Vaccines
The mood at the World Vaccines Congress in Washington, D.C. was bleak given Robert F. Kennedy Jr.’s rise to lead the Trump Administration’s Health and Human Services Department, but vaccine lawyers offered an optimistic outlook and ideas for countering his vaccine agenda.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.
Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.
US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease
Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.
Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.
All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote
Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.
The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.
Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.
FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
The disruption of CDC’s Advisory Committee on Immunization Practices meeting schedule adds fuel to concerns about potential alterations of the vaccine schedule raised by former FDA Commissioner Scott Gottlieb.
Only government staff participated in the meeting defining the next season’s influenza vaccine composition after the annual public FDA vaccines advisory committee meeting was cancelled.
President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.
Martin Makary said he would re-evaluate the topics that deserve a Vaccines and Related Biological Products Advisory Committee review, but did not commit to rescheduling the cancelled meeting on influenza vaccine strain selection.