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The move comes amidst a turbulent time at HHS.
HHS is winding down mRNA vaccine development at BARDA.
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HHS is winding down mRNA vaccine development.
In a move that is likely to have reverberations throughout the pharma industry, HHS announced that it is taking the first major step in what it calls a “coordinated wind-down” of mRNA vaccine development activities under BARDA.1 As a result, multiple contracts face either cancellation or de-scoping, and multiple major pharma companies will be impacted.
The announcement from HHS cites a review of mRNA-related investments that began during the COVID-19 pandemic as the reason for the current decision. While the COVID response has become a political lightning rod in recent years, many experts still cite the cooperation between the government and pharma industry as being responsible for the development of COVID-19 vaccines and saving countless lives.
The wind-down will begin with the following steps:
Overall, the initial steps of the wind-down will result the in the cancellation of nearly $500 million. Not all mRNA related contracts are being cancelled, with several final-stage contracts still planned to be completed.
In the announcement, HHS Secretary Robert F. Kennedy Jr. said, “We reviewed the science, listened to the experts, and acted. 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.”
Kennedy also included this statement, “Let me be absolutely clear: HHS supports safe, effective vaccines for every American who wants them. That’s why we’re moving beyond the limitations of mRNA and investing in better solutions.”
Secretary Kennedy has often been accused of being anti-vax, although he denies this description. Critics, however, maintain that his actions are weakening the country’s vaccine ecosystem.
According to reporting from BBC,2 Kennedy claims that mRNA vaccines promote new viral mutations and can prolong pandemics. The report also states that health experts have pushed back against Kennedy’s assessment and do not believe that mRNA vaccines promote mutation.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told the news outlet that mRNA vaccines are “remarkably safe” and cited them as a key tool in preventing severe infections from a variety of diseases.
This announcement comes during a turbulent time at HHS.
In late July, FDA CBER Head Vinay Prasad announced he was stepping down from the role. While the initial announcement included a friendly comment from FDA leadership, later reporting suggested Prasad may have been pushed out. According to anonymous sources at Politico, President Trump may have wanted Prasad out after being pressured by conservative activists, such as Laura Loomer, who criticized the CBER Head for decisions he made that they considered pro-vaccine.
Prasad also stepped down amidst other controversies. In a story that caught the industry by surprise, the agency came under fire for a CRL that had been sent to Replimune in response to trial data for a melanoma treatment. The trial’s investigators stated the reasons FDA provided for the CRL had not been brought up during previous meetings with the agency.
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