Bill of Health - Globe and vaccine, covid vaccine

Biotech Companies Are Opening Manufacturing Sites in Africa: Will This Help Vaccine Equity?

By Sarah Gabriele

Two pharmaceutical giants of the pandemic, Moderna and BioNTech, are taking steps for increasing the manufacturing capacity for the COVID-19 vaccine in Africa. Last March, Moderna announced its plan to set up a manufacturing facility in Kenya to produce messenger RNA (mRNA) vaccines, including COVID-19 shots. Similarly, in 2021, BioNTech started planning its own manufacturing plant in Africa, which will be composed of modular shipping containers.

Measures to address global vaccine inequity could not come sooner. As of December 15, 2022, only 34% of the population in Africa has received at least one dose of the COVID-19 vaccine, with Moderna and BioNTech having provided fewer doses compared to Oxford-AstraZeneca and Johnson & Johnson. After failing to successfully deliver vaccines equitably during the first two years of the pandemic, Moderna and BioNTech appear now to be taking steps to shoulder greater responsibility for vaccine equity.

However, if companies are ethically required to address the availability of vaccines, these well-intended efforts might still fail to fulfill their moral obligations. Indeed, while the construction of these new sites might sound like great news for fostering the delivery of vaccines in low- and middle-income countries, we should be aware that these manufacturing sites, as well as the existence of manufacturing capacity, might not be enough to achieve desired outcomes.

First, building new manufacturing facilities in low- and middle-income countries does not always increase the availability of vaccines or medicines in the countries where the manufacture is occurring. Thinking back to the early stages of the pandemic; although pharma has a strong manufacturing presence in India, very few of the COVID vaccine doses manufactured in India were intended for the Indian market. Today, the new manufacturing sites established in Kenya have been solely dedicated to providing vaccines in low- and middle-income countries. However, if, for example, the demand for vaccine in higher-income countries was to increase due to new variants or new diseases, companies might find it more profitable to export the products manufactured in Africa, creating again a gap in vaccine equity.

Another concern for vaccine inequity lies in the fact that these new manufacturing sites might not be there to stay. BioNTech has planned to introduce modular mRNA manufacturing facilities, called BioNtainers, which come with the advantage of easier installation, as well with the disadvantage of not being permanent. Moderna has already disclosed that its factory in Kenya will not have “fill and finish” capacities to bottle and prepare the vaccine for distribution; these capacities might be expanded in the future. The lack of adequate resources for providing a final product available for distribution, and the lack of certainty over whether these capacities will ever be made available or permanent raises the question of whether Moderna and BioNTech are planning on providing stable infrastructure or not.

Finally, the creation of these new hubs might distract from other efforts that are still required to address vaccine inequity, such as sharing of knowledge. Indeed, the know-how underlying the mRNA vaccine has many other potential uses and is thus incredibly valuable. For these reasons, COVID vaccine manufacturers are reluctant or unwilling to do so. While Moderna and BioNTech are taking active steps toward increasing manufacturing capacities internationally, these same companies also have decided not to participate in the World Health Organization’s COVID-19 mRNA technology transfer hub in South Africa, which was established last year with the aim of expanding sharing of knowledge of vaccine manufacturing in low- and middle-income countries.

The WHO technology transfer hub was a major component in the development of South Africa’s first mRNA vaccine by Afrigen Biologics and Vaccines. The Afrigen vaccine was developed independently after the WHO hub failed to bring on board Pfizer and Moderna, both of which have argued they need to oversee any technology transfer due to the complexity of the manufacturing process. While it is true that Moderna’s vaccine has been used in comparative studies in mice to test the effectiveness of the vaccine being developed by Afrigen, Moderna simply “allowed” its vaccine to be used.

If pharma giants truly are committed to addressing vaccine inequity, just doing “something” (like building manufacturing capacity in Africa) might not be enough. Creating new manufacturing sites is a commendable effort. However, building these new sites might create new challenges. Further, these facilities alone are unlikely to achieve vaccine equity; further steps might be needed, including, possibly, sharing know-how. In this respect, institutions, including international organizations, should join forces to incentivize and enable companies to share their know-how, finding ways to ensure that the knowledge shared is not used to compete against the same companies who provided it.

sgabriele

Sarah Gabriele is a second-year Master of Bioethics candidate at Harvard Medical School. She obtained her law degree from the University of Trento (Italy) and an LL.M. from the Washington University in St. Louis. After graduating from law school, she worked at Hogan Lovells in their Milan office, specializing in pharmaceutical patent litigation. Currently, she is a student fellow with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and a research specialist at PORTAL, in the Division of Pharmacoepidemiology and Pharmacoeconomics of Harvard Medical School and Brigham and Women’s Hospital.

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