A member of the Food and Drug Administration (FDA) independent advisory panel said Tuesday the safety of the Pfizer COVID-19 vaccine for children aged 5 to 11 years of age will remain unknown until after children are already vaccinated.
“We’re never gonna learn about how safe the vaccine is until we start giving it,” said Dr. Eric Rubin during the meeting. “That’s just the way it goes.”
On Friday, the FDA, as expected, authorized the Pfizer vaccine for children of this age group, making it available to 28 million children in the United States, NBC News reported.
Days earlier, the panel, known as the Vaccines and Related Biological Products Advisory Committee voted 17-0 in favor of emergency authorization of the Pfizer vaccine for 5-11 children, Scripps National reported.
One doctor abstained from that vote.
According to Scripps, the panel was asked to respond to the following question:
Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in children 5-11 years of age?
The children’s vaccine is a lower dose of the COVID-19 vaccine adults are already taking.
A Centers for Disease Control and Prevention (CDC) advisory panel will now review the FDA’s decision.
If CDC Director Dr. Rochelle Walensky signs off on vaccinating young children, the shots can be administered widely.
Moderna also announced Monday an interim analysis of data showed its COVID vaccine is effective in children aged 6 to 11, and that it plans to submit its study to FDA, European Medicines Agency (EMA), and other global regulators, reported ABC15 News.
Fox News’ Life, Liberty & Levin host Mark Levin asked Yale epidemiology professor Dr. Harvey Risch Monday evening about the Biden administration’s intentions to ramp up vaccinations for young children throughout the country.
“Does the science support this kind of activity?” Levin asked.
Well, this is a risk benefit analysis, and from what I understand the adverse events occurring from COVID itself in five to 11 year olds are so infrequent that the hazards from the vaccines are likely to be greater than the hazards from the illness, and so the the benefit is against vaccination for almost all of that age group.
Risch said the vaccine might be considered, however, for children “with chronic conditions like obesity, diabetes, asthma, respiratory diseases.”
“So, why do you think there is this move and almost obsession with vaccinating little kids?” Levin asked.
“I really don’t understand the mindset of government officials who think that noble lying, so-called noble lying, to the population is a valid approach to governance and public health,” the Yale professor asserted.
“If you’re a parent, and you have a seven or eight year old, and the federal government is going to insist that those kids get vaccinated, or, if you live in a state like California, where Gov. Newsom is going to do that and so forth … what would you do?” Levin continued. “Would you get your kid vaccinated? Would you talk to your local doctor? What would you do?”
If the child has chronic conditions that make their risk appreciable, then there’s a reason that they would, should be considered for vaccination. Other than that, if it were my child, I would homeschool them. Honestly, I would organize with other parents to take them out of the school and create homeschooling environments. There’s no choice. Your child’s life is on the line. It’s not a high risk, vaccination is not a high risk, that’s going to kill every child by doing so. However, it’s enough of a risk that, on the average, the benefit is higher for homeschooling than it is for vaccination and being in school. And that’s just the bottom line.
In September 2020, Yale News reported a study from Yale and Albert Einstein College of Medicine, published at Science Translational Medicine, that showed children experience a different immune system response to infection by the COVID-19 virus.
The study’s finding “helps explain why COVID-19 outcomes tend to be much worse in adults,” Yale News noted, adding:
[T]he new study, which examined serum and cell samples obtained from pediatric and adult patients diagnosed with COVID-19, found that children actually express higher levels of two specific immune system molecules. The researchers believe this may contribute to the better outcomes.
“The suggestion is that kids have a more robust, earlier innate immune response to the virus, which may protect them from progressing to severe pulmonary disease,” said Betsy Herold, the study’s co-senior author and a professor of pediatrics and microbiology-immunology at Albert Einstein College of Medicine.
Robert F. Kennedy, Jr., chairman of Children’s Health Defense (CHD), and Meryl Nass, M.D., wrote last week to each member of the FDA’s advisory committee highlighting the most recent research showing children ‘have virtually zero risk of hospitalization and death from the COVID-19 virus,” a press release stated.
“Conversely, according to Pfizer’s own study trial data, the chance of death in children from the Pfizer vaccine is 107 times higher than death due to COVID,” said Dr. Brian Hooker, CHD Chief Science Officer.
According to Medscape, some members of the FDA panel were somewhat anxious about their decision to recommend the shots for young children.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville, Tenn.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
“This is a much tougher one than we had expected going into it,” Rubin, who is also editor-in-chief of New England Journal of Medicine, said about the decision of whether to give the jabs to young children.
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