‘Unconscionable’: FDA Approves New COVID Vaccines — Even for Infants as Young as 6 Months — Based on Minimal Data or Testing

by Michael Nevradakis, Ph.D. The Defender

fda approves new covid vaccine infants feature

The U.S. Food and Drug Administration said the new vaccines are “formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.” However, the vaccines target the XBB.1.5 variant, which “is declining in the U.S.,” according to CNBC.

The U.S. Food and Drug Administration (FDA) on Monday approved updated mRNA COVID-19 vaccines produced by Pfizer-BioNTech and Moderna, paving the way for their approval by the Centers for Disease Control and Prevention (CDC).

The CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting today to vote on whether to recommend the two vaccines, CNBC reported. Following ACIP’s vote, CDC Director Mandy Cohen is “likely” to approve its recommendation, Endpoints News reported, opening the door for the vaccines’ public availability.

The vaccines received FDA approval for people ages 12 and up, and Emergency Use Authorization (EUA) for children from 6 months to 11 years. Ages 5 and over will be eligible to receive a single dose, previously vaccinated children between 6 months and 4 years of age will receive one or two doses, while unvaccinated children in the same age group will be eligible for two Moderna doses or three Pfizer-BioNTech doses.

According to the FDA, the new vaccines are “formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death.”

However, the vaccines target the XBB.1.5 variant, which “is declining in the U.S.,” according to CNBC, citing CDC data.

Linda Wastila, Ph.D., professor of geriatric pharmacotherapy at the University of Maryland School of Pharmacy and director of research for the Peter Lamy Center for Drug Therapy and Aging, accused the FDA of acting unethically.

Wastila told The Defender:

“It is unethical to continue to approve and authorize mRNA vaccines for COVID-19 when the pandemic has disappeared. It is unethical to promote these boosters as safe and effective when it is clear they are not, and the government is ignoring evidence that the vaccines can provide considerable harm.

“The fact that these vaccines were authorized for children when a public health emergency no longer exists is unconscionable.”

Dr. Pierre Kory, president and chief medical officer of the Front Line COVID-19 Critical Care Alliance (FLCCC), said, ”It is unconscionable that the government can recommend this booster for 6-month-olds when the FDA has no data on how children might be affected.”

In a separate statement, the FLCCC said, “By leveraging the unnecessary Emergency Use Authorization … the FDA is pushing forward with an experimental vaccine booster based on limited safety and efficacy data.”

“There is no need to vaccinate healthy children for COVID-19,” Kory said. “To give them an untested booster goes against everything we are trained to do as physicians.”

Canadian physician Dr. William Makis said, “There is no ‘COVID-19 emergency’ for children, therefore there is no legitimate scientific basis for an ‘emergency authorization’ of a new COVID-19 booster in this age group,” adding, “any doctor still administering COVID-19 mRNA vaccines to children of any age is engaging in medical malpractice.”

According to The New York Times, “Federal officials have been retreating from labeling the new formulation as boosters to previous shots, preferring to recast them as an annual immunization effort akin to the flu vaccine,” due to “the fatigue that some Americans have expressed about yet another round of shots against the virus.”

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said, “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death.”

While ACIP, whose meeting was still in progress at the time of this writing, still needs to formally recommend the vaccines, approval appears to be all but certain.

Harvey Risch, M.D., Ph.D., professor emeritus and senior research scientist in epidemiology (chronic diseases) at the Yale School of Public Health, told The Defender that “rubber-stamp approval” is the likely outcome of today’s meeting.

Pfizer CEO Albert Bourla said, “We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities.”

Dr. Meryl Nass, an internist and member of the Children’s Health Defense scientific advisory committee, live-blogged the ACIP meeting for CHD.TV. She said that, early in the meeting, “They are only presenting old data — presumably a bait-and-switch to the new vaccine.”

“They have removed the authorizations for the bivalent boosters so as of today, you can only receive a vaccine for which no data have been made public — the vaccines are being grandfathered in, in a manner used for flu shots yearly, as an amendment to the existing licenses issued for the initial monovalent vaccines,” she told The Defender.

