Nairobi, 4 July, 2022- Though the African Union aims to manufacture 60% of the vaccines used by the continent locally, currently, Africa imports more than nine in 10 vaccines used by its population.
However, with the outbreak of coronavirus, several African countries have expressed interest to venture into human vaccine manufacturing.
“Africa is about to take off in terms of vaccine manufacturing, many of our countries are interested and willing. There is also interest from development partners to support vaccine manufacturing. But this should be done in a very analytical way,” Dr. Patrick Osewe, Chief of Health Sector Group, Asian Development Bank during an Africa Science Media Centre (AfriSMC) press briefing.
The countries should be able to analyze if they have the capacity, technical know-how and regulator in place to manufacture vaccine. Also they should consider whether the vaccine is for the domestic market or export, he said.
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 with four being the ultimate goal where the regulator is fully fledged and can regulate any conditions.
Organizations like United Nations International Children Emergency Fund (UNICEF) and others can still purchase drugs that is being manufactured from level three regulators as well, Dr. Osewe said, noting that below that level, the manufacturer can not export the vaccine.
For the national regulator to reach level four, there has to be partnership with an institution like a development bank. The country also has to have a five year strategic plan and needs to implement good review practices focused on biologicals and vaccines, he said.
Besides, there has to be pharmacovigilance after the vaccine is produced and is being used in the populations as well as a good reporting mechanism from patients to the regulator. Automation of the regulatory functions is also central to achieving this level.
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 including bioscientists 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.
Additionally, Dr. Osewe urged countries to expand their focus beyond the pandemic, saying: “If the focus is only on COVID then that’s a challenge because it’s beginning to end in most countries but also rising in a few others. At some point it will end completely or become endemic.”
He observed that though the mRNA technology is promising for conditions like cancer, it has not been commercialized anywhere. “If COVID comes to an end and most countries have established the vaccine manufacturing then it will be a big challenge on what to do with those facilities,” he said.
Already, six African countries- Egypt, Senegal, Kenya, South Africa, Tunisia and Nigeria – are the recipients of mRNA technology under the global mRNA technology transfer hub initiative.
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