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The US Department of Health and Human Services (HHS), under the leadership of Secretary Robert F. Kennedy Jr., further distanced itself from mRNA technology on Tuesday. The health department's Biomedical Advanced Research and Development Authority (BARDA), which helps fund the development of vaccines, therapeutics and diagnostics to combat public health emergencies, is terminating about $500 million in investments across 22 mRNA vaccine programmes.Kennedy said the wind-down of agency support for the technology is because "the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu," though he did not provide any data to support this claim. It's not the first time Kennedy has cast doubt, without scientific evidence, on the safety and efficacy of mRNA vaccines. Back in 2021, he spoke out against a proposed school vaccine mandate in Louisiana, calling the mRNA COVID-19 vaccines developed by Moderna, and partners Pfizer and BioNTech, "the deadliest vaccine ever made."In an interview with FirstWord earlier this year, virology and immunology expert Paul Offit called Kenendy a "science denialist and a virulent anti-vaccine activist" (see – ViewPoints: A vaccine expert's grim verdict on Kennedy's health agenda).After assuming leadership of HHS, Kennedy directed the Centers for Disease Control and Prevention to no longer recommend COVID-19 vaccines for pregnant women and healthy children between the ages of six months and 17 years old. This change is now being challenged in court by a coalition of healthcare organisations, including the American Academy of Pediatrics, who called it a "baseless and uninformed policy decision" that exposes "vulnerable populations to a serious illness with potentially irreversible long-term effects and, in some cases, death."The broad grant terminations come a few months after Moderna disclosed that BARDA was pulling its funding for an experimental mRNA-based bird flu jab. At the time, an HHS spokesperson claimed that mRNA technology was "under-tested," and that it was "not scientifically or ethically justifiable" to continue funding Moderna's H5N1 mRNA vaccine.After that announcement, Pfizer CEO Albert Bourla came to the defense of Moderna, calling the HHS's claims "completely inaccurate."Moderna is also developing an mRNA based flu vaccine, which it plans to incorporate with its next-generation COVID-19 jab for a single combination shot to protect against both viral illnesses. While the biotech has shared compelling data on both components, this latest move from Kennedy casts doubt on the combination vaccine's regulatory chances.Pharma caught in the falloutThe mRNA vaccine grant terminations will also affect Emory University and Tiba Biotech, who have had their contracts cancelled, and BARDA's mRNA-related work with Luminary Labs, ModeX and CSL Seqirus will be narrowed.Proposals or pre-award solicitations from Pfizer, Sanofi, CSL Seqirus and Gritstone were also rejected, and a nucleic acid-based vaccine project with AstraZeneca will be restructured. For future contracts, HHS will prioritise whole-virus vaccine technologies and other, unspecified "novel platforms."

Department of Health and Human Services Secretary Robert F. Kennedy Jr. has targeted vaccines extensively since taking office as HHS secretary.\n 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.

HHS Secretary Robert F. Kennedy Jr. announced the cancellation or reworking of almost two dozen contracts for the development of mRNA vaccines, including for flu and Covid-19, on Tuesday night. The contracts were being run by BARDA, also known as the Biomedical Advanced Research and Development Authority, a division inside HHS focused on advancing new therapeutic technologies and thinking ahead about future health threats. Kennedy, in a recorded video posted on social media Tuesday evening, claimed that “mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract.” He also alleged that the vaccines drive antigenic shift because of breakthrough infections that are not staved off. “After reviewing the science and consulting top experts at NIH and FDA, HHS has determined that mRNA technology poses more risk and benefits for these respiratory viruses,” Kennedy said. Covid-19 shots based on mRNA technology have been administered billions of times around the globe during the pandemic and afterwards. Their development was directed by the first Trump administration under the Operation Warp Speed program, and the shots are broadly credited with saving lives and lessening the severity of illness. Despite his claims about the technology’s ineffectiveness, the FDA under Kennedy has approved three mRNA product submissions for Moderna, including a next-generation Covid-19 vaccine. The agency also granted label expansions to the company’s RSV vaccine, and converted emergency use authorization of the first-generation Covid-19 vaccine to full approval for the youngest children. The two Covid-19-related approvals fit within the agency’s new framework announced in May, limiting them to all people 65 and older and young people at higher risk of severe disease. Those approvals have caused frustration among some of Kennedy’s staunchest allies who helped catapult him onto the national scene. The 22 contracts include pre-award solicitations from Pfizer, Sanofi, CSL Seqirus, Gritstone bio and others. BARDA will also restructure collaborations with AstraZeneca, HDT Bio and the Access to Advanced Health Institute. Contracts with Emory University and Tiba Biotech are being canceled and contracts with Luminary Labs, ModeX, and Seqirus are being shrunk. The decision follows BARDA and HHS’ decision earlier this year to cancel a contract with Moderna worth hundreds of millions of dollars to develop a vaccine against H5N1. The agency said the total amount of the canceled projects nears $500 million. Chris Meekins, a former deputy assistant secretary at the Administration for Strategic Preparedness and Response during President Donald Trump’s first term, said in a statement to Endpoints that “ending BARDA’s investment in mRNA technology creates a national security vulnerability.” “These tools serve as a deterrent to prevent other nations from using certain biological agents,” he said, describing the speed of the technology as a “national security asset.” Pfizer, one of the world’s major manufacturers of the mRNA Covid-19 shots, didn’t immediately respond to a request for comment. Its competitor Moderna said that it doesn’t have an active collaboration with BARDA. HHS said in a release that while some contracts will be allowed to run their course, “no new mRNA-based projects will be initiated.” “We’re prioritizing the development of safer, broader vaccine strategies, like whole-virus vaccines and novel platforms that don’t collapse when viruses mutate,” Kennedy said in his recording. Editor’s note: This story was updated to include a comment from Chris Meekins.