Pfizer and BioNTech have applied for
emergency use authorisation from the US Food and Drug Administration (FDA) of their
COVID-19 vaccine for children between the age of six months and five years, the
companies said on Tuesday.

In a release, the companies said they have initiated a
rolling submission of data to the FDA “following a request” from the agency and
expect to complete the process in the coming days.

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Since the pandemic began, more than 10.6 million children have tested positive for COVID in the US, with children under the age of four accounting for over 1.6 million of them. 

Hospitalisation among children has also spiked during the recent omicron surge, with children under the age of four accounting for 3.2% of the total hospitalisations acorss the US for the week ending January 22. 

Approving a vaccine for use in this age group will help reduce COVID infections and related hospitalisation. 

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The FDA said in a tweet that they will hold
a meeting on February 15 to consider the approval. “Having a safe and effective
vaccine available for children in this age group is a priority for the agency,”
interim FDA head Janet Woodcock said, adding that the FDA requested the application
“in light of the recent Omicron surge”.

If the agency grants the approval, the two-shot
vaccine will become the first to be available for use in children of this age
group in the United States.

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The companies are currently seeking approval
for only two doses of the vaccine, but said that a third might be needed “to
achieve high levels of protection against current and potential future
variants,” Pfizer CEO Albert Bourla said in a statement.

“If two doses are authorized, parents will
have the opportunity to begin a COVID-19 vaccination series for their children
while awaiting potential authorization of a third dose,” he added.

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Pfizer said that it has significantly
reduced the dosage of the vaccine for the age group in order to side effects.
Children under five will get only three micrograms per dose, against 10 for ages
five to 11 and 30 for over 12 years old.

If the FDA grants emergency use of the
vaccine, an advisory committee of the Centres of Disease Control and Prevention
(CDC) will meet to consider whether to recommend its use or not.