FDA delays approval of Covid-19 vaccine for children under 5 years old

The US Food and Drug Administration (FDA) on February 12 said that it has not yet approved Pfizer’s Covid-19 vaccine for children under 5 years old.

The decision was made based on new data showing that the vaccine is less effective in this age group. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said further review of data from clinical trials with a three-dose regimen in young children is needed.

“The data we obtained made us realize that we need to look at more research from the ongoing three-dose course before deciding whether to approve the vaccine,” Mark said.

Pfizer will release the complete data on the three-dose regimen in early April. The FDA could make an authorization decision days or weeks later.

New information leaves many parents feeling frustrated. Sheila Krogh-Jespersen, Northwestern University assistant professor of medical sociology and a mother of three, is one of them. Jespersen said most of her family members tested positive this week. Two older children have high fever. “I’m desperate,” she said.

“Since the vaccine came out, we have been waiting for the moment to get our children vaccinated, so that they can have a normal childhood,” said Andrew, an electrical engineer and parent of a two-year-old boy. know. His child still has to wear a mask when playing with friends at kindergarten.

He believes that the new FDA decision makes it difficult for parents, while the vaccine is safe and can give them more peace of mind when the US is about to remove the regulation on masks.

Joel Wertheimer, the father of a 4-month-old girl, said he would take his child to get vaccinated as long as the vaccine is safe, even if it is not very effective.

“We always do things like that, protecting our children 20-30% is also good,” he said.

A 5-year-old girl chats with a nurse before getting a Covid-19 vaccine. Photo: NY Times

Some experts say that the FDA’s delay in approving the vaccine may confuse many parents. “This could very well be the right decision, but it’s a blow to parents,” said Associate Professor Jason L. Schwartz, faculty of public health at Yale University.

Tara C. Smith, an infectious disease expert and epidemiologist at Kent State University, said that in the near future, the FDA will have more complete data. “After Omicron, it’s hard to think that the pandemic will end any time soon,” she said.

Sean O’Leary, vice chair of the Infectious Diseases Committee of the American Academy of Pediatrics, said: “While I want to vaccinate children early, I think it’s better to follow the protocol and closely monitor the data. “. He believes that the decisions of the FDA and Pfizer are correct.

Thuc Linh (Follow NY Times)


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