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, who are at higher risk from the novel coronavirus. Pfizer’s vaccine is authorized for ages 16 and older.
In a study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 cases among those given dummy shots, Pfizer reported in a media release on Wednesday.
It’s a small study, that hasn’t yet been published, so another important piece of evidence is how well the shots revved up the kids’ immune systems. Researchers reported “robust antibody responses,” the release said.
Children have the same side effects as adults, the company says. 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.
In the coming weeks, Pfizer plans to ask the US Food and Drug Administration (FDA) and European regulators to permit the emergency use of the injections for the group starting at 12 years old.
A Pfizer Canada spokesperson said the company intends to send data to file the data supporting authorization for children aged 12 to 15 with Health Canada.
Dr. Supriya Sharma, chief medical advisor for Health Canada, said in a Facebook Live event with federal public health officials on Wednesday that it will be months before the department receives Pfizer’s full data on children aged six to 12.
Health Canada staff need to check that the company’s data shows safety and effectiveness, is high quality and that the benefits outweigh the risks in different populations before any approvals, she said.
Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected soon from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as six months old.
AstraZeneca last month began a study of its vaccine among 6- to 17-year-olds in Britain. Johnson & Johnson is planning its pediatric 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 three.
While most COVID-19 vaccines being 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 more adults.
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