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Updated 10:40 a.m.: FDA committee meeting now in Pfizer/BioNTech vaccine review

December 10, 2020 at 6:07 am Updated: December 10th, 2020 at 10:40 am sbracken
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screenshot_2020-05-05-get-the-facts-on-our-covid-19-vaccine-candidates-pfizer

The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting right now in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.

Two days ago, an FDA committee released a 53-page report after reviewing the data from the development and clinical trials of the vaccine and determined the vaccine is safe and is effective.   The regulatory agencies in the United Kingdom and just yesterday, in Canada.  In the United States, if the EUA is granted, vaccine distribution will begin immediately.   The vaccine will be distributed initially based on state population.  Hawaii’s initial order of the Pfizer/BioNTech vaccine is for 4,875 doses, with up to 80,000 doses by the end of December.  The Pfizer/BioNTech vaccine requires two doses, so up to 40,000 people could get vaccinated from the first shipments.  The priority for vaccinations in the state will be front line health care workers, seniors in community living settings, and first responders.

The FDA will review the Moderna COVID-19 vaccine request for an EUA on Dec. 17, 2020.

More than 15 million people in the U.S. have had confirmed COVID-19 cases, with nearly 290,000 people dying.

The meeting began at 3 a.m. HST and is scheduled to go until around 9 a.m. HST but is continuing until all the testifiers have been heard. (10:40 a.m. update)

You may watch the livestream here:

Tags: COVID-19 vaccine, Pfizer/BionTech
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