FDA reverses decision and agrees to review Moderna’s flu vaccine
The Food and Drug Administration reversed its decision on Moderna’s flu vaccine and agreed to review it for possible approval.
Just last week, Moderna announced that the agency had rejected its request to review a new flu vaccine. The FDA said the company’s research design was flawed.
But in the subsequent discussions, the authority gave in and agreed to an inspection, the company announced on Wednesday. As part of the revised approach, Moderna said it has agreed to split its flu vaccine application by age. It is planned to apply for standard approval for people aged 50 to 64 and accelerated approval for people aged 65 and over. The company also said it has agreed to conduct an additional study in people aged 65 and over once the vaccine comes to market.
The FDA did not provide a detailed explanation Wednesday as to why it suddenly changed direction. But his initial refusal to even consider Moderna’s application sparked swift and high-profile rebukes and spooked the pharmaceutical industry – beyond vaccine makers – as well as investors. The investment firm Blackstone alone invested $750 million in the development of a flu vaccine by Moderna.
Top industry executives traveled to the White House for high-level meetings, including with President Trump. Some focused on ways to circumvent tariffs threatened by Mr. Trump or reduce drug prices.
But industry executives have become increasingly vocal about their displeasure or discomfort with the government’s dismantling of vaccine policy and the FDA’s recent tendency to reject drugs after years of agreements on trial standards. A number of pharmaceutical companies have also expressed similar concerns after the FDA declined to review their applications or withheld approvals.
Dr. Moderna President Stephen Hoge said on Fox Business on Wednesday that Moderna and its competitors need clear and consistent rules from regulators. “What we cannot allow are arbitrary changes to these rules after the game has been played,” he said.
The company’s flu vaccine uses messenger RNA technology, which Health and Human Services Secretary Robert F. Kennedy Jr. has repeatedly criticized as unsafe and ineffective. The mRNA approach, which instructs the body to produce a fragment of a virus that triggers an immune response, has been widely successful in Covid vaccines and is widely considered safe by public health experts and scientists.
The technology allows companies to pivot quickly to update a vaccine, unlike the traditional method often used for flu shots.
During Mr. Trump’s first term, the administration enthusiastically supported mRNA-based Covid vaccines. But last year, the second Trump administration turned against the technology, sending shockwaves through the vaccine industry. Hundreds of millions of dollars in research contracts and projects have been canceled, and authorities under Mr. Kennedy’s purview have sharply limited recommendations for administering Covid vaccines to certain groups of people.
When he initially rejected the novel flu vaccine last week, Dr. Vinay Prasad, the agency’s top vaccine official, sent a rejection letter citing concerns that the control vaccine, which Moderna used in a study of people over 65, was not the best option available. He wrote the letter over the objection of the second-highest ranking vaccine scientist at the FDA
According to federal recommendations, a vaccine with a higher dose than normal is the most effective protection for older people.
When the rejection caused an uproar, the agency began retreating. Dr. FDA Commissioner Marty Makary was conciliatory, saying on Fox Business that Moderna could return as part of “the normal back-and-forth dialogue that the FDA has with companies.”
Andrew Nixon, a spokesman for the Department of Health and Human Services, confirmed that the FDA has since held meetings with Moderna and decided to accept a revised approach.
“The FDA will maintain its high standards throughout the review and potential approval phases, as it does with all products,” Mr. Nixon said in a statement.
The dispute over Moderna’s study design came to public attention when Moderna provided a schedule of its original meetings with the FDA to prepare for the clinical trial. The company said the agency found its plan to use a widely used vaccine, Fluarix Quadrivalent from GSK, “acceptable” even though regulators preferred a different vaccine.
Moderna reported that the vaccine was found to be safe and effective in its study. It has worked well in preventing flu cases across all age groups. Most side effects were mild, such as fatigue, muscle pain, headache, and pain at the injection site. However, the study found that these side effects were more common and more severe in adults under 65 than in their older counterparts.
The study also found that side effects with Moderna’s flu vaccine were worse than with the comparator shot.
On Tuesday evening, Dr. Makary did not indicate that the authority intended to change course soon. At an event in Washington hosted by PhRMA, the drug industry’s trade group, he said: “I think if you’re going to talk about what happened last week, you should know the exact details of the trial results, which are public information.”
He also defended the government’s drastic cut in recommended vaccinations for children, saying the changes should increase confidence in federal guidance. “I want more children to be vaccinated,” he said.
John F. Crowley, president of BIO, a trade group for biotechnology companies, said the development of mRNA vaccines is “critically important to public health.”
“The FDA’s decision to review Moderna’s flu vaccine now is absolutely the right thing to do for continued American biotech innovation,” he said in a statement. “The past week has highlighted the need for greater consistency and predictability from the FDA if we are to ensure that the U.S. remains a global leader in biomedical research.”
Moderna said it has agreed with the FDA to launch a new study in the future to compare the flu vaccine for people 65 and older with one with a higher dosage or a similar option, which would give doctors more information about which choice is best.
The company said the FDA has set a deadline of August for a decision on whether to approve the vaccine. If approved, it will be available to these older adults when flu season begins later this year.
No mRNA-based flu vaccine is approved worldwide. Regulators in Europe, Canada and Australia are reviewing Moderna’s vaccine.
The approval of the flu vaccine is central to Moderna’s future growth. Moderna shares rose 6 percent by Wednesday’s close. The company’s shares have fallen sharply since their peak during the Covid pandemic as it struggled to develop a second stock amid falling demand for Covid vaccinations.
