US authorizes 14 million doses of Johnson&Johnson’s COVID vaccine

The U.S. Food and Drug Administration on Tuesday authorized around 14 million more doses of Johnson & Johnson’s COVID-19 vaccine manufactured at a problem-plagued Baltimore factory, according to two sources familiar with the plans.

The FDA confirmed it had authorized a batch of the one-dose vaccine made at Emergent BioSolutions Inc’s plant, but did not say how many doses were in the batch.

All the J&J doses authorized from the plant to date are expected to be exported to other countries, one of the sources said. The doses are already in vials, ready for use, the other source said.

Production of J&J’s vaccine at the Baltimore site was halted by U.S. authorities in April following the discovery that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J’s vaccine.

A box of Johnson & Johnson’s coronavirus disease (COVID-19) vaccines is seen at the Forem vaccination centre in Pamplona, Spain, April 22, 2021. REUTERS/Vincent West

An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant. J&J was put in charge of manufacturing at the plant and AstraZeneca’s shot is no longer being made there.

The agency said it was still not ready to authorize the Emergent plant to restart making the J&J vaccine.

Last week, the U.S. drug regulator cleared for use around 10 million doses of the vaccine, according to two sources familiar with the matter, but said J&J had to throw away millions more the shot that were manufactured there.

The New York Times said the batches being discarded amount to around 60 million doses, citing people familiar with the matter.

The FDA said additional batches already produced at the plant are still under review and the agency will inform the public when those reviews are finished.

Safety concerns about the J&J vaccine paired with flagging U.S. demand for vaccinations in general have slowed rollout of the one-shot vaccine to a crawl. Just under 10 million out of the 21 million doses produced for the United States sit unused.

(Reporting by Michael Erman in Maplewood, N.J., Additional reporting by Amruta Khandekar; Editing by Arun Koyyur and Lincoln Feast.)