‘Like dogs chasing their tails’

The Times reported that the XBB.1.5 variant “was dominant when vaccine makers began to formulate and test a new version” of their COVID-19 vaccines, and they are monovalent — “they do not include protection against the original virus.”

“Experts say the new COVID jab should fortify protections against severe infection,” the Times reported, while the FDA claimed that “Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.”

However, Wastila told The Defender “I do not understand why public health and political leaders are advocating for a booster that is already obsolete.”

“The approved and authorized boosters are like dogs chasing their tails — the mild variants they are supposed to help mitigate serious disease are already waning, already being overtaken by the next generation of mild, mutated viruses,” she said.

Yet, CNBC reports that “While the shots do not target the variants dominant now, the vaccine makers have said the shots will still offer protection against those strains,” citing data showing COVID-19 hospitalizations “have increased for seven straight weeks.”

Cardiologist Dr. Peter McCullough told The Defender, “XBB.1.5 is 3.1% of strains as of Sept. 2, and expected to be extinct by the time any American is injected. The current dominant and growing strains are EG.5 at 21.5% and FL.1.5.1 at 14.5%.”

“There are no randomized clinical trials demonstrating either Pfizer or Moderna XBB.1.5 boosters would work” against the new strains, he added.

Writing on his Substack, Dr. Robert Malone, pioneer and expert in mRNA and DNA vaccines and therapies, noted that the XBB.1.5 variant “is on its way to becoming extinct,” while new variants “have evolved even further to escape the antibody pressure elicited by the globally deployed leaky ‘vaccines.’”

He noted that “the FDA administrative bureaucracy self-determined that they could continue to bypass their normal (already lax) procedures for evaluating purity” by authorizing the agency to approve new COVID-19 vaccines and boosters for 180 days after the public health emergency expired May 11.

The PREP Act (Public Readiness and Emergency Preparedness Act) liability shield for the COVID-19 vaccines will remain in place through Dec. 31, 2024.

Little data, but ‘a lot of red flags’ surrounding the updated COVID vaccines

According to CNBC, “Pfizer, Moderna and Novavax have released early trial data indicating their new shots provide protection against Eris,” adding that Pfizer and Moderna have also said their updated shots produced a “strong immune response against BA.2.86,” another emerging COVID-19 subvariant.

In its announcement, the FDA said:

“The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants. …

“Based on an evaluation of the totality of the evidence, the benefit-risk profile is favorable for individuals 6 months of age and older to receive an updated COVID-19 mRNA vaccine.

“Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.”

In the same announcement, Marks said, “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality.”

However, according to the Times, only Moderna has shared trial data of its updated vaccine, which shows that testing was conducted on 100 people. It does not appear that any children or pregnant women were included in that sample.

Also according to the Times, Pfizer spokesperson Jerica Pitts said the updated Pfizer-BioNTech COVID-19 vaccine “involved tests in animals,” and that “Trials following people who received the shot are continuing.” Yet, Pfizer claims the new vaccine generates antibodies that “effectively neutralize” the EG.5 subvariant.

“The only testing has been on antibody levels,” said Risch. “No clinical testing has been done on the new boosters.”

“It is safe to say that even if safety was a consideration, a sample of 100 is insufficient to detect most safety issues in a general population, much less vulnerable individuals, such as older adults, pregnant women, and children,” Wastila said.

According to Risch, even if there were pregnant women and children included in Moderna’s 100-person sample, the sample size would nevertheless be inadequate.

“Our current estimate of serious adverse events/death after the COVID-19 shots is 1 in 140 people,” he said. “So, one would need upwards of 1,000 people just to see anything, and maybe 5,000-10,000 to have a reasonable numerical estimate.”

Kory said the FDA’s exclusive reliance on data provided by the manufacturers “is a great conflict of interest” and “not how [they] are going to rebuild trust with the public.”

On his Substack, Malone also noted that the risk of the new COVID-19 subvariants — and subsequent need, or lack thereof, for vaccines targeting them, has not been tested, but that the vaccines’ EUA status enabled them to quickly attain FDA approval.

