FDA Quickly Authorizes COVID Shots for Infants and Young Children

The Food and Drug Administration (FDA) quickly authorized the Moderna and Pfizer-BioNTech COVID vaccine shots for infants and young children Friday, paving the way for the Centers for Disease Control and Prevention (CDC) advisory committee to vote on authorization over the weekend to allow the youngest children to get the shots as early as next week.

Per the press announcement by the FDA, the Emergency Use Authorization (EUA) for the Moderna COVID vaccine for older children and adults has been “amended” to “include use of the vaccine in individuals 6 months through 17 years of age,” while the EUA for the Pfizer COVID shot will now include use of the vaccine for babies as young as “6 months through 4 years of age.”

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age,” said FDA Commissioner Robert M. Califf, M.D., adding:

As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death. Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

Once the CDC’s Advisory Committee on Immunization Practices (ACIP) votes to authorize the vaccines, Director Dr. Rochelle Walensky will provide the final sign-off.

On Thursday, Walensky told a Senate health committee hearing her staff would work over the Juneteenth federal holiday weekend “because we understand the urgency of this for American parents.”

On Wednesday the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the EUA for the Moderna and Pfizer shots for the youngest children, despite an abundance of calls from physicians, children’s health organizations, and members of Congress to refrain from approving the shots for a population that shows the least risk for serious disease from COVID.

Senator Ron Johnson (R-WI) posted his concerns about the lack of information on the “long-term safety profile” of the vaccines along with a video of a question put to FDA official Dr. Peter Marks, who directs the agency’s Center for Biologics Evaluation and Research, regarding the incidence of myocarditis, an inflammation of the heart muscle, in 12-17-vaccinated children.

“This is, this is a known phenomena in the 12 to 17 year-old age range and the, the rate that it was seen in, in the, in the 12 to 17 year-olds who were vaccinated seem to be about fivefold higher than the baseline rate that we would expect,” Marks acknowledged. “And that’s why this is not a slam dunk.”

He added:

It’s very challenging when something’s only three to five times more common in a vaccinated population. You don’t know whether it’s just cases that have kind of, cases that would have been there that aren’t really associated with the vaccine that have come up, or how much actually the vaccine has increased that risk.

In response to the American Medical Association’s (AMA) announcement, it plans to put a stop to “disinformation” that it claims has been spread by some health professionals about the COVID vaccines, Dr. Mary Talley Bowden, founder of BreatheMD and advocate for healthcare transparency, provided a list of reasons why parents should be cautious about having their children take the COVID vaccines:

Dr. Clare Craig, a British diagnostic pathologist who is co-chair of the HART Group, explained why the FDA “should NOT have granted approval” for COVID vaccines for infants and very young children.

Craig zoned in on the Pfizer trial that she says has “shocked” her.

“The trial recruited 4,526 children aged from 6 months to 4 years old,” she explained, adding, “3,000 of these children did not make it to the end of the trial.”

“That is a huge number,” she asserted. “Two-thirds of them. Why was there this drop off? That needs to be answered. And without an answer to that, on that basis alone, this trial should be deemed null and void.”

Craig continued:

So, what did the trial show? Well, they defined severe COVID as children who had a slightly raised heart rate or a few more breaths per minute. There were 6 children aged 2 to 4, who had severe COVID in the vaccine group, but only 1 in the placebo group. So, on that basis, the likelihood that this vaccine is actually causing severe COVID is higher than the likelihood that it isn’t. There was actually one child who was hospitalized in this trial. They had a fever and a seizure. They had been vaccinated.

Craig then asserted what Pfizer did then was “to utterly twist the data”:

They vaccinated the children and they waited 3 weeks after the first dose, before the second dose. In that 3-week period, 34 of the vaccinated children got COVID, and only 13 in the placebo group, which worked out as a 30% increased chance of catching COVID in that 3-week period if you were vaccinated. So, they ignored that data.

Craig continued that, during the 8-week gap between the second and third doses, many children got COVID in the vaccine group – “and they ignored that data,” she said.

“There was then several weeks after the third dose which they also ignored, which meant that in the end, they had ignored 97% of the COVID that occurred during the trial,” Craig asserted. “And they just looked at tiny numbers, so tiny in the end they were comparing three children in the vaccine arm who had COVID with seven in the placebo arm, and they said that this showed the vaccine was effective.”

The rush to approve the COVID shots for the youngest of children has met with an uproar from many in the healthcare community, given that children are the least likely to develop serious illness from COVID and that the CDC has already assessed that about 74.2 percent of children in the nation have had COVID already.

On Wednesday Robert F. Kennedy, Jr. founder and chairman of Children’s Health Defense, tweeted, “If Pfizer’s COVID-19 vaccine is added to the pediatric vaccine schedule, and if it’s mandated like other childhood vaccines, it will become an evergreen market representing billions of dollars to the drug companies.”

In an interview with NewsNancy, Kennedy elaborated on that point.

“Well, they have to give it to kids because here’s why,” he began. “They cannot market this vaccine without having immunity shield.”

The pharmaceutical companies would never market an approved vaccine “without getting liability protection,” Kennedy said, and explained the EUA vaccines have liability protection.

“So, as long as you take it in emergency use, you can’t sue them,” he said. “Once they get approved, now you can sue them, unless it can get recommended for children.”

“All vaccines that are officially recommended for children get liability protection, even if an adult gets that vaccine – that’s why they’re going after kids,” he asserted. “They know this is gonna kill and injure a huge number of children, but they need to do it for the liability.”

In comments to The Star News Network, Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons (AAPS), also warned of the dangers already observed, but not widely reported, in adults who have been vaccinated and boosted.

“Apparently, at least 30,000 cases of Adult Sudden Death Syndrome post-vaccine, with no other credible explanation, are allowed, but how many in children are allowed?” she asked. “It is far too early to see long-term effects such as infertility, cancer, or autoimmune diseases.”

Orient asserted the use of the mRNA “experimental gene-therapy products in children is reckless and irresponsible at best.”

“Manufacturers are comfortable with their liability protection, but are doctors safe if they fail to warn parents, and if parents ignore mild symptoms that call for an urgent cardiac workup?” she asked.

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Susan Berry, PhD is national education editor at The Star News Network. Email tips to [email protected].