The Food and Drug Administration has granted emergency-use authorization for the Pfizer-BioNTech coronavirus vaccine to be given to adolescents from 12-to-15 years old, marking the next big step in the effort to vaccinate every American who opts in.
Pfizer, the first of three vaccine producers to receive emergency authorization in the United States, was also the first company to run clinical trials in children under 16. Now that the FDA has given the green light, the Centers for Disease Control and Prevention’s vaccine advisory panel will meet on Wednesday to recommend how the vaccine should be administered in the 12-to-15 age group; the Pfizer candidate is currently the only shot available in the 16-to-18 age group. Doses are expected to be given out immediately, after CDC Director Rochelle Walensky approves the panel’s recommendation.
The FDA made its decision after results of a trial of close to 2,300 adolescents between 12 and 15 years old, as the Washington Post notes:
Researchers took blood samples and measured antibody levels triggered by the shots and found stronger immune responses in the teens than those found in young adults. There were 16 cases of covid-19 in the trial, all of them among adolescents who received a placebo, suggesting the regimen offered similar protection to younger recipients as it does to adults.
Companies producing the vaccine sought approval for adults first for a variety of trial-related and pandemic-specific reasons, the primary one being that COVID-19 disproportionately impacts older people. Though children and adolescents can transmit the virus, they appear to be less efficient at doing so and experience less severe cases. Of the 581,000 coronavirus deaths in the United States, around 300 have been people under the age of 18. Trials are also typically reserved for adults first, then moved into younger age groups to determine if side effects change or the effective dose should be made smaller.
The other two vaccine providers approved for emergency use in adults are taking steps to provide shots for children as well. Last Thursday, Moderna claimed that an initial analysis of its trial in teenagers showed that its shot was 96 percent effective in the 3,235 participants in the trial, whose ages ranged from 12 to 17. Johnson & Johnson is in the planning stage to initiate pediatric trials of its one-dose vaccine. Both Pfizer and Moderna are also currently testing the vaccine in children as young as infants, and Pfizer last week announced it was seeking full FDA approval of its shot in adults.
Vaccinating teenagers will be a significant boost in the campaign to reach something resembling herd immunity in the United States, as Dr. James Wood, a professor of pediatrics at the Indiana University School of Medicine, told Intelligencer’s Paola Rose-Aquino last month: “Getting kids vaccinated all the way down to infant years is going to be a key for the whole community to be protected. Until that has occurred, we don’t expect to reach that herd immunity level.” It will also be essential for the plan to return all schools to in-person learning in the fall. On April 30, President Joe Biden said all K-12 schools in the country “should probably all be open” for the coming school year.