Pfizer Inc and its partner BioNTech SE said on Tuesday that they had submitted an application to the US health regulator for the authorisation of a booster dose of their Covid-19 vaccine for children aged 5 to 11 years.
The companies earlier this month reported data from a mid-to-late stage study showing a third dose of their shot increased protection against the original coronavirus version and the Omicron variant among children in the age group.
It is unclear how much demand there is for a third vaccine dose in the age group. Just 28% of children aged 5 to 11 years - around 8.2 million - are fully vaccinated, according to data from the US Centers for Disease Control and Prevention.
There has also been some scepticism on the need for boosters in younger children given the reduced risk of severe infection and hospitalisation in the age group.
Pfizer and BioNTech have filed for the clearance of a 10-microgramme booster dose for children 5 to 11 years. Adults receive a 30-microgramme dose of the vaccine.
The primary two-dose Covid-19 shot from Pfizer and BioNTech was authorized in the United States for children 5 to 11 years in October.
The US Food and Drug Administration (FDA) in January authorised the use of a third dose of the companies' Covid-19 vaccine for children ages 12 to 15. The agency has also authorised a booster shot for children aged 5 through 11 years who are immunocompromised.
Rival Moderna Inc is still waiting for a decision from US regulators on the use of its primary Covid-19 series among age groups under 18 years.
It plans to submit an application to the FDA for the authorisation of its Covid-19 vaccine among kids six months to five years by the end of April.
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