FDA: Pfizer Covid vaccine data fits with guidance on emergency authorization

US Food and Drug Administration (FDA) staff said on Tuesday that data on Pfizer’s coronavirus vaccine was in line with its guidance on emergency use authorization, raising hopes it could soon be available to Americans aged 16 and above.

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The comments were made in documents released ahead of Thursday’s meeting of outside experts to discuss whether the vaccine developed by Pfizer with German pharmaceutical partner BioNTech should be authorized for emergency use in America.

Pfizer cleared the latest hurdle in the race to get its Covid-19 vaccine approved for emergency use, as FDA documents did not raise any new issues about its safety or efficacy.

The documents were released ahead of Thursday’s meeting of outside experts, who will discuss whether the Pfizer/BioNTech shot should be authorized for inoculating Americans.

A two-dose vaccination was highly effective in preventing confirmed cases of Covid-19 at least seven days after the last dose, FDA staff said.

The FDA said there was currently insufficient data to make conclusions about the safety of the vaccine in those younger than 16 years of age, pregnant women and those whose immune systems were compromised.

The FDA is expected to decide on whether to authorize the vaccine within days or weeks.