Israeli authorities said on Sunday that minors aged 5 to 11 will now be eligible for the weaker dosing of the Pfizer COVID-19 vaccine after a majority of experts on its advisory committee voted in favor of the vaccine’s safety profile.
The decision comes on the heels of an emergency approval for the pediatric vaccine in the United States.
The U.S. Centers for Disease Control and Prevention (CDC) last week recommended the Pfizer-BioNTech pediatric shot for broad use in children aged 5-11, after the Food and Drug Administration (FDA) granted emergency use authorization.
When Pfizer’s data was reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee, 17 of 18 panelists voted to recommend it for the age group.
One panelist, National Institutes of Health official Dr. Michael Kurilla, abstained from voting over what he said was limited safety and efficacy data, but said that he would be in full support of the FDA approving the vaccine for a tailored subgroup of children, which he said would be a safer approach.
Pfizer’s data has not yet been publicly released beyond the regulatory authorities, with the company saying that it plans to submit it for peer-reviewed publication soon. There was no control group of non-vaccinated children in the clinical trial, and it wasn’t clear how many COVID-19 cases occurred among the participants.
Kurilla also drew attention to the pediatric vaccine’s limited durability due to its lower dosage, as well as CDC data that indicated some 40 percent of children in the age group had already recovered from COVID-19, giving them some level of immunity against re-infection—another reason why he supported a more directed vaccination roll-out for a subset of at-risk children to lessen the risks.
“There are high-risk groups within the 5–11 age group that would benefit from the vaccine,” he previously told The Epoch Times.
Despite voting in favor of the vaccine, several of the FDA panelists joined Kurilla in voicing concerns about the risks of vaccination, saying they were against any vaccine mandates by schools given cases of heart inflammation—both myocarditis (heart inflammation) and pericarditis (inflammation of the tissue surrounding the heart)—already seen in youth post-vaccination.
However, after eight hours of discussion, the FDA panel overwhelmingly decided that, based on statistical modeling, the benefits of the shot outweighed the risks, even after expressing serious reservations regarding the decision.
Panel members attributed their decision to the very small percentage of children who have experienced severe disease and required intensive care.
According to the modeling, for males 5 to 11, vaccination was estimated to prevent 203 hospitalizations per million while leading to 156 excess hospitalizations per million due to heart inflammation, and prevent 67 intensive care unit stays versus leading to 57 excess stays due to heart inflammation. However, for females, the gap between the predicted benefit and primary risk is much wider, leading to an overall “clear benefit,” Hong Yang, a senior FDA adviser, told panel members.
During the meeting, members also heard there have been over 1.9 million infections in children aged 5 to 11 in the United States since the start of the pandemic, but that just 0.4 percent, or 8,400 of those cases, have required hospital care, with 94 of them dying.
An estimated 20 percent of the hospitalized children were admitted for a reason besides COVID-19, and nearly 70 percent of the children had serious pre-existing health conditions like heart disease, illustrating the natural resilience healthy children have shown in the face of COVID-19.
Pfizer’s clinical trial did not focus on measuring vaccine efficacy against the virus. Instead, it compared the amount of neutralizing antibodies children produced after receiving the vaccine compared to data from the adult trial.
The FDA noted no new or unexpected side effects. Other than heart inflammation, side effects linked to the Pfizer vaccine include headache, fatigue, fever, chills, swollen lymph nodes, loss of appetite, nausea, and a sore arm.
“Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days,” the agency added in a press release.
Pfizer and BioNTech also are studying the effects of the vaccine in children as young as 6 months of age.
The update comes as all three vaccines authorized or approved for use in adults in the United States continue to wane in effectiveness, particularly against infection by the CCP (Chinese Communist Party) virus, which causes COVID-19.
The Biden administration had said on Oct. 20 before the FDA’s approval that it had “procured enough vaccine to support vaccination for the country’s 28 million children ages 5-11 years old.” On Oct. 28, Pfizer announced that it had sold 50 million doses of its pediatric vaccine.
Moderna for Children
Moderna said in October that its COVID-19 vaccine was effective and safe for children aged 6 to 11, citing a new study.
However, the FDA at the end of the month announced that is was delaying its decision on whether to approve the vaccine for children as it was still investigating the risk of myocarditis.
Moderna’s vaccine regime proposes a 50-microgram dose for children aged 6 to 11, while Pfizer’s shot uses 10 micrograms—a third of the dose given to adults.
Their regulators have told health officials that the U.S. decision was based on a “very small clinical trial by vaccine clinical trial standards, only a few thousand children,” and that they “do not want to cut corners on the study and data for children.”
The FDA has said that the study wasn’t large enough to detect the known rare side effects, including myocarditis.
If regulators are convinced that the vaccine is safe and effective for children, the roll-out can begin, Australians were told over the weekend. A decision is expected in the first part of January.
Recently, the CDC, in an unusual move, overrode advice from its advisory panel on limiting boosters to those aged 65 and older, and to those with underlying medical conditions.
Dr. Rochelle Walensky, the CDC’s head, overruled the CDC’s advisory panel after the majority of members voted against the wider approval of boosters to those aged 18 and above with certain jobs or living situations.
The vote came after two top FDA scientists resigned in protest of the pre-emptive announcement by federal health officials. Those officials, Marion Gruber and Phil Krause, later wrote an article in a medical journal asserting that there’s no evidence the general population should get boosters, with the FDA separately signaling that boosters may not be needed.
Christopher Burroughs and Zachary Stieber contributed to this report.