The FDA also expanded the EUA to include a third primary series dose for children aged five to 11 years, with certain kinds of immunocompromise
Pfizer and BioNTech announced that the US Food and Drug Administration (FDA) has amended the Emergency Use Authorisation (EUA) for a booster dose of their Covid-19 vaccine to include people aged 12 and above.
Also, the US agency has authorised a third primary series dose for immunocompromised children aged five to 11 years, at least 28 days after the second dose.
The booster dose of Pfizer-BioNTech Covid-19 Vaccine, also called Comirnaty, was previously authorised in the US, for use in people aged 16 years and above, after the primary series.
Also, a booster dose of Comirnaty was authorised for immunising people aged 12 years, with certain kinds of immunocompromise.
The expanded EUA allows for the administration of a booster dose in 12-year-olds, five months after the primary series, with the same dosage strength as in the primary series.
Pfizer said that adults, who received primary vaccination with a different FDA authorised Covid-19 vaccine are also eligible for the booster dose.
Pfizer chairman and CEO Albert Bourla said: “The recent rise in Covid-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorisation 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 hospitalisations.”
FDA said that the health benefits of a booster dose of Comirnaty in providing continued protection against Covid-19, outweighed the potential risks in this population.
The US agency reviewed the real-world data from a booster dose trial in Israel, including safety data from more than 6,300 individuals, aged 12 to 15 years.
According to the data, no new safety concerns associated with the booster were observed in this age group, with no new cases of myocarditis or pericarditis reported.
Also, the FDA reduced the time for administration of a booster dose from at least six months to five months from the primary series, based on the same data.
Pfizer and BioNTech aim to supply the vaccine, including booster doses, under an existing supply agreement with the US government.
BioNTech CEO and co-founder Ugur Sahin said: “The booster vaccination increases the level of immunity and improves protection against Covid-19 across all age groups that have been authorised 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.”