(LifeSiteNews) – The U.S. Food & Drug Administration (FDA) approved a new mRNA-based COVID-19 vaccine from Moderna over the weekend, further dashing hopes that a new administration would close the book on the controversial shots.
The new vaccine, mNEXSPIKE, is approved for “active immunization to prevent coronavirus disease 2019,” to be taken by “individuals who have been previously vaccinated with any COVID-19 vaccine and are: 65 years and older, or 12 through 64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19,” according to the FDA.
A patient packaging insert will notify users of the potential for myocarditis or pericarditis, the odds of which it puts at “approximately 8 cases per million doses in people 6 months through 64 years of age and approximately 25 cases per million doses in males 12 years through 25 years of age”; and says generally subsides “a few days after receiving treatment with medicines used to reduce inflammation.”
“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.”
In keeping with an announcement last month by FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad, there is no blanket recommendation for all Americans to receive the new shot, but the “risk factors” it will be recommended for include asthma, cancer, cerebrovascular disease, chronic kidney diseases, a handful of chronic liver and lung diseases, diabetes, disabilities such as Down’s syndrome, heart conditions, HIV, dementia, Parkinson’s, obesity, smoking, tuberculosis, and more. Late last month, Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. announced COVID vaccines will not be recommended to healthy children or pregnant women.
Still, the news indicates the Trump administration’s overall view of COVID vaccination will remain favorable and raises questions as to just how thoroughly the previous shots’ adverse events have been investigated for a new vaccine to be approved less than five months into the new administration.
For the past four years, President Donald Trump has dismissed objections to the COVID shots, which were developed in record time by his administration’s Operation Warp Speed initiative.
Since leaving office, he repeatedly promoted the shots as “one of the greatest achievements of mankind.” The negative reception to such comments got him to drop the subject for a while, but in July 2022, he complained that “we did so much in terms of therapeutics and a word that I’m not allowed to mention. But I’m still proud of that word, because we did that in nine months, and it was supposed to take five years to 12 years. Nobody else could have done it. But I’m not mentioning it in front of my people.”
Pressed on the vaccines’ performance in a September 2024 interview with Sharyl Attkisson, Trump reiterated that “I think I did an amazing job with Covid” while granting, “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.”
Trump joining with Kennedy during the campaign caused many “COVID accountability” activists to hope for a change in direction. But during his confirmation hearings, Kennedy called Operation Warp Speed an “extraordinary accomplishment,” and since taking office most of the secretary’s activities have focused on other issues, such as conventional vaccines and food additives. Makary pledged during his own confirmation hearings simply to take an objective look at the evidence.
Meanwhile, a new interim Senate report headed by Republican U.S. Sen. Ron Johnson of Wisconsin alleges that Biden administration officials “were well aware of the risk of myocarditis following COVID-19 vaccination,” yet “opted to withhold issuing a formal warning to the public for months about the safety concerns, jeopardizing the health of young Americans.”