FDA panel recommends Pfizer shot for kids 5-11

By Art Moore

 

(Image by Anastasia Gepp from Pixabay)

An FDA panel on Tuesday recommended emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 by a vote of 17-0, with one abstention.

However, during the hearing, many members, including the chairman, expressed concern about being given a “binary choice.” They argued data indicate the risks outweigh the benefits for healthy children while those with underlying conditions who do face significant risks from contracting COVID-19 should have access to the vaccine.

The question before the panel, the Roster of the Vaccines and Related Biological Products Advisory Committee, was: “Based on the totality of the scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine when administered as a 2-dose series (10 ug each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age?”

FDA officials now will decide whether or not to accept the panel’s recommendation, as soon as Tuesday night. If the FDA authorizes the vaccine, the process will move to a panel of the Centers for Disease Control and Prevention that will meet next Tuesday to discuss the same data.

President Biden’s chief medical adviser, Dr. Anthony Fauci, said Sunday on ABC’s “This Week” that if the CDC approves, it’s likely that the vaccines “will be available for children from 5 to 11 within the first week or two of November.”

Committee member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, expressed the concern of many members about “a side effect that we can’t measure yet,” referring to the heart inflammation condition called myocarditis.

But he concluded there was no other way forward.

“We’re never going to learn about how safe the vaccine is unless we start giving it,” he said. “That’s just the way it goes.”

Pfizer’s briefing document, issued before the hearing, says on page 10 “the number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination.”

“Long-term safety of COVID-19 vaccine in participants 5 to <12 years of age will be studied in 5 post-authorization safety studies, including a 5-year follow-up study to evaluate long term sequelae of post-vaccination myocarditis/pericarditis.”

The risk of myocarditis was cited last month by an FDA advisory panel that voted 16-2 against Pfizer booster shots for people 16 to 65.

See Rubin’s comment:

After the vote, members were given the opportunity to explain their choice.

Dr. H. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine in Boston, voted yes. However, he reiterated his belief that the vaccine should be made available largely for children with comorbidities.

Meissner, the director of Pediatric Infectious Disease at Tufts, noted that many advocates of the COVID vaccine for children have compared the shot to the MMR vaccine, for mumps, measles and rubella.

“I don’t think that is a fair comparison, because we know that vaccine is safe. We have tested that vaccine for decades, and we have a very good sense of what the adverse events are,” he said.

“We do not have that with this particular messenger RNA vaccine,” said Meissner.

He said he believes there are “some children” in the 5-11 age group “who are deserving of this vaccine, and may very well derive benefit, but there are other children who may be at increased risk of myocarditis.”

Dr. James Hildreth, president and CEO of Meharry Medical College in Tennessee, also questioned the policy of administering vaccines for all children, given their low risk of harm from COVID.

“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,” he said. “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.”

Meissner reminded his colleagues that the rate of hospitialization for COVID in the age group is less than 10 per million. Meanwhile, the rate of myocarditis in young people, according to Israeli data, is as high as 100 to 150 per million.

During the discussion, it was acknowledged that there isn’t any relevant data on the risk of myocarditis for children, and the risk will have to be monitored as the vaccine is distributed.

If authorized, another FDA panel, the Advisory Committee on Immunization Practices, will be given the task of developing recommendations on how to use the vaccines.

Meissner said that if the ACIP does recommend the vaccine for young children, “hopefully it will be for children who have other risk factors.”

Before the vote, Meissner said it’s not clear that the vaccine will reduce the rate of transmission of the virus, and it probably will not reduce infection. It’s value is in reducing the risk of severe disease.

“The issue is side effects or adverse events,” he said. “I’m torn. Many parents are eager to administer the vaccine to their children because they are so frightened, perhaps overly so. On the other hand, I think we saw that approximately 68% of children hospitalized with COVID-19 have underlying comorbidities

Meissner concluded the vaccine “should be available for parents eager to get it because their child has comorbidities or they are concerned.”

He and others on the panel expressed the fear that if they voted yes, some states would mandate vaccination for schools.

“That would be an error at this time, until we get more information about the safety,” Meissner said.

See the hearing:

The only member who didn’t vote yes was Dr. Michael Kurilla of the National Institutes of Health, who said he “resented” the fact that the panel was given a “binary” choice.

He said that while it technically is not the panel’s job to address vaccine mandates, their vote will give states the grounds to impose them on schools.

Kurilla, the director of the Division of Clinical Innovation at the National Center for Advancing Translation Sciences for the National Institutes of Health, asked if the question could be rephrased, since many members favored making it available to “children at higher risk with comorbidities.”

Kurilla was informed that the committee could vote only on the question at hand.

‘We are being silenced’
Among the public commenters was Steve Kirsch, who gave a 30-slide presentation.

Public commenter Kristi Dobbs, a dental hygenist and mother of four who said she is “pro-science,” described the many severe reactions she suffered after being administered the Pfizer vaccine.

She reported her injuries to top federal health officials, she said, who have known about her injuries and the injuries of many others since at least early this year.

“I have met countless others that have been injured by the COVID-19 vaccine, and because of the intentional suppression of these reactions, the injured have been unable to get essential medical care, research for treatment, and there is clearly no recovery plan or financial support,” Dobbs said.

“We are being silenced, abandoned and captive by this collatoral damage.”

She concluded that if “we impose these vaccines on our most vulnerable, our children, it will be an absolute crime against humanity.”

Hear public commenter Luke Yamaguchi:

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