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The final battle

US panel endorses Pfizer Covid-19 vaccine, massive campaign now waits FDA approval

The vote by independent experts convened by the US Food and Drug Administration to recommend granting emergency approval for Pfizer-BioNTech's Covid-19 vaccine came as the country logged more than 3,000 virus deaths in one day
The vote by independent experts convened by the US Food and Drug Administration to recommend granting emergency approval for Pfizer-BioNTech's Covid-19 vaccine came as the country logged more than 3,000 virus deaths in one day Angela Weiss AFP/File
Text by: Jan van der Made with RFI
3 min

An independent panel of experts has overwhelmingly voted to recommend that the Food and Drug Administration (FDA) authorize Pfizer's Covid-19 vaccine for emergency use in people ages 16 and older. A positive FDA decision will open the door for US citizens to be vaccinated against the disease.

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The vote Thursday afternoon was 17 in favor of the authorization and four against, with one person abstaining.

The members of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, were not given an opportunity to explain their votes against recommending authorization.

However, there was much discussion before the final vote about authorizing the shots for teenagers 16 and 17 years old. Some experts worried there was not enough data to make an informed decision about the vaccine in adolescents.

Emergency use

In a reaction, the head of the FDA says his agency has told Pfizer that it “will rapidly work” to grant emergency use of its Covid-19 vaccine following a positive recommendation by government advisers.

The FDA decision will kickstart an unprecedented vaccination campaign needed to eventually defeat the virus. The FDA’s greenlight of the vaccine, co-developed with BioNtech, was practically assured after the positive vote by the VRBPAC a day earlier.

The FDA’s brief statement came less than an hour after President Donald Trump tweeted directly at FDA Commissioner Stephen Hahn, complaining that FDA “is still a big, old, slow turtle.”

FDA staff have repeatedly said they expect to issue a decision within days of Thursday’s meeting. Many FDA observers predict action by Saturday ahead of a Sunday meeting by the Centers for Disease Control and Prevention (CDC.

The panel of CDC advisers will vote on who should get priority for the initial shots. Federal officials plan to allocate the first 6.4 million doses of the vaccine to states based on their population.

In parallel development, on December 17, the VRBPAC will meet in open session to discuss Emergency Use Authorization of the Moderna, Inc., Covid-19 Vaccine for the prevention of Covid-19 in individuals 18 years and older.

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