EXCLUSIVE: Healthshare Org Urges Incoming Trump Admin To Make ‘Radical’ Change To FDA, Healthcare System
'Plagued by waste and inefficiency'
In a post-election interview on Wednesday, Robert F. Kennedy Jr. revealed some of his plans for a major overhaul of the country’s key health agencies.
An MSNBC reporter asked RFK Jr. whether he will terminate “the top level federal service workers that are currently at" the Food and Drug Administration and Centers for Disease Control and Prevention.
“In some categories,” Kennedy responded. “There are entire departments, like the nutrition departments at FDA, that have to go.”
He said workers in certain departments, including nutrition, are “not doing their job” or “protecting our kids.”
“Why do we have Froot Loops in this country that have 18 or 19 ingredients, and you go to Canada, and it’s got two or three?” Kennedy questioned.
When asked whether he plans to eradicate any of the agencies, Kennedy replied, “To eliminate the agencies, as long as it requires congressional approval, I wouldn’t be doing that.”
Kennedy explained that he is confident he could “get the corruption out of the agencies.”
“It’s what I’ve been doing for 40 years. I’ve sued all those agencies. I have a PhD in corporate corruption, and that’s what I do. And once they’re not corrupt, once Americans are getting good science and are allowed to make their own choices, they’re going to get a lot healthier,” he added.
Less than a week before Election Day, Kennedy told NewsNation Trump’s plans for him in his future cabinet.
“President Trump has asked me to reorganize the federal health agencies. The agencies that have a portfolio that affects human health, which is CDC, [National Institutes of Health], FDA, as well as some of the agencies within the United States Department of Agriculture,” Kennedy said.
Kennedy said he was asked by Trump to end corruption and conflicts of interest as well as “measurably reduce chronic disease in our children within two years.”
On Sunday, he remarked, “I want to be in the White House. And [Trump has] assured me that I’m going to have that.”
Kennedy stated that he had not yet decided whether he wants to head the United States Department of Health and Human Services.
“I want to be in the position where I’m most effective to end the chronic disease epidemic,” Kennedy continued. “And I’m confident that if I wanted to do HHS secretary, the president would fight like hell to make that happen.”
Last week, Vice President Kamala Harris slammed Kennedy as “someone who has routinely promoted junk science and crazy conspiracy theories.”
She called him the “exact last person in America who should be setting health care policy for America’s families and children.”
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The U.S. Food and Drug Administration has approved Moderna's mRNA-1345 vaccine, which allegedly protects adults aged 60 and older from respiratory syncytial virus infection-caused lower respiratory tract disease.
The agency's breakthrough therapy designation approval for the drug, which will be marketed as mResvia, is only the second Moderna drug the FDA has approved. More significantly, it is the first mRNA vaccine to have been approved to address a disease other than COVID-19.
'We did not refer your application to the Vaccines and Related Biological Products Advisory Committee.'
Even though that amounts to a big step, it appears the regulator was keen to jump past additional levels of scrutiny.
The FDA noted in its Friday approval letter, "We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your [biologics license application], including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion."
The advisory committee's job is to review and evaluate data concerning the "safety, effectiveness, and appropriate use of vaccines and related biological products," then provide independent expert advice to the agency.
According to the pharmaceutical company, the approval was based on "positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 or older in 22 countries."
Nearly 20,000 of the trial participants were based in the United States. There are at least 11 other studies under way examining the impact of the novel drug on other demographics.
The company claimed in a Feb. 29 overview of its trial data that the vaccine "continued to be efficacious through median 8.6 months follow-up" and was shown to prevent severe RSV disease "base on analysis of shortness of breath and medically attended RSV-[lower respiratory tract disease]."
The vaccine's efficacy is allegedly 83.7%. Reuters noted, however, that the label indicates the shot is only 79% effective at preventing at least two symptoms of RSV, such as fever and cough.
While the overview insisted that the vaccine was relatively effective and safe, it nevertheless highlighted a number of "systemic reactions" reported within seven days of vaccination, such as headache, fatigue, myalgia, arthralgia, and chills, besides customary injection site pain.
A Moderna-funded study published in the New England Journal of Medicine similarly alleged that a single dose of the vaccine "resulted in no evident safety concerns."
Despite similarly having been presented as a safe vaccine, Moderna's COVID-19 vaccine was linked in various studies, including in an FDA-funded study, to an increased risk of myocarditis and pericarditis, particularly in men ages 18-25.
Extra to heart inflammation, the Global COVID Vaccine Safety Project — a Global Vaccine Data Network initiative supported by both the CDC and the Department of Health and Human Services — revealed in a February study in the esteemed journal Vaccine that "Bell's palsy had an increased [observed to expected] ratio after a first dose of [Pfizer's] BNT162b2 and [Moderna's] mRNA-1273."
The study also noted that "there were also increased OE ratios for febrile seizures following a first and second dose of mRNA-1273 ... and for generalized seizures following first mRNA-1273 dose and fourth BNT162b2 dose."
Blaze News previously reported that the University of Auckland, which hosts the Global Vaccine Data Network, noted that there were safety signals for "acute disseminated encephalomyelitis (inflammation and swelling in the brain and spinal cord) after viral vector and mRNA vaccines."
Despite outstanding concerns about its only other approved vaccine, Moderna appears confident in its product and has evidently secured the FDA's confidence as well. Its next stop is the Centers for Disease Control and Prevention, whose Advisory Committee on Immunization Practices will review the vaccine during its June 26-27 meeting.
Analysts estimate Moderna will do roughly $340 million in RSV vaccine sales this year and possibly $830.5 million in 2025, reported Reuters.
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