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The U.S. Food and Drug Administration’s advisory panel today voted to recommend the agency allow Pfizer to amend its Emergency Use Authorization for its COVID vaccine for children 5 through 11 years old, despite a host of objections from scientists and physicians.
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The U.S. Food and Drug Administration’s (FDA) advisory committee today endorsed Pfizer’s COVIDvaccine for children ages 5 to 11, despite strong objections raised during the meeting by multiple scientists and physicians.
The vote passed with 17 supporting it and one abstention.
Before the shots can be rolled out, the FDA will have to formally authorize the vaccine, and the Centers for Disease Control and Prevention (CDC) must also weigh in with its own recommendations — but the Biden administration’s announcement last week that it has already ordered 68 million doses of the pediatric vaccine suggests Pfizer’s request will sail through.
During today’s meeting, the Vaccines and Related Biological Products Committee (VRBPAC) heard evidence from Pfizer and regulators, and listened to concerns from numerous experts.
According to the FDA website, as of Oct. 25, the agency had received 139,470 comments from the public prior to today’s meeting — a number federal officials described as strikingly high.
As he opened the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said, “I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public both for and against” authorization.
The dose for younger children would be one-third the strength given to people 12 and older, with two shots given three weeks apart.
Based on CDC data presented during the meeting, among children 5 to <12 years of age, there have been approximately 1.8 million confirmed and reported COVID cases since the beginning of the pandemic, and only 143 COVID-related deaths in the U.S. through Oct. 14.
In this same age group, there were 8,622 COVID-related hospitalizations through Sept 18.
“This translates to cumulative incidence rates of approximately 6,000 and 30 per 100,000 for confirmed COVID cases and COVID-related hospitalizations, respectively, among children 5 to <12 years of age,” Pfizer’s application said.
Children with underlying medical conditions, such as asthma, diabetes and obesity, made up two-thirds of severe COVID cases.
Pfizer provided safety data on two study cohorts of children ages 5 to 11, both of roughly equal size. The first group was followed only for about two months, the second for only two-and-a-half weeks.
The two-month cohort included 2,268 children ages 5 to 11. Of the 2,268 children, 1,518 received the vaccine and 750 received a placebo. Each received two shots spaced three weeks apart.
Pfizer’s study found its vaccine was about 91% effective against symptomatic COVID in children, based on 16 cases of COVID in the placebo group and three cases in the vaccinated group over the brief follow-up period.
Most side effects occurred within a couple of days and included pain at the injection site, fatigue, headache, muscle pains and chills, Pfizer said.
Long-term safety of Pfizer’s COVID-19 vaccine “to evaluate long-term sequelae of post-vaccination myocarditis/pericarditis” in participants 5 to <12 years of age will not be studied until after the vaccine is authorized for children,” Pfizer’s application noted.
Pfizer data insufficient, kids’ risk of vaccine injury greater than COVID risk, experts say
Experts raised concerns over the lack of safety and efficacy data presented by Pfizer for use of its COVID vaccine in younger children, and they pointed to increasing safety signals based on reports to the Vaccine Adverse Event Reporting System (VAERS).
They also questioned the need to vaccinate children — whose risk of dying from COVID is “almost nil” — at all.
According to Dr. Meryl Nass, member of the Children’s Health Defense Scientific Advisory Panel, Pfizer once again did not use all of the children who participated in the trial in their safety study.
“Three thousand children received Pfizer’s COVID vaccine, but only 750 children were selectively included in the company’s safety analysis,” Nass said. “Studies in the 5-11 age group are essentially the same as the 12-15 group — in other words, equally brief and unsatisfying, with inadequate safety data and efficacy data, with no strong support for why this type of immuno-bridging analysis is sufficient.”
Nass said, “All serious adverse events were considered unrelated to the vaccine.”
Dr. Ofer Levy, a VRBPAC member, asked for evidence that Pfizer’s vaccine prevents transmission.
Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, said they did not assess whether the vaccine prevents transmission, but said there is evidence the vaccine prevents transmission in adults.
When questioned further, Gruber was unable to cite specific evidence to back his assertion.