U.S. FDA asks COVID-19 vaccine developers for two months of safety data

(Reuters) - The U.S. Food and Drug Administration told coronavirus vaccine developers that it would need at least two months of safety data after a full vaccination regime to review applications for emergency use authorization of an experimental vaccine.

The agency's advise was released on Tuesday as part of documents posted ahead of a meeting of its expert panel later this month to discuss coronavirus vaccines under development.

Pfizer Inc and BioNTech gave the median patient in their 44,000 volunteer trial the second dose of their vaccine, which is considered a leading candidate in the race for a coronavirus vaccine, in late September.

If the FDA follows the advise released on Tuesday, it would not likely authorize the vaccine before sometime in late November.

The agency's staff also wrote that the FDA expects to hold separate meetings of its vaccine advisory committee before issuing an emergency use authorization for any experimental shot.

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There is no approved vaccine yet for the novel coronavirus in the United States.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Shounak Dasgupta)

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