FDA committee endorses emergency use for COVID-19 vaccine shot

A U.S. Food and Drug Administration advisory committee on Thursday endorsed Pfizer’s COVID-19 shot, a major step toward a vaccination campaign against the pandemic.

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The question, “based on the totality of scientific evidence available, do the benefits of the Pfizer–BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 and older?” passed by a 17-4 vote, with one absention.

The meeting included members of the FDA’s Vaccines and Related Biological Products Advisory Committee, which is made up of medical experts.

The vote cleared the way for the FDA to authorize the vaccine within days, The New York Times reported. It also will allow health care workers and nursing home residents to begin the vaccines early next week.

The vaccine has already been given to people in Bahrain and the United Kingdom, the newspaper reported. The vaccine was authorized in Britain on Dec. 2 and was approved in Canada on Wednesday, the Times reported.

The vote is nonbinding, The Washington Post reported. The ultimate decision will come from the FDA; however, the agency typically follows the advisory committee’s recommendation.

If the FDA approves the emergency use authorization for the vaccine, shipping can go forward. Shots cannot be administered until the U.S. Centers for Disease Control and Prevention advisory committee recommends the vaccine.

“Jill and I grieve with everyone mourning a loved one lost to this deadly virus,” President-elect Joe Biden said in a statement. “But today’s approval by the Food and Drug Administration of the Pfizer-BioNTech COVID-19 vaccine is a bright light in a needlessly dark time.”

Biden added that “vaccines don’t equal vaccinations”.

“Our challenge now is to scale up manufacturing and distribution to distribute 100 million shots in the first 100 days of my administration,” Biden said. “Before I take office, we need the Trump Administration to purchase the doses it has negotiated with Pfizer and Moderna and to work swiftly to scale manufacturing for the U.S. population and the world. And, we will need Congress to fund our distribution efforts.”

The CDC’s Advisory Committee on Immunization Practices has scheduled emergency meetings for Friday and Sunday, CNN reported. This committee, which is separate from the FDA advisory committee, will recommend whether the CDC should offer the vaccine in the U.S. If the CDC committee gives its approval, Pfizer shots can be administered.

“Given the enormity of our mission, clinical data were important to us in deciding on the right candidate for a COVID-19 vaccine,” Pfizer’s Kathrin Jansen told the advisory committee. “We evaluated not just one, but four different candidates in Phase 1 to be able to make real-time scientific decisions to select the best candidate.”

The fact sheet and prescribing information provided with the vaccine will warn that people with a history of severe allergic reactions to any of the vaccine’s components should not receive it.

“Over the last couple of weeks, we have been working with Pfizer on generating fact sheets and prescribing information,” Marion Gruber, director of the Office of Vaccines Research and Review in the FDA Center for Biologics Evaluation and Research, told the FDA committee. “The fact sheet and the prescribing information will state that this vaccine should not be administered to individuals with known history of severe allergic reactions to any components of Pfizer’s COVID-19 vaccine and the warning statement will say appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Pfizer Covid-19 vaccine.”

For more information on the vaccine and the FDA’s process to consider it for emergency use, click here.

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