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FDA Warns Against Unauthorized Use of Pfizer Covid-19 Vaccine in Children Under 12 Years of Age

2021-08-24T09:45:10.037Z


The FDA warns against "off-label use" of the covid-19 vaccine in children under 12 years of age. He says doing so "would not be appropriate."


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(CNN) -

Although the U.S. Food and Drug Administration (FDA) has fully approved the Pfizer / BioNTech vaccine against covid-19 for people 16 years of age and older, and continues Being licensed for people 12 years of age or older, the agency cautions against "off-label use" of the vaccine in children under 12 years of age.

He says doing so "would not be appropriate."

"Off-label use" refers to an approved product that is used in a way or in a patient for which it was not necessarily approved;

It commonly occurs with some drugs, such as when chemotherapy approved for one type of cancer is used to treat a different type.

The Pfizer / BioNTech Covid-19 vaccine is not currently approved or licensed for children under 12 years of age, and the appropriate dose for this age group has not yet been determined.

"We do not have data on the appropriate dosage nor do we have complete data on safety in children younger than what is listed in the emergency use authorization," Acting FDA Commissioner Dr. Janet Woodcock said during a conference call on Monday. Monday.

"So it would be a big concern for people to vaccinate children because we don't have the right dose and we don't have the safety data, and we don't have all the efficacy data," Woodcock said.

"We do not recommend that children under the age of 12 get vaccinated with this vaccine. It would not be appropriate."

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Meanwhile, the FDA and the American Academy of Pediatrics (AAP) strongly recommend that all eligible adolescents, ages 12 to 17, get vaccinated as soon as possible, especially as the highly communicable delta variant of the coronavirus continues to circulate nationwide. .

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Until last week, the AAP reported 180,000 new cases of covid-19 among children and adolescents, according to the Academy.

So far, around 8.5 million or 34% of all teens ages 12 to 17 are fully vaccinated against COVID-19.

More people would get vaccinated by full FDA clearance 3:33

'Not just little adults'

It's clear that many parents are eager to vaccinate younger children, but Woodcock said children "are not just little adults."

"We really would have to have the data and the appropriate dose before recommending that children be vaccinated," Woodcock added Monday.

The AAP also "strongly discourages" off-label use of the vaccine in children under 12 years of age, noting that the dose of the vaccine for adults is much higher than the doses being tested in young children.

"Clinical trials for the COVID-19 vaccine in children 11 years and younger are underway, and we need to see the data from those studies before applying this vaccine to younger children," said Dr. Lee Savio Beers. , president of the AAP in a statement Monday, following FDA approval.

"The dosage may be different for younger ages," Beers said.

"The AAP recommends not giving the vaccine to children under 12 years of age until cleared by the FDA."

Dr. Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases, also urged physicians to wait until clinical trials in young children are completed before administering the vaccine to those under 12 years of age.

"We do not want individual physicians to be calculating doses and dosing schedules one by one for younger children based on experience with the vaccine in older patients," Maldonado said in a statement Monday.

"We have to do this based on all the evidence for each age group, and for that we need trials to be completed. I know parents are eager to protect their children, but we want to make sure that children have the full benefit of trials. ongoing clinical trials ".

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Ongoing Covid-19 Vaccine Trials in Younger Children

In a letter sent to Woodcock earlier this month, the AAP asked the FDA to work aggressively to authorize a vaccine for children under 12 years of age.

Pfizer has said it expects to have data from a vaccine trial in children ages 5 to 11 by the end of September, and the company could request that its vaccine be licensed for younger ages shortly thereafter.

The company has also said that data for even younger children, ages 2 to 5, could be available soon after.

Moderna and Johnson & Johnson are also working on children's studies.

  • 7 Ways to Support Kids' Immune Systems as They Go Back to School and Await the Covid-19 Vaccine

Last month, the FDA asked Pfizer and Moderna to double the number of children ages 5 to 11 in clinical trials.

The FDA also requested six months of follow-up safety data, instead of the two months it requested with adults.

"We know that parents are eager to provide their children with the protection of this vaccine, and the American Academy of Pediatrics shares that sense of urgency," Beers said Monday.

"The delta variant has led to a significant increase in the number of children and adults infected with the virus. While we wait for a vaccine to be licensed for younger children, it is important that everyone who is eligible now gets vaccinated. That will help reduce the spread of the virus and protect those who are too young to be vaccinated. "

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Source: cnnespanol

All news articles on 2021-08-24

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