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Pfizer/BioNTech submits to the FDA the marketing application for the third dose of mRNA COVID-19 vaccine

 Last Update: 2021-10-23
 Source: Internet
 Author: User

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Article source: Medical Rubik's Cube Info

Author: Shi Bei

On August 25, Pfizer/BioNTech jointly announced that it had submitted a rolling submission of the third dose of COMIRNATY (COVID-19 vaccine, mRNA) to the FDA for the supplementary license application (sBLA) for the enhanced injection of biological products

This sBLA data submission is based on data from a phase III clinical trial.

In subjects who had no evidence of SARS-CoV-2 infection within 1 month of the third dose of vaccine, COMIRNATY induced the production of powerful neutralizing antibodies against the wild-type strain

In addition, after the third dose, 99.

Pfizer and BioNTech plan to submit these data to peer-reviewed journals in the next few weeks and submit these data to the European Medicines Agency (EMA) and regulatory agencies in other countries and regions around the world

The third dose of COMIRNATY booster injection has not been widely used in the United States.

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