October 16, 2021

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The FDA Reportedly Forces J&J To Scrap About 60 Million Doses Of Its Covid Vaccine

According to The New York Times, which cited persons familiar with the situation, federal authorities are pushing Johnson & Johnson to destroy nearly 60 million doses of Covid-19 vaccine made at a problematic Baltimore factory owned by Emergent BioSolutions owing to suspected contamination.

An investigation in April identified multiple infractions, including the possibility that J&J’s vaccinations were contaminated with a critical component from AstraZeneca’s Covid vaccine.

According to the New York Times, the examination raised concerns about 170 million doses of both vaccinations.

The FDA verified that many batches were not “suitable for use,” but did not specify how many dosages were thrown out.

According to an emailed statement from the FDA, two batches of vaccine components generated at the factory have been cleared for use. According to the Associated Press, the two batches will total 10 million doses.

“The FDA has decided that many other batches are not fit for use,” the agency said in an emailed statement.

“Additional batches are currently under examination, and the agency will keep the public informed when those evaluations are completed,” it added.

The United States presently possesses enough doses of two additional vaccines licensed by Pfizer and Moderna to completely vaccinate the American population.

The Johnson & Johnson vaccination will continue to be provided in the United States and donated to other nations.

According to the New York Times, the rescued dosages would be accompanied by a notice that federal officials cannot verify that the manufacturing plant’s operator, Emergent BioSolutions, followed appropriate manufacturing methods.

The FDA undertook a thorough evaluation of facility records and the findings of quality tests undertaken by the manufacturer before making its conclusion, according to the agency.

“While the FDA is not yet ready to add the Emergent BioSolutions plant to the Janssen EUA as an approved manufacturing facility, the agency is continuing to engage with Janssen and Emergent BioSolutions management to resolve difficulties there.”

In a statement released Friday afternoon, Johnson & Johnson executive vice president Kathy Wengel said, “Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities.”

The Biden administration intended to give more doses of the injections, but the Emergent facility enquiry blocked those intentions.

According to the World Health Organization, 11 billion vaccine doses are required throughout the world to help prevent the pandemic from spreading further.

President Joe Biden is likely to announce at this weekend’s G-7 meetings that the US is purchasing 500 million doses of Pfizer’s two-shot vaccine to deliver to developing nations.

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