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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...

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Cidara’s Non-Vaccine Flu Preventive Offers Respite From Vaccine Conflicts

 
• By Bridget Silverman

Cidara's CD388 drug-Fc conjugate received a breakthrough designation as the Phase III ANCHOR trial started for once-per-season prevention of influenza in a higher-risk population.

EU Decision Time For Insmed’s Brensocatib And Sanofi’s Belumosudil

 
• By Eliza Slawther

Insmed’s first-in-class bronchiectasis drug, brensocatib, is among the products that are up for an opinion by the European Medicines Agency’s human medicines committee this week on whether they should be approved for use in the EU.

US FDA Vaccines AdComm Rejoins Influenza Strain Discussion

 
• By Bridget Silverman

Unanimous vote on trivalent Southern hemisphere 2025-2026 influenza vaccine composition by US FDA advisory committee agrees with World Health Organization, but committee members want to keep quadrivalent capacity available

CDC Should Boost Vaccine Monitoring Transparency, Communication - National Academies Report

 
• By Sue Sutter

The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.

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NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.