Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a US 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 US studies in children 11 and younger, working their way to as young as 6-months-old.
“We are longing for a normal life. This is especially true for our children,” BioNTech CEO Ugur Sahin said in a statement.
AstraZeneca last month began a study of its vaccine among 6- to 17-year-olds in Britain. Johnson & Johnson is planning its own paediatric studies. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.
While most COVID-19 vaccines being used globally were first tested in tens of thousands of adults, paediatric studies won’t need to be nearly as large. Scientists have safety information from those studies and from subsequent vaccinations in millions more adults.
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.
It’s not clear how quickly the FDA would act on Pfizer’s request to allow vaccination starting at age 12. The agency has taken about three weeks to review and authorise each of the vaccines currently available for adults. That process included holding a public meeting of outside experts to review and vote on the safety and effectiveness of each shot.
The process for reviewing data in children could be shorter, given FDA’s familiarity with each vaccine. An agency spokeswoman said the FDA had no information to share on how the review would work, including whether additional public meetings would be required.
Children represent about 13 per cent of COVID-19 cases documented in the US. While children are far less likely than adults to get seriously ill, at least 268 have died from COVID-19 in the US alone and more than 13,500 have been hospitalised, according to a tally by the American Academy of Paediatrics. That’s more than die from the flu in an average year. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus.
Caleb Chung, who turns 13 later this week, agreed to volunteer after his father, a Duke University paediatrician, 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 really do to fight back against the virus,” Caleb said in a recent interview. The study “was really somewhere that I could actually help out”.
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 so that kids can get protected. Adults can’t do that for them,” Chung said.