Pfizer announced Wednesday that its COVID-19 vaccine is safe and strongly protective in kids as young as 12. The company is working toward possibly beginning shots in this age group before they head back to school in the fall. Most COVID-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the coronavirus. Pfizer's vaccine is authorized for ages 16 and older, but vaccinating children will be critical to stopping the pandemic and helping schools look a little more normal after months of disruption.
In the vaccine study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed no cases of COVID-19 among fully vaccinated adolescents compared to 18 in those given dummy shots, Pfizer reported. Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
It's another positive development in the race against the virus even as U.S. cases, at 66,000 new infections a day, are rising again and deaths are averaging nearly 1,000 a day. CDC Director Dr. Rochelle Walensky warned Americans again Wednesday that "we can't afford to let our guard down." Dr. Philip J. Landrigan of Boston College said the results are encouraging. “It’s hard to get kids to comply with masking and distancing, so something that gives them hard protection and takes them out of the mix of spreading the virus is all for the good,” he said.
Pfizer and its German partner BioNTech plan to ask U.S. Food and Drug Administration and European regulators to allow emergency use of the shots starting at age 12.
Pfizer CEO Albert Bourla said in a statement,
We share the urgency to expand the use of our vaccine.
He expressed the hope of starting to vaccinate this age group before the start of next school year in the United States.
Pfizer isn't the only company seeking to lower the age limit for its vaccine. Results are also expected by the middle of this year from a U.S. study of Moderna's vaccine in 12- to 17-year-olds. But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6 months old.
Ugur Sahin, BioNTech's CEO, said in a statement, "We are longing for a normal life. This is especially true for our children."
AstraZeneca recently began a study of its vaccine in Britain among 6- to 17-year-olds. Johnson & Johnson is planning its own pediatric studies, and Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.