Articles

Pfizer-BioNTech’s COVID-19 vaccine shows 100% efficacy in young adolescents

by Scarlett S. Stock Market Analyst

Pfizer Inc (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX), on 31 March 2021,  updated the market that their COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and strong antibody responses in a Phase 3 trial in adolescents 12-15 years of age.

Source: Copyright © 2020 Kalkine Media Pty Ltd.

With experts highlighting that vaccinating children is vital to achieving herd immunity, this update comes as important positive news.

DO READ: Experts believe vaccinating children is key to achieving herd immunity

Top-line findings from pivotal Phase 3 trial in children

The companies stated that the vaccine was well-tolerated and exceeded the efficacy recorded earlier in vaccinated participants aged 16-25 years. These are top-line findings from a pivotal Phase 3 clinical trial, which is performed on 2,260 adolescents.

Interestingly, Pfizer and BioNTech plan to submit the trial findings to the Food and Drug Administration (FDA) for a requested amendment to the Emergency Use Authorization (EUA) of BNT162b2.

Also, the companies will submit data to the European Medicines Agency (EMA) for EU Conditional Marketing Authorization for COMIRNATY® to expand use in children aged 12-15 years as soon as possible.

Moreover, the companies will continue monitoring all the participants for long-term protection as well as safety for an additional two years after the administration of the second dose.

Albert Bourla, Chairman and CEO of Pfizer, commented:

Phase 3 clinical trial information

First published at Kalkine Media


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About Scarlett S. Advanced   Stock Market Analyst

37 connections, 0 recommendations, 172 honor points.
Joined APSense since, July 17th, 2019, From Sydney, Australia.

Created on Apr 1st 2021 05:41. Viewed 319 times.

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