U.S. regulators are forcing Johnson & Johnson To throw away that one-shot millions of doses COVID-19 vaccine It was determined to be “unsuitable for use” and was produced at a problematic Baltimore plant.
The Food and Drug Administration confirmed to NBC News that it had instructed Emergent BioSolutions, a factory that manufactures J & J vaccines, to destroy approximately 60 million COVID-19 shots.
The FDA has announced in a statement that it has determined that two batches from the factory may be released, and additional batches are still under review. These batches are equivalent to about 10 million batches.
The dose generated at the Emergent BioSolutions plant known as Bayview will be the first dose from the factory approved for use. The dose of J & J administered is from other plants.
Emergent is one of J & J’s mass production contractors for one-shot vaccines. The concentrated vaccine is shipped to other factories for final stages, such as diluting it to the appropriate concentration and packaging it in vials.
Approximately 100 million doses of vaccine made from bulk vaccines manufactured at Emergent’s factory were reserved for additional testing by FDA staff after factory employees accidentally contaminated the batch. It was.
Due to this pollution, the FDA closed the factory in mid-April and sent a team of inspectors. They spent a week touring the factory and watched security camera footage of employees inadvertently handling vaccine ingredients. Inspectors reported unsanitary conditions, poorly trained employees, and other issues.
As J & J is the only pharmaceutical company with a licensed vaccine that requires only a single dose and standard refrigeration, this revocation is a major vaccination, especially for people in remote areas and poor countries. I can no longer be a player.
After a two-week hiatus, health officials have requested the CDC to resume distribution of the Johnson & Johnson COVID-19 vaccine.
Due to this problem, J & J imported millions of batches from a Dutch factory and failed to keep its supply promise.
The Emergent factory has a history of being pointed out by the FDA on issues such as mold, dirty walls and floors, poorly trained employees, and inadequate strategies to prevent pollution, but by the Trump administration. It has been given a major role in the production of the COVID-19 vaccine. Emergent has a favorable contract to produce millions of COVID-19 vaccines for both J & J and AstraZeneca at the Bayview plant.
Emergent’s CEO attributed pollution and other issues to 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 US manufacturing partner for a UK pharmaceutical company, but has not yet requested a marketing license in the United States.
60 million J & J vaccine doses from problematic Baltimore plant must be discarded – NBC4 Washington
Source link 60 million J & J vaccine doses from problematic Baltimore plant must be discarded – NBC4 Washington