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Pfizer urged to hold off on coronavirus vaccine until late November: report - FiercePharma

Pfizer urged to hold off on coronavirus vaccine until late November: report - FiercePharma

Pfizer urged to hold off on coronavirus vaccine until late November: report - FiercePharma
Sep 28, 2020 38 secs

But more than 60 researchers and bioethicists urged the partners to wait for more safety data before submitting their shot for a green light, Bloomberg reports.

That would give trial investigators enough time to compile at least 2 months of safety data after participants receive their second doses.

A Pfizer spokeswoman said the company is “very appreciative” of the experts’ input, and that the company is “committed to providing sufficient efficacy and safety data to help FDA determine the best regulatory mechanism for making the vaccine available to the public.” .

“We anticipate providing FDA with safety data, including the median of two months safety data after the second dose, on a rolling basis,” she added.

The drugmaker will track safety and outcomes data for two years during the trial. .

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