FDA orders destruction of 60 million doses of J&J vaccine

You may remember that at the end of March news broke that a Baltimore company called Emergent Biosolutions that had been producing the Johnson & Johnson and the AstraZeneca vaccine somehow got them confused and spoiled an estimated 15 million doses. The facility was shutdown and regulators from the FDA came in to determine exactly what happened and what should be done about it. Today the FDA announced that the situation is much worse than we knew.

The Food and Drug Administration has ordered Johnson & Johnson to scrap 60 million doses of its Covid-19 vaccine made at a contractor’s troubled Baltimore plant, according to three people familiar with the matter.

The agency also cleared for use a much smaller number of shots, about 10 million, made at the facility owned by Emergent BioSolutions.

The NY Times reports there are actually 170 million doses that have been in limbo for the past two months. It’s still not clear what will happen with the rest.

For weeks the F.D.A. has been trying to figure out what to do about at least 170 million doses of vaccine that were left in limbo after the discovery of a major production mishap involving two vaccines manufactured at the Baltimore factory.

More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were put on hold after Emergent discovered in March that its workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to produce AstraZeneca’s. Federal officials then ordered the plant to pause production, stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed Johnson & Johnson to assert direct control over the manufacturing of its vaccine there…

Inspectors are still reviewing the plant and are not expected to decide whether the company can reopen it until later this month, according to people familiar with the situation.

All of the J&J vaccine doses that were delivered here in the US were produced in the Netherlands so there’s no issue with contamination for doses that have been delivered. However, the mistake at this one facility, along with the pause on the J&J vaccine for 10 days in April, definitely slowed down the expected surge in vaccinations.

President Biden set a goal of having 70% of the country vaccinated with at least one shot by July 4th. That seemed possible at the time as the daily vaccination rate was climbing past 3 million shots per day. But as of now it looks like we might not make that goal:

For months, President Joe Biden has laid out goal after goal for taming the coronavirus pandemic and then exceeded his own benchmarks. Now, though, the U.S. is unlikely to meet his target to have 70% of Americans at least partially vaccinated by July 4…

About 15.5 million unvaccinated adults need to receive at least one dose in the next four weeks for Biden to meet his goal. But the pace of new vaccinations in the U.S. has dropped below 400,000 people per day — down from a high of nearly 2 million per day two months ago.

That figure of 400,000 doses a day may have been a blip around the end of May. It looks like things have picked up in June.

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