COVID-19 Vaccines: Novavax Gets Reprieve With US FDA Panel Supporting JN.1 Formulation

Advisory committee members said having Novavax’s protein-based vaccine available in the fall was important, but would not have been possible if a different variant strain were used. They also worried separate recommendations by vaccine type would cause confusion.

Tree trunk
A JN.1 vaccine will target the trunk of the tree, not the branches, a CDC official said. • Source: Shutterstock

The 2024-2025 formulations for COVID-19 vaccines should uniformly target the JN.1 variant, a US Food and Drug Administration advisory committee said, declining the agency’s invitation to suggest separate variant-based recommendations according to vaccine type.

Members of the Vaccines and Related Biological Products Advisory Committee unanimously voted in favor of a monovalent JN.1-lineage vaccine composition...

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

More from US FDA Performance Tracker

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

 

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

 

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

 

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

 

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.

More from Regulatory Trackers

US FDA Emphasizes Primary Endpoint Primacy In Vatiquinone, Lytenava CRLs

 

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.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Global Pharma Guidance Tracker - July 2025

 

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.