1. Pink Sheet
  2. >>Vaccines

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.

During the discussion leading up to four votes on recommendations for Pfizer Inc.’s Prevnar 20 in pediatrics, unflappable ACIP chair Grace Lee, Stanford University, ruefully referred to the pneumococcal...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Vaccines

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

More from Pink Sheet

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.