Pfizer seeks EMA approval for Covid vaccine for children 5-11
The manufacturers of the Comirnaty Covid-19 vaccine are seeking approval to use their jab to protect children from the ages of 5 through 11 against the coronavirus disease. Pharmaceutical firms Pfizer and BioNTech submitted data from their Phase 2/3 study to the European Medicines Agency, the companies said in a statement on Friday.
The trial includes children as young as six months old. The data given to the EMA tracked the 2,268 participants who were at least five years old, but younger than 12. They received a first shot of 10 micrograms, followed by a second shot 21 days later. The results demonstrated a "strong immune response in this cohort of children one month after the second dose," the companies said.
"The antibody responses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30-µg doses." The same data was also given to the Food and Drug Administration in the United States, and will also be handed over to other regulatory bodies.
The companies want an adjustment to their Conditional Marketing Authorization in the European Union to permit the use of the vaccine by everyone from the age of five. It is currently approved for use by everyone aged 12 and up.
Trial participants younger than five receive a smaller dose of 3 micrograms per shot. It was not yet clear when, or if, the companies planned to seek market approval for the youngest people.