FDA Drops Placebo-Controlled Trial Requirement for NEW mRNA Vaccines

"The FDA reversed course and accepted an amended application with the promise that Moderna would conduct an additional study in ​older adults once the (mRNA flu) vaccine is approved.” - REUTERS

May 28, 2026: REUTERS reported that the FDA is currently reviewing Moderna’s mRNA flu vaccine and that the FDA will be holding a meeting of outside experts next ​month (June 2026) to review Moderna’s biological license application (BLA).

Background

May 21, 2025: The FDA announced that the agency would be requiring placebo-controlled trials for approval of new mRNA vaccines and for the use of the COVID-19 mRNA injections in healthy adults.

February 3, 2026: Holding true to the FDA’s new policy, FDA Vaccine Chief and CBER Director - Dr. Vinay Prasad - refused to review Moderna’s FDA application (BLA) for mRNA-1010 because the biotech firm used an existing flu vaccine instead of placebo as the control arm.

Prasad even ordered a 75% refund of the FDA application fee to Moderna.

February 18, 2026: Two weeks later, the FDA reversed Prasad’s decision, and agreed to review the application for flu vaccine mRNA-1010.

March 6, 2026: Approximately 1-month after refusing to review Moderna’s application, the FDA announced that Dr. Vinay Prasad would be leaving the FDA sometime in April.

FDA Reverses Course for Approval of New mRNA Technologies

March 21, 2026: Per REUTERS, “After meeting with the ​Moderna, the FDA reversed course and accepted an amended application with the promise that Moderna would conduct an additional study in ​older adults once the vaccine is approved.”

“A decision is expected by August 5.” - REUTERS

mRNA Are High-Risk, Dual-Use Gene-Editing Technologies with Zero Benefit

It’s important to note that mRNA injections are dangerous (aka - ‘high-risk’) dual-use gene-editing technologies that provide zero benefit in preventing viral infections, transmission, severity of disease, hospitalizations and/or deaths.

“As the pandemic showed us, mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract.” - HHS Secretary RFK Jr., AP News, Aug 6, 2025

In fact, the mRNA injections are shown to increase the risk of infection, disabilities and death, especially in healthy children and teenagers.

Video Clip from Sept. 19, 2025 Advisory Committee to the CDC

The Use of mRNA Injections for Infectious Disease Prevention or Treatment is Unlawful

Bottom line, the FDA was and is acting in a reckless and unlawful manner by ignoring the original laws of the FD&C Act in granting Pfizer FDA approval on August 23, 2021, and the agency is violating the safety laws of the National Childhood Vaccine Injury Act.

With HHS ignoring MAHA demands to have the shots pulled, compassionately educating our communities and organizing peaceful protests against the mass use of high-risk (dangerous) biologics and devices in adults and children, may be the most effective tactic to protect our bodily sovereignty.

It’s important to note that the MRNA injections were and are also unlawfully and fraudulently approved and promoted as ‘safe and effective’ by the departments of HHS.

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