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Wrapping up a busy week before the long weekend, with coverage of yesterday’s hearing on vaccine safety systems, a bill to reauthorize the Rare Pediatric Disease Priority Review Voucher Program, and what Agriculture Secretary Tom Vilsack said yesterday about climate tech for farmers. (691 words, 3 minutes, 27 seconds) We’re taking a break on Monday, February 19, for President’s Day. We will return on Tuesday, February 20. |
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Members of Congress examine vaccine safety systems |
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We need robust vaccine safety monitoring systems and speedy, appropriate compensation for vaccine-related injuries to instill confidence in vaccines, Members of Congress said at yesterday’s House Oversight Subcommittee on the Coronavirus Pandemic hearing. The challenge: Patients experiencing harmful vaccine side effects may receive up to $500,000 in compensation for vaccines covered under the U.S. Vaccine Injury Compensation Program (VICP). COVID-19 vaccines are currently covered by the Countermeasures Injury Compensation Program (CICP), which pays much lower compensation, Subcommittee Chair Brad Wenstrup (R-OH) explained.
COVID-19 vaccines are currently covered by the countermeasures program—but should be covered by VICP, said Rep. Mariannette Miller-Meeks, MD (R-IA). “The CICP was not designed for a pandemic as large as the COVID-19 pandemic,” she said, noting a backlog in COVID-19 vaccine compensation claims. Adding COVID-19 vaccines to the VICP requires congressional action, explained HRSA Director of Division of Injury Compensation Programs, Dr. George Reed Grimes.
Vaccines to protect against RSV and Dengue are routinely recommended and also require Congressional action to be added to the VICP. They are currently not covered under either CICP or VICP.
Why it matters: “We wouldn’t be able to expect people to line up and get vaccinated during the next pandemic if they feel they are abandoned,” said Rep. Wenstrup. He called for the urgent need to restore trust in vaccination and public health.
The impact: Vaccines have been saving lives since the cowpox vaccine in 1796, but misinformation has led to “a startling decline in immunization,” said Rep. Debbie Dingell (D-MI). She urged “constructive reforms that enhance community engagement and strengthen the vaccine systems.” Dr. Jernigan (CDC) highlighted the robustness of the U.S. vaccine safety systems saying "this approach to monitoring works" and emphasizing the safety monitoring system for COVID-19 is the most comprehensive system we've ever had.
The proposed reforms: BIO supports adding COVID-19, RSV, and Dengue fever vaccines to the VICP to ensure patients who have rare vaccine injuries are fairly compensated.
Watch: Rep. Miller-Meeks says that VICP coverage is appropriate for COVID-19 vaccines. |
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House introduces bill to reauthorize Rare Pediatric Disease Priority Review Voucher Program |
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The legislation—which BIO supports—would reauthorize a program that incentivizes the development of novel therapies to treat pediatric rare diseases.
The bill: The Creating Hope Reauthorization Act of 2024 (H.R. 7384), introduced Feb. 15, would reauthorize the Rare Pediatric Disease Priority Review Voucher Program (PPRV), which expires Sept. 30.
The co-sponsors: Rep. Michael McCaul (R-TX) introduced the bill with the following co-leads: Reps. Anna Eshoo (D-CA), Gus Bilirakis (R-FL), Nannette Barragan (D-CA), Michael Burgess, M.D. (R-TX), and Lori Trahan (D-MA).
Why it matters: “The PPRV program provides critical incentives to promote R&D for drugs to treat rare diseases impacting children across the country,” said BIO Interim CEO Rachel King. “Rare diseases, by definition, impact a small percentage of the patient population. The costs of drug development paired with the risk involved of bringing a successful drug to market can often discourage investment in the rare disease space. This is especially true for rare diseases unique to children.”
Read and share BIO’s statement. |
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USDA forum promotes biotech as climate tech |
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Biotech as climate tech in agriculture is most effective when appropriately measured and remunerated, said participants on the first day of the U.S. Department of Agriculture’s 100th Annual Agricultural Outlook Forum.
Commoditizing climate: In his opening keynote, U.S. Agriculture Secretary Tom Vilsack said farmers and the climate could benefit from finding ways to make sustainability pay—“so we’re not just selling a commodity. We’re now selling an environmental result,” he explained.
What USDA’s doing: USDA’s Partnership for Climate Smart Commodities invested $3 billion in 141 projects involving 205 climate practices, Vilsack said.
A great example: Sustainable aviation fuels (SAFs), which are “creating whole new industries” by using agriculture to benefit the environment.
“If you can measure it, you can treasure it,” said Paul Bloom of SAF producer Gevo, explaining why data is essential for quantifying and remunerating the true benefits of SAFs. He noted that climate-smart farming can further reduce biofuel’s carbon footprint.
What they’re saying: “We’re focusing on how we deliver not just the net zero, but potentially net negative biofuel,” Bloom said. Read more on Bio.News. |
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Clinical research and trials stand at the core of innovation and the development of drugs, vaccines, devices, and interventions. But the still-prevalent racial and ethnic disparities prove the need for a much-needed reform—sooner, rather than later. Bio.News spoke with Gary A. Puckrein, Ph.D., President and CEO of the National Minority Quality Forum (NMQF), about the state of clinical trial diversity and what the industry is doing about it.
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President Biden’s Friday: Speaking at the scene of the East Palestine, PA, train derailment a year after the accident, per the Pittsburgh Post-Gazette.
What’s Happening on Capitol Hill: Enjoy the long weekend. |
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