The Department of Health and Human Services (HHS) announced this week it is beginning a "coordinated wind-down" of federally funded mRNA vaccine development.
This includes terminating awards and contracts with pharmaceutical companies and universities and canceling 22 investment projects worth nearly $500 million. While some final-stage contracts will be allowed to be completed, no new mRNA-based projects will be initiated, the HHS said.
"We reviewed the science, listened to the experts, and acted," Secretary Robert F. Kennedy Jr. said in a press release on Tuesday. "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."
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Infectious disease experts told ABC News that mRNA technology has been very successful in preventing severe disease, hospitalization and deaths, especially during the COVID-19 pandemic, potentially affecting our preparedness for future pandemics.
Ending mRNA vaccine development may also squash enthusiasm for technology that has been hailed as a potential promise for cancer and HIV vaccines.
"It's an excellent technology. It saved millions of lives and did it in a remarkably safe manner," Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, told ABC News. "I think it's an unscientific move, a move that goes against existing science."
Affecting future pandemic preparedness
Last year, the federal government awarded Moderna $176 million to help expedite the development of an mRNA-based bird flu vaccine. Earlier this year, the vaccine manufacturer received an additional $590 million to speed up the development.
However, in its press release, the HHS said it was cancelling the award, which has been issued by the Biomedical Advanced Research and Development Authority, to Moderna and the University of Texas Medical Branch.
Dr. Peter Hotez, a professor of pediatrics and molecular virology at Baylor College of Medicine in Houston, told ABC News the wind-down is a blow to pandemic preparedness. During the COVID-19 pandemic, mRNA technology demonstrated its ability to scale up vaccine production quickly.
"The message to the companies will clearly be that they can no longer rely on the U.S. government for supporting any mRNA vaccine work, which is unfortunate, or even tragic, because the mRNA platform is one of the few that we have for pandemic threats in terms of something that we can make a vaccine for very quickly," he said. "So what, what Mr. Kennedy's and HHS' actions are doing is weakening our pandemic preparedness and weakening our biosecurity."
The HHS also said it was terminating contracts with Emory University and Tiba Biotech. Researchers had been working on using mRNA technology to develop a nasal influenza vaccine.
Emory has also been working on a dry powder inhaled mRNA-based treatment for influenza and COVID with TFF Pharmaceuticals, funded by BARDA. It's unclear if this is one of the 22 contracts that have been canceled.
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Hotez said COVID-19 and influenza can have very severe consequences and that it's incorrect for Kennedy to mischaracterize them as harmless upper respiratory infections.
"COVID and flu are not [only] upper respiratory infections," he said. "The reason we develop vaccines for COVID and flu is because they cause systemic illness and lower respiratory infections and cardiovascular illness. … This is part of the anti-vaccine playbook, to diminish the severity of the illness, and to say something like influenza or COVID is an upper respiratory infection, it's just very, very misleading."
Cancer vaccines, HIV treatments
mRNA technology has also been hailed as a potential vector for providing personalized cancer treatments and protection against HIV transmission.
In February, a small preliminary study published in the journal Nature found a personalized mRNA vaccine may reduce the risks of pancreatic cancer returning after surgery. Additionally, a University of Florida study found an experimental mRNA vaccine paired with anticancer drugs boosted an anti-tumor response.
Meanwhile, earlier this month, an early-stage clinical trial found two mRNA vaccine candidates triggered a strong immune response against HIV. Results from the trial showed that 80% of participants who received one of two vaccine candidates produced antibodies.
Although antiretroviral therapy has been the standard treatment for HIV infection, and is effective in preventing transmission, it is hard to scale up worldwide due to its costs, making mRNA vaccines to be anti-HIV vaccine strategy, researchers from the U.S., Germany and Romania wrote in a commentary in June 2022.
It's unclear if any of the BARDA contracts are specifically for cancer vaccines or HIV vaccine development, but Hotez said the real damage is denigrating mRNA technology.
"What he's done is he's caused uncertainty among the American people about the safety and effectiveness of mRNA for any condition, including cancer," he said. "And in fact, mRNA technology is probably the most exciting technology we have now for cancer and also other non-communicable illnesses. … Even though he may not be canceling any cancer vaccine contracts through BARDA, it may have collateral deleterious in terms of squashing enthusiasm for the technology."
Offit added that mRNA is not brand-new technology. mRNA was discovered independently by two teams in 1961, including French and American molecular biologists.
Breakthroughs in developing mRNA vaccines began in the early 2000s, eventually leading to the development of COVID-19 vaccines in 2020. This makes the technology primed for being used in other avenues, such as cancer vaccines, Offit said.
"We now know a lot about mRNA," he said. "We know a lot about its safety. We know a lot about its safety in young children, including babies. We know a lot about it regarding gene therapy. We know a lot about this safety in terms of pregnant people, where that's often not the case with new technology."
Offit went on, "So you have this background of information that enables you to move forward in a number of areas, involving babies or involving pregnant women. But there was an attempt by this administration to squelch that, to sit on all that for no good reason other than a political reason."
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