FDA reverses decision and agrees to review Moderna’s flu vaccine
- The San Juan Daily Star
- 2 hours ago
- 4 min read
By CHRISTINA JEWETT and REBECCA ROBBINS
The Food and Drug Administration reversed its decision on Moderna’s flu vaccine and has agreed to review it for possible approval.
On Feb. 10, Moderna announced that the agency had rejected its application for review of a new flu vaccine. The FDA said the company’s research design had been flawed.
But in subsequent discussions, the agency had relented and agreed to begin a review, the company said Wednesday. As part of the revised approach, Moderna said that it had agreed to split up its application for the flu vaccine based on age. It plans to seek standard approval for people 50 to 64 years old and accelerated approval for those 65 and older. The company also said it had agreed to conduct an additional study among those 65 and older once the vaccine reached the market.
The FDA did not provide a detailed explanation Wednesday as to why it suddenly changed direction. But its initial refusal to even consider Moderna’s application drew swift and highly public rebukes, and startled the pharmaceutical industry — beyond just vaccine manufacturers — as well as investors. Blackstone, the investment firm, had invested $750 million in Moderna’s development of a flu vaccine.
Top industry executives have traveled to the White House for high-level meetings, including with President Donald Trump, some focused on ways to avoid Trump’s threatened tariffs or to lower drug prices.
But industry executives have grown increasingly vocal in expressing their displeasure or unease at the administration’s dismantling of vaccine policy and the FDA’s recent pattern of rejecting drugs after yearslong agreements on study standards. A number of drug companies have also raised similar concerns after the FDA refused to review their applications or denied approvals.
Dr. Stephen Hoge, Moderna’s president, said on Fox Business on Wednesday that Moderna and its peers needed clear and consistent rules from regulators. “What we can’t have is somewhat arbitrary changes to those rules after the game has been played,” he said.
The company’s flu vaccine uses messenger RNA technology, which Health 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 sets off an immune response, was widely successful in COVID vaccines and is considered generally safe by public health experts and scientists.
The technology enables companies to rapidly pivot in order to update a vaccine, in contrast with the traditional method often used for flu shots.
In Trump’s first term, the government enthusiastically supported the mRNA-based COVID vaccines. But in the past year, the second Trump administration has turned against the technology, sending shock waves through the vaccine industry. Hundreds of millions of dollars in research contracts and projects have been canceled, and agencies under Kennedy’s purview have sharply limited the recommendations for administering COVID vaccines to certain groups of people.
In initially rejecting the novel flu vaccine last week, Dr. Vinay Prasad, the agency’s top vaccine official, signed a refusal letter citing concerns that the control vaccine Moderna had used in a study of people older than 65 was not the best available option. He issued the letter over the objection of the second-highest-ranking vaccine scientist at the FDA.
Federal recommendations say a vaccine using a higher dose than normal is the most effective protection for older people.
When the rejection caused an uproar, the agency began retreating. Dr. Marty Makary, the FDA agency commissioner, appeared conciliatory, saying on Fox Business that Moderna could come back as part of “the normal back-and-forth dialogue that the FDA has with companies.”
Andrew Nixon, a spokesperson for the Department of Health and Human Services, confirmed that the FDA had held meetings with Moderna since then and had decided to accept a revised approach.
“FDA will maintain its high standards during review and potential licensure stages as it does with all products,” Nixon said in a statement.
The dispute over Moderna’s study design spilled into public view, with Moderna providing a timeline of its original meetings with the FDA in preparation for the clinical trial. The company said the agency had found its plan to use a widely distributed vaccine, Fluarix Quadrivalent, by GSK “acceptable,” although the regulators preferred another vaccine.
Moderna reported that its study had found the vaccine to be safe and effective. It worked well across age groups in preventing flu cases. Most of the side effects were mild, like fatigue, muscle pain, headache and pain at the injection site. But the study found that these side effects were more frequent and harsher for adults below age 65 than for their older counterparts.
The study also found that the side effects were worse with Moderna’s flu vaccine than with the shot used as a comparison.
As late as Tuesday evening, Makary had not indicated that the agency planned to imminently change course. At an event held in Washington by PhRMA, the pharmaceutical 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.”
Going forward, Moderna said, it had agreed with the FDA to launch a new study to compare its flu vaccine for those 65 and older to one with a higher dosage or a similar option, which would give doctors more information on which choice is best.
The company said that the FDA had set a deadline of August to decide whether to approve the vaccine. If it is authorized, it will be available for those older adults when flu season begins later this year.
No mRNA-based flu vaccine has been approved anywhere in the world. Regulators in Europe, Canada and Australia are reviewing Moderna’s vaccine.