There is a “real possibility” that the Johnson & Johnson vaccines ready to be distributed to South Africans from the Gqebherha plant will not be suitable for use.

This is according to the health ministry, commenting on Friday night after the US Food and Drug Administration (FDA) confirmed that just two batches of the vaccine from a Baltimore laboratory were being released, while others were not. The number of vaccines per batch was not specified in the FDA statement.

The New York Times reported earlier in the day that the FDA would ask J&J to discard 60 million vaccine doses.

In a statement on Friday, the health ministry said the implications of the FDA decision were that the vaccines awaiting distribution from the Gqebherha plant needed further assessment by the SA Health Products Regulatory Authority, which would “soon advise if they are suitable for use in SA”.

“There is now a real possibility that they may not be, however this is for the regulator to rule on,” the ministry said.

It added, however, that there were 300,000 doses of the vaccine cleared to be shipped to SA 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 °C (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 & Johnson available to the international community, including SA,” the ministry said.

TimesLIVE