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US FDA’s Search For Class-Wide Vaccine Blood-Clot Effect Makes Scientific Sense, But Raises Questions

 
• By Derrick Gingery

Several adenovirus vaccine developers say the products cannot be compared, potentially complicating the US FDA and CDC’s decision on ending the recommended pause in the use of Janssen’s vaccine.

Box of AstraZeneca COVID-19 vaccine
The US FDA could use data on the AstraZeneca COVID-19 vaccine to inform its review of rare blood clots seen with the Janssen vaccine. • Source: Alamy

The US Food and Drug Administration likely is using safety evidence from one or more unapproved products to inform its response to the rare blood clots seen with Janssen Biotech Inc.'s coronavirus vaccine, a move that could complicate lifting the recommended pause in administration that some argue already is too long.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is expected to receive additional data during...

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US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

Merck’s Clesrovimab Vote Reflects New ACIP Members’ Skepticism

 
• By Sue Sutter

The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.

New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine

 
• By Sue Sutter

The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.

Cassidy Confirms Agreement With Kennedy Did Not Include Maintaining CDC Vaccine Advisors

 
• By Sarah Karlin-Smith

Sen. Bill Cassidy and HHS Secretary Robert F. Kennedy Jr. agree the disbanding of ACIP did not violate their agreement, but the perception that Kennedy is not following the spirit of the pledge could be more important long-term.

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Canada Unveils Draft List of Essential Drugs For Universal Pharmacare

 
• By Neena Brizmohun

The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Post-BIO Podcast: Thoughts From The Frontlines

 
• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.