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.
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.
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.
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.