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Summary
- Pfizer-BioNTech's COVID-19 vaccine, BNT162b2 shows a response in nearly ten days of the first dose, as per the FDA.
- The federal agency will decide whether to give vaccine an Emergency Use Authorization to BNT162b2 on 10 December 2020.
- So far, no serious safety concerns have been seen with the BNT162b2 shot.
According to new documents released by the US regulator, Pfizer-BioNTech's COVID-19 vaccine, BNT162b2 shows response within almost ten days of the first dose. In the documents, the US Food and Drug Administration (FDA) mentioned that BNT162b2 was found to be strongly protective against COVID-19 and appeared safe.
Let us discuss in detail-
Pfizer-BioNTech COVID-19 Vaccine protects against COVID-19 within about ten days of first dose
Pfizer (NYSE:PFE) and BioNTech’s (NASDAQ:BNTX) COVID-19 vaccine is safe, effective, and starts working within ten days of the first dose FDA highlighted in its document.
The US regulator released a document ahead of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on 10 December 2020.
Similar to the data published by Pfizer, the FDA’s document indicates that BNT162b2 is 95% effective at protecting against COVID-19, without any serious safety concerns.
The FDA also disclosed that the information given by the Sponsor was adequate for review and to make decisions about the safety of BNT162b2 for the proposed indication and population for the intended use under the Emergency Use Authorization (EUA).
© Kalkine Group 2020
The VRBPAC meeting is being organized to discuss and offer recommendations on whether-
- It is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 in individuals of ≥16 years, based on the totality of scientific evidence available.
- The known and potential benefits of the vaccine outweigh its known and potential consequences for use in individuals of ≥16 years.
Moreover, the committee will also discuss if the vaccine manufacturer should conduct any additional studies to collect additional information on the safety and effectiveness of the vaccine after issuance of the EUA.
While the US regulatory agency will decide whether to give vaccine EUA on 10 December, other nations have already initiated administration of the vaccine. The UK regulator, Medicines and Healthcare products Regulatory Agency (MHRA) authorized the vaccine for emergency use last week.
Moreover, FDA has determined that the chemistry, manufacturing, and control (CMC) information is consistent with the recommendations set down in FDA’s Guidance on EUA for Vaccines for preventing COVID-19. Per se, FDA has decided that the manufacturer has given sufficient information to make sure the quality and consistency of the vaccine for authorization under a EUA.
