FDA asks J&J to discard 60 million vaccine doses made at Baltimore plant: NYT report
The SA health ministry said it is “waiting with bated breath” for the formal announcement from the FDA over the fate of the vaccines
The US Food & Drug Administration has asked Johnson & Johnson to discard 60 million doses of its Covid-19 vaccine that were manufactured at the troubled Baltimore factory, the New York Times reported on Friday, citing people familiar with the matter.
According to the New York Times article, the FDA said the doses should be discarded “because of possible contamination”.
The article continues that the FDA planned on allowing 10 million doses to be released, but with a caveat that it “cannot guarantee” that the company that ran the Baltimore plant followed “good manufacturing practices”.
It was not immediately clear what this meant for SA's vaccine rollout.
In a short update to local journalists, SA health ministry spokesperson Dr Lwazi Manzi said: “Colleagues, please I am being inundated with calls on the FDA. We are all waiting with bated breath. The FDA has not issued their statement.”
The FDA said in a news release that it had agreed that two batches of the vaccine were authorised for use, but that multiple other batches were not suitable for use and that others were being evaluated.
The agency added that it was not yet ready to authorise Emergent's plant for manufacturing the J&J vaccine.
It did not disclose how many doses were in a batch.
— Additional reporting by TimesLIVE