FDA Panel OKs Low-Dose Pfizer COVID Vaccine for Children 5 and Up
A Food and Drug Administration advisory has approved the use of low-dose Pfizer's COVID vaccine for children 5- to 11-year-olds.
The FDA panel, together with the Centers for Disease Control and Prevention team, decided that the vaccine for children outweighs any possible risks with its benefits, according to a BBC News report.
The full team of the FDA and CDC have yet to approve the recommendation. Both agencies are seen to follow the panel's decision.
Once approved pediatric doctors could find themselves administering shots to some 28 million school-aged children.
In addition, 15 million doses will go out to pediatric offices, children's hospitals, and pharmacies around the country.
Pfizer's COVID Vaccine for Children
Many panelists decided that it's important to give parents the choice to protect their children, especially those at high risk of illness or who live in places where COVID restrictions were not imposed, such as schools without mask mandates.
Panel member of the CDC, Dr. Amanda Cohn, said that the age group deserves and should have the same opportunity to be vaccinated as every other age, according to an Associated Press News report.
There have been over 8,300 hospitalizations in the 5- to 11-year-old age group, with about a third requiring intensive care and around 100 deaths. Over 25,000 primary care providers and pediatricians have signed up for the rollout of the vaccines.
Meanwhile, there is also a strong opposition regarding the vaccination of younger children.
Dr. Jay Portnoy of Children's Mercy Hospital in Kansas City, Missouri, said that he was persuaded by the data showing that the vaccine works despite over 4,000 emails urging him to vote against the vaccine.
The FDA vaccine chief, Dr. Peter Marks, also said that the vaccine was approved solely for emergency use, making it unusual to recommend it for other groups.
The Biden administration officials see the pediatric dose as crucial to keeping schools open and restoring a sense of normalcy, according to The New York Times report.
Data from Pfizer showed that the vaccine had a 90.7 percent efficacy rate in preventing symptomatic COVID in a clinical trial of 5- to 11-year-olds.
Many advisory committee members expressed concern about limited safety data, noting the risk of myocarditis, a rare condition involving inflammation of the heart muscle in young vaccine recipients. The condition has been reportedly tied to the Pfizer-BioNTech and Moderna vaccines, especially in younger men.
Dr. James E.K. Hildreth, the president and chief executive of Meharry Medical College, also said that many children between 5 and 11 may have already some immunity after contracting the virus. Hildreth said that the need to vaccinate broadly in the age group might be less urgent with that case in mind.
Hildreth added that children at the highest risk need to be vaccinated. However, he said that vaccinating all of the children to achieve that seems too much for him.
The CDC would likely recommend the rollout of the shots for children.
READ MORE: Moderna Scientists Warn Against New COVID Variants That Could Drive a New Wave of Transmission
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Written by: Mary Webber
WATCH: FDA Advisory Panel OKs Pfizer Covid Vaccine For Kids 5 To 11 - from NBC News