At the WIRED Health summit on Tuesday, Moderna CEO Stéphane Bancel said the recent changes to Covid-19 vaccine policy made by Health and Human Services secretary Robert F. Kennedy, Jr. are a “step backward.”
Moderna is one of the manufacturers of mRNA-based Covid-19 vaccines, and last month the company received approval from the Food and Drug Administration for an updated version of the shot. But as part of that approval, the FDA imposed new restrictions on who can receive the vaccine. Previously, Covid vaccines were recommended for anyone 6 months or older. Now, the FDA says they should only be given to individuals at high risk of serious disease, either because they are 65 and older or have other health problems.
“I think it complicates things for people,” Bancel said. “You might have somebody in your household—a parent, a spouse, a kid—who is at high risk” that you want to protect, he said. Before, healthy individuals could just go to a pharmacy to receive a Covid shot. Now, several states require a prescription to get a Covid shot because of the FDA’s changes.
Kennedy has been on a crusade against vaccines since he stepped into the role of HHS secretary in February; earlier this week, the Senate Finance Committee grilled him about his actions in office so far.
In May, Kennedy terminated a $590 million contract with Moderna for the development of an mRNA-based bird flu vaccine candidate. The contract was awarded during the final days of the Biden administration in January, just before President Donald Trump’s second term began. Bird flu is widespread in wild birds and has been causing outbreaks in poultry and US dairy cows since March 2024. It has caused sporadic cases in people, most of them farm workers, but poses a pandemic potential if it develops the ability to spread from person to person.
That same month, Kennedy announced that HHS would no longer recommend mRNA Covid-19 vaccines for healthy children and pregnant women. In June, the FDA said it would require new labels on mRNA vaccines to include safety information about the risks of myocarditis and pericarditis, rare side effects observed mostly in young men following administration of the shots.
In August, as a part of a “coordinated wind-down” of mRNA vaccine research, HHS canceled 22 related contracts and investments worth nearly $500 million. Kennedy incorrectly said in a statement these vaccines “fail to protect effectively against upper respiratory infections like Covid and flu.” HHS is instead shifting funding to an older vaccine platform known as “whole-virus” vaccines.
Despite the administration’s backlash against mRNA vaccines, Bancel said he is “encouraged by the dialog” that the company has had with the FDA. In addition to getting updated Covid shots, albeit with limitations, Moderna also received expanded approval this year for its respiratory syncytial virus, or RSV, vaccine to include adults ages 18 to 59 who are at increased risk of disease. The vaccine was initially approved in May 2024 for adults aged 60 years and older.
“I think a lot of people back in January, including my own team, were quite worried that we might not get those approvals,” Bancel said.
The administration’s crackdown on mRNA research so far has not extended to the cancer space, and Moderna is developing several mRNA therapies against cancer, including personalized cancer vaccines. The company has 45 cancer-related programs in the pipeline and has said it expects 10 FDA approvals in the next three years. “We are using exactly the same technology to go from infectious disease to cancer,” Bancel said.
He also addressed accusations that the Covid vaccines have not been well tested. “I don’t think there’s been a vaccine more studied for efficacy and safety in the history of vaccines,” he said. “In terms of vaccine efficacy and safety, there’s been studies done in literally millions of people in the real world.”