mRNA Vaccine Subjects Children's Trial Suspended

mRNA Vaccine Subjects Children's Trial Suspended

Jan. 2, 2025

THE PLANDEMIC - FOLLOW THE MONEY

Dr. John Campbell

Moderna halted its clinical trial of experimental mRNA vaccines for respiratory syncytial virus (RSV) in babies after the shots were linked to severe side effects.

The U.S. Food and Drug Administration (FDA) disclosed this week in a briefing document that rather than protecting babies as anticipated, the vaccine likely caused higher rates of severe RSV illness among the vaccinated babies enrolled in the Phase 1 clinical trials.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet Thursday “to discuss considerations for RSV vaccine safety in pediatric populations” based on Moderna’s clinical trial data.

Although the FDA never cites Moderna by name in the document as the company that made the vaccine in question, the agency lists the investigational vaccines, mRNA-1345 and mRNA-1365, and describes trial outcomes.

The FDA document also stated that enrollment is now on hold for all investigational trials for RSV vaccines for infants and toddlers under age 2 and children ages 2 through 5 who haven’t previously had RSV illness.

In September, Moderna announced it had put the brakes on its plan to roll out its mRESVIA RSV vaccine for babies, “based on emerging clinical data.”

This is not the first time that an attempt to develop an experimental RSV vaccine for children caused severe illness. The FDA said a formalin-inactivated RSV vaccine trialed in the 1960s led to two toddler deaths, and 80% of vaccine recipients required hospitalization for severe RSV.

The illnesses were attributed to vaccine-associated enhanced respiratory disease (VAERD) — a phenomenon that occurs when vaccination promotes immune responses that exacerbate the disease caused by subsequent infection with the pathogen the vaccine was meant to protect against.

The trials were halted in 1967, and clinical RSV vaccine research stalled until recently.

In 2023, the FDA gave Moderna the green light to move ahead with its clinical trial, also called the Rhyme Trial, to test the safety and immunogenicity of its two investigational mRNA RSV drugs in children ages 5-23 months.

The study received approval after the FDA fast-tracked Moderna’s investigational RSV vaccines in 2021, a process that speeds up the development and approval of a drug.

Results shared in the briefing document indicate that Moderna’s investigational vaccines also triggered a potential VAERD safety signal in small children.

Commenting on the briefing document, Dr. Meryl Nass, an internist, told The Defender:

“FDA is trying to cover itself, to avoid claims of negligence. It should have anticipated VAERD, because it happened before in RSV trials — and killed babies — and because it is happening now with the COVID vaccines, which, after roughly 6 months, depending on age and dose, make the recipient more likely to get COVID.”

In May, the FDA approved Moderna’s mRNA-1345, marketed as mRESVIA, for adults age 60 and over. It is Moderna’s only product, other than the COVID-19 vaccines, approved for market.

The FDA approved the drug without input from VRBPAC, which typically makes recommendations about such drugs because the agency said in its approval letter that it didn’t see any “concerns or controversial issues” that would make input necessary to the approval process.

Nass said that “FDA now has to worry about whether the adult RSV vaccine also may cause disease enhancement in the elderly, or other problems not appreciated or ignored in the clinical trials.”

Photo credit: depositphotos.com

https://childrenshealthdefense.org/defender/moderna-stops-mrna-rsv-vaccine-trial-babies-side-effects-fda/

Moderna Halts mRNA RSV Vaccine Trial for Children After Five Infants were Hospitalized
https://www.thegatewaypundit.com/2024/12/moderna-halts-mrna-rsv-vaccine-trial-children-after/

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Covid Vaccine Injury Global Study: www.react19.org/study

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