Sumary of FDA tells J&J to discard more batches of vaccine from Baltimore plant:
- Johnson that more batches of COVID-19 vaccine produced at a plant under scrutiny for its manufacturing practices must be discarded..
- It did not say how many doses of the country only authorized one-shot COVID-19 vaccine were impacted, but The New York Times reported that the agency asked the drug maker to throw out around 60 million doses because of potential contamination..
- Johnson had already discarded a batch of COVID-19 vaccine totaling a reported 15 million doses earlier this year after a quality check at the Baltimore facility “identified one batch of drug substance that did not meet quality standards,”.
- the ingredients of the two vaccines earlier this year, leading to the contaminated doses, The New York Times first reported..
- “The FDA decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S..
- The FDA also said that it has extended the time that the vaccine can be refrigerated from 3 months to 4 1/2 months…