Pfizer plans to seek authorization for Covid-19 vaccine next month

Cornelia Mascio
Ottobre 17, 2020

Pfizer Inc said on Friday it could file for USA authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, suggesting it is possible a vaccine could be available in the United States this year.

General availability is when every American who wants the vaccine can get it.

Dr. Soumya Swaminathan said Wednesday that she hoped a vaccine would be approved by 2021, but that it would likely be available in "limited quantities".

"I think most people agree that the people at highest risk of both transmission, getting the disease, and getting sick from it are healthcare workers, frontline workers, and then the elderly and the vulnerable, " she said, adding that a healthy, young person might have to wait until 2022 to get vaccinated because of the massive amounts of vaccine that will be needed to protect the first groups. The current front-runners are Pfizer and Moderna Inc. They aim to deliver tens of millions of doses in the U.S. by the end of the year.

"This means we may know whether or not our vaccine is effective by the end of October", he said. "It's not going to work like that because no one has ever produced vaccines in these volumes that are going to be needed".

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It is unclear when a vaccine will be available for children as major drugmakers have yet to include them in late-stage trials. Pfizer and BioNTech have approval from regulators to start recruiting volunteers as young as 12 for vaccine studies.

Pfizer/BioNTech said it may have data as early as October and Moderna says it could have similar evidence in November.

Two American companies expect to apply for emergency approval for their Covid-19 vaccines by late November, welcome news as the United States crossed eight million confirmed cases amid a third surge of its coronavirus epidemic.

In July, the U.S. Department of Health and Human Services and the Department of Defense (DoD) announced an agreement with Pfizer for an initial order of 100 million doses of a coronavirus vaccine for the price of $1.95 billion, following EUA or licensure. Topol recently had a virtual meeting with company executives to express his concerns and said he was frustrated they would not answer directly when he asked if they would seek broader use of a vaccine before November 3. Money for vaccine distribution was allocated in drafts of the stimulus bill that has not yet been passed, amid opposition from Senate Republicans and inchoate negotiating tactics from the President. But the company won't have data showing that the vaccine is safe before the third week of November at the earliest.

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