The EUA allows children in the age group of six months to four years to get a primary series made up of two 3-µg doses of the original Covid-19 vaccine of the companies, followed by a third 3-µg dose of the bivalent vaccine
Pfizer-BioNTech bivalent vaccine authorised as the third 3-µg dose in the three-dose primary series for children, aged between six months and four years. (Credit: Pfizer Inc.)
Pfizer and BioNTech have been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as the third 3-µg dose in the three-dose primary series for children, aged six months through four years of age.
Children in the age group can get a primary series made up of two 3-µg doses of the original Covid-19 vaccine of the companies, followed by a third 3-µg dose of this bivalent vaccine.
According to Pfizer, the updated Covid-19 vaccines can boost protection against severe illness and reduce hospitalisation caused by SARS-CoV-2 in the age group.
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.
“Nearly 40 million Americans have received a booster dose of an updated vaccine. 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.”
Pfizer stated that the amendment made to the EUA is backed by clinical data from adults who had the Omicron BA.4/BA.5-adapted bivalent vaccine as well as post-authorisation experience with the bivalent vaccine in five-year-olds and those older than that. It is also supported by post-authorisation experience with the original Pfizer-BioNTech Covid-19 vaccine as a three-dose primary series for children, aged six months through four years of age.
BioNTech CEO and co-founder Ugur Sahin said: “As the virus evolves it remains our goal to be able to provide access to variant-adapted vaccines against COVID-19 to a broader population.
“With this authorisation, the adapted vaccine based on the Omicron sublineages BA.4 and BA.5 can become an important part of the primary vaccination series for young children.”
Currently, the Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine is authorised to be used as booster for ages five years and older in the US as well as in the European Union (EU).