Pfizer-BioNTech vaccine safe and effective in children as young as 12, say companies

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The Pfizer-BioNTech vaccine was safe and effective in adolescents as young as 12, the drug companies announced Wednesday in a joint news release.

Data from a trial of the vaccine in nearly 2,300 people between the ages of 12 and 15 will be submitted to the Food and Drug Administration in the coming weeks, with the hope that vaccinations could begin before the next school year.

“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination,” said Ugur Sahin, chief executive of BioNTech, the German company that developed the vaccine in partnership with U.S. pharmaceutical giant Pfizer.

The vaccine was 100% effective at preventing symptomatic illness within the trial, with 18 cases of covid-19 in the group that received a placebo and none in the group that received the vaccine, the companies said. The vaccine triggered immune responses that were even more robust than those seen in young adults.

The data is the beginning of what many families, eager for normalcy to return, have been waiting to see. The Pfizer-BioNTech vaccine is currently authorized by the FDA for emergency use for people 16 and older. If regulators extend the authorization to younger age groups, Pfizer chief executive Albert Bourla said that vaccinations could begin before the school year.

Last week, Pfizer-BioNTech also started a trial in younger children, ages 6 months to 11 years. That trial will step down in age, establishing a safe dose first in children 5 to 11, then in 2- to 5-year-olds and then in children from 6 months to 2 years.

U.S. biotech firm Moderna is also conducting similar trials to test its coronavirus vaccine in teenagers and young children. Its vaccine is authorized by the FDA for emergency use for people over age 18.