Moderna is launching a large-scale clinical trial of a shot to combat bird flu in humans after Health and Human Services Secretary Robert F. Kennedy Jr.’s department had canceled hundreds of millions of dollars in funding previously committed to aid in vaccine development.
The company is developing the vaccine using messenger RNA (mRNA), which is the technology used in the most commonly administered coronavirus vaccines and was hailed during President Donald Trump’s first term as a major medical achievement. It has since come under intense scrutiny from Kennedy and other conservatives, and the Department of Health and Human Services last year announced a winding down of investments in 22 mRNA vaccine development projects.
Last May, HHS pulled millions of dollars that President Joe Biden’s administration had said it would provide to Moderna to accelerate mRNA-based pandemic influenza vaccines amid an outbreak of bird flu in dairy cattle. The move delayed a large-scale clinical trial for several months as Moderna sought alternative funding sources, according to Chris Ridley, a Moderna spokesman.
The Coalition for Epidemic Preparedness Innovations, a global partnership to speed up the development of vaccines and other countermeasures, is investing up to $54.3 million to support the bird flu vaccine. On Tuesday, Moderna said the first participants in the large-scale clinical trial have received the vaccine in both the United States and Britain.
The trial is expected to enroll about 4,000 adults ages 18 and older. Moderna had previously announced positive interim data about immune response and safety from an early-stage clinical trial of roughly 300 healthy adults ages 18 and older.
Stéphane Bancel, Moderna’s CEO, called the launch of the trial a milestone for efforts to “strengthen global pandemic preparedness.”
“Our platform technology’s efficiency and scalability are critical to supporting global health security and responding to potential future threats,” he said in a press release.
Last year, HHS said the decision to pull Moderna’s funding was made after a “rigorous review,” adding mRNA technology “remains under-tested” and accused the Biden administration of concealing “legitimate safety concerns.”
In a statement Tuesday, HHS spokesman Andrew Nixon said the department “sees promise in mRNA technology for recurrence of hard-to-treat cancers” and recently committed to a public-private partnership.
“Last year, HHS wound down its investments in mRNA vaccines for upper respiratory viruses because they do not protect effectively against infections from mutating strain of viruses such as COVID and flu,” Nixon said. “Also, these companies had already been massively subsidized by the government, and we decided to reinvest the money in other more promising technologies.”
Medical experts say coronavirus vaccines using mRNA technology have been shown to be safe and effective. Unlike traditional vaccines, which use dead or weakened versions of the virus or viral proteins to train the immune system, mRNA vaccines deliver genetic instructions that prompt the body’s cells to trigger an immune response. Because they rely on genetic sequencing rather than growing the virus in a lab, they can be developed more quickly than conventional vaccines.
On Monday, Food and Drug Administration Commissioner Marty Makary was questioned by CNN on the health department’s cancellation last year of mRNA vaccine research contracts. He said he was “excited” about the potential technology.
“We just felt like it should be the companies that made $50 billion from mRNA technology during the covid pandemic that should be funding their own research, not taxpayer dollars,” Makary said. “Taxpayer dollars should be going for research that nobody else in the market or investor community will fund.”
Carolyn Y. Johnson contributed to this report.
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