“Nothing in the FDA justification addresses the risk to human health posed by these viral variants,” he wrote. “The FDA has completely avoided any justification for the use of the emergency use authorization pathway, rather than a more standard, traditional testing and evaluation process. Because they do not think that they need to.”

Similarly, at a Sept. 7 press conference, Florida Surgeon General Joseph Ladapo said “There’s essentially no evidence” supporting the updated vaccines, and “no clinical trial showing that it is a safe product for people … but there are a lot of red flags.”

“It’s truly irresponsible for [the] FDA, CDC and others to be championing something … when we don’t know the implications of it,” he added.

According to Wastila, “Both Moderna and Pfizer have failed to deliver on promised post-marketing studies” from prior COVID-19 vaccines. “We have yet to see the results from the bivalent vaccine safety studies in pregnant women; the myocarditis studies in young people also have not been completed nor have most results been shared.”

‘The beginning of their public backslide’

Notably, public health officials and the news media appear to be walking back rhetoric that claimed those who were vaccinated would not catch COVID-19 or transmit it.

“As with earlier shots, the updated ones are not expected to eliminate the chances of contracting a mild case of COVID. Instead, they are expected to reduce the chances of severe illness, hospitalization or death,” the Times wrote.

This contrasts with statements made by Dr. Anthony Fauci during a May 2021 MSNBC interview, where he said the COVID-19 vaccines “protect you completely against infection,” and that those infected aren’t likely to transmit the virus or have symptoms.

Indeed, the FDA conceded, in its announcement, that “Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines.”

Wastila, who as part of the Coalition Advocating for Adequately Labeled Medicines, submitted a citizen petition to the FDA on Jan. 31 with concerns about inadequate COVID-19 vaccine labeling, said the FDA’s “acknowledgment that the boosters may not be needed by all individuals is the beginning of their public backslide.”

“The way Fauci and his cohorts have changed their narrative on the vaccine is deeply troubling and sows more distrust among the public and clinicians,” Kory said. “It is hard to believe and be led by officials who constantly change their story in a way that appears to suit their need to never admit that they may have gotten something wrong.”

Notably, FDA adviser Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told the Daily Mail “We are best served by targeting these booster doses to those who are most at risk of severe disease,” and that “Boosting otherwise healthy young people is a low-risk, low-reward strategy.”

In separate remarks shared with KFF Health News, Offit, who is 72, said “I don’t plan to get it myself,” referring to the updated COVID-19 vaccine.

Dr. Ashish Jha, former White House COVID-19 adviser and now dean of Brown University’s School of Public Health, told KFF that “a reasonable person” could disagree regarding the need for healthy young people to get the updated vaccine.

The Times wrote “Young males have experienced higher rates of myocarditis … after getting vaccinated, although many recovered after a few months,” quoting University of Pittsburgh drug safety expert Walid Gellad, M.D., MPH, who said, “The benefits are just getting lower and lower for young healthy people who’ve had COVID before.”

“Paradoxically, those who most need protection … are often likely to have weakened immune systems that fail to generate the hoped-for response to vaccination,” KFF said.

McCullough said “None of the changes in the mRNA genetic code [of the new vaccines] appear to make it safer, and we can expect more Americans to suffer injuries, disabilities, and death as a result of the unprecedented vaccine campaign.”

He added that the Vaccine Adverse Event Reporting System (VAERS) “hit a grim milestone this August, with 18,015 COVID-19 vaccine deaths, with approximately 1,100 dying on the same day they took the shot,” while Kory noted that VAERS data now shows that “400,000 people required medical care after receiving a COVID vaccine.”

VAERS has historically been shown to report only 1% of actual vaccine adverse events.

‘People aren’t stupid’

Risch called the updated COVID-19 vaccines “a useless idea,” noting that “Almost everybody has had COVID-19 at least once and/or has been vaccinated and has a substantial degree of immunity. That puts them at low risk of serious responses to the viruses circulating now and through the fall and winter.”

