Pfizer says its COVID -19 vaccine is safe and effective in children aged 5-11 years

A vial of Pfizer-BioNTech Covid-19 vaccine will be unveiled at a pop-up vaccine clinic in Los Angeles on August 23, 2021.

ROBYN BECK / AFP via Getty Images

Pfizer said Monday that its COVID-19 vaccine works for children ages 5 to 11 and that it will soon seek U.S. permission for this age group — an important step toward beginning vaccinations for adolescents.

The vaccine made by Pfizer and its German partner BioNTech is already available to all 12 and older. But with the kids now back in school and the extra-contagious delta variant causing a big leap in pediatric infections, many parents are eagerly awaiting vaccinations for their younger children.

For elementary school children, Pfizer tested a much lower dose — one-third of the amount given in each shot now. But after their second dose, children ages 5 to 11 developed antibody levels that fight coronavirus just as strongly as teens and young adults, Dr. Bill Gruber, a senior vice president of Pfizer, to the Associated Press.

The child dose also proved to be safe with similar or fewer temporary side effects – such as sore arms, fever or pain – that teens experience, he said.

“I think we really hit the sweet spot,” said Gruber, who is also a pediatrician.

Gruber said the companies aim to apply to the Food and Drug Administration before the end of the month for emergency use in this age group, shortly after followed up with applications to European and UK regulators.

Former FDA commissioner Scott Gottlieb – who is now a board member of PfiZer – told CBS Mornings on Monday that if all goes well, the government’s green light could come “as early as around Halloween – maybe a little later.”

Earlier this month, FDA chief Dr. Peter Marks AP that when Pfizer reverses its survey results, his agency would evaluate the data “hopefully within weeks” to determine if the shots are safe and effective enough for younger children.

Many western countries have so far not vaccinated younger than 12 years and are awaiting evidence of what is the right dose and that it works safely in smaller tots. But Cuba last week began immunizing children as young as 2 with its homemade vaccines, and Chinese regulators have cleared two of its brands down to 3 years.

While children are at lower risk of serious illness or death than older people, more than 5 million children in the United States have tested positive for COVID-19 since the pandemic began, and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have increased dramatically as the delta variant swept through the country.

“I feel a great sense of urgency” by making the vaccine available to children under 12, Gruber said. “There are fabricated demands that parents should have their children back to a normal life.”

Pfizer said it studied the lower dose in 2,268 kindergarten and elementary school children. The FDA required what is called an immune “bridge” study: evidence that younger children developed antibody levels that have already been shown to be protective in teens and adults. That’s what Pfizer reported Monday in a press release, not a scientific publication. The study is still ongoing and there have not yet been enough COVID -19 cases to compare rates between those vaccinated and those who received placebo – something that could offer further evidence.

The study is not large enough to detect extremely rare side effects, such as heart inflammation, which sometimes occurs after the second dose, mainly in young men. The FDA’s Marks said the pediatric examinations should be large enough to rule out any higher risk to young children. Pfizers Gruber said that once the vaccine is approved for younger children, they will be closely monitored for rare risks just like everyone else.

Another American vaccine manufacturer, Moderna, is also studying its shots in primary school children. Pfizer and Moderna are also studying even younger tots, down to 6-month-olds. Results are expected later in the year.


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