Moderna’s SpikeVax Gets Full FDA Approval for High-Risk Children Amid Lawsuit Over Vaccine Policy Shift

Moderna received full FDA approval for its COVID-19 mRNA vaccine, called SpikeVax, for use in children aged 6 months to 11 years who are considered high risk. Previously, this vaccine was only given an Emergency Use Authorization (EUA) for this age group. In May, the CDC announced a change in its COVID-19 vaccine policy, no longer recommending COVID-19 vaccines for healthy pregnant women and children. The FDA also announced in May that the agency would no longer routinely approve new formulations of the COVID-19 vaccine for healthy individuals under the age of 65.

A CDC page last updated on October 2nd states, “Infants younger than 6 months of age and children with one or more underlying medical conditions are at higher risk of severe COVID-19 disease.” A separate CDC page lists 22 underlying conditions and risk factors that “increase a person’s risk of severe illness.” These conditions include some chronic lung diseases, chronic kidney diseases, cystic fibrosis, and cancer. The underlying conditions and risk factors list also includes physical inactivity, obesity, and asthma.

The Physical Activity Alliance released its 2024 report in October, concluding that only 20-28% of children receive an hour of physical activity per day, which is the recommended amount. There is limited data on the likelihood of adverse effects from vaccines for children or individuals of any age with underlying medical conditions.

On June 25, the FDA approved a new required warning label for SpikeVax and Comirnaty, an mRNA COVID-19 vaccine manufactured by Pfizer. The warning label states, “Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age.”

The FDA is requiring Pfizer and Moderna to conduct studies to assess the potential long-term health effects for individuals who have developed myocarditis after receiving an mRNA COVID-19 vaccine. The FDA stated that these studies are underway as of June 25.

The vaccine insert shares solicited adverse reaction data with up to 46.5% of babies (6-36 months) experiencing a loss of appetite, up to 12.2% experiencing groin swelling/tenderness. 29.3% of those 37 months to 11 years experiencing nausea/vomiting and up to 27% experienced groin swelling/tenderness. There were 50 reports of herpes zoster, also known as shingles, in the SPIKEVAX group compared to 23 in the placebo group in the blinded portion of the study. In the 28-day post-vaccination period, there were 22 cases in the SPIKEVAX group and 15 in the placebo group. The insert states the data is “insufficient to determine a causal relationship with the vaccine.”

Earlier this week, the American Academy of Pediatrics (AAP) and several other groups filed a lawsuit against HHS Secretary Kennedy, FDA Commissioner Marty Makary, NIH Director Jay Bhattacharya, and other officials claiming the HHS directive to remove the recommendation of COVID-19 vaccinations for healthy children and healthy pregnant women is arbitrary and capricious.

In the lawsuit, the plaintiffs claim that the directive must be vacated to protect pregnant women, unborn children, and all children. “Unless the Secretary’s baseless and uninformed policy decision is vacated, pregnant women, their unborn children, and, in fact, all children remain at grave and immediate risk of contracting a preventable disease,” the lawsuit complaint states. “This decision immediately exposes these vulnerable populations to a serious illness with potentially irreversible long-term effects and, in some cases, death. This is not a public health emergency that demands immediate legal action and correction.”

The directive being referenced does not prevent healthy children and pregnant women from accessing COVID-19 vaccines. The CDC is no longer recommending the vaccine for these groups, but they can still access the vaccine through shared decision-making with their doctors. The lawsuit states that the “disease” of COVID-19 is preventable, but there is no scientific evidence that any of the COVID-19 vaccines prevent infection.

A 2024 study states, “It has been assumed that the COVID-19 vaccination reduces the risk of transmission to others. Results during the delta predominance show that the viral load in the vaccinated population is not consistently lower compared to the unvaccinated, and during the omicron predominance, the viral load was even somewhat higher.”

A House report released in October evaluated the effectiveness of a PR campaign called “We Can Do This” to promote the COVID-19 vaccine. The campaign relied upon CDC guidance that asserted COVID-19 vaccines are “highly effective against transmission.” The House report concluded that this claim and several others by the CDC lacked scientific evidence to support the assertion and that these statements undermined the CDC’s credibility.

Secretary Kennedy has not yet made any statements regarding the allegations made in the lawsuit.