The FDA has announced that it has determined that it can release two batches from the plant. However, some other batches are not suitable for use.
Washington — US regulators allow 10 million Johnson & Johnson COVID-19 vaccines from a troubled Baltimore plant, but more due to potential contamination The decision needs to be abandoned, said a person familiar with the decision. The Associated Press on Friday.
The Food and Drug Administration has announced that it has determined that it can release two batches from the plant. However, some other batches are not suitable for use, so additional batches are still under consideration.
A second person familiar with this decision confirmed that 10 million doses would be possible. I spoke to the AP on condition of anonymity because I was not authorized to publish the details of the AP.
Dosages occurred at the Emergent BioSolutions plant known as Bayview, which manufactures J & J vaccines. These doses are the first from factories approved for use. The dose of J & J administered came from other plants.
Emergent is one of J & J’s contractors for mass production of one-shot vaccines. The concentrated vaccine is then diluted to the appropriate strength and shipped to other factories for final steps such as vialing and packaging.
Approximately 100 million doses made from bulk vaccines manufactured at the Emergency factory were set aside for additional testing by FDA staff after factory employees accidentally contaminated the batch.
Due to the pollution, the FDA closed the factory in mid-April and sent a team of inspectors. They spent a week walking through the factory, seeing security camera footage showing employees carelessly handling vaccine material. Inspectors reported unsanitary conditions, poorly trained employees, and other issues.
As J & J is the only pharmaceutical company to have a licensed vaccine that requires only one dose and standard refrigeration, this revocation will immunize people, especially in remote areas and poor countries. J & J’s efforts to become a major player are hampered.
This issue forced J & J to import millions of doses from its Dutch factory and miss supply promises.
The Emergent factory has a history of being quoted by the FDA on issues such as mold, dirty walls and floors, poorly trained employees, and poor strategies to prevent pollution, but COVID by the Trump administration. -19 Given a major role in the production of vaccines. Emergent has signed a favorable contract to produce millions of COVID-19 vaccines for both J & J and AstraZeneca at the Bayview plant.
Emergent’s CEO blames pollution and other issues for the complexity of scaling up a factory in just a few months to produce two different vaccines.
The Biden administration is working to find another American manufacturing partner for a UK pharmaceutical company, but it has not yet requested permission to distribute it in the United States.
Two J & J COVID vaccine batches available from Baltimore plant
Source link Two J & J COVID vaccine batches available from Baltimore plant