FDA grants EUA for Omicron-adapted Covid-19 vaccine for children below five

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Pfizer and have received the US Food and Drug Administration (FDA) emergency use authorization (EUA) for their BA.4/BA.5-adapted bivalent 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 — 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.”

FDA grants EUA for Pfizer and BioNTech's Omicron-adapted Covid-19 vaccine for children below five

FDA grants EUA for Pfizer and BioNTech’s Omicron-adapted Covid-19 vaccine for children below five. Photo courtesy of x3 from Pixabay.

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.

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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.”

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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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