US FDA asks J&J to discard 60 million vaccine doses made at Baltimore plant – NYT

On Wednesday 14 April the South African Health Products Regulatory Authority (SAHPRA) issued a statement that the use of the J&J vaccine in South Africa would also be temporarily halted while scientific reviews were conducted.
By Reuters
11 Jun 2021 0

The US Food & Drug Administration has asked Johnson & Johnson to discard 60 million doses of its COVID-19 vaccine manufactured at the problem-plagued Baltimore factory, the New York Times reported on Friday, citing people familiar with the matter.

A further 10 million J&J doses would be allowed to be distributed with a warning that there was no guarantee contract manufacturer Emergent BioSolutions Inc had followed proper practices, the newspaper said.

The FDA said in a news release that it had agreed that two batches of the vaccine were authorized 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 authorize Emergent’s plant for manufacturing the J&J vaccine.

It did not disclose how many doses were in a batch. DM

(Reporting by Mrinalika Roy in Bengaluru; Editing by Arun Koyyur and Bill Berkrot)


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