By Mary Hearty
With African countries showing interest in setting up their own COVID-19 vaccine manufacturing facilities in order to become self-reliant, they have been urged to expand their focus beyond COVID-19.
These sentiments were shared by Dr. Patrick Osewe, Chief of the Health Sector Group at the Asian Development Bank (ADB) during a media briefing held by Africa Science Media Centre (AfriSMC).
“If the focus is only COVID-19, then we have a big challenge because what happens afterwards as the disease is beginning to wane in many countries though rises have been reported in a few countries. At some point, the COVID-19 pandemic will wane and perhaps become an endemic disease,” Dr. Osewe said, noting that, if the capacity is built for other vaccines then that is quite promising.
Dr Osewe noted that setting up these facilities require a very strong regulator who will ensure the safety of the vaccines, a key factor if the intention of manufacturing is to export.
The World Health Organization (WHO) has a global benchmarking tool used to assess where the regulator falls, and they are classified as either maturity level one, two, three or four.
“At level four, they are fully fledged regulator and you can regulate any condition and people will have confidence that you have done a good job,” the global health expert said.
He noted that some of the things required to reach this level include institutional development plan, strategic plan, implementation of good review practices focused on biologics and vaccines, pharmacovigilance after vaccines are produced to determine side effects as well as automation of regulatory functions.
Although it is challenging to reach that level, Dr. Osewe said, level three is also good enough as international organizations like the United Nations Children’s Fund (UNICEF) can still purchase vaccines from facilities that are being regulated by level three and four. However, those below level three cannot export vaccines, a big challenge for many countries.
Apart from a mature regulator, Dr Osewe said in order for a country to manufacture vaccines, there must be a state of the art vaccine manufacturing plant to strengthen national bio-security and resilience.
Additionally, the country should have highly skilled human resources who are required at different stages of vaccine manufacturing.
Also, he stated that a country needs a technology partner who has experience as vaccines are manufactured under sterile conditions and can be very complicated.
A country must also have a strong national immunization technical advisory group that has the relevant experts, and strong links of communication with local communities to curb hesitancy.
Four competencies that Dr Osewe explained are required for vaccine manufacturing are: clear process of how the product is made; compliance of the company to successfully complete the process; testing of the product and supporting operations; and regulatory authorization to release and distribute the project.
In terms of the regulatory process for approval, he said a company must develop a proof of concept testing, manufacture of clinical materials and toxicology analysis; submission of investigational new drug application; testing for safety and effectiveness; and submission of biological license application for final review and licensure.
Since vaccines are therapeutics for people who are not sick, he said good manufacturing practices are very tightly managed and controlled, with many companies following WHO standards and the national and local level compliances in terms of waste disposal, fire, among others.
A study that investigated rapid investment in Africa’s vaccine manufacturing capacity observed that COVID-19 vaccine manufacturing in the continent would result in the production of five billion COVID-19 vaccine doses.
In 2021, the estimated capacity was about 825 million doses, with South Africa producing 500 million, Morocco 60 million, Algeria 65 million then Egypt 200 million.
In 2022 and 2023, the target was to produce 3.1-3.5 billion vaccines. South Africa planned to produce one billion Corbevax doses, 250 million Afrigen mRNA doses and 150 million Pfizer doses, among others countries.
So far, countries that currently have the capacity to produce vaccines in Africa are: South Africa, Nigeria, Morocco, Egypt, Algeria and Senegal. On the other hand, there is also a lot of discussions ongoing with Moderna across many countries including Kenya, Uganda, Ghana, Rwanda, among others. Rwanda has collaborated with Ghana because Rwanda does not have a strong regulator but Ghana has a level three regulator.