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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.
- 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.
- 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.
- 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.
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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.
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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.
“The truth is we don’t really know that much about these vaccines,” Witczak said. “The ‘safe and effective’ messaging is being thrown around by everyone from government officials to media, community, religious leaders, to Hollywood celebrities. Then you add in all the promotions like multimillion dollar lotteries, free donuts, free shots at the local bar and so on. This subconsciously creates the illusion that there are no downsides whatsoever, nothing to weigh or consider.”
Witczak added: ”We simply cannot ignore the growing evidence of harm and just accept the narrative that adverse reactions are a good thing — and that means the shot is working.”
Witczak and Doshi were two of 27 researchers and clinicians around the world who launched a citizen’s petition demanding the FDA withhold full approval of COVID vaccines until efficacy and safety measures are met.
Dr. Cody Meissner, director of pediatric infectious diseases at Tufts University School of Medicine, said children are at low risk of severe disease from the virus and more study is needed about safety in younger age groups.
“Before we start vaccinating millions of adolescents and children, it’s important to find out what the consequences are,” Meissner said, noting a low COVID hospitalization rate among children.
“As more people are immunized and become immune from infection, I think it’s likely that we are going to get this pandemic under pretty good control,” he said. “I do not feel we can justify an EUA. The burden of disease is so small and the risks are just not clear.”
But other members of the committee sharply disagreed.
“I think we need these vaccines sooner rather than later in children,” said Dr. Mark Sawyer, a pediatrics professor at the University of California San Diego School of Medicine.
“It just seems silly to think that we’re not going to have to include children as part of that,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, co-inventor of Merck’s lucrative rotavirus vaccine and advisor to the FDA. “They can suffer and be hospitalized and occasionally die.”
“The notion that we are not going to have to vaccinate children going forward I think is wrong,” Offit added.
“I think that we need to have EUA ready to go if we start to see an upsurge of cases in the fall,” said Dr. Stanley Perlman, professor of pediatrics at the University of Iowa.
Risk of heart inflammation
Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, said during the meeting “there are ‘very few’ reports of myocarditis or pericarditis in 12- to 15-year-olds who have been given coronavirus vaccines.”
However, the CDC data Shimabukuro presented showed a higher-than-expected number of cases of heart inflammation among young people recently vaccinated with their second doses of mRNA vaccine. The agency identified 226 reports that might meet the agency’s “working case definition” of myocarditis and pericarditis following the shots.
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Among 16- to 17-year-olds through May 31, 79 cases of myocarditis and pericarditis were reported. The expected rate among people in this age group is between two and 19 cases, Shimabukuro said during his presentation.
CDC data also showed that among 18- to 24-year-olds, there were 196 reports of myocarditis and pericarditis. The expected rate is between eight and 83 cases.
The CDC’s Advisory Committee on Immunization Practices scheduled an emergency meeting for June 18 to update data and further evaluate myocarditis following vaccination with Pfizer and Moderna vaccines.
The FDA’s meeting ended with remarks by Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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“I also want to take a moment to remember all the children who have died of COVID-19 in this pandemic, because that should not be forgotten here,” Marks said. “I just want to reiterate something here — this is an illness that takes the lives of children. We know that over 300 children have died in the pandemic so far.”
As Dr. Sidney Wolf, founder and senior advisor of Health Research Group, pointed out during the FDA meeting, CDC data from Jan. 1 to March 31 showed only 204 hospitalizations and 0 deaths in the 12- to17-year-old age group due to COVID.
As The Defender reported May 26, two papers recently published in the journal of Hospital Pediatrics, found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.
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