Pfizer seeks authorization for updated Covid vaccine, without fresh clinical trial data

‘Pfizer and BioNTech said Monday that they have asked the Food and Drug Administration to authorize a new booster shot targeted at the Omicron BA.4/BA.5 strain of the coronavirus that causes Covid-19, the first step in a process that could lead to more effective booster shots.

Notably, in the same press release, the companies said that a clinical study investigating the safety, tolerability, and immunogenicity of the vaccine, which also includes the original Covid strain, is expected to start this month, meaning data would not be available for the FDA to consider.’

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www.statnews.com/2022/08/22/pfizer-seeks-authorization-for-updated-covid-vaccine-without-fresh-clinical-trial-data/

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