Pfizer announced Wednesday that its COVID-19 vaccine is safe and strongly protective in kids as young as 12, a step 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 at higher risk from the coronavirus. Pfizer’s vaccine is authorized for ages 16 and older. But vaccinating children of all ages will be critical to stopping the pandemic — and helping schools, at least the upper grades, start to look a little more normal after months of disruption.
In a 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 among those given dummy shots, Pfizer reported. It’s a small study that hasn’t yet been published, so another critical piece of evidence is how well the thephotoss revved up the kids’ immune systems. Researchers reported high levels of virus-fighting antibodies, somewhat higher thanthose seen in young adult studiess. 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.
Pfizer isn’t the only company seeking to lower the age limit for its vaccine. In the coming weeks, Pfizer and its German partner BioNTech plan to ask the U.S. Food and Drug Administration and European regulators to allow emergency use of the shots starting at age 12. “We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement. He expressed “the hope of starting to vaccinate this age group before the start of the next school year” in the United States. Resultsare also expectedn 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 six months—AstraZenecaneca last month started an analysis of its vaccine among 6- to 17-year-olds in Britain. Johnson & Johnson is planning on pediatric studies. And in China, Sinovac recently announced it had submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3. While most COVID-19 vaccineg used globally were first tested in tens of thousands of adults, pediatric studies won’t need to be nearly as large. Scientists have safety information from those studies and subsequent vaccinations in millions of more adults.
It’s unclear how quickly the FDA would act on Pfizer’s request to allow vaccination starting at age 12. One key question is the dosage: Pfizer gave the 12-and-older participants the same dose adults receive while testing different doses in younger children. Another question is when the country would have enough shots — and people to get them into adolescents’ arms — to let kids start getting in line. Supplies are set tto increase over the spring and summer steadily. At the sam me, tates are opening vaccinations to younger, healthier adults who haven’t had a turn until now.
Children represent about 13% of COVID-19 cases documented in the U.S. And while children are far less likely than adults to get seriously ill, at least 268 have died from COVID-19 in the U.S. alone, and more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. That’s more than dying from the flu in an average year. Additionally, a few have developed a severe inflammatory condition linked to the coronavirus. Caleb Chung, who turns 13 later this week, agreed to volunteer after his father, a Duke University pediatrician, presented the option. He doesn’t know if he received the vaccine or a placebo.
“Usually, I’m just at home doing online school, and there’s not much I can do to fight back against the virus,” Caleb said in a recent interview. The study “was somewhere that I could aehelput.” His father, Dr. Richard Chung, said he’s proud of his son and all the other children volunteering for the needle pricks, blood tests, and other tasks a study entails. “We need kids to do these trials stoget protected. Adults can’t do that for them,” Chung said. AP video journalist Federica Narancio contributed to this report. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
