HQ Team
March 15, 2023: The FDA cleared the emergency use of bivalent Pfizer-Biotech COVID-19 vaccine for a single dose booster in children aged six months to four years.
The booster dose is to be administered at least two months after completion of primary vaccination with three doses of monovalent vaccine of the company, according to an FDA statement.
“Today’s authorization provides parents and caregivers of children six months through four years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, bivalent,” said Peter Marks, M.D., PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“Currently, available data show that vaccination remains the best defence against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine,” he said.
Primary vaccination
The FDA evaluated immune response data from 60 children aged six months to four years who had completed primary vaccination with three monovalent Pfizer-BioNTech COVID-19 Vaccine doses and received a booster dose of Pfizer-BioNTech COVID-19 vaccine, bivalent in a clinical study.
A month after receiving the bivalent Pfizer-BioNTech COVID-19 vaccine, the study participants demonstrated an immune response to the original SARS-CoV-2 virus strain and Omicron BA.4/BA.5.
The authorization was also supported by the FDA’s previous analyses of the effectiveness of primary vaccination with the monovalent vaccine in individuals 16 years of age and above 55.
EMA application
Pfizer and BioNTech have also applied to the European Medicines Agency to extend the Omicron BA.4/BA.5-adapted bivalent vaccine’s marketing authorization to include use in children six months through four years of age as both primary series (all three doses) and booster vaccination (fourth dose).
Currently, the bivalent vaccine is authorized in the European Union as a booster dose for ages five years and older.
According to a Pfizer statement, the companies plan to submit applications to other regulatory authorities worldwide to use their Omicron BA.4/BA.5-adapted bivalent vaccine among children under five.
5.5 billion on a single dose
More than 5.55 billion people worldwide have received a dose of a Covid-19 vaccine, equal to about 72.3 per cent of the world population, according to data compiled by the Our World in Data project at the University of Oxford.
More than 2.72 billion additional doses have been administered worldwide.
Additional doses include booster doses given to fully vaccinated individuals when the protection from the original shots has declined.
The tally also had extra shots given to people, such as the immunocompromised, who did not have a robust immune response from their initial doses.
