Pfizer and BioNTech’s updated Covid-19 vaccine, Comirnaty 2023-2024, and Moderna’s Spikevax were indicated for people aged 12 years and above and were authorised for emergency use in children aged six months through 11 years
Pfizer-BioNTech’s updated Covid-19 vaccines approved in US. (Credit: Pfizer Inc.)
The US Food and Drug Administration (FDA) has approved the updated Covid-19 vaccines from Pfizer-BioNTech and Moderna, which target the XBB.1.5 subvariant of the Covid-19 virus.
The US health regulator approved Pfizer and BioNTech’s supplemental Biologics License Application (sBLA) for their Omicron XBB.1.5-adapted Covid-19 vaccine.
The vaccine, Comirnaty 2023-2024, is indicated for people aged 12 years and above and is also authorised for emergency use in children aged six months through 11 years.
Children below five years may receive the updated vaccine if they did not complete a three-dose series with previous Covid-19 vaccine formulations.
The US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the XBB.1.5-adapted Covid-19 vaccine for the 2023-2024 fall and winter season.
The approval is supported by the previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the Covid-19 vaccines by Pfizer and BioNTech.
Last month, the Omicron XBB.1.5-adapted Covid-19 vaccine, Comirnaty Omicron XBB.1.5, received the European Commission (EC) approval for individuals aged six months and above.
Pfizer chairman and CEO Albert Bourla said: “This decision comes at a time when Covid-19 cases are once again climbing. We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities.”
BioNTech CEO and co-founder Ugur Sahin said: “With today’s decision, an updated vaccine will shortly become available that helps address multiple Omicron XBB-related sublineages, which currently account for the vast majority of Covid-19 cases globally.
“Studies about confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory viruses. Our goal is to provide people worldwide with Covid-19 vaccines that are adapted to circulating virus variants or sublineages.”
The FDA also approved Moderna’s Spikevax, for use in people ages 12 years and above.
In addition, the US health regulator granted Emergency Use Authorisation (EUA) for Moderna’s updated Covid-19 vaccine for individuals six months through 11 years of age.
The company said that its updated Covid-19 vaccine contains spike proteins for the XBB.1.5 sub-lineage of SARS-CoV-2, to prevent Covid-19 in individuals six months of age and older.
With the FDA approval, Moderna plans to start shipping its updated Covid-19 vaccine doses to sites across the US, which are expected to be available in the coming days.
Moderna CEO Stéphane Bancel said: “Covid-19 remains a leading cause of death in the US and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season.
“As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season.
“We appreciate the FDA’s timely review and encourage individuals who intend to get their flu shot to also get their updated Covid-19 vaccine at the same time.”