Pfizer, BioNtech Submit Data To FDA For Covid Vaccine Booster Authorisation

In the coming weeks, the data will also be submitted to the European Medicines Agency (EMA) and other regulatory authorities, stated the drugmakers.

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The initial data from an early-stage trial to support application seeking authorisation of a booster dose of their coronavirus vaccine has been submitted by American pharmaceutical Pfizer and its German partner BioNtech SE, the drugmakers made the announcement on Monday,

In the coming weeks, the data will also be submitted to the European Medicines Agency (EMA) and other regulatory authorities, stated the drugmakers. Earlier the third dose of Covid-19 vaccine produced by Pfizer -BioNTech and Moderna was authorized by the US regulators, for people with compromised immune systems who are likely to have weaker protection from the two-dose regimens.

An emergency use authorisation has been amended by the US Food and Drug Administration for both vaccines, paving the way for people who have had an organ transplant, or those with a similar level of the weakened immune system, to get an extra dose of the same shot they have initially received.

An advisory panel to the US Centers for Disease Control and Prevention (CDC) voted to recommend the additional shots, and the agency’s director signed off on that recommendation earlier. However, according to an agency spokesperson, immunocompromised individuals can begin receiving the shots immediately.

Mixing of mRNA vaccines is permitted for the third shot if their original vaccine is not available.

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