1. Pink Sheet
  2. >>Vaccines

J&J Vaccine: Some CDC Advisors Question Warning’s Strength As Clot Reports Grow, Female Use Drops

 
• By Sarah Karlin-Smith

Some ACIP members argued woman older than 50 should also be singled out in warning for Johnson & Johnson’s COIVD-19 vaccine and said that people need to be more clearly told they can get alternative vaccines that don’t have this risk.

Johnson and Johnson COVID-19 vaccine
CDC advisors discussed updated safety data on J&J's COVID-19 vaccine on 12 May • Source: Valerio Rosati / Alamy Stock Photo

New updated US data on the rare blood clots seen in people who received Johnson & Johnson’s COVID-19 vaccine, including more reports in older people, caused some members of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to push for stronger warnings on the vaccine at a 12 May meeting.

The CDC’s Vaccine Safety Technical Work Group, which includes ACIP member Grace Lee, is continuing to recommend that the benefits outweigh the risks of the vaccine and that no updates...

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.