FDA Advisory Panel Approves Pfizer Vaccine for Children Ages 5 to 11

The FDA is now expected to rule in the coming days over a final approval. If the FDA approves the vaccine, children will be eligible for the COVID-19 vaccine.

“This is a much tougher one, I think, than we had expected coming into it,” said committee member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine. “The data show that the vaccine works, and it’s pretty safe … we’re worried about a side effect that we can’t measure yet,” he said, referring to a heart condition called myocarditis.

The advisory panel also looked at whether the vaccines were needed in children, considering the lower risk of the virus infecting children.

“It just seems to me that in some ways, we’re vaccinating children to protect the adults, and it should be the other way around,” said committee member Dr. James Hildreth, president and CEO of Meharry Medical College in Tennessee. “I do believe that children at highest risk do need to be vaccinated. But vaccinating all of the children … that seems a bit much for me.”

Dr. Paul Offit, a vaccine researcher at Children’s Hospital of Philadelphia and a committee member, said he also worried that studies on side effects were limited.

“It’s always nerve-wracking, I think, when you’re asked to make a decision for millions of children based on studies of only a few thousand children,” he said. “The question is, when do you know enough? And I think we certainly know that there are many children between 5 and 11 years of age who are susceptible to this disease who could very well be sick and are hospitalized or die from it.”

But Dr. Amanda Cohn, committee member and chief medical officer at the Centers for Disease Control and Prevention, said the benefits outweigh the risks.

“When I look at this question, it is pretty clear to me that the benefits do outweigh the risk, when I hear about children who are being put in the ICU, who are having long-term outcomes after their Covid, and children are dying,” she said. “We vaccinate routinely against a couple of vaccine-preventable diseases for which far fewer deaths and hospitalizations and ICU admissions occur.”

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Amanda Casanova is a writer living in Dallas, Texas. She has covered news for ChristianHeadlines.com since 2014. She has also contributed to The Houston Chronicle, U.S. News and World Report and IBelieve.com. She blogs at The Migraine Runner.