Pfizer, BioNtech submit data to FDA for Covid vaccine booster authorisation
Premium- The data will also be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks, the drugmakers said
American pharmaceutical Pfizer and its German partner BioNtech SE have submitted initial data from an early-stage trial to support application seeking authorisation of a booster dose of their coronavirus vaccine, the drugmakers announced on Monday.
The data will also be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks, the drugmakers said.
Earlier, the US regulators authorised a third dose of Covid-19 vaccines by Pfizer -BioNTech and Moderna for people with compromised immune systems who are likely to have weaker protection from the two-dose regimens.
The US Food and Drug Administration amended its emergency use authorisation 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. Immunocompromised individuals can begin receiving the shots immediately, according to an agency spokesperson.
Mixing of mRNA vaccines is permitted for the third shot if their original vaccine is not available.
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