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US FDA Vaccine Approvals Set Up CDC Votes On Merck’s Capvaxive, Moderna’s mResvia

 
• By Bridget Silverman

Advisory Committee on Immunization Practices expected to vote 26-28 June on use of Merck’s 21-valent pneumococcal vaccine, Moderna’s mRNA vaccine for RSV, and an expanded age range for GlaxoSmithKline’s Arexvy RSV vaccine.

Vaccine for older woman
ACIP will consider two newly approved vaccines for adults and one with an expanded indication