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FDA Advisory Meeting Breaks Out Into Conflict After Vote to Authorize Covid Vaccines for Young Children

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VBRPAC) meeting on Tuesday broke into conflict over a question that is polarizing the nation: Should children as young as five years old be getting the Covid vaccines?

The VRBPAC meeting encountered significant pushback over the FDA’s insistence on the language used to recommend vaccines for children between 5 and 11 years old. The vote, however, was 17 to 0 in favor with one exemption.

“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 (10 micrograms each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age?”

The votes were: Yes: 17; No: 0; Abstain: 1.

“Panel chair Arnold Monto has now tried to get the FDA to change the wording of the question twice — and has been rebuffed by the FDA’s Peter Marks both times,” Stat News reported on the minutes. “Several panelists clearly worry that while they believe the vaccine should be an option, particularly for kids who are at risk, they’re not sure the data exist for a wide approval.

“Help us out in terms of what happens if we vote yes,” Monto said, “and clearly if we vote no the vaccine will not be available to anyone.”

“Marks once again said that he’d like to stick with the question as worded,” Stat News noted. “Amanda Cohn, a CDC representative on the panel, chimed in to say that she thought the panel’s discussion reflected the difficulty of balancing risks and benefits in children. But she said that she believed that, as worded, the benefits of the vaccine clearly outweigh the risks and that the measures for detecting rare side effects will allow the U.S. to change course if myocarditis is more problematic than it appears.”

“To me, the question is pretty clear: 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,” Cohn said.

But a number of medical health professionals and parents were very concerned about the FDA’s push towards vaccinating children.

Earlier in the discussion, James Hildreth, CEO of Meharry Medical College, said, “This is a really tough one. I do believe children at highest risk do need to be vaccinated, but vaccinating all the children to achieve that seems a bit much to me.”

Michael Kurilla, an NIH researcher, called it “ the toughest decision” and said he resented the “binary presentation” of the question. “But the panel may decide to clear the vaccine, and leave restrictions on the vaccine to the CDC’s ACIP committee,” Matthew Herper of Stat News reported.

The group then continued to pushback on the FDA’s strong-arming of the vote phrasing.

“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 (10 micrograms each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age?”

“The answer is binary, as chair Arnold Monto has informed the group more than once,” Stat News noted. “They are to vote yes or no.”

“It’s clear some people on the committee think the vaccine should be available, but maybe isn’t something all children in this age group need,” appeared to be the working consensus of many.

“Cody Meissner, at pediatrician at Tufts Medical Center, raised concerns that if the vaccine is authorized for this age group, school mandates will follow,” the report said. “Meissner said he opposes them.”

“Ofer Levy, director of Harvard Medical School’s Precision Vaccines Program, asked if the wording of the question could be changed to give the committee some leeway,” the minutes noted.

The public comments section of the meeting – one full hour – is where things got really heated. It begins about 4 hours and 32 minutes into the video below.

One of the most interesting and pointed objections to the sweeping recommendation that healthy children as young as five years old get the vaccines came from Dr. Jessica Rose.

Dr. Rose’s outstanding rebuttal can be viewed in full below following the National Association of Pediatric Nurse Practicioners’ endorsement of the vaccines for children:

“Emergency use authorization of biological agents requires the existence of an emergency, and the non-existence of alternate treatments,” Dr. Rose said. “There is no emergency and Covid-19 is exceedingly treatable.”

Dr. Rose then made pains to point out that 19 times the expected myocarditis events in children are being reported to VAERS following Covid-19 vaccination. She also criticized the targeted censorship of academic journal reporting that highlights the inordinate myocardities and pericarditis events in this age cohort.

Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer, however, touted the FDA panel’s vote.

“COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the U.S., as they remain at risk for this infection. About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications. In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner. We thank the FDA advisory committee for their review and positive recommendation in support of Emergency Use Authorization to help protect this young population,” she claimed.

However, this population is not statistically at significant risk from COVID-19. This is an empirical fact borne out by the data. The latest CDC data records “542 deaths involving Covid-19” among those under 18 since January 2020. When ruling out 94% of this population due to serious underlying comorbidities, such as heart disease and cardiopulmonary disorders, that results in a case survival rate for healthy children under the age of 18 is 99.99996%.

A new Wall Street Journal report also provided research from the United Kingdom that shows tha event children who were infected have an extremly high case survival rate.

“Children are at extremely slim risk of dying from Covid-19, according to some of the most comprehensive studies to date, which indicate the threat might be even lower than previously thought,” WSJ notes.

“Some 99.995% of the 469,982 children in England who were infected during the year examined by researchers survived,” one study found.

“In fact, there were fewer deaths among children due to the virus than initially suspected,” it continues. “Among the 61 child deaths linked to a positive Covid-19 test in England, 25 were actually caused by the illness.”

The FDA panel also ignores natural immunity, which is highly prevalent among the childhood population. The CDC’s figures estimated that at least 120 million Americans had been infected with Covid-19 by the end of May, thus possessing natural immunity, which is superior to vaccinated immunity. That figure can be projected to be at least 160 million currently, due to the Delta variant wave and the CDC’s estimate there are at least four Covid infections for every case reported.

The Covid-19 vaccines also do not ‘stop the spread,’ according to the CDC’s admission, and their lowering of transmission is not highly effective and wanes quickly. This calls into question whether a vaccine recommendation and predictable subsequent mandates are justifiable on public health grounds.

The FDA’s refusal to widely examine and publicize reports on Covid antibodies among the childhood population, acknowledge natural immunity from prior infection, or the extremely low risk posed to healthy children, should be glaring red flags that the public health agency’s motive is to push the vaccines at all costs, regardless of the medical necessity, the ethics, and the actual science.


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OPINION: This article contains commentary which reflects the author's opinion.