Third dose vaccine and Delta variant, Pfizer-BioNTech send first data to Fda

Third dose vaccine and Delta variant, Pfizer-BioNTech send first data to Fda

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Third dose vaccine and Delta variant, Pfizer-BioNTech send first data to Fda

Third dose vaccine and variant Delta, Pfizer and BioNTech announce that they have presented the initial data of their trial to the US Food and Drug Administration (Fda) to support the evaluation of the third dose of Covid vaccine for a future authorization of this booster in people ages 16 and up. The data in question – phase 1 – will be “also presented to the European Medicines Agency Ema and other regulatory bodies in the coming weeks”, announce the two companies that have launched a phase 1/2/3 clinical trial program that evaluates the safety, tolerability and immunogenicity of a third dose of the Covid vaccine in US adult participants enrolled in the Phase 1 two-dose cycle trial. Participants received a 30 microgram booster dose of their vaccine (BNT162b2), 8-9 months after receiving the second dose.

DELTA VARIANT – After the third dose of Covid vaccine, significantly higher levels of neutralizing antibodies are observed “against the initial Sars-CoV-2 virus (wild type) and against the Beta and Delta variants, compared to the levels observed after” the vaccination cycle at “two doses”. These are some of the first results released by Pfizer and BioNTech companies.

“A booster dose” of Covid vaccine, “given between 6 and 12 months after primary vaccination” with two doses, “could help maintain a high level of protection against the virus” in the words of Albert Bourla, president and CEO of Pfizer. , posted on Twitter along with today’s announcement.

“Vaccination is our most effective means of preventing Covid infection, especially serious illness and hospitalization, and its profound impact on the protection of people’s lives is indisputable – says Bourla – However, with the continuing threat of Delta variant and the possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus. The data we have seen to date suggests that a third dose of our vaccine elicits antibody levels that significantly exceed those observed after the “original” regimen. “in two doses. We are pleased to present these data to the FDA”.

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