- Pfizer and BioNTech’s coronavirus vaccine was strongly protective against COVID-19 in a Phase 3 study of adolescents, which could clear the way for expanded use of the shot beyond its current authorization for people 16 years and older.
- In a placebo-controlled trial of 2,260 volunteers aged 12 to 15 years, no vaccinated volunteers developed COVID-19, compared to 18 in the placebo group. Side effects were “generally consistent” with what’s been reported among 16- to 25-year-olds, and antibody responses were higher in adolescents, the two companies said in a statement Wednesday.
- The positive result is the first from an efficacy trial of a coronavirus vaccine in adolescents. Pfizer will submit the data to the FDA as an amendment to its emergency use authorization in the U.S. in the coming weeks. Tests of its shot and one from Moderna, meanwhile, are ongoing in children six months to 11 years old.
After a slow start, the U.S. rollout of coronavirus vaccines has quickened, with more than 50 million people fully vaccinated and an average of roughly 3 million people given a shot each day.
But the population won’t reach herd immunity until at least 70% of the country has been immunized. Getting shots to children, who currently aren’t eligible for vaccination, is the next key step. Moreover, restoring pre-pandemic school activities will require a large portion of children and adolescents be protected against infection, too.
Pfizer CEO Albert Bourla said the companies are asking for emergency authorization now “with the hope of starting to vaccinate this age group before the start of the next school year.”
While the number of cases in the adolescent study are few, the estimated protection appears equal to the strong 95% efficacy reported in Pfizer and BioNTech’s larger adult study last November.
Moderna is currently testing its similarly designed vaccine in a study of 3,000 volunteers between 12 and 17 years old. Results are expected this spring. Currently, Pfizer’s vaccine is cleared for people as young as 16, while Moderna’s is authorized for adults 18 and over.
Moderna plans to establish efficacy by showing the antibody levels its vaccine spurs in adolescents are similar to what’s been observed in adults. The clinical trial file does not include an analysis based on cases of COVID-19.
Both developers also aim to extend authorization to young children. There, Moderna may be a step ahead. On March 16, the Massachusetts-based biotech began a trial called KidCOVE testing its vaccine in nearly 7,000 children aged six months to 11 years old.
Pfizer and BioNTech started dosing children 5 to 11 years old last week, and should start testing in 2 to 5 year olds next week.