FDA Approves New COVID Vaccines for Infants as Young as 6 Months — Based on Minimal Data or Testing

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.


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.”


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.”


“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 Jerb/20230911213153/https:/ica 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.”

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.


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.”


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.


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.

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.”


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.


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.


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.”


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.”


Watch today’s ACIP meeting here:


Via https://childrenshealthdefense.org/defender/fda-approves-new-covid-vaccines-infants-minimal-data-testing/