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J&J Offers Sliding Timeframe for Covid Boosters Based on Individual Patient and Geographic Need

 
• By Sarah Karlin-Smith

Johnson and Johnson’s one-shot Covid vaccine gets a solid efficacy boost with second shot administered two months after primary vaccination, but the company will argue based on much more limited data that a longer window between shots may be preferable for some populations.  

J&J Janssen sign
J&J’s COVID-19 booster application heads to the FDA’s VRBPAC on 15 October • Source: Alamy

Johnson & Johnson is seeking US Food and Drug Administration authorization for a booster dose of its COVID-19 vaccine that could be given between two and more than six months after the first dose depending on the burden of the virus in a particular region and an individual’s circumstances such as occupation and health status.

The company says booster timing should depend on the epidemiologic profile of the virus in the region and “perhaps most...

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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

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.

Global Pharma Guidance Tracker - August 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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.