Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine filed with FDA for emergency use authorisation as third 3-microgram dose in COVID-19
Pfizer announced that the companies have submitted an application to the FDA for emergency use authorisation (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-microgram dose in the three-dose primary series for children 6 months through 4 years of age
With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization.
If authorized, children in this age group would receive a primary series consisting of two 3-microgram doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-microgram dose of the Omicron BA.4/BA.5-adapted bivalent vaccine. An application to extend Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine marketing authorization in the EU to include children ages 6 months through 4 years is under discussion with the European Medicines Agency (EMA).
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