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Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity

 
• By Sarah Karlin-Smith

The Centers for Disease Control and Prevention’s ACIP is not able to take on all vaccine-like preventative medicines and still has to grapple with how to handle therapeutic vaccines. 

close up of feet in mismatched socks
The vaccine pipeline is growing at a rate that the CDC's ACIP cannot match. • Source: Shutterstock

The vaccine pipeline is outpacing the US Centers for Disease Control and Prevention’s ability to review the products, a situation that could present challenges for future coverage and reimbursement of new products.

Key Takeaways

  • The CDC’s top ACIP concern is that its workload is growing faster than its membership.

CDC’s Associate Director for Vaccine Policy Melinda Wharton said she is very concerned about the mismatch between the number of...

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More from US FDA Performance Tracker

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
• By Bridget Silverman

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

J&J’s Inlexzo Is A Rare 505(b)(2) NDA To Qualify For US FDA’s Real-Time Oncology Review

 
• By Bridget Silverman

A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.

Rare Disease Tests Aplenty On US FDA’s September User Fee Calendar

 
• By Bridget Silverman

US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.

More from Regulatory Trackers

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.

Rare Disease Tests Aplenty On US FDA’s September User Fee Calendar

 
• By Bridget Silverman

US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.

US FDA Emphasizes Primary Endpoint Primacy In Vatiquinone, Lytenava CRLs

 
• By Bridget Silverman

The complete response letters call for a new trial for PTC’s vatiquinone and more confirmatory evidence for Outlook Therapeutics’ Lytenava, while Telix’s Zircaix CRL shows quality challenges for a novel radiopharmaceutical approach.