US FDA Commissioner Makary says FDA supports mRNA vaccines but US taxpayers should not bear the cost

By Ahmed Aboulenein

WASHINGTON, Feb 23 (Reuters) – U.S. Food and Drug Administration Commissioner Marty Makary on Monday defended his agency’s position and record on mRNA vaccines, days after it changed course and agreed to review a Moderna flu vaccine.

The FDA supports mRNA vaccines, but taxpayers should not foot the bill, Makary said, referring to several Health Department moves last year to cut funding for mRNA vaccine research. He spoke at an event announcing an FDA-proposed framework to speed the approval of gene therapies to treat rare diseases.  

Asked if there was a contradiction between embracing genome editing, a technique used in gene therapy, but not mRNA vaccines, Makary said, “I think that would be quite a stretch to say we’re not embracing mRNA vaccines. We’ve approved two mRNA vaccines at the beginning of my time.”

The FDA has approved two messenger RNA vaccines against RSV – one from Moderna and the other from GSK.

“I would love to see the data on mRNA helping patients with cancer and a number of conditions,” Makary added.

Moderna and Merck are also working on a personalized treatment that uses mRNA technology in combination with Merck’s immunotherapy Keytruda to fight cancer. 

MAKARY SAYS U.S. DEFUNDED MRNA OVER MONEY

Makary defended the U.S. Department of Health and Human Services’ August decision to wind down mRNA vaccine development activities under its biomedical research unit. At the time, Secretary of Health and Human Services Robert F. Kennedy Jr., a longtime anti-vaccine activist, said “the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu,” despite scientific evidence to the contrary.

That followed the HHS’s termination in May of more than $700 million in funding for Moderna to develop an mRNA vaccine to protect against pathogens with pandemic potential including bird flu, which had touched off a major outbreak in dairy cows that was infecting workers.

Makary said the department cut funding for the development of mRNA vaccines because companies that make the drugs can afford their own research.

“There was funding for mRNA technology at HHS. That funding was pivoted to other causes, and I’ll tell you why. It’s not because we don’t believe in mRNA technology. It’s because the companies that made mRNA vaccines made over $50 billion, they can fund their own research. It doesn’t have to be on the backs of American taxpayers,” said Makary.

Moderna, as well as Pfizer and BioNTech SE, made mRNA COVID shots as part of the government’s COVID pandemic effort. The Pfizer/BioNTech shot was self-funded while Moderna used government funding.

Makary said the government should fund research in areas that are underfunded, such as “bespoke conditions and rare diseases, conditions that have been in the blind spots of modern medicine.”

(Reporting by Ahmed Aboulenein in Washington; Additional reporting by Julie Steenhuysen in Chicago; Editing by Caroline Humer and Matthew Lewis)