Good news for parents of tweens and teens – clinical trials have shown that the Pfizer vaccine is safe for kids ages 12 and up. Pfizer/BioNTech said Wednesday that those who received the shot as part of a clinical trial showed no signs of infection. And interestingly, the vaccine seems to be even more effective in adolescents than in adults, said the companies.
If the findings hold up, middle school and high school students could potentially be vaccinated before the start of the next school year, with elementary school students not far behind. The Pfizer/BioNTech COVID vaccine showed 100 percent efficacy and that it is well-tolerated in kids ages 12 to 15, the companies announced this morning. The vaccine is currently authorized for use in individuals ages 16 and older.
Data will be submitted to the FDA as soon as possible in hopes of expanding the emergency use of the two-dose vaccine.
In the Phase 2 trial of the vaccine, which included 2,260 participants ages 12-15 in the US the vaccine elicited strong antibody responses one month after the second dose. Pfizer said the response actually exceeds that which was demonstrated in people ages 16-25 in previous trials.
Pfizer/BioNTech said side effects seen in the tweens and teens were similar to those seen in 16 to 25-year-olds. Side effects from the shot include pain at the injection site, fatigue and fever. The participants in the trials will be monitored for two years after their second dose.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Pfizer CEO Albert Bourla.
“We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
Still, not everyone is ready for their kids to get the shot. ParentsTogether, a nonprofit family advocacy group representing more than 2.5 million parents, found that only 58% of parents or caregivers say they would vaccinate their children against COVID-19, despite 70% of parents saying they would vaccinate themselves. It remains to be seen if attitudes will change once the vaccine is approved for adolescents.