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For Kids, Benefits of COVID Vaccine ‘Don’t Outweigh Risks,’ Experts Tell FDA

During an FDA meeting Thursday to discuss granting Emergency Use Authorization for COVID vaccines for children under 12, several experts spoke out against the plan, saying the benefits don’t outweigh the risks for young children.

An advisory committee to the U.S. Food and Drug Administration (FDA) held a virtual meeting Thursday to discuss what data would be needed to vaccinate children under 12 against COVID.

While some advisors said it’s too soon to rush the use of vaccines in the pediatric population because kids are at such low risk from the virus, most argued that it’s important to have authorizations on hand should there be a resurgence of the virus in the fall and winter.

The members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) were not asked to provide specific advice or to vote during the meeting.

The role of the FDA is to advise companies on what kind of clinical trials and data the agency wants to see before extending Emergency Use Authorization (EUA) or full approval of drugs, including vaccines, for use in new age groups.

The following issues were discussed during the meeting:

  1. What’s needed in terms of data — including safety data, database size and duration follow-up — to support EUA and licensure for COVID vaccines for pediatric age groups 6 to 12 years, 2 to 6 years and 6 months to 2 years of age.
  2. Provided there is sufficient evidence of effectiveness to support the benefit of a COVID preventive vaccine for adolescents 12 to 18 years old, safety data, including database size and duration of follow-up, would be needed to support licensure of the vaccine.
  3. Studies following licensure and/or issuance of an EUA needed to further evaluate safety and effectiveness of COVID vaccines in different pediatric age groups.

Pfizer’s COVID vaccine is currently authorized for emergency use in people as young as age 12. Moderna is authorized for people 18 and older, although the company has asked the FDA to authorize its use in children as young as 12. Johnson & Johnson’s vaccine is authorized in people 18 and older.

Both VRBPAC members and public health experts and scientists expressed concerns about using COVID vaccines in the pediatric population.

Peter Doshi, Ph,D, associate professor University of Maryland School of Pharmacy and senior editor of The BMJ, said during the open public hearing session, there is no emergency that would warrant using EUA to authorize COVID vaccines for children.

Pointing to Pfizer’s trial of 12- to15-year-olds which supported the recent EUA, Doshi said the harms outweighed the benefits and those who had the placebo were “better off” than those who received the vaccine.

In terms of the benefits, Doshi said “the reported 100% efficacy in Pfizer’s trial was based on 16 COVID cases in the placebo group versus none in the fully vaccinated group. But there were about 1,000 placebo recipients so just 2% got COVID. Put another way, 2% of the fully vaccinated avoided COVID, whereas 98% of the vaccinated wouldn’t have gotten COVID anyway. “

On the other side of the ledger, Doshi said, side effects were common:

“Three in 4 kids had fatigue and headaches, around half had chills and muscle pain, around 1 in 4 to 5 had fever and joint pain. The list goes on. In sum, all the fully vaccinated 12- to 15-year-olds avoided symptomatic COVID but most wouldn’t have gotten COVID even without the vaccine. So, the benefit is small but it came at the price of side effects that were mild to moderate in severity and lasted a few days.”

Doshi said few children in Pfizer’s trial benefited because they didn’t get COVID, already had COVID or were asymptomatic. Doshi pointed to data from the Centers for Disease Control and Prevention (CDC) showing 23% of 0- to 4-year-olds and 42% of 5- to17-year-olds have already had COVID and have robust natural immunity.

As for long-term side-effects, Doshi said many severe side effects occur beyond six weeks after dosing, specifically referencing a quote by top FDA advisor Dr. Paul Offit who stated otherwise.

Vaccinating children for the benefit of adults is an “unproven hypothetical benefit,” Doshi said. He reminded the FDA they cannot authorize or approve a medical product in a population unless the benefits outweigh the risks in that same population.

“If the FDA does not have a high bar for EUAs and licensing, the point of regulation is lost,” Doshi said.

Kim Witczak, an FDA consumer representative, expressed great concerns over the premature approval of COVID vaccines for children. Witczak said data shows children are neither in danger or dangerous and questioned the timing of last Friday’s CDC announcement of the rise in children being hospitalized with COVID.

“The media ran with it and more fear was stirred — perfectly timed in advance of this meeting,” Witczak said.