Pfizer “very close” to an authorization request for its COVID-19 vaccine

WASHINGTON | The CEO of the American pharmaceutical group Pfizer confirmed on Tuesday that an application for marketing authorization for its COVID-19 vaccine would be filed very soon in the United States, which could allow the first vaccinations in December if all goes well. .

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“We are very close to filing an emergency authorization request”, declared Albert Bourla during a conference organized by the Statnews site. He has not confirmed or denied that this will happen this week; previously he had said the request would likely be made in the third week of November.

This experimental vaccine was developed with the German company BioNTech.

An emergency clearance is a temporary or conditional clearance granted by the United States Medicines Agency (FDA) to respond to an emergency such as a pandemic. It can be revoked or modified if new data on efficacy or safety appear later.

In Europe, the Medicines Agency uses an accelerated procedure allowing it to examine the data as they appear, even before a formal request for authorization is filed by the manufacturer. Pfizer is one of three projects benefiting from this “continuous review”, along with those of Oxford / AstraZeneca and Moderna.

According to the first results of the clinical trial conducted with 44,000 volunteers in several countries, Pfizer’s vaccine is more than 90% effective in preventing COVID-19, the disease caused by the coronavirus.

A second vaccine should be examined soon by the FDA: that of Moderna, which announced Monday an effectiveness of 94.5%.

The FDA has not said how long it will take to review data on the efficacy and safety of vaccines, the two main criteria, along with the ability to mass-produce doses.

For Pfizer, efficacy data was released publicly on Nov. 9, and Albert Bourla said on Tuesday that safety data was now being compiled, although it was not made public.

Moncef Slaoui, scientific manager of the US government’s Operation Warp Speed ​​to develop vaccines, said on Monday that the green light would likely come in December.

“We hope that these vaccines will both be approved around the second half of December,” Slaoui said Monday on MSNBC.

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