FDA Vaccine Panel Unanimously Ignores Calls to ‘Do No Harm’ and Recommends COVID Vaccines for Babies and Toddlers￼
The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21-0 Wednesday in favor of recommending Emergency Use Authorization (EUA) for the mRNA COVID vaccines of drug company giants Moderna and Pfizer/BioNTech for infants, toddlers, and preschool-age children.
Members of the advisory panel said the benefits of the vaccines outweigh the risks and they wanted families to have the choice to vaccinate their infants and young children, MedPage Today reported.
“I know that there are a lot of very relieved parents, almost certainly who are listening to this right now,” VRBPAC panelist Jay Portnoy, M.D., of Children’s Mercy Hospital in Kansas City, reportedly said. “They’ve been waiting for a very long time.”
Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research, claimed the rate of hospitalizations among young children during the Omicron surge was “troubling,” even worse than what is usually seen during the flu season.
Marks appears to be repeating White House COVID-19 Response Coordinator Dr. Ashish Jha’s narrative that “COVID is a far greater threat to kids than flu is,” based on a study by Harvard Medical School instructor Jeremy Faust.
In a Wall Street Journal column on June 5, however, Dr. Jay Bhattacharya, professor of health policy at Stanford University and a founding fellow at the Academy for Science and Freedom, debunked Jha’s claim, asserting it amounts to “scare-mongering,” and that the study by Faust Jha refers to is “flawed.”
Faust claimed COVID killed more than 600 children in 2021, while the flu killed “an average” of only 120 children annually.
But, Bhattacharya pointed out those data are “severely skewed” because just about everybody admitted to the hospital now receives a COVID test, while hardly any receive a flu test.
Between October 2018 and September 2019, 1.4 million flu tests were reported to public-health and clinical labs,” the Stanford health policy professor observed. “As of May 31, 2022, there had been 897 million PCR tests for Covid.”
Bhattacharya then noted the issue of the meaning of “COVID deaths”:
[E]vidence from audits of death certificates found that 35% of all pediatric deaths in 2020 “had co-occurring diagnosis codes that could not be plausibly categorized as either a chain-of-event or significant contributing condition,” according to a study published by the Centers for Disease Control and Prevention. Put another way, in at least 35% of pediatric “Covid deaths,” Covid couldn’t have been the cause.
Finally, Bhattacharya observed, “Faust relies on a figure for confirmed flu deaths that is well known to underestimate actual flu deaths by an order of magnitude.”
“Correcting for the lack of flu testing, the National Center for Immunization and Respiratory Diseases estimated 1,261 pediatric flu deaths in the 2012-13 season rather than the 142 that Dr. Faust reported.”
The White House’s “false message” that COVID is a high risk for children “undermines public health and erodes public confidence,” Bhattacharya concluded.
Two weeks ago, Jha said he was already planning for the distribution of the vaccines for babies and the youngest children as early as June 21 if the FDA and Centers for Disease Control and Prevention (CDC) approve.
Despite objections from numerous physicians, organizations, and at least 16 members of Congress urging the FDA to consider the risks now associated with the COVID vaccines, as well as questions about their efficacy and necessity when nearly 75 percent of all children and teens have already been exposed to the virus, per the CDC, the advisory panel went ahead and recommended approval.
“The chance of a child dying of COVID-19 is virtually zero, and the majority of children already have antibodies,” Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons (AAPS), told Lumen-News. “So why should they take any risk from a vaccine that has not even been shown to prevent infection or transmission?”
“The number of children in studies is tiny, not nearly enough to determine safety,” Orient observed. “Yet some children under five have already had heart damage after getting the as-yet-unauthorized vaccine off label. How many child heart attacks or deaths are too many?”
Dr. Katarina Lindley of the World Council for Health spoke during the FDA public hearing call. Lindley observed CDC’s assessment that about 74.2 percent of children have had COVID already.
“Over 150 studies show natural immunity is superior,” she stated. “The infection fatality rate under five years of age is 0.1 in 100,000, or, 1 in a million. The risk of the shot in the already immune is higher than 1 in a million.”
“Both Pfizer and Moderna expressly eliminated those that were naturally immune from their studies,” Lindley pointed out. “They did this to avoid the hyperimmune response and, possibly, death. Vaccinating the already immune presents a serious threat for a hyperimmune response.”
“Voting for some children to have a severe adverse reaction, and possibly death, if you vaccinate the already immune, there is zero reward,” she asserted. “These vaccines are not medically necessary or clinically indicated.”
Rep. Louie Gohmert (R-TX) noted during the public hearing portion of the meeting that VRBPAC did not respond to questions by the members of Congress concerning the vaccines’ safety, efficacy, and necessity.
“I’m deeply concerned that the push to vaccinate these children is nothing more than a dystopian experiment with unknown consequences,” Gohmert said, adding:
In conclusion, some of us have grave concerns that in balancing the risk to rewards here, all the risks are to the innocent children and all of the billion-dollar rewards go to the government-protected pharmaceuticals, leaving me to wonder if Republicans get a majority I may need to have a bill […] to allow civil and criminal liability to vaccine providers and accessories despite an EUA which would force more sensitivity towards vaccine harm to our young children.
The “good news,” Jha said – two weeks ago – is “that we have plenty of supply of both Pfizer and Moderna vaccines to start our vaccination program” for infants and toddlers.
“And we are going to make 10 million doses available to states, pharmacies, and community health centers, and federal entities to order initially,” the COVID czar said, offering that, “starting tomorrow, states can begin to place their orders.”
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