In a new document posted ahead of a key meeting of the US Food and Drug Administration’s vaccine advisers, Pfizer says its vaccine is safe and 90.7% effective against symptomatic Covid-19 in children ages 5 to 11.
In the trial, which included around 2,000 children, there were three Covid-19 cases among the group that received the vaccine and 16 cases in the placebo group. In the trial, twice as many children received the vaccine as the placebo.
Pfizer/BioNTech are seeking FDA emergency use authorization of a two-dose regimen of their 10-microgram dose for children ages 5 to 11. The two doses would be administered three weeks apart.
Last month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 vaccine was safe and generated a “robust” antibody response in children ages 5 to 11. The trial included 2,268 participants ages 5 to 11. Participants’ immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”
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The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet October 26 to discuss whether to recommend the vaccine for authorization for those ages 5 to 11.
If authorized, this would be the first Covid-19 vaccine for younger children. The Pfizer/BioNTech vaccine is approved for people age 16 and older and has an EUA for people ages 12 to 15.