KUALA LUMPUR, April 28 – Pfizer Inc and BioNTech SE said Tuesday that they have filed a formal application with the United States’ Food and Drug Administration (FDA) for an emergency-use authorisation (EUA) of a Covid-19 booster dose for children ages five through 11.
Both pharmaceutical companies earlier this month said a third Covid vaccine dose raised antibodies to fight the Omicron coronavirus variant by 36 times in this age group.
In a clinical trial involving 140 children with no evidence of prior Covid-19 infection, antibody levels against the original strain of the SARS-CoV-2 virus were six times higher one month after a booster dose than a month after the second vaccine dose.
Pfizer and BioNTech said they plan to submit this data to the European Medicines Agency and other regulatory agencies for authorisation in the coming weeks.
The primary two-dose Covid-19 shot from Pfizer and BioNTech was authorised in the US for children aged five to 11 in October last year. Earlier this year in January, the FDA authorised a booster shot for children aged five to 11 who are immunocompromised.
Boosters are also available in America for kids aged 12 and older who are immunocompromised, and for adults. Second boosters are authorised for people aged 50 and older, to be administered four months after the first booster dose.
Rival Moderna Inc is still waiting for a decision from US authorities on the use of its primary Covid-19 series among age groups under 18 years.
Moderna is also planning to submit an application to the FDA for the authorisation of its Covid-19 vaccine among kids aged six months to five years in April.