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Pfizer and BioNTech obtain FDA support for Covid-19 vaccine authorisation

by JMC on December 11, 2020

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favour of Emergency Use Authorisation (EUA) grant to Pfizer and BioNTech’s Covid-19 mRNA vaccine, BNT162b2.

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favour of Emergency Use Authorisation (EUA) grant to Pfizer and BioNTech’s Covid-19 mRNA vaccine, BNT162b2.

The committee voted 17 to 4 in support of the FDA granting authorisation for the vaccine.

Pfizer noted that the VRBPAC recommendation is based on the totality of scientific evidence shared by Pfizer and BioNTech, including a Phase III clinical study data announced last month and published in The New England Journal of Medicine.

In the trial which enrolled 43,448 subjects aged 16 years and above, 21,720 received a two-dose regimen of 30 μg BNT162b2 which was given 21 days apart, and 21,728 received placebo.

Data showed that the vaccine was well-tolerated and had an efficacy of 95% against Covid-19.

As per the final analysis data, the vaccine had an efficacy rate of 95% in subjects without prior infection, which was the first primary objective, in each case after seven days of administering second vaccine dose.

The trial also met the second primary objective, with the vaccine showing similar efficacy rate in participants with and without prior infection.

In addition, no serious safety concerns related to the vaccine were reported by the data monitoring committee.

Source: https://www.pharmaceutical-technology.com/news/pfizer-biontech-fda-authorisation/

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