Pfizer and BioNTech’s COVID-19 vaccine has been given emergency use authorisation by the US Food and Drug Administration (FDA) for children aged six months through to four years old.
The authorisation was based on data from a phase 2/3 randomised, controlled trial involving 4,526 children aged six months to four years.
Participants were given the third 3µg dose at least two months after the second dose, during a time when Omicron was the prevailing variant. After a third dose in this particular age group, the vaccine elicited a strong immune response, alongside a favourable safety profile similar to placebo.
In both age groups, the antibody responses were comparable to people aged 16 to 25 years who had received two doses of the vaccine.
“Tens of millions of older children across the globe have already been vaccinated with our COVID-19 vaccine, helping to prevent symptomatic, severe disease and hospitalisation. We know many parents in the US have been eagerly awaiting an authorised vaccine for their children under five and we are proud to now offer them a vaccine option with a favourable safety profile,” said Albert Bourla, chairman and CEO, Pfizer.
The three 3µg doses of the Pfizer/BioNTech COVID-19 vaccine showed a favourable safety and tolerability profile comparable to placebo, with no identification of new safety signals.
Speaking on behalf of BioNTech, Professor Ugur Sahin, CEO and co-founder of BioNTech said: “We are committed to providing access to our COVID-19 vaccine to all age groups. Parents in the US now have the option to vaccinate their children under five years of age, and we are working to ensure that other countries worldwide will follow.”
The companies plan to submit requests for authorization of their COVID-19 vaccine in this age group to the European Medicines Agency and other global regulators in early July.