The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel today unanimously voted 21-0 to recommend Pfizer and Moderna’s COVID-19 vaccines for infants and young children, stating the totality of the evidence available shows the benefits of the vaccines outweigh the risks of use.
Pfizer’s three-dose vaccine would cover children 6 months to 5 years old, while Moderna’s two-dose vaccine covers children 6 months to 6 years old.
States have already ordered millions of doses made available prior to FDA authorization by the Biden administration.
Depending on whether the FDA and Centers for Disease Control and Prevention (CDC) accept the recommendations of their advisory panels, White House officials have said the administration of vaccines for these age groups could start as early as June 21.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) ignored pleas from experts, the vaccine injured and a congressman representing 17 other lawmakers to halt authorization until questions about the safety and efficacy of COVID-19 vaccines for the nation’s youngest children could be properly addressed.
Many of the committee members, including pediatrician Dr. Ofer Levy, said the decision to authorize the shots was about providing a choice to parents who wanted access to COVID-19 vaccines, despite concerns by public commenters the panel was not adhering to the requirements for Emergency Use Authorization (EUA) and that authorization would eventually lead to mandates — as it did with adult vaccines.
“I know that the death rate from COVID and young children may not be extremely high,” said Dr. Jay Portnoy, professor of pediatrics at Children’s Mercy Hospital in Kansas City, Missouri. “It’s absolutely terrifying to parents to have their child be sick.”
Portnoy said there are “so many parents who are absolutely desperate to get this vaccine” and he thinks the committee “owes it to them to give them the choice.”
Several committee members, including Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, raised concerns about Pfizer’s COVID-19 vaccine for kids and the minimal protection it provided after two doses.
Offit said he still supports authorizing a three-dose regimen for the youngest age groups but expects four doses may be needed.
Moderna’s vaccine for infants and toddlers consists of two 25-microgram shots, while Pfizer’s vaccine is a triple-dose regimen of 3-microgram shots each.
Combining all ages together, Pfizer said its three-dose regimen for children 6 months to 5 years old was 80% effective at preventing illness from the Omicron variant based on preliminary data from its clinical trial.
The 80% number was calculated 30 days after the third dose. As noted by committee members, the efficacy number is likely to go down after 30 days and post-approval monitoring was suggested.
Moderna said its two-shot vaccine was about 51% effective against infection from Omicron in children under 2, and about 37% among kids 2 to 5 years old, citing different efficacy numbers than what was reported by the company in March.
In a March 23 press release, Moderna said its vaccine in the 6-month to 2-year age group was only 43.7% effective. In the older age group, the company said its vaccine was 37.5% effective.
A top official at Moderna has already said a booster will be necessary.
All previously authorized COVID-19 vaccines and boosters for all age groups were required to meet the FDA’s 50% requirement prior to obtaining EUA.
But Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, last month told the House Select Subcommittee on the Coronavirus Crisis the agency would not withhold authorization of a pediatric vaccine if it fails to meet the agency’s 50% efficacy threshold for blocking symptomatic infections.
Congressman calls out FDA for failing to answer lawmakers’ questions
During the public hearing portion of the meeting, Rep. Louie Gohmert (R-Texas) said there are many unanswered questions regarding the safety and efficacy of COVID-19 vaccines, especially for babies and young children.
“I’m deeply concerned that the push to vaccinate these children is nothing more than a dystopian experiment with unknown consequences,” Gohmert told the committee. “Some of us have outlined these questions in a letter to VRBPAC but have not received any answers, and I pose some of them here.”
Gohmert said:
“Number 1, why has the FDA refused to release the hundreds of thousands of pages of data from preapproval manufacturer studies, post-approval adverse events data and other post-approval manufacturer data?
“Number 2, what is the cardiac risk factor in administrating these COVID vaccines to children?
“Number 3, world-renowned immunologists have raised concerns about potential antibody-dependent enhancement, or ADE, resulting from COVID vaccines, and since ADE was a problem in prior unrelated respiratory vaccine trials, we need to know what studies, if any, the FDA has that it’s used regarding ADE from COVID vaccines in children 5 and under or any age group. Can the FDA affirm there’s no risk of ADE for vaccinated children?
“Number 4, if widely approved among children 5 and under, how many lives, if any, does FDA estimate will be saved next year? Given the injuries reported in the FDA’s VAERS [Vaccine Adverse Event Reporting System] system, how will FDA evaluate serious vaccine injuries versus serious COVID outcomes?
“Number 5, is it possible the proposed COVID vaccines in young children could create increased risk in future novel COVID variants?
“Number 6, why has the FDA recently lowered the efficacy bar for COVID vaccines for youngest children? This change significantly lowers the expected benefits from any COVID vaccination for young children and it’s of particular concern given that over 70% of that age cohort already is seropositive.”
Gohmert said these questions and 13 other questions posed by lawmakers are critical and deserve answers from the FDA and VRBPAC prior to any EUA with the “accompanied protection for liability for all harm done.”
Gohmert added:
“In conclusion, some of us have grave concerns that in balancing the risk to rewards here, all the risks are to the innocent children and all of the billion-dollar rewards go to the government-protected pharmaceuticals, leaving me to wonder if Republicans get a majority I may need to have a bill […] to allow civil and criminal liability to vaccine providers and accessories despite an EUA which would force more sensitivity towards vaccine harm to our young children.”
Vaccine-injured speak out
During the public hearing session of the meeting, numerous individuals discussed the injuries they experienced after being vaccinated with Moderna and Pfizer’s COVID-19 vaccines, pleading with officials to look at what’s occurring with the adult population before they authorize vaccines for kids.
Jasmine King, a 38-year-old lawyer whose law license lapsed after she was injured by her first dose of Moderna, said she has been to more than 50 doctor appointments and has spent more than $20,000 in co-pays, treatments and supplements to heal from her injuries.
King said she is being monitored for Lou Gherig’s disease and developed sensory nerve symptoms, motor nerve problems, heart palpitations and autonomic nervous system issues after being vaccinated.
King asked the advisory panel to look at what’s happening in the adult population to see what could happen in the pediatric population — if authorization is given — and consider vaccine injuries when discussing the risks of COVID-19.
Kathlyn Hinesley pointed out that the FDA is legally prohibited from approving any biological product for emergency use unless there’s an emergency that poses a risk of death to the target group, the product is effective in preventing the disease, it is safe and the benefits must outweigh the risk.