Vaccines

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.

US FDA Commissioner nominee Martin Makary’s 6 March Senate confirmation hearing should offer insight on his alignment with HHS Secretary Robert F. Kennedy Jr.'s views and willingness to insulate the FDA from an unusual level of micromanagement by the department and White House.

Reporter and editors from the Pink Sheet and Medtech Insight discuss the impact of the FDA’s decision to call back many of the employees it laid off, the decision to cancel an upcoming FDA advisory committee meeting on flu vaccines, and Eli Lilly’s plans to increase domestic manufacturing.

The Vaccines and Related Biological Products Advisory Committee meeting next month was scheduled to select strains for the 2025-2026 flu vaccine. The cancellation could mean delays in vaccine availability.

Robert F. Kennedy Jr.'s Make America Healthy Again Commission will solicit public "expertise" in open forums, which could enable defenses of vaccines and certain drugs the panel is targeting. Seven members so far have been tapped.

With timing that is purely coincidental, but supremely ironic, the US FDA approved two new vaccines on 14 February, the second day of HHS Secretary Robert F. Kennedy Jr.’s tenure on the job.

The February meeting of US CDC’s Advisory Committee on Immunization Practices was indefinitely delayed to accommodate public comment, which did not open as scheduled on 3 February.

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

President Trump's Executive Order creating the commission names mental health and weight-loss drugs as treatments of concern. But it does not mention vaccines, which Kennedy has criticized.

Robert F. Kennedy Jr. will become HHS secretary while retaining his anti-vaccine positions. His first action likely will be creating a new safety commission, which industry must hope holds off more drastic action.

Outreach by Kennedy and the Trump Administration appears to have quelled Sen. Cassidy’s fears about oversight of vaccine regulations and safety monitoring.

The US FDA faces many communications challenges with vaccine skepticism rampant. Is doing everything right going to be good enough?

The chair of the Senate Health, Education, Labor and Pensions Committee questioned whether Kennedy could reject anti-vaccine views in the face of data affirming their safety and efficacy.

Health and Human Services Department Secretary nominee Robert F. Kennedy Jr. falsely said prescription drugs are the third leading cause of death and made other comments on corporate capture, mifepristone, anti-depressants, and ADHD treatments, suggesting someone who often sows doubt and misleads on the risk-benefit balance of pharmaceuticals.

Japan ships the first batch of 50,000 mpox vaccine doses to DRC after training local healthcare providers dealing with the persistent outbreak.

In his final days as commissioner, Robert Califf posted thoughts on the COVID-19 vaccine experience and the limited booster uptake, suggesting that a placebo-controlled trial of the next booster update be run to improve confidence and develop better evidence in subgroups.

The Japanese pharma firm sued a politician, claiming defamatory actions on social media related to its novel COVID-19 vaccine.