Pfizer could seek emergency authorization for coronavirus vaccine by late November

Henrietta Brewer
October 18, 2020

Last month, President Donald Trump said that a COVID-19 vaccine would be distributed within 24 hours of completion of phase 3 trials and FDA approval.

The company said it hopes to move ahead with the vaccine after safety data is available in the third week of November, immediately lifting the company's shares two percent in the US.

Dozens of companies, from biotech start-ups to Big Pharma, are racing to develop a safe and effective COVID-19 vaccine, because the world needs it and for the potential pay day.

Once all these steps have been completed, we will proceed to request your approval: "Assuming positive data, Pfizer will request the use of emergency authorization in the U.S. shortly after the safety milestone is achieved in the third week of november".

"As part of Operation Warp Speed, my administration has manufactured one of the most promising vaccines in advance, and it will be fairly long in advance, as soon as a vaccine is approved, the administration will deliver it to the American people immediately".

Several drugmakers including Pfizer, AstraZeneca, Johnson & Johnson and Novavax Inc have said they expect to produce at least 1 billion doses of their vaccines next year if they get regulatory authorization. The U.S. Department of Defense and the CDC plan to start distribution of vaccines within 24 hours of regulatory authorization.

AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States as early as October but its US trial has been on hold since September. It has signed a deal to buy Pfizer vaccine shots if they work.

The approval will be requested through the Food and Drug Administration.

"The spread of the coronavirus appeared to be accelerating this week in the US with a key indicator in 44 of the 50 states and Washington, D.C. flashing an "ominous" warning sign", a health official told the Wall Street Journal on Tuesday. But it must also satisfy regulators' vigorous safety requirements.

Pfizer has been trying to demonstrate that its decision-making is being driven by science rather than politics, Mizuho analyst Vamil Divan said.

Eric Friedlander, cabinet secretary, says getting vaccinated with not only COVID-19, but all other vaccinations is vital. "People should actually be willing to take it".

Gov. Jared Polis set a hopeful timetable of late November as being when Colorado could get emergency authorization of a vaccine, which would be prioritized for frontline workers and nursing home residents.

Pfizer/BioNTech said it may have data as early as October and Moderna says it could have similar evidence in November. Trials of two candidate vaccines - made by Johnson & Johnson and Eli Lilly - were "paused" recently over safety concerns.

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA.

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