Pfizer and BioNTech yesterday submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine for children five through 11 years of age, Pfizer said in a statement.
It also said that the submission included data from the phase-II/III clinical trial in children between five and 11 years of age, who received a booster dose approximately six months after the second dose of the Pfizer-BioNTech COVID-19 vaccine 10-µg two-dose primary series, which was authorised under EUA for this age group in October 2021. Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 vaccine with no new safety signals.
The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world for authorisation in the coming weeks, the statement further mentioned.
The phase-I/II/III trial initially enrolled up to 4,500 children aged six months to under 12 years of age in the US, Finland, Poland and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. The trial was originally designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages five to under 12 years; ages two to under five years; and ages six months to under two years. Based on the phase-I dose-escalation portion of the trial, children aged five to under 12 years received a two-dose schedule of 10-µg each, while children under age five years received a lower 3-µg dose for each injection in the phase-II/III study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.
In December 2021, Pfizer and BioNTech announced the companies would test a third 3-µg dose given at least two months after the second dose in children under age 5 years, and a third dose of the 10-µg formulation in children five to under 12 years of age. The companies expect to share data from the ongoing study in children six months to under five years of age later this quarter, the statement further mentioned.
Pfizer-BioNTech COVID-19 Vaccine is FDA-authorised under EUA for active immunisation to prevent COVID-19 in individuals five years of age and older. It is also FDA-authorised to provide a two-dose primary series to individuals five years of age and older, and a third primary series dose to individuals five years of age and older with certain kinds of immunocompromise, according to the statement.
Apart from it, it is also authorised for the following:
- A first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 vaccine or Comirnaty.
- A first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorised or approved COVID-19 vaccine. The booster schedule is based on the labelling information of the vaccine used for the primary series.
- A second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorised or approved COVID-19 vaccine.
- A second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise, and who have received a first booster dose of any authorised or approved COVID-19 vaccine.