The US Food and Drug Administration (FDA) has granted an amendment to the Emergency Use Authorization (EUA) for Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for usage in children aged six months to four years.
The vaccine is indicated for use as a third 3µg dose in the three-dose initial regimen for children of this age group.
Earlier this month, the companies sought FDA EUA for the Omicron-adapted vaccine for use in children aged below five years.
Doses of the vaccine could be shipped immediately after the companies receive the US Centers for Disease Control and Prevention (CDC) recommendation.
The EUA is backed by findings from adults inoculated with the bivalent vaccine and experience with this vaccine in people aged five years and above, following authorisation.
In addition, post-authorisation experience in children aged six months to four years inoculated with the original vaccine of the companies as an initial series of three doses supported the EUA.
Results from the Omicron BA.1-adapted bivalent vaccine in adults, pre-clinical, and manufacturing findings from 3µg Omicron BA.4/BA.5-adapted bivalent vaccine also provided support for the authorisation.
At present, the Omicron BA.4/BA.5-adapted vaccine has received authorisation as a booster for individuals aged five years and above in the US and the European Union (EU).
Pfizer chairman and CEO Albert Bourla said: “This authorisation offers an opportunity for parents to help better protect their young children against Covid-19, including disease caused by Omicron sublineages.
“It is critical that we all continue to do our part to help protect ourselves by staying up to date with Covid-19 vaccinations, as recommended by public health authorities, especially now as we plan to gather for the holidays and head into the winter season.”
The companies are discussing an application to expand the marketing authorisation for the Omicron BA.4/BA.5-adapted vaccine in the EU in children of this age group.