The FDA is pushing for new trials before future COVID shot recommendations but plans to continue endorsing the shots for pregnant women, the elderly, and a wide range of other ‘risk factors.’
WASHINGTON, D.C. (LifeSiteNews) -- Despite announcing new safety trials before future COVID-19 shot recommendations, the U.S. Food & Drug Administration (FDA) under the Trump administration still plans to recommend the controversial shots for a significant number of Americans, including pregnant women, according to a new paper.
As LifeSiteNews previously covered, FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad co-authored a paper in the New England Journal of Medicine, as part of a health safety initiative from Health & Human Services (HHS) Secretary Robert F. Kennedy Jr.
“For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted,” it announced. “Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment.”
While the announcement of more scrutiny was welcome to many, the paper also said that “FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes, as described by the CDC.”
Those risk factors, according to a list provided in the article, 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.
Notably, the list also includes “pregnancy and recent pregnancy,” mental or emotional issues such as depression and schizophrenia, and “physical inactivity.”
“So the news leak was a lie. The shots will continue to be given to children and pregnant women,” lamented Dr. Mary Talley Bowden, founder of Americans for Health Freedom.
While the news represents a modest overall reduction in the number of people for whom the vaccines will be recommended, and new trials leave open the possibility that future findings could more drastically change the recommendations, at the moment the government is poised to continue recommending that a great many Americans take the jab.
For the past four years, Trump has refused such appeals about the evidence against 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.”
When 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, meanwhile, pledged during his own confirmation hearings simply to take an objective look at the evidence.
Earlier this month, populist podcaster Tucker Carlson interviewed former biology professor and COVID dissenter Bret Weinstein, during which the latter said that “everybody tells me that there’s no way forward” on dumping the jabs “by reaching President Trump,” because “the president has a certain amount of pride in Operation Warp Speed. And I think he feels mistreated over the rejection of Operation Warp Speed as an accomplishment. And that has caused him to dig his heels in.”
Meanwhile, a new interim Senate report headed by Sen. Ron Johnson (R-WI) 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."
