FDA panel recommends EUA for Pfizer’s COVID-19 vaccine candidate

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FDA panel recommends EUA for Pfizer’s COVID-19 vaccine candidate
tjordan_drupal
Dec 11, 2020

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee Dec. 10 recommended the approval of Pfizer, Inc.’s BNT162b2 mRNA COVID-19 vaccine. The panel voted 17-4, with one abstention, that FDA issue an emergency use authorization.

In a statement following the vote, FDA Commissioner Stephen Hahn, M.D., said the agency informed Pfizer that it will rapidly work toward finalization and issuance of an EUA, while the Centers for Disease Control and Prevention and Operation Warp Speed were concurrently notified so as to execute plans for timely vaccine distribution.

Health care workers and nursing home residents will be first in line to receive the vaccine, which is administered in two doses 21 days apart.

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FDA panel recommends EUA for Pfizer’s COVID-19 vaccine candidate
tjordan_drupal
Dec 11, 2020

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee Dec. 10 recommended the approval of Pfizer, Inc.’s BNT162b2 mRNA COVID-19 vaccine. The panel voted 17-4, with one abstention, that FDA issue an emergency use authorization.

In a statement following the vote, FDA Commissioner Stephen Hahn, M.D., said the agency informed Pfizer that it will rapidly work toward finalization and issuance of an EUA, while the Centers for Disease Control and Prevention and Operation Warp Speed were concurrently notified so as to execute plans for timely vaccine distribution.

Health care workers and nursing home residents will be first in line to receive the vaccine, which is administered in two doses 21 days apart.

COVID-19: Vaccines and Therapeutics
COVID-19: CDC, FDA and CMS Guidance

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