Pfizer and BioNTech’s Comirnaty gets the FDA nod, Booster Dose to be administered on individuals of 12 years and older

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Pfizer and BioNTech, on Monday, announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) to include individuals 12 years of age and older. 

The FDA action also reduced the time between completion of primary series and booster dose to at least 5 months for all eligible individuals and authorized a third primary series dose for individuals 5 through 11 years of age with certain kinds of immunocompromise.

“The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic. We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations.”

Albert Bourla, Chairman and Chief Executive Officer, Pfizer

The booster dose is the same dosage strength (30-µg) as the dose approved in the primary series. A booster dose of the Comirnaty was previously authorized by the FDA for emergency use after completion of a primary series in individuals belonging to two age categories were, 16 and older, and 18 and older. The second category, vaccinated with a different authorized COVID-19 vaccine, was also eligible.

“The booster vaccination increases the level of immunity and improves protection against COVID-19 across all age groups that have been authorized to receive one.In the current situation, it is important to offer all eligible individuals a booster, particularly against the backdrop of the newly-emerging variants such as Omicron.”

Ugur Sahin, M.D., CEO and Co-founder, BioNTech

‘Real-world evidence from the Ministry of Health of Israel on the administration of over 4.1 million third doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 5 months after the primary series revealed no new safety concerns in adolescents 12 through 17 years of age.’ company said in its latest release.

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