US Panel Endorses Covid-19 Vaccine; Campaign Needs FDA Approval

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.

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, did not receive 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.”

While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!

— Donald J. Trump (@realDonaldTrump) December 11, 2020

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 also 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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Source: (RFI)