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Moderna, Janssen And ‘Mix & Match’ Boosters Create A ‘Not Simple’ Array Of Dosing Options

 
• By Sue Sutter

After US FDA authorization for additional COVID vaccine shots, the focus now shifts to CDC’s advisory committee, which may be concerned about variations in eligible populations, timing and dosing when it comes to giving a booster different from the primary vaccination series.

Hedge maze
Getting a COVID-19 booster may involve navigating a maze of considerations around primary vaccination series, timing, dose and eligibility. • Source: Alamy

The US Food and Drug Administration’s emergency use authorization of Moderna, Inc. and Janssen Biotech Inc. COVID-19 vaccine booster doses, as well as heterologous “mix and match” booster strategies for the three currently available vaccines, will add further complexity to immunization recommendations that already vary by product, eligible population and dose.

On 20 October, the agency authorized a single booster dose for Moderna’s mRNA vaccine in three high-risk groups at least six months after completion of the two-dose primary series – an action that aligns Moderna’s EUA with that for the booster dose of

More from Vaccines

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

More from Pink Sheet

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.