CNBC noted “It’s unclear how many Americans will … get another shot in the coming months,” reporting that according to CDC data, only 17% of the U.S. population received Pfizer’s and Moderna’s previous boosters, released in September 2022.

According to the Times, “Nursing homes … have fallen behind on booster rates,” with Medicare data indicating that only approximately 62% of residents are up-to-date.

A survey of 2,196 people published Sept. 4 in Vaccine found that the main reasons for not receiving the previous bivalent booster included immunity due to prior infections, concerns about side effects and a belief that boosters do not provide protection.

“When the pandemic ‘hit,’ there was a lot of fear and uncertainty. The government’s policy reactions to COVID-19 further fueled this fear,” Wastila said. “But two years have passed, and now you can’t hide the burgeoning disability in previously healthy adults and children, turbo cancers and inexplicable sudden deaths.”

“You also can’t hide all the COVID-19 cases that have occurred in vaccinated and boosted individuals, nor can you hide the relative mildness of COVID-19 variants,” she said. “People aren’t as afraid as they were in 2020. People aren’t stupid.”

Malone wrote that while there are “271 deaths per week … with COVID … we lose 200-300 mostly young people per day to Fentanyl and other opiates.”

He also referred to recent documents obtained via a Freedom of Information Act request revealing that most people being hospitalized with COVID-19 are vaccinated and that the FDA and CDC hid data on the spike in deaths among this population.

Wastila said this data is “of great concern” and that “there does appear to be a dose response to this risk — the more shots, the greater likelihood of hospitalization and/or death,” adding that “These current boosters will only further this ‘negative effectiveness’ response, will only further weaken and destroy recipients’ immune systems.”

Moderna planning ‘awareness campaign’ for ‘consumers to get vaccinated’

According to CNBC, the FDA did not announce a decision regarding Novavax’s updated COVID-19 vaccine, although according to Novavax, the vaccine is still under review and is ready to ship pending FDA approval. CNBC noted that the Novavax uses “protein-based technology” that is “decades old,” instead of mRNA technology.

Kory, however, said “Novavax still utilizes the spike protein as an antigen, and the spike protein causes significant damage to vessel walls and micro-clotting,” adding that “the adverse event rates in the Novavax trial are as elevated as the mRNA vaccines.”

Risch said the FDA’s delay may be due to “crony capitalism,” saying that “Compared to Pfizer and Moderna, Novavax doesn’t pay enough fees to support [the] FDA.”

The Biden administration will “urge” people to get COVID-19 and flu vaccines, and RSV (respiratory syncytial virus) shots for those eligible, at the same time, the Times reported.

The Times claimed this practice “has been studied and considered by some experts to be safe,” but experts who spoke with The Defender disagreed. Wastila said, “There are no real-time clinical studies of concurrent use of COVID-19 and flu vaccine administration … the few studies that have looked at this issue have been retrospective.”

“Policymakers and clinicians fail to recognize that not all flu shots are the same nor are all COVID-19 shots the same. What is the reaction between a nasally administered flu vaccine and the current Pfizer booster or Moderna or Novavax vaccine?” Wastila asked.

According to a MedPage Today story published last month, there is no data available for administering the COVID-19, flu and RSV vaccines at the same time.

Similar messaging to that of the Biden administration is emanating from the vaccine manufacturers. According to CNBC, Bourla and Moderna CEO Stéphane Bancel both urged the public to receive their COVID-19 and flu vaccines at the same time.

According to KFF, Moderna recently told investors “it was focused on increasing sales” of its vaccines via “awareness campaigns” which will “connect COVID-19 with seasonal flu vaccines with the goal to drive consumers to get vaccinated this fall.”

“Government and medical authorities are making a mockery of the scientific process for reviewing and understanding the risks and benefits of vaccines,” Kory said. “It is against our oath as physicians to advise patients to use a therapy or vaccine that we have so little knowledge of.”

“COVID-19 is likely here to stay, and we need to manage it in ways that support public health and not pose a greater risk than the virus itself,” he added.

Watch today’s ACIP meeting here:

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