AP Source: J&J’s dose will be released, but many will be thrown

US regulators are allowing the release of 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory

US regulators are allowing the release of 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory, but potential contamination should cause many more ingredients to be thrown out, a person familiar with the decision told The Associated Press. Told on Friday.

The Food and Drug Administration announced that it has determined that two batches can be issued from the plant. But it said several other batches are not suitable for use and additional batches are still under review.

A second person familiar with the decision confirmed it would allow 10 million doses to be released. Both men spoke to the AP on condition of anonymity because they were not authorized to release details about it.

The dosage originated at an Emergent Biosolutions factory, known as Bayview, which is making the vaccine for Jammu and Kashmir. Those doses will be the first factory doses approved for use. The J&J dose that was administered came from other plants.

Emergent is one of several J&J contractors that produce their one-shot vaccines in bulk. Concentrated vaccines are shipped to other factories for final stages, which include diluting them to the right strength, pouring into vials, and packaging them.

About 100 million doses made from the bulk vaccine produced at Emergent’s factory were set aside for additional testing by FDA employees after factory workers accidentally contaminated a batch.

That contamination prompted the FDA to close the factory in mid-April and dispatch a team of inspectors. He visited the factory for a week and reviewed security camera footage that showed workers recklessly handling vaccine material. Inspectors reported unhygienic conditions, poorly trained staff and other problems.

Shortcomings have hindered J&K’s efforts to become a major player in immunizing people, especially in remote areas and poor countries, given that it is the only drug manufacturer with an authorized vaccine that only needs a single dose and standard refrigeration. Is required.

The problems forced J&K to import millions of doses from its factory in the Netherlands and miss supply commitments.

Emergent’s factory had a history of FDA citations for problems including mold, dirty walls and floors, poorly trained staff and an inadequate strategy to prevent contamination, yet it was given a major role in COVID-19 vaccine production by the Trump administration was. Emergent was assigned a lucrative contract to manufacture millions of COVID-19 vaccines for both J&J and AstraZeneca at the Bayview factory.

Emergent’s chief executive has blamed contamination and other problems on the complexity of scaling up the factory in just months to make two different vaccines.

The Biden administration is working to find a separate US manufacturing partner for the British drugmaker, which has yet to request authorization to distribute it in the US.


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