ACIP vaccine vote criticized

ACIP vote on hepatitis B vaccines raises concerns. Plus, PPRV reauthorization passes the House. (983 words, 4 minutes, 54 seconds)

ACIP recommendation to change 35-year-old vaccine practice is widely criticized

A federal panel’s unprecedented recommendation to change the childhood vaccination schedule without scientific basis spurred wide criticism, including from BIO.

What happened: The Advisory Committee on Immunization Practices (ACIP), which suggests Centers for Disease Control and Prevention (CDC) recommendations, voted Dec. 5 to remove the recommendation of routine vaccination for hepatitis B for newborns whose mothers have tested negative for hepatitis B and change it to "individual decision-making." This is a departure from a practice followed since 1991 of giving all newborns the vaccine.

Why birth doses matter: “Vaccination within 24 hours of birth followed by 2 to 3 additional doses protects children for life,” a CDC web page says. U.S. hepatitis B infections dropped from 23,177 in 1988 to 2,214 in 2023 thanks to birth-dose vaccination, a September ACIP presentation says.

BIO’s reaction: “Today’s decision to change the recommendation for hepatitis B vaccination for newborns, despite 35 years of progress toward eliminating the disease in children, will result in increased rates of hepatitis B, causing liver disease and cancer,” says a Dec. 5 BIO statement.

Unusual moves at ACIP include creating a working group to revisit settled science about childhood vaccines—an effort encouraged by a White House memo—and invitation of a controversial vaccine injury lawyer to the meeting.

BIO’s overall concerns: “This year we’ve seen this once-transparent, apolitical process led by clinicians and infectious disease experts eroded meeting by meeting,” BIO’s statement says. “Adopting recommendations without rigorous analysis leaves American children and families vulnerable to deadly infectious diseases that have long been preventable because of vaccines.”

Urging course correction: “BIO urges ACIP to reaffirm its long-standing, transparent, balanced, evidence-based processes that support timely vaccine access and safeguard the nation’s ability to prevent deadly infectious diseases,” BIO says.

BIO lauds bipartisan House vote to reauthorize PPRV

BIO praised the Dec.1 bipartisan House vote to encourage rare-disease research through reauthorization of the Pediatric Priority Review Voucher (PPRV).

The legislation: Named for a patient advocate who died of a rare cancer at 16, the Mikaela Naylon Give Kids a Chance Act promotes rare disease research through several measures, including reauthorizing the PPRV program for five years. The program enjoyed bipartisan renewal since its creation in 2012 but expired a year ago.

What’s PPRV? A Food and Drug Administration (FDA) incentive program giving vouchers to companies that gain approval for rare disease drugs. The voucher can be used to expedite FDA review of a future drug, or it can be sold.

How well does it work? Fifty-three vouchers have been awarded across 39 rare pediatric diseases. Prior to the program, only three of those diseases had any FDA approved treatment.

BIO’s advocacy: BIO has been advocating PPRV reauthorization since before the program expired in 2024. BIO’s campaign to promote PPRV is explained in a series of videos from children with rare diseases and a fact sheet.

BIO’s view: “This commonsense legislation brings hope to the families of the sickest children by renewing a program, which, for more than a decade, has helped incentivize the development of treatments for rare pediatric diseases at no cost to taxpayers,” says a Dec. 1 statement from BIO.

What’s next: The legislation must be passed by the Senate. “We urge the Senate to get this essential legislation across the finish line and reauthorize the PPRV program,” says BIO’s statement.

What Else to Read

New BIO-CSBA report documents best practices by states seeking to encourage biotech. A multitude of state-level pro-biotech policies are detailed in "The U.S. Bioscience Industry: A Powerful Engine for State Economies," released Dec. 2 by BIO, in partnership with the Council of State Bioscience Associations (CSBA). BIO’s seventh biennial report on bioscience economic development initiatives details a range of creative strategies, including: R&D tax credits; matching grants; angel investor tax credits; manufacturing tax exemptions; initiatives to support biomanufacturing; and initiatives supporting workforce development. Read more here.

Pharmacy benefit manager (PBM) legislation launched by Senate Finance Committee Chair Mike Crapo (R-ID) and Ranking Member Ron Wyden (D-OR). The bill, introduced Dec. 4 with a long list of co-sponsors from both parties, would: delink PBM compensation and negotiated rebates; increase PBM reporting requirements; reinforce requirements that plan sponsors contract with any willing pharmacy; require participation by retail community pharmacies in the National Average Drug Acquisition Cost (NADAC) survey; and mandate PBMs pass Medicaid payments directly to pharmacies. Read more here.

BIO submits letter supporting USPTO rule change on PTABs. BIO’s written comments praise a new rule proposed by the U.S. Patent and Trademark Office (USPTO) to limit patent challenges duplicating a Patent Trial and Appeals Board (PTAB) Inter Partes Review (IPR) challenge. BIO has supported legislation that would make this and other PTAB reforms to strengthen patents. Under the proposed change, “The Office will not institute an IPR when a petitioner intends to pursue invalidity challenges under §§ 102 or 103 in other venues, such as district court,” according to the Federal Register. “BIO supports this rulemaking initiative and the policy objectives it seeks to accomplish,” BIO says in comments addressed to USPTO.

BIO statement on Dr. Pazdur’s retirement from FDA. BIO President & CEO John F. Crowley released a statement after Dr. Richard Pazdur announced he is retiring from the Food and Drug Administration (FDA) following 26 years at the agency and shortly after being promoted to Director of FDA’s Center for Drug Evaluation and Research. “Dr. Pazdur has dedicated decades of his career to public service and the needs of patients.” Crowley stated. “Dr. Pazdur’s departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA. ... This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.” Crowley concluded: “We are at a tipping point. It is time to right this ship.” Read more here.

Beltway Report

Yesterday, the House Rules Committee released the text of the National Defense Authorization Act (NDAA) for Fiscal Year 2026, including a number of provisions related to biotechnology as a national security imperative. A vote is expected this week. The New Democrat Coalition Health Care Working Group on Dec. 3 released an action plan that includes recommendations to lower costs, expand access, and protect coverage for Americans, as well as to support small and mid-sized biotechnology companies and strengthen intellectual property protections for early-stage research. The Senate Homeland Security Investigations Subcommittee has scheduled a Dec. 10 hearing on “Defining Our Healthcare Problem, and Principles We Should Follow to Solve it.” A Dec. 10 joint hearing by the House Oversight subcommittees on Economic Growth, Energy Policy, & Regulatory Affairs, and Health Care & Financial Services will investigate “Lowering the Cost of Healthcare: Technology’s Role in Driving Affordability.”