Overview

• The CDC’s Advisory Committee on Immunization Practices meets next week, where FDA staff are expected to brief members on reported links between Covid shots and 25 pediatric deaths, with the presentation and methods not yet finalized.
• FDA Commissioner Marty Makary says an investigation and a public report are forthcoming in the next few weeks, while an HHS spokesperson says staff routinely review safety data and that details should be treated as speculation until presented.
• Former agency officials and outside experts dispute the planned use of VAERS, noting the database accepts unverified submissions and that causation requires follow-up studies; prior research finds mRNA vaccines are safe overall with rare myocarditis primarily in young males.
• Vaccine-maker shares fell after the reports, with Pfizer down more than 3%, Moderna more than 7%, Novavax more than 4%, and BioNTech more than 10% during Friday trading.
• The briefing comes after policy shifts under HHS Secretary Robert F. Kennedy Jr., including narrowed FDA approvals limiting routine access to older and high‑risk adults and a reconstituted ACIP that will set recommendations affecting eligibility, insurance coverage, and pharmacy administration.