FDA Approves Moderna ‘Spikevax’ COVID-19 Vaccine for Young Children

In an epic MAHA™ fail, the FDA under Health Secretary RFK Jr has now approved Moderna’s mRNA COVID‑19 vaccine for children aged six months through eleven years.

Spikevax Approval for Young Children

The mRNA COVID‑19 vaccine manufacturer Moderna on July 10 announced that the US Food and Drug Administration (FDA) has licensed its “Spikevax” shot for use in children aged six months through eleven years who are considered at increased risk of severe COVID‑19 disease.

Previously, for that age group, Moderna’s mRNA COVID‑19 vaccine was being administered under Emergency Use Authorization (EUA), a regulatory status for FDA unapproved pharmaceutical products that are still considered experimental.

The EUA status was based on the determination of then Secretary of the Health and Human Services (HHS) Alex M. Azar II on March 27, 2020, that the COVID‑19 pandemic posed “a public health emergency” and that “circumstances exist justifying the emergency use” of “an unlicensed biological product”.

The FDA’s approval letter to Moderna, dated July 9 and signed by the Director of the FDA’s Center for Biologics Evaluation and Research (CBER), Dr. Vinay Prasad, states that Spikevax is now licensed for use “in individuals who are 65 years of age and older, or 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID‑19”.

Moderna’s press release thanked the FDA for what it called a “diligent scientific review”. The approval letter references three clinical trials underlying the FDA’s supplement approval, one of which is relevant for individuals aged twelve years and older, for whom the shot was already approved.

Of the two relevant for younger children, only one was a randomized, placebo-controlled trial. But like the original trials for adults, long-term safety data won’t be forthcoming because the placebo group was vaccinated away after the FDA granted the shot EUA status for children aged 5 through 7 years.

For efficacy estimates, the primary outcome measured was antibody levels, which is scientifically fraudulent since no correlates of immunity have been established for SARS‑CoV‑2. Just because a person has a certain antibody titer does not mean they are protected against COVID‑19, and a low level of antibodies does not mean that a person is not protected.

A secondary endpoint of the trial was efficacy against infection. No significant efficacy was observed for asymptomatic infection. The results indicated modest efficacy against the outcome of one or more symptoms plus a positive PCR test, but this was based on less than 3 months of follow-up, thus ignoring the known rapid waning and observational studies finding negative vaccine effectiveness after several months.

Like the original trials, it was not designed to measure meaningful outcomes such as efficacy against severe disease, hospitalization, or death. Consequently, the benefits of the shot in young children, who are generally at low risk of severe COVID‑19, have not been shown to outweigh the risks.

The approval of Moderna’s Spikevax runs counter to the intent of health freedom advocates who voted for Donald Trump with the hope of getting Robert F. Kennedy, Jr. into a position to do something to stop people from being harmed by the systematic violation of the right to informed consent that results from public vaccine policies.

We can recall, of course, how the mRNA COVID‑19 vaccines were initially sold to the public based on the lie that two doses would confer durable sterilizing immunity, stopping infection and transmission and thereby creating “herd immunity” that would end the COVID‑19 pandemic.

Many other lies have been told to the public about the safety and effectiveness of these mRNA products, some of which I detailed in my June 3 article “The Deception of the FDA’s New COVID-19 Vaccine Guidance”.

Among the concerns is the finding that vaccine vials are contaminated with plasmid DNA from the manufacturing process, which increases the risk of genomic integration with human DNA and the risk of cancer, but which the FDA has to date completely ignored.

Kennedy launched the “Make America Healthy Again™” or MAHA™ campaign after quitting the presidential race to join forces with Donald Trump, and supporters have been promised that the FDA would now make “evidence-based” decisions. The approval of Spikevax for young children demonstrates the emptiness of that promise and adds to a growing list of deceptive betrayals.