccine that would partly be supplied to the rest of Africa.

The drive for increased vaccine manufacture in Africa has, however, to contend with several issues such as how the intended local vaccine production will be expanded yet there is high level supply of subsidized vaccines from agencies such as UNICEF.

In addition, unlike in other pharmaceutical markets, Africa still struggles with low staffing levels of skilled workers especially in bio-manufacturing and may require time and huge government investment, in partnership with the private sector, to build the required workforce.

Africa’s human vaccine market is further likely to be influenced by the cost of vaccine production, progress in the integration of regional markets and the pricing of the vaccines as compared to those imported from big markets such as India and China.

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REFERENCES;

1. https://www.cdc.gov/malaria/malaria_worldwide/impact.html

2. https://www.path.org/media-center/gsk-path-and-bharat-biotech-sign-product-transfer-agreement-help-ensure-long-term-supply-rtssas01e-malaria-vaccine/

3. https://www.path.org/media-center/path-malaria-vaccine-initiative-welcomes-positive-opinion-by-european-regulators-on-gsks-mosquirix-rtss/

4. https://www.marketsandmarkets.com/Market-Reports/vaccine-adjuvants-market-152603894.html

5. https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwiwn5nHzvHyAhUyD2MBHfUOD0kQFnoECAIQAQ&url=https%3A%2F%2Fwww.who.int%2Fimmunization%2Fresearch%2Fforums_and_initiatives%2F1_Wlliam_Ampofo_Vaccine_Manufacturing_Africa.pdf%3Fua%3D1&usg=AOvVaw0T4uoGXSt2zGD9zF-YS3VC

6. https://www.afro.who.int/news/inside-africas-drive-boost-medicines-and-vaccine-manufacturing

About the Author:

With great honor and pleasure, PharmaSources.com has now invited Shem Oirere as one of the original writers. He graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.