The Department of Health and Human Services (HHS) has announced a plan to end mRNA vaccine work funded by the Biomedical Advanced Research and Development Authority (BARDA), a major escalation of Secretary Robert F. Kennedy Jr.’s campaign against both vaccines and mRNA in general.
While no timeline for the wind-down was given, the decision affects 22 projects valued at around $500 million collectively, according to an Aug. 5 release. Additionally, no new mRNA projects will be started.
“We reviewed the science, listened to the experts and acted,” RFK Jr. said in the release. “BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.”
The cancellation ends the contract for Moderna’s bird flu vaccine candidate, which the company already announced was being cut by the HHS in May. The Big Biotech isn't aware of any new contract cancellations with BARDA and doesn't have any active collaborations with the unit, a Moderna spokesperson confirmed with Fierce.
The move also terminates contracts to Emory University and Tiba Biotech and reduces mRNA work from contracts with Luminary Labs, ModeX and Seqirus.
In addition, proposals from Pfizer, Sanofi and others that involve mRNA have been rejected, and AstraZeneca’s nucleic acid vaccine collaboration with the Department of Defense will be restructured, with the HHS’ contributions immediately canceled, an HHS spokesperson told Fierce Biotech on Aug. 5.
BARDA contracts that are nearing completion, like Arcturus’ for a bird flu mRNA vaccine and Amplitude’s for a trans-amplifying RNA therapeutic platform, will be allowed to finish, according to the release.
The HHS has also told Global Health Investment Corporation—which manages BARDA’s investment fund, BARDA Ventures—to “cease all mRNA-based equity investments.”
RFK Jr. said that instead of mRNA, the agency would invest in “better solutions,” like vaccines that use whole viruses and undisclosed novel platforms. Asked for specifics, the HHS spokesperson pointed Fierce to the May 1 announcement of Generation Gold Standard, a planned universal vaccine platform supported by the HHS and the National Institutes of Health (NIH).
“The long-term effects and safety of these vaccines have not necessarily been studied,” the HHS spokesperson said. “Until we can prove that mRNA technology is safe and effective, we have to focus on other platforms.”
The spokesperson cited a recent Senate report accusing the Biden administration of “efforts to downplay and delay warning the public about the risks of myocarditis associated with the mRNA COVID-19 vaccines.”
Cases of myocarditis, or inflammation of the heart muscle, have been observed after mRNA COVID vaccination in a few rare cases. Catching COVID-19 increases the risk of myocarditis at a higher rate than vaccination does.
The lack of long-term safety data on mRNA vaccines is because the first products to receive approval were for use against COVID-19. Multiple studies conducted so far have concluded that the vaccines are safe and effective, and the research underlying the science goes back to the discovery of mRNA in the early 1960s.
“The announcement that HHS will discontinue mRNA vaccine development funding through BARDA represents a concerning policy shift that could undermine America's leadership in critical biotechnology innovation," Jeff Coller, Ph.D., Bloomberg Distinguished Professor of RNA biology and therapeutics at Johns Hopkins University, said in an Aug. 6 statement to Fierce. "The science is clear: mRNA medicines are safe and highly effective."
"This decision risks ceding America's competitive advantage in biotechnology to other nations that are expanding their investments in mRNA research and development," Coller added. "As other countries advance these proven, safe and effective therapies, American patients may increasingly depend on foreign innovation for breakthrough treatments."
mRNA is a type of molecule that occurs in every living cell. mRNA vaccines work by instructing the body to make proteins that are similar to those found on pathogens. Once created, the immune system can respond to those proteins and learn to recognize them in the event of a future infection. The mRNA message itself is quickly degraded by the body.
Moderna’s mRNA vaccine for COVID-19 was developed in partnership with the first Trump administration as part of Project Warp Speed.
RFK Jr. has made a career out of anti-vaccine conspiracy and has targeted vaccines extensively since taking office as HHS secretary. In June, he removed all 17 members of the Centers for Disease Control and Prevention's (CDC's) vaccine advisory panel, replacing them with eight new members well-known for being critical of vaccines and COVID-19 measures.
Those eight new CDC advisory panel members have much less experience in vaccine research than their predecessors, with four of them never publishing scientific research on vaccines during their careers, according to an analysis by Science.
And, under RFK Jr., the NIH has allegedly ended dozens of grants funding research on vaccine hesitancy. NIH officials also told scientists to remove references to mRNA vaccines from grant applications in March, according to a report from KFF Health News.
Editor's note: This story was updated at 10 a.m. ET on Aug. 6 with a statement from Jeff Coller, Ph.D.