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Pediatric Prevnar 20 Heads To US Vaccine Schedule As CDC Vaccine Cmte Strives To Streamline

 
• By Bridget Silverman

Advisory Committee on Immunization Practices recommends routine use of the high-valence pneumococcal vaccine in under-2 year olds and older children with risk conditions.

pneumococcal vaccine PCV ACIP
Pfizer and Merck have produced succeedingly higher-valence pneumococcal vaccines for both adult and pediatric use that extend serotype coverage.

The strain of incorporating a steady drumbeat of newly Food and Drug Administration-approved vaccines is stressing the already complex US vaccination schedule, members of the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices indicated at the panel’s 21-23 June 2023 meeting. The meeting itself illustrates the scope of the challenge, requiring three days to consider data for 10 vaccine settings for diseases from common respiratory viruses to emerging diseases like dengue, chikungunya and mpox – and, of course, COVID-19.

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‘Highly Problematic’: Acting FDA Commissioner Paused Planned OK Of Novavax Shot

 
• By Sarah Karlin-Smith

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.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 
• By Sarah Karlin-Smith

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.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 
• By Sarah Karlin-Smith

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."

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

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.

More from Pink Sheet

Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster

 
• By Jessica Merrill

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

 
• By Francesca Bruce

Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.

New Measures Can Cut Israel’s Drug Approval Time To Just 70 Days

 
• By Neena Brizmohun

Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.