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