FDA Adviser Explains Why He Didn’t Support The Pfizer Vaccine For Children!
The FDA should decide whether they will approve the vaccine for young children or not. All 17 others voted to advise the administration, or the FDA, to authorize the vaccine for children aged 5-11. The agency supported the shot, and it will formalize the authorization very soon. The CDC, after that, will decide if the children should get the vaccine.
Before the vote, there was a discussion of eight hours supported by presentations. Some of the members were concerned about the safety issues.
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Dr. Michael Kurilla, an expert of infectious diseases and pathology directing a division inside the NIH, was the only one who didn’t support the recommendation.
Kurilla talked to The Epoch Times via email, and he opposed the binary wording of the question, and he opened up the possibility that children from 5 to 11 can get the Pfizer vaccine. Also, he was concerned about the most extended follow-up for the clinical trial, the age group of three months. According to the data, children aren’t exposed to the risk of the virus, and they have some level of immunity.
If the authorization moves as expected, some age groups could get two doses of 10 micrograms each, placed in three weeks distance.
The exact dosage interval, with a dosage level three times as high, is recommended for adults. Because they have the same interval, we can predict that the effectiveness will wane in children. So, if the dosage is lower, that questions whether the protection against severe disease will be as strong as in adults?
“Real-world evidence involving adults suggest the 3-week dosing interval is suboptimal in terms of durability and is likely to be similar in children, leading to waning immunity within 4–6 months,” Kurilla said. “Because the Pfizer vaccine offers protection against serious disease even after antibody titers have waned, there is some other basis for immunity, but at the lower dose in children, there is no expectation that those same immune processes will behave similarly to the higher adult dose.”
Low Hospitalization Rate
In the meeting, members realized that there were more than 1.9 million infections in the US, and only 0.4% needed hospitalization, and we had only 94 death cases out of 8,400 hospitalizations.
They stated that 20% of the hospitalized children had additional diseases besides C-19, and seven out of 10 children had severe health conditions like heart disease.
The CDC says that 40% of the children have had C-19. The recovery process creates some immunity, and some studies say that natural immunity is better than the one from the vaccines.
“The benefit here is assumed to be prevention of severe disease, which is what we’re all hoping for,” Kurilla said during the meeting. But among the recovered, he added later, “The question becomes, does this vaccine offer any benefits to them at all?”
Kurilla signaled he would have voted “yes” if the FDA had proposed opening up access to the vaccine to a subset of the 5–11 group. He also explained why he abstained.
“My abstention was based on the specific question the FDA asked. A ‘no’ vote would have been misconstrued as my opinion about the vaccine,” he told The Epoch Times. “There are high-risk groups within the 5–11 age group that would benefit from the vaccine, suggesting a more tailored approach.”
Others Question Widespread Use!
Some members were concerned and questioned if the children should get the vaccine.
“I’m torn. On the one hand, we know that many mothers and fathers and parents are eager to administer this vaccine to children because they’re so frightened, perhaps overly so, … that they really are anticipating having access to this vaccine in children,” said Dr. Cody Meissner, the director of pediatric infectious disease at Tufts Medical Center.
“On the other hand, I think we saw that approximately 68 percent of the children who are hospitalized with COVID-19 have underlying comorbidities. That means about 32 percent do not. And then if we were to take 40 percent of that group that may have immunity already, we’re getting down to a tiny percent of otherwise healthy 6- to 11-year-old children who might derive some benefit,” he added.
However, others stated that these children should get the vaccine. Their protection would stop the hospitalizations, and the schools would remain open.
“We don’t want children to be dying of COVID, even if it is far fewer children than adults, and we don’t want them in the ICU,” said Dr. Amanda Cohn, a CDC official.
Jeannette Lee is a biostatistics professor at the University of Arkansas for Medical Sciences. The data by Pfizer impressed her. They were based on an approach immunobridgining. Pfizer’s trial presented that the jab triggered antibodies in children. They were compared to the adults, and the comparison served as proof that the vaccine protects the children.
Kurilla disapproved of the approach, “it’s being based on an immunogenicity marker that we know wanes.”
“There are high-risk individuals, and I think they do need to be attended to, that we do need to provide a vaccine for them. But for many others, one dose—or no dose, even if they’ve had prior COVID infection. I think they may not need anything more,” he said.
Side Effects
Cases of heart inflammation after receipt of the Pfizer and Moderna vaccines are highest in young male teenagers. Reports claim that the cases are higher than expected in males from 12 to 49 after the second Pfizer dose. Also, there were 12 to 24 female increased cases after the second Pfizer dose.
More than half of the children with myocarditis and pericarditis needed hospitalization.
Pfizer stated that neither one from 5 to 11-year-old kid in the trials experienced post-vaccination heart inflammation. A third of the amount of that given to older people is a try to curb side effects.
Among young males, “the benefits appear to outweigh the risks,” Hong Yang, an FDA scientist, told members. Among young females, “the benefits clearly outweigh the risks,” she added.
“What will the actual myocarditis rate be in these younger kids?” Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital, wondered. That group “may be less susceptible to myocarditis, but right now that’s a speculation,” he added. “We don’t know that for sure.”
Some public faces expressed concern saying that the safety data wasn’t enough to authorize the vaccine for such young children.
“I am not as concerned about myocarditis in this age group as I am in the older kids,” Dr. Melinda Wharton, another CDC official, said.
“If the surveillance systems do start seeing severe outcomes and deaths from vaccination, I’m quite confident that those surveillance systems will tell us that we need to pause as we did with the J&J vaccine to really have a good idea of what the effects are vaccinating this age group,” said Dr. Patrick Moore, professor at the University of Pittsburgh Cancer Institute.
The ‘Yes’ Votes.
The majority of members stated that the vaccine’s benefits for 5-11 aged children outweighed the risk and potential risk.
“I think this vaccine will likely be effective in reducing pediatric COVID in this age group and may also help reduce transmission. On the safety end, I’m encouraged by the lower dose, … finding a dose that’s immunogenic and had not too much in terms of reactogenicity,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital.
Dr. Eric Rubin is an adjunct professor at the Harvard TH Chan School of Public Health and stated that the parents should be able to choose if they would allow their children to be vaccinated.
“The question of how broadly to use it, though, I think is a substantial one. And I know it’s not our question, but I—and I know we’re kind of punting that to [the CDC’s advisory panel]—but I do think that it’s a relatively close call,” he said.
Soon after, in a comment that was widely distributed online, he added: “We’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes. That’s how we found out about rare complications of other vaccines, like the rotavirus vaccine.”
Rubin told The Epoch Times in an email, responding to critics: “The clinical trial of the Pfizer-BioNTech COVID-19 vaccine in children showed no adverse events. All data to date indicate that it is safe. It will prevent the hospitalization of children with severe disease, as it does with adults. The vaccine works and saves lives.”
