Johannesburg – South African health inspectors will carry out further checks on a batch of Johnson & Johnson Covid-19 vaccines following a contamination error earlier this year at the U.S. plant where the doses were produced, the health ministry said.
South Africa’s department of health said that they acknowledge the statement issued by the US FDA in relation to the doses of JnJ vaccines produced at the Emergent BioSolutions Plant in Baltimore, USA.
The FDA has been investigating the plant following revelations that some of the batches may have been contaminated.
“We confirm that the FDA announced that two batches of these doses are safe and have been cleared for emergency use,” the department of health said in a statement.
The implications for South Africa are as follows:
- The vaccines awaiting distribution from the Gqebherha plant need further assessment by SAHPRA and SAHPRA will soon advise if they are suitable for use in South Africa. There is now a real possibility that they may not be, however, this is for the regulator to rule on.
- In total, 300 000 doses are· cleared to be shipped to South Africa as a matter of extreme urgency. Furthermore, the FDA announced that, after careful evaluation of these doses, they approved an extension of the expiry date after determining that the vaccine can be stored in 2-8 degrees Celsius (normal bar fridge) for 4,5 months instead of 3 months.
“Work is being undertaken to identify more safe doses for the rest of the mass vaccination programme. We further note that the FDA is still evaluating some batches and we will await those outcomes, in the hopes that this will make more doses of Johnson and Johnson available to the international community, including South Africa,” the department of health further stated.
Meanwhile, according to reports, The Food and Drug Administration has told Johnson & Johnson to throw out about 60 million Covid-19 vaccine doses from the beleaguered plant.
The New York Times reported that the vaccine doses were made at a factory for Emergent BioSolutions, a biotech firm that’s known for producing anthrax vaccines.
Further reports state that the factory was closed for two months because of regulatory concerns after Emergent BioSolutions discovered that workers had accidentally mixed up ingredients in a batch of Johnson & Johnson vaccine doses.
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