Moderna CEO Criticizes HHS Secretary's COVID - 19 Vaccine Policy Changes

At the WIRED Health summit on Tuesday, Stéphane Bancel, the CEO of Moderna, characterized the recent alterations to the COVID - 19 vaccine policy by Health and Human Services secretary Robert F. Kennedy, Jr. as a "step backward."

I. Moderna and the New COVID - 19 Vaccine Restrictions

Moderna, a key manufacturer of mRNA - based COVID - 19 vaccines, obtained approval from the Food and Drug Administration (FDA) last month for an updated version of the vaccine. However, as part of this approval, the FDA imposed new restrictions on vaccine recipients. Previously, COVID vaccines were recommended for individuals six months or older. Now, the FDA stipulates that they should only be administered to those at high risk of serious disease, such as those 65 years and older or individuals with other health problems.

Bancel expressed his concerns, stating, "I think it complicates things for people. You might have someone in your household—a parent, a spouse, a child—who is at high risk" that one would want to protect. Before, healthy individuals could easily obtain a COVID shot at a pharmacy. Now, due to the FDA's changes, several states require a prescription for the vaccine.

II. Kennedy's Anti - Vaccine Crusade and Related Actions

Since assuming the role of HHS secretary in February, Kennedy has been on an anti - vaccine campaign. This week, the Senate Finance Committee questioned him about his actions in office.

A. Termination of Bird Flu Vaccine Contract

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 in the final days of the Biden administration in January, just before President Donald Trump's second term commenced. Bird flu has been widespread in wild birds and has caused outbreaks in poultry and US dairy cows since March 2024. Although it has led to sporadic human cases, mostly among farm workers, it has the potential to cause a pandemic if it acquires the ability to spread from person to person.

B. Recommendations Regarding mRNA COVID - 19 Vaccines

In the same month, Kennedy announced that HHS would no longer recommend mRNA COVID - 19 vaccines for healthy children and pregnant women. In June, the FDA mandated new labels on mRNA vaccines to include safety information about the risks of myocarditis and pericarditis, rare side effects mainly observed in young men after vaccination.

C. Cancellation of mRNA Vaccine Research Contracts

In August, as part of a "coordinated wind - down" of mRNA vaccine research, HHS canceled 22 related contracts and investments worth nearly $500 million. Kennedy wrongly claimed in a statement that these vaccines "fail to protect effectively against upper respiratory infections like COVID and flu." Instead, HHS is redirecting funding to an older vaccine platform known as "whole - virus" vaccines.

III. Moderna's Positive Developments and Outlook

Despite the administration's negative stance towards mRNA vaccines, Bancel said he is "encouraged by the dialog" that Moderna has had with the FDA. Besides obtaining approval for updated COVID shots, albeit with limitations, Moderna also received expanded approval this year for its respiratory syncytial virus (RSV) vaccine. The vaccine, initially approved in May 2024 for adults aged 60 years and older, now includes adults ages 18 to 59 who are at increased risk of the disease.

Bancel remarked, "I think a lot of people back in January, including my own team, were quite worried that we might not get those approvals."

The administration's crackdown on mRNA research has not extended to the cancer field. Moderna is developing several mRNA therapies against cancer, including personalized cancer vaccines. The company has 45 programs in the pipeline, covering cancer, rare diseases, and more, and anticipates 10 FDA approvals in the next three years. Bancel stated, "We are using exactly the same technology to go from infectious disease to cancer."

IV. Addressing COVID Vaccine Testing Accusations

Bancel also addressed the accusations that COVID vaccines have not been thoroughly tested. He said, "I don't think there's been a vaccine more studied for efficacy and safety in the history of vaccines. In terms of vaccine efficacy and safety, there's been studies done in literally millions of people in the real world."

Update 9/10/25 10:25am ET: This story has been updated to clarify that Moderna's 45 pipeline programs address a range of diseases, including but not limited to cancer.