The Meals and Drug Administration is refusing to contemplate Moderna’s utility for a brand new flu vaccine made with Nobel Prize-winning mRNA expertise, the corporate introduced Tuesday.
The information is the newest signal of the FDA’s heightened scrutiny of vaccines beneath Well being and Human Companies Secretary Robert F. Kennedy Jr., notably these utilizing mRNA expertise, which he has criticized earlier than and after turning into the nation’s high well being official.
Moderna says it acquired what known as a “refusal-to-file” letter from the FDA that objected to the way it performed a 40,000-person medical trial evaluating its new vaccine to one of many customary flu pictures used at this time. That trial concluded the brand new vaccine was considerably more practical in adults 50 and older than that customary shot.
The letter from FDA vaccine director Dr. Vinay Prasad stated the company does not think about the appliance to comprise an “satisfactory and well-controlled trial” as a result of it did not evaluate the brand new shot to “the best-available customary of care in the US on the time of the research.” Prasad’s letter — which Moderna revealed on-line — pointed to some recommendation that FDA officers gave Moderna in 2024, beneath the Biden administration, which Moderna did not observe.
In keeping with Moderna, that suggestions stated it was acceptable to make use of the standard-dose flu shot the corporate had chosen — however that one other model particularly really helpful for seniors could be most well-liked for anybody 65 and older within the research. Nonetheless, Moderna stated, the FDA did conform to let the research proceed as initially deliberate.
The corporate stated it additionally had shared with the FDA further knowledge from a separate trial evaluating the brand new vaccine towards a licensed high-dose shot used for seniors.
The FDA “didn’t determine any security or efficacy considerations with our product” and “doesn’t additional our shared purpose of enhancing America’s management in creating modern medicines,” Moderna CEO Stephane Bancel stated in a press release.
CBS Information has reached out to the FDA for remark.
It is uncommon for FDA to refuse to file an utility, notably for a brand new vaccine, which requires firms and FDA employees to interact in months or years of discussions.
Moderna has requested an pressing assembly with the FDA, and famous that it has utilized for the vaccine’s approval in Europe, Canada and Australia.
Within the final 12 months, FDA officers working beneath Kennedy have rolled again suggestions round COVID-19 pictures, added further warnings to the 2 main COVID vaccines — that are made with mRNA expertise — and eliminated critics of the administration’s method from an FDA advisory panel.
Kennedy introduced final 12 months that his division would cancel greater than $500 million in contracts and funding for the event of vaccines utilizing mRNA, zeroing in on analysis into coronavirus and flu vaccines.
Kennedy stated the Division of Well being and Human Companies had decided that “mRNA expertise poses extra danger than advantages for these respiratory viruses.” Vaccine consultants condemned the choice, with Jerome Adams, who served as surgeon normal in President Trump’s first time period, writing on social media, “fairly frankly this transfer goes to value lives.”
The FDA for many years has allowed vaccine makers to shortly replace their annual flu pictures to focus on the newest strains by exhibiting that they set off an immune response in sufferers. That is a much more environment friendly method than working long-term research monitoring whether or not sufferers get the flu and the way they fare.
In an inside memo final 12 months, Prasad wrote that the streamlined methodology would now not be permitted – main greater than a dozen former FDA commissioners to pen an editorial condemning the statements.
Democratic Sen. Patty Murray of Washington condemned the FDA’s determination on Moderna, saying Kennedy’s workforce was “blocking an up to date flu vaccine for no motive grounded in science.”
“American vaccine coverage has been hijacked by a conspiracy theorist—but most Republicans are blissful to simply sit on their fingers,” Murray wrote on X.
