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Pfizer says it will not have a coronavirus vaccine until late November, allaying fears of a rush for approval before Election Day - The Washington Post

Pfizer says it will not have a coronavirus vaccine until late November, allaying fears of a rush for approval before Election Day - The Washington Post

Pfizer says it will not have a coronavirus vaccine until late November, allaying fears of a rush for approval before Election Day - The Washington Post
Oct 16, 2020 1 min, 26 secs

Pharmaceutical giant Pfizer on Friday dashed prospects for a coronavirus vaccine being approved before the election with an open letter explaining the company would not apply for regulatory clearance for its vaccine candidate until the third week of November at the earliest.

President Trump has for months suggested a vaccine could be imminent, raising concerns that political pressure could force a vaccine through the regulatory process prematurely so that it would be approved by Election Day without evidence that it is safe and effective.

Chief executive Albert Bourla wrote in the letter that while the company projects it may have enough data to determine whether the vaccine is effective in October, there will not be sufficient safety follow-up to satisfy criteria laid out by the Food and Drug Administration until late November.

The letter was welcomed by Eric Topol, a physician-scientist at Scripps Research Translational Institute who joined other experts in writing to Bourla in late September, asking the company not to seek authorization for a vaccine before late November.

Topol recently had a virtual meeting with company executives to express his concerns and said he was frustrated they would not answer directly whether they would seek broader use of a vaccine before Nov3

Bourla made clear that while the company won’t seek approval until reaching the safety threshold, it could announce data on whether the vaccine candidate works before the election.

The agency put forth a requirement — despite White House objections — that vaccine candidates must have a minimum of two months of follow-up data on half of the participants in the study.

Moderna, a biotechnology company, will not have enough safety data to apply for regulatory authorization until two days before Thanksgiving, according to spokesman Ray Jordan.

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