Vaccines
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.
New general texts to be published in the European Pharmacopoeia in July 2025 are intended to support the rapidly developing mRNA vaccine field, which has become an increasingly important technology in recent years.
At the J.P. Morgan Healthcare Conference, GSK, Sanofi and Pfizer said they are prepared to address questions about vaccines under a new US administration, while former FDA Commissioner Scott Gottlieb warned of threats to public safety.
Some pharma industry CEOs appear to have done well in their meeting with President-elect Donald Trump and his health care team.
The FDA wants to update 2017 requirements for the data needed before initiating RSV vaccine trials in infants and toddlers after vaccine-associated enhanced respiratory disease triggered an indication-wide research hold.
International regulators want developers of new mpox vaccines to consider alternatives to placebo-controlled studies when these are not feasible, such as the use of animal models and immunobridging studies.
Pulling a product that was granted an emergency use authorization is easier than pulling a fully licensed vaccine, which could place Pfizer and Moderna’s COVID-19 vaccine pediatric indications at risk, along with Novavax’s vaccine in all age groups.
GSK’s Arexvy and Pfizer’s Abrysvo are FDA-approved for individuals younger than 60 years old, but CDC’s Advisory Committee on Immunization Practices wants more data on Guillain-Barré syndrome cases in older adults and efficacy in severely immune-compromised persons before making a recommendation.
Despite the recent anti-vaccine rhetoric in the final weeks of the Trump campaign, pulling an established safe and effective product off market would be difficult. But there’s little to stop political interference in approvals.
The US CDC committee appears on track to recommend GSK’s five-in-one vaccine when use of both a quadrivalent vaccine and a separate meningitis B vaccine are indicated at the same visit, the approach adopted for Pfizer’s Penbraya.
Advisory Committee on Immunization Practices wants to shift from a risk-based to an age-based recommendation for PCV-naïve adults between the ages of 50 and 64. The recommendation would put Merck’s recently approved Capvaxive and Pfizer’s market-leading Prevnar 20 on equal footing.