New mRNA COVID Vaccine Approved as Questions About Safety and Policy Direction Persist

The U.S. Food and Drug Administration (FDA) has unfortunately approved another mRNA-based COVID-19 vaccine, sparking renewed debate over vaccine policy, safety oversight, and the direction of the Trump administration’s health strategy.

The newly authorized shot, mNEXSPIKE from Moderna, supposedly targets high-risk individuals and arrives amidst mounting skepticism from more and more Americans who expected the new administration to take a fresh look at pandemic-era health policies.

A New mRNA Shot for the High-Risk Population

According to Moderna and the FDA, mNEXSPIKE is approved for “active immunization to prevent coronavirus disease 2019” and is intended for people previously vaccinated against COVID-19.

The targeted groups include individuals aged 65 and older, as well as those between the ages of 12 and 64 who have at least one underlying medical condition that puts them at increased risk for severe COVID outcomes.

The vaccine is not being promoted as a one-size-fits-all solution. Following remarks by FDA Commissioner Dr. Marty Makary and vaccine advisor Dr. Vinay Prasad, the agency has not issued a universal recommendation for the new vaccine. Instead, eligibility guidelines include a long list of health conditions—ranging from asthma and cancer to dementia and diabetes—as well as risk factors such as obesity and smoking.

Adverse Reactions Still a Concern

Although the shot is FDA-approved, the product’s patient packaging insert explicitly warns of potential side effects—particularly myocarditis and pericarditis, which are types of heart inflammation.

According to the document, the risk is “approximately 8 cases per million doses” in people aged six months to 64 years, and up to 25 cases per million among males aged 12 to 25. While Moderna says most cases resolve “a few days after receiving treatment with medicines used to reduce inflammation,” critics argue that even these seemingly small odds become meaningful when scaled up to millions of doses.

The warnings also revive unresolved questions about how prior adverse events have been handled—or ignored—by public health authorities. An interim Senate report led by Sen. Ron Johnson (R-WI) recently accused the Biden administration of delaying formal public warnings about myocarditis risks, potentially endangering young Americans.

With a new vaccine now on the market less than five months into the Trump administration, some are asking whether sufficient investigation into prior side effects has really occurred.

Continuity in Vaccine Policy, Despite Campaign Rhetoric

The approval of another mRNA shot may be seen by some as a continuation of existing pandemic-era vaccine policy—an unexpected move for those who believed that a Trump-Kennedy ticket would mark a clear break from the past.

While Robert F. Kennedy Jr., now serving as Secretary of Health and Human Services, announced last month that COVID shots would no longer be recommended for healthy children or pregnant women, he also called Operation Warp Speed—Trump’s vaccine acceleration program—an “extraordinary accomplishment” during his confirmation hearings.

Despite strong early support from voters who wanted greater accountability and caution around mRNA technology, Kennedy has so far focused his efforts on other areas, such as food safety and standard childhood vaccines. FDA officials, for their part, have promised to review the evidence objectively—but the latest approval has led many to wonder what, if anything, has actually changed.

Trump’s Mixed Messaging on COVID Shots

President Trump’s stance on the COVID vaccines remains a source of confusion and tension within his base. As the driving force behind Operation Warp Speed, Trump repeatedly praised the vaccines after leaving office, calling them “one of the greatest achievements of mankind.” Yet the backlash from voters prompted him to go quiet for a time.

In July 2022, Trump acknowledged the political fallout from his pro-vaccine comments, saying, “I’m not mentioning it in front of my people.” However, he defended the vaccine rollout as a monumental logistical success, stressing that it had been accomplished in record time. When pressed in a September 2024 interview with journalist Sharyl Attkisson, he struck a more cautious tone, saying, “I think they’re doing studies on the vaccines that we’re gonna find out. And it’ll come out one way or the other.”

More Needs To Change

The mNEXSPIKE approval reveals a subtle but significant reality: despite a change in administration and rising public demand for vaccine transparency, federal health policy on COVID immunization remains largely intact.

Moderna CEO Stéphane Bancel hailed the approval as a win for public health, pointing to 47,000 COVID-related deaths in the U.S. last year as justification for continued vaccination efforts among the most vulnerable.

Yet for many Americans, especially those who have followed the controversies surrounding myocarditis, rushed approvals, and lack of long-term data, this moment feels less like progress and more like déjà vu. The political optics are difficult to ignore. With the Trump administration still praising Warp Speed, Kennedy downplaying mRNA concerns, and the FDA moving ahead with new approvals, public skepticism continues to grow.

The promise to “look at the evidence” objectively will be put to the test in the months ahead. Will this administration finally take a critical, science-driven approach to past vaccine decisions? Or will the machinery of pandemic-era health policy simply roll on under new management?

Ask your doctor if spike proteins are right for you.

Source: https://www.offthegridnews.com/happening-now/new-mrna-covid-vaccine-approved-as-questions-about-safety-and-policy-direction-persist/