FDA tells Johnson & Johnson 60 million doses of vaccine cannot be used – –

FDA tells Johnson & Johnson 60 million doses of vaccine cannot be used – –

After arriving in Britain for the Group of 7 summit this week, Mr Biden announced another donation plan: 500 million doses of Pfizer whose administration the company is selling at cost for a donation of around 100 country over the next year. While important, it is still a long way from the 11 billion doses that the World Health Organization has declared needed worldwide to eradicate the pandemic.

Dr Luciana Borio, who oversaw public health readiness for the National Security Council under President Donald J. Trump and was acting chief scientist at the FDA under President Barack Obama, said the rejection of the doses Johnson & Johnson should focus on the Biden administration. the risks of looking into Emergent.

“This is a company that we rely on to make biodefense products,” she said. “It’s important to go back now and ask what we know about their manufacturing capacity. “

Experts have called the FDA’s plan to allow 10 million doses to be used in the United States or overseas with a warning about making a product that is only allowed in the event of emergency. The agency has generally taken this step for fully approved drugs that are in short supply, they said. The agency’s guidelines for vaccines under emergency use authorization make it clear that regulators expect sites that produce vaccines to operate with standard manufacturing practices.

In its statement, the FDA said that Emergent’s Johnson & Johnson doses could only be exported on condition that the two companies disclose how the doses were manufactured “under an appropriate confidentiality agreement, with regulatory authorities in countries where the vaccine can be used. Experts said this actually amounted to a warning from the agency that it was concerned about whether workers had adhered to proper manufacturing standards.

“The fact that they can’t say for sure that they’re okay contributes to the perception that it’s not the best,” Johns Hopkins vaccine researcher Dr Limaye said of the Johnson vaccine & Johnson.

The FDA said that before regulators decided what to do with the Johnson & Johnson doses, they “conducted a thorough review of the facility records and the results of the quality tests performed.” They also reviewed the ongoing public health emergency.


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