FDA refuses to consider Moderna flu shot in move experts claim is part of ‘anti-vaccine agenda’ | Trump administration

Moderna’s clinical trial on a new, potentially more effective flu vaccine was a “brazen failure” and the FDA is now questioning it, a senior US Food and Drug Administration (FDA) official said.

The FDA unexpectedly refused to consider Moderna’s application for a flu vaccine based on messenger RNA (mRNA) technology, a decision that experts say has already had a chilling effect on vaccine development.

Officials say the problem stems from the design of the study, which required control group participants over the age of 65 to receive a high dose of the flu vaccine instead of the standard flu vaccine.

Outside experts say the reasons run deeper.

“This is all pretext and confusion when the real agenda is to reject conventional science and serve a predetermined anti-vaccine agenda,” said Richard Hughes IV, a partner at Epstein Becker Green and a law professor at George Washington University.

Dorit Reiss, a law professor at UC Law San Francisco, said that “personally disparaging a company is not a legitimate reason to refuse to review an application” and that the denial must “address the substantive reasons.” “They’re finding reasons not to approve mRNA, and eventually they’ll do that to all vaccines,” says Angela Rasmussen, an American virologist at the Vaccine and Infectious Diseases Organization at the University of Saskatchewan.

Andrew Nixon, a spokesman for the U.S. Department of Health and Human Services, said concerns that mRNA and other vaccines were targeted by authorities were “unfounded.”

Moderna’s “brazen failure” to design the study differently “raises significant ethical concerns,” the senior FDA official, who asked not to be named during a news conference with reporters on Wednesday, said.

Reiss said even the way the FDA communicated on the issue raised alarm.

“The fact that you don’t identify yourself shows to me that you don’t want to stand behind the decision because you know that the decision is weak, flawed and indefensible, politically motivated, fundamentally not valid,” he said. “Not being named here is an act of cowardice and shows that the government knows there is no case.”

The vaccine application was rejected because it lacked an “adequate and well-controlled” trial and because the control group did not have “the best standard of care available in the United States at the time of the study,” according to a letter signed by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER).

Moderna says the FDA often weighs in on its own processes and has never objected to the study so far.

“This was an FDA-approved trial design,” said Moderna spokesman Chris Ridley.

When the Guardian asked whether the FDA had approved the design, the official did not respond directly and confirmed that the FDA had given a “written recommendation” to include a high-dose vaccine for elderly participants, “but of course they said it was important for patients to obtain informed consent in case they did not follow the recommendation.”

But at other points in the press conference, the official characterized the FDA’s position in stronger terms.

Regarding the directive he gave to Moderna, the official said, “We told you not to employ people over the age of 65.” “You didn’t do what we told you, so go back to the drawing board.”

In April 2024, Moderna said CBER told the company in writing that “while we agree that it would be acceptable to use a licensed standard dose of influenza vaccine” in the control group, “we recommend using a vaccine that is preferably recommended for use in older adults” such as a high-dose vaccine. The FDA said such a move “may help inform ACIP’s recommendation for use of your vaccine in the older adult population,” according to Moderna.

Advisory Committee on Vaccination Practices (ACIP) And HKM Recommend higher dose vaccines whenever possible, but standard vaccines are recommended if higher doses are not available.

Moderna included information about the decision to use the standard flu vaccine for all ages in the consent form signed by all trial participants, a plan FDA officials agreed to, according to Moderna. Hughes said it’s unlikely the FDA would tell Moderna not to pursue such a trial, and that the company would do so.

“It’s very risky for a manufacturer to grossly flout the agency’s guidance and proceed down a path that is clearly not in line with what was agreed upon with the agency. It’s more likely that the FDA will reverse the situation at the 11th hour,” he said.

The FDA last year approved vaccines from Novavax and Pfizer only for certain groups of people. Hughes noted that after serious side effects were observed, the FDA revoked the license altogether rather than adding a warning label to the new Chikungunya vaccine.

In the Moderna decision, Prasad overruled agency scientists who recommended reviewing the application, including a memo from vaccine office director David Kaslow. based on to Stadium News. The FDA official, who declined to be named Wednesday, described the news as “rumor in the halls of the FDA” and “a disgruntled individual reaching out and telling their version of the story, thus gaining disproportionate coverage.”

Prasad’s tenure at the FDA has been tumultuous. he was was fired from the FDA in July and from the Wall Street Journal on Wednesday before being reinstated. reported There are allegations of verbal and sexual harassment by Prasad at the agency.

Moderna may administer the vaccine to people between the ages of 50 and 64, the official said.

“If they come back, maybe they can show some humility and [say] He said: ‘Yes, we didn’t follow your advice, this is the data we have and let’s look at 50 to 65 [sic] “The group where there is a little more balance,’ then the review team can say: ‘We’ll take this group into consideration,'” they said.

Moderna added a group of participants over the age of 65 to the trial who received high doses of the vaccine. But the FDA said the evidence was not solid enough to be considered for approval.

“They looked at the immediate antibody response,” the official said. “People have been critical of using an antibody carrier when you have a measurable result in the real world.” Antibody responses are frequently used in vaccine trials, especially influenza vaccines.

“Moderna exposed participants ages 65 and older to an increased risk of serious illness by providing them with substandard care contrary to the recommendations of FDA scientists,” HHS spokeswoman Nixon said.

Rasmussen found these arguments unconvincing: “They don’t seem to find anything in the entire trial that would suggest there would be a problem, so you’re focusing on older people.”

HHS announced He said last year that all new vaccines should be compared with placebos rather than existing vaccines, which would violate current standards of care.

“Changing your location midstream is a problem for companies,” Reiss said. “This will really deter companies from doing vaccine trials. We need better and more flu vaccines, not less.”

The Moderna decision “has a huge chilling effect because no other manufacturer will want to make these types of investments,” Rasmussen said. “If you don’t have access to the U.S. market, you can’t do business appropriately.”

Rasmussen said the mRNA flu vaccine could be extremely useful for people with egg allergies, and mRNA is also a more flexible way to respond to flu mutations and even pandemics: “This is something that’s extremely important from a public health perspective.”