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Pfizer/BioNTech’s COVID vaccine gets the FDA advisors’ nod.

The FDA, who will have the final authority on whether to approve the COVID vaccine or not, will now decide about the approval.

Key points:

1. Advisors to the FDA voted in favor of the authorization for Pfizer and BioNTech’s COVID vaccine.

2. 17 advisors voted in favor of the approval; 4 voted against and one abstained.

3. Majority of advisors believe that the Pfizer/BioNTech COVID vaccine’s benefits outweigh its shortcomings.

Vaccine advisors to the FDA recommend COVID vaccine in the US: 

Vaccine advisers to the United States Food and Drug Administration voted Thursday to advocate the enterprise provide emergency use authorization to Pfizer and BioNTech’s coronavirus vaccine. Four participants of the Vaccines and Related Biological Products Advisory Committee voted no, 17 voted yes and one abstained.

Shortcomings are lesser than its benefits, says Dr James Hildreth:

Dr James Hildreth, president, and leader govt officer of Meharry Medical College, stated he might have been hoping extra minorities have been enrolled withinside the scientific trials of the vaccine. Several committee participants expressed subject approximately reviews of allergic reactions in folks that have been vaccinated in Britain, which legal Pfizer’s vaccine beforehand of the United States.

Covid-19 vaccine update: US panel's nod to Pfizer; India says no compromise  on regulatory norms for vaccine - Coronavirus Outbreak News

Some sensitive reactions have been recorded after taking the vaccine in the UK:

FDA body of workers stated that, as with all vaccines, office work might accompany the Pfizer vaccine to warn in opposition to administering it to all people with a record of extreme hypersensitive reactions to vaccines or hypersensitive reactions to any of the substances of the vaccine. A EUA is brief of complete approval. Pfizer might record a separate utility for complete FDA acclaim for its vaccine. Plus, Thursday’s vote does not suggest the vaccine could be legal immediately.

The final seal of approval to be given by the FDA:

The FDA will now determine whether or not to just accept the advice however has signaled that it’s going to the difficult the EUA for the vaccine. Importantly, the very last choice approximately whether or not to authorize the vaccine for emergency use could be made through the FDA’s professional officials.

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