Vaccines

At a CDC vaccine advisory committee criticized for “promoting an anti-vaccine agenda,” the new CDER director championed the committee’s plans and suggested the FDA would make more frequent vaccine label updates due to revised safety frameworks.

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.

Because combination vaccines remain in the US childhood vaccine schedule, ACIP's reconsideration of hepatitis B vaccine dose timing could impact uptake of other immunizations, Demetre Daskalakis told the Pink Sheet.

Flu vaccines are specifically mentioned in the CBER director's internal email, but all new and some older vaccines seem to be affected. The impact on development programs is unclear.

Cidara's CD388 drug-Fc conjugate received a breakthrough designation as the Phase III ANCHOR trial started for once-per-season prevention of influenza in a higher-risk population.

Insmed’s first-in-class bronchiectasis drug, brensocatib, is among the products that are up for an opinion by the European Medicines Agency’s human medicines committee this week on whether they should be approved for use in the EU.

Unanimous vote on trivalent Southern hemisphere 2025-2026 influenza vaccine composition by US FDA advisory committee agrees with World Health Organization, but committee members want to keep quadrivalent capacity available

The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

The World Health Organization wants vaccine manufacturers and the scientific community to share certain types of data before its Technical Advisory Group on COVID-19 Vaccine Composition meets in December.

The risks, as well as the benefits, of vaccination could be long-term, Advisory Committee on Immunization Practices member Retsef Levi said. The FDA’s Tracy Beth Høeg also said long-term safety data are needed to inform the benefit-risk analysis of the hepatitis B birth dose.

The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

The Advisory Committee on Immunization Practices recommended against continued use of Merck’s measles, mumps, rubella and varicella combination vaccine in very young children, but voted to retain coverage for the same use in the Vaccines for Children program.

The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.

Japan's government has already allocated more than $400m to repatriate manufacturing of important drugs and continues to provide support as it expands a list of "national security" drugs.

The ACIP put hepatitis B and MMRV vaccines on its agenda, despite having no new reason to relitigate the products, worrying public health experts that more anti-vaccine moves are coming.

The CDC and its Advisory Committee on Immunization Practices reportedly are planning to make unsubstantiated claims about COVID-19 vaccine adverse events with little recourse for manufacturers and other stakeholders.

FDA Commissioner Martin Makary also wrote in a JAMA article that the agency is not banning pharmaceutical advertising, but said industry has exploited weak enforcement.