World

U.S. authorizes 14M more J&J COVID-19 vaccine doses from Baltimore factory: report – National

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.

Read more:
Unused J&J COVID-19 vaccine doses will be given back to the company, Tam says

Story continues below advertisement

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.










Debate rages over whether to waive COVID-19 vaccine patents


Debate rages over whether to waive COVID-19 vaccine patents

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.

Story continues below advertisement

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.)

View link »





You May Also Like

World

France, which has opened its borders to Canadian tourists, is eager to see Canada reopen to the French. The Canadian border remains closed...

Health

Kashechewan First Nation in northern Ontario is experiencing a “deepening state of emergency” as a result of surging COVID-19 cases in the community...

World

The virus that causes COVID-19 could have started spreading in China as early as October 2019, two months before the first case was identified in the central city of Wuhan, a new study...

World

April Ross and Alix Klineman won the first Olympic gold medal for the United States in women’s beach volleyball since 2012 on Friday,...

© 2021 Newslebrity.com - All Rights Reserved.