The vaccine is indicated for people aged 12 years and above. Credit: Ground Picture/Shutterstock.com.

The US Food and Drug Administration (FDA) has approved Pfizer and BioNTech’s supplemental biologics license application (sBLA) for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

The vaccine is indicated for use in people aged 12 years and above.

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The regulator also granted emergency use authorisation (EUA) for the vaccine’s use in children aged six months to 11 years.

This vaccine for the season is recommended for use as a single dose in most people aged five years and above. 

For children aged below five years, additional vaccine doses can be given if they were not previously inoculated with a three-dose vaccine regimen.

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The latest FDA decision comes after its Vaccines and Related Biological Products Advisory Committee (VRBPAC) provided guidance recommending approval for an Omicron XBB.1.5-adapted monovalent Covid-19 vaccine for the fall and winter season in 2023 and 2024. 

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Pfizer and BioNTech were producing the 2023–2024 Covid-19 vaccine at risk to guarantee prompt supply.

Pfizer chairman and CEO Albert Bourla said: “This decision comes at a time when Covid-19 cases are once again climbing. Now, most people six months or older in the US are eligible to receive this season’s Covid-19 vaccine, even if they have never been vaccinated against Covid-19 before. 

“We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their Covid-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak.”

In a similar development, the US FDA granted approval for sBLA of Moderna’s updated Covid-19 vaccine, Spikevax, for use in people aged 12 years and above. 

The company’s vaccine also received EUA for use in children aged six months to 11 years.