Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. addressed concerns regarding the FDA’s approval of a new mRNA COVID-19 jab manufactured by Moderna.

“I want to address those of you who have anxieties about @US_FDA’s limited approval of a new mRNA COVID vaccine for high-risk populations. Moderna has agreed to a true placebo-controlled trial of the new vaccine, which is similar to the existing mRNA vaccine but uses a smaller protein,” RFK Jr. said.

“The FDA will monitor and collect data throughout the trial for every adverse outcome—not just a table list of expected outcomes. FDA will scrutinize every aspect of the trial. We will deliver on our promise to use gold standard science and common sense,” he added.

I want to address those of you who have anxieties about @US_FDA’s limited approval of a new mRNA COVID vaccine for high-risk populations. Moderna has agreed to a true placebo-controlled trial of the new vaccine, which is similar to the existing mRNA vaccine but uses a smaller…

— Secretary Kennedy (@SecKennedy) June 3, 2025

Per Bloomberg:

Under Kennedy, US health agencies have taken steps to limit who can get Covid vaccines, arguing there’s a lack of evidence for repeat doses. The FDA indicated last month it would no longer approve Covid booster shots for healthy adults and children without new studies.

Moderna’s second-generation vaccine was approved for all adults 65 and older, as well as anyone 12 and over who has at least one risk factor for severe disease. The company’s older Covid shot had previously been approved for people 12 years of age and older regardless of their underlying health.

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Requiring vaccine makers to test their shots against a placebo group is unusual and has raised ethical concerns. Giving people an inert substance when a vaccine exists can potentially expose them to preventable illness. Moderna’s new Covid vaccine, which will be sold under the name mNexspike, was tested against its older Covid shot, called Spikevax.

RFK Jr.’s statement faced much criticism on social media.

Unethical to continue this experiment. Unethical. How many times do we have to say it?

— Mary Talley Bowden MD (@MdBreathe) June 4, 2025

You are the clinical trials people.
And it’s already been approved.

— Kelly DNP Functional/Integrative Medicine (@kacdnp91) June 3, 2025

There's no such thing as a postmarket RCT. You just made that up. All of the study completion dates are after Trump has already left office (2029 to 2032). Tell the intern who wrote this to stop lying because it's making @RobertKennedyJr look bad.

— Toby Rogers (@uTobian) June 3, 2025

You’re trusting Moderna after they’ve refused to investigate why their shots harmed countless people?

And we’re supposed to trust the FDA which has done nothing but ignored science and swept injuries and deaths under the rug?

Trust is gone and you’re never earning it back.

— Louie Traub (@louietraub) June 3, 2025

The anxiety? This technology is killing people!!! Pull it off the market. Make them do proper clinical trials WITH long term safety studies. There is NO STATE OF EMERGENCY and therefore no EUA should be granted. Back to normal proceedures OR pull the Prep Act protections And…

— Brian Tyson, MD 🇺🇸 (@btysonmd) June 4, 2025

Full text:

The anxiety? This technology is killing people!!! Pull it off the market. Make them do proper clinical trials WITH long term safety studies. There is NO STATE OF EMERGENCY and therefore no EUA should be granted. Back to normal proceedures OR pull the Prep Act protections And vaccine liability protection.

Anything short of that is called MANIPULATION AND IT IS ILLEGAL AND UNETHICAL!!

“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” Moderna CEO Stéphane Bancel said.

“COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA’s timely review and thank the entire Moderna team for their hard work and continued commitment to public health,” he added.

We announced today that the U.S. FDA has approved mNEXSPIKE®, a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes… pic.twitter.com/RJ1CezICKZ

— Moderna (@moderna_tx) May 31, 2025

From Moderna:

The FDA’s approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax®), Moderna’s original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.

In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.

Moderna expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA®, the Company’s approved respiratory syncytial virus (RSV) vaccine.

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mRNA-1283 is under review with regulators in multiple markets around the world.

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