FDA directs Johnson & Johnson to throw away millions of COVID-19 vaccines

Johnson & Johnson to throw away millions of COVID-19 vaccine doses that had been manufactured at a problem-plagued Baltimore factory, as directed by the US Food & Drug Administration. However, as millions of dosed were asked to be thrown away, millions of doses were also cleared for use.

People familiar with the matter had been quoted by the New York Times saying that around 60 million of doses were being discarded. FDA in a news release said that it had authorised two batches of the vaccine for use, and the other batches were not suitable for use. FDA has not yet disclosed or even confirmed the number of vaccine doses but mentioned that many other batches were being evaluated for use.

In April, US authorities halted the production of J&J’s vaccine at the Baltimore site and J&J was kept in charge of the manufacturing of the plant.

The agency said it was not yet ready to give authorisation to Emergent BioSolutions Inc’s plant for manufacturing the J&J vaccine. Production of J&J’s vaccine at the controversial Baltimore site was halted by the United States authorities in April and J&J was put in charge of manufacturing at the plant.

One source familiar with the matter told Reuters that the J&J doses are expected to be exported to other countries. The doses are already in production and are ready for use, the other source said.

On Friday, an Europe’s drug regulator has said that as a precaution, the batches of the J&J COVID-19 vaccines, made around the time the contamination issues were revealed at the Baltimore plant, will not be used. Reuters reported millions of doses were affected and it has become harder for J&J to meet the target of delivering 55 million doses to Europe by the end of this month.

On Friday, Canada’s drug regulator as well said that they will not be releasing the shipment of J&J’s COVID-19 vaccine which were manufactured at the Baltimore plant. Health Canada planned to make an inspection of the manufacturing plant this summer. It decided not to accept any product or ingredients from the plant until the said inspection was completed.

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