A big week in COVID vaccine news

BIO to focus on human health and biopharmaceutical innovation

BIO announced plans to dedicate its focus entirely to human health and to transition the work of its Agriculture and Environment (A&E) section to other organizations.  

Why it matters: Effective July 1, this change enables an enhanced strategic focus on these respective areas. In support of the transition, BIO is hiring two senior executives to lead Regulatory Affairs and a new “Center of Excellence” focused on Emerging Companies & Economic Growth.  

“The field of biotechnology is increasingly diverse, with great threats and significant opportunities,” said John F. Crowley, President and CEO of BIO. “In consultation with the BIO Executive Committee and the Agriculture and Environment Governing Board, BIO has determined that these organizational changes will enable greater focus and impact on behalf of our healthcare members, and will sharpen our advocacy work on critical policy priorities for the improvement of human health – modernizing the FDA’s regulatory processes; building back a robust biopharmaceutical manufacturing base across the US and our allies; preserving strong IP protections; fostering capital formation; protecting our national security; and enabling 21st Century access to medicines. At the same time, this change will enable A&E member companies to enhance their focus on agricultural and environmental biotech at expert third-party organizations.”

COVID vaccine recommendations dominate the headlines

Advice on COVID-19 vaccine schedules for pregnant women and children continued changing last week.

A timeline:

May 20: The Food and Drug Administration (FDA) announced it would mostly limit COVID-19 vaccine updates to people over 65 and those at higher risk—including pregnant women.

May 27: Health and Human Services Secretary Robert F. Kennedy, Jr., announced COVID-19 vaccines would no longer be recommended for healthy children and pregnant women. FDA Commissioner Dr. Marty Makary, MD and National Institutes of Health Director Jay Bhattacharya, MD joined Kennedy for the announcement.

May 30: CDC issued guidance saying children whose parents want them vaccinated “may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider.” Regarding pregnant women, a note on CDC’s website this morning said advice was being updated.

What's next: CDC’s Advisory Committee on Immunization Practices (ACIP) is typically the body that makes recommendations on vaccination. They are scheduled to meet June 25-27.

BIO’s view: Sudden changes in the time-tested process of approving and recommending vaccines creates uncertainty, which could reduce access to vaccines for those who need them and undermine trust in immunization—not only for COVID-19, but for all preventable diseases.

What Else to Read This Week

FDA approves Moderna’s new COVID vaccine. mNEXSPIKE® (mRNA-1283) is approved for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factors. Moderna said the vaccines will be available in the U.S. in time for the 2025-26 respiratory virus season. 

WHO member states adopt world’s first Pandemic Agreement.The May 14 agreement is aimed at strengthening global coordination and equity in preparedness and response for public health emergencies. The text outlines objectives around pathogen access, equitable benefit sharing, and international collaboration, though many key operational components will be determined in follow-on negotiations. The final text introduces new language for technology transfer agreements, moving from “voluntary and mutually agreed terms” to “willingly undertaken and on mutually agreed terms.” Contracts with sufficient flexibility and reasonable obligations will be critical to supporting a sustainable R&D ecosystem. BIO says the Agreement’s expansion of WHO’s core mandates warrants caution to ensure it does not inadvertently hinder the biotechnology industry’s essential contributions to global health security.

BIO group to suggest global guidelines for regulating cell and gene therapies. “Being able to demonstrate comparability when manufacturing changes are made is an essential part of biologics life cycle management,” said Kathleen Francissen, Ph.D. She’s rapporteur of a BIO-led group that proposed the development of guidance on comparability of cell and gene therapies “subject to changes in their manufacturing process” for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). “You have to think about comparability assessments differently … and look at things more holistically,” Francissen said. Read more on Bio.News.

More than half of the 450 million people with autoimmune and autoinflammatory arthritis disease are undiagnosed or misdiagnosed. The International Foundation for Autoimmune and Autoinflammatory Arthritis (AiArthritis) is working to change that, and to increase the number of patients who have a voice when it comes to harmful policies that threaten access to care. “We don’t represent the patient voice. We are the patient voice,” says AiArthritis. “It takes the voice of lived experience to identify what is missing in current efforts to improve patient lives.” Read more on Bio.News.

How do you launch a patient advocacy group? Patient advocates offered advice during BIO’s May virtual coffee chat. Many advocates are thrown into the challenge due to a family member’s disease journey, and quickly find themselves navigating a host of issues from fundraising and engaging the community to training grassroots advocates and navigating evolving policy priorities, and more—but help is available!

Beltway Report

Congress returns from Memorial Week Recess to resume negotiations of the One Big Beautiful Bill Act while the House and Senate Appropriations Committees will get to work to advance annual government funding bills.