Approximately 60 million doses of Johnson & Johnson COVID-19 vaccine have been discarded due to potential contamination. Baltimore factory with problems, According to Friday’s report.
The vaccine was manufactured at an Emergent BioSolutions plant known as Bayview, which was forced to shut down in April. After material mix-up A one-time shot of 15 million J & Js was destroyed.
Later, sources told The Associated Press that about 100 million doses were secured for testing at factories that manufacture both J & J Shots and Pfizer Shots.
The Food and Drug Administration (FDA) announced on Friday that it would grant an emergency use authorization for only two batches of Johnson Pharmaceuticals so far.
Other batches are still under review, according to the FDA.
Meanwhile, the FDA has determined that “some other batches are not suitable for use,” the federal agency said. Told the New York Times It has reached about 60 million shots.
“These steps followed an extensive review of records, including tests conducted to assess the facility’s manufacturing history and product quality,” said the director of the FDA’s Center for Biopharmaceutical Evaluation and Research. One Peter Marks said.
According to AP, security camera footage showed employees inadvertently handling vaccine ingredients.
Inspector also reported Unsanitary condition And untrained employees.
The FDA said it would allow the use of batches “based on this review, taking into account current COVID-19 public health emergencies.”
However, the dose contains a warning that regulators cannot guarantee that Emergent BioSolutions comply with good manufacturing practices, the Times said.
The FDA also announced that it will extend the shelf life of the J & J COVID-19 vaccine from three months to four and a half months. Expirs this month..
“Action to extend the best-by date of refrigerated products” [J&J] Vaccines mean that the jurisdiction that has the dose at hand has additional time to administer the vaccine, “Marks said.
Reported that 60 million J & J COVID-19 vaccines were discarded
Source link Reported that 60 million J & J COVID-19 vaccines were discarded