The US Food and Drug Administration (FDA) released a statement on its website yesterday, 11 June, in relation to the doses of Johnson and Johnson 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.
The FDA announced that two batches of these doses are safe and have been cleared for emergency use.
The implications for South Africa:
- The vaccines awaiting distribution from the Gqeberha 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 for 4,5 months instead of 3 months.
The Department of Health says work is being undertaken to identify more safe doses for the rest of the mass vaccination programme.
The Department says the FDA is still evaluating some batches and they 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.