Pfizer Submits Variation To EMA For COVID-19 Vaccination Of Children 6 Months To Less Than 5 Yrs

(RTTNews) - Pfizer Inc. (PFE) and BioNTech SE (BNTX) said that they have submitted a variation to the European Medicines Agency requesting to update the Conditional Marketing Authorization in the European Union with data supporting the vaccination of children ages 6 months to less than 5 years with the 3-microgram dose of COVID-19 vaccine, COMIRNATY, as a three dose series.

The submission included data from a phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age.

In the trial, children received the third 3-microgram dose at least two months after the second dose at a time when Omicron was the predominant variant. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo.

The companies noted that no new safety signals were identified, and the frequency of adverse reactions observed in children 6 months to less than 5 years were generally lower than in children 5 to less than 12 years.

The U.S. Food and Drug Administration granted emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine as a three 3-microgram dose series in this age group on June 17. The companies also plan to submit these data to other regulatory agencies around the world.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization for active immunization to prevent COVID-19 in individuals 6 months of age and older.