FDA Panel Recommends Pfizer Low Dose Covid Vaccine For Children Ages 5-11

A key FDA advisory committee on Tuesday recommended a lower dose of Pfizer and BioNTech Covid-19 vaccine for children ages 5-11, an important step towards protecting 28 million U.S. children from virus as a delta variant. distributed by.

The approval of the Advisory Committee on Vaccines and Associated Biological Products will now be reviewed by the FDA, which may make a final decision within a few days. The vote was almost unanimous: 17 people supported it and one abstained.

The agency doesn’t always follow the advice of its independent committee, but it often does. The Centers for Disease Control and Prevention’s vaccine advisory group is expected to present its own recommendations next week. If it gets approval and CDC Director Dr. Rochelle Walenski walks out of it, the shots for young children could start immediately.

The Biden administration said it plans to dispense doses as soon as the FDA and CDC clears it, which is expected to happen early next month. The administration said it has purchased enough vaccine to vaccinate all 28 million children aged 5 to 11 in the United States, and will distribute it in smaller doses and with smaller needles to make it easier for pediatricians and pharmacists to administer the vaccine to children.

Many parents say they are anxiously awaiting approval for the vaccine, as schools are now open throughout the United States and the delta option is driving a dramatic increase in the incidence of illness in children.

Children between the ages of 5 and 11 account for approximately 9% of all reported Covid cases in the United States, according to data presented to the FDA on Tuesday. The number of new cases of Covid in children remains exceptionally high, according to the American Academy of Pediatrics, with more than 1.1 million cases of children reported in the past six weeks.

However, some parents and support groups argue that the Covid vaccine is unnecessary for children, as research shows that children are less likely to experience symptoms of the disease, even if they become infected at the same rate as adults.

Some committee members said on Tuesday that vaccinating younger groups would help the US move into an “endemic” phase of Covid, when the virus is still circulating, but at lower levels than it is now. Others noted that there is still unknown data, such as the incidence of myocarditis in young children, but still emphasized that the benefits of vaccinations outweigh the risks. One member inquired whether they should be given advice only for children at risk.

“We don’t want children to die from Covid, even if the children are much smaller than the adults, and we don’t want them to be in intensive care,” said branch member Dr. Amanda Cohn before the vote.

Before the vote, Dr. Peter Marks, the FDA’s chief vaccine regulator, asked committee members to conduct today’s debate “politely,” saying there are strong feelings on both sides.

“To be clear, today’s discussion will be about the scientific evidence presented, not the vaccine requirements that are left to other organizations outside the FDA,” Marks said at the start of the meeting. “I ask that we speak politely today and focus on the science behind these issues so that we can have a productive discussion.”

On October 7, Pfizer asked the FDA to approve the vaccine for children aged 5 to 11. The company released data that showed that a two-dose regimen of 10 micrograms – a third of the dose used for teens and adults – is safe and produces a strong immune response in clinical trials in young children. He said the shots were well tolerated and elicited an immune response and side effects comparable to those seen in a study of people aged 16 to 25.

Dr. Doran Fink, deputy director of the FDA’s vaccines division, said on Tuesday that a “small army” of FDA personnel has been working around the clock for the past month to ensure that the data on the children they present today is as accurate as possible.

Late Friday, FDA officials released an analysis that said the lower dose of Pfizer vaccine is safe and very effective for young children. They noted an increased risk of myocarditis and pericarditis, but said the benefits of the injections, including preventing serious illness, hospitalization, and death, usually outweigh the risk of rare inflammatory heart disease.

As of October 6, Dr. Matthew Oster, a CDC spokesman, told the FDA Vaccines Committee 1,640 cases of myocarditis in people under 30 who received Pfizer or Moderna’s Covid vaccines. Only 877 people met the CDC case definition. He added that the agency has not seen an increase in the incidence among children aged 12 to 17.

This is an evolving story. Please stay tuned.

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