Pfizer Inc and BioNTech on Monday announced that the companies have submitted an application to the U.S. Food and Drug Administration (USFDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose.
According to the pharma major, this dose will come 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 hospitalisation, the company claims.
“If authorised, children in this age group would receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg 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),” the company said in a statement.
According to Pfizer, the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorised as a booster dose for ages 5 years and older in the U.S. and European Union (EU).
The vaccine, COMIRNATY, is based on BioNTech’s proprietary mRNA technology and was developed by both BioNTech and Pfizer.