Pfizer and BioNTech have received the US Food and Drug Administration (FDA) emergency use authorization (EUA) for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for children aged six months to four years.
The shot is authorized as the third 3-µg dose in the three-dose primary series.
Albert Bourla — Pfizer Chairman and CEO said: “This authorization 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.”
The emergency use authorization was based on clinical results from adults who were administered the Omicron BA.4/BA.5-adapted bivalent vaccine and experience with the shot among people aged five years and above. lt was also backed by experience with the original Pfizer-BioNTech Covid-19 Vaccine as a three-dose primary series for children aged six months to four years.
In addition, the approval was backed by clinical findings from the bivalent vaccine in adults and pre-clinical and manufacturing results from 3-µg Omicron BA.4/BA.5-adapted bivalent vaccine.
Prof. Ugur Sahin — BioNTech Co-founder and CEO said: “With this authorization, 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 authorized as a booster dose for people aged 5 years and above in the US and European Union (EU).
The European Medicines Agency (EMA) is currently reviewing an application to extend Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine marketing authorization in the EU for children aged six months to four years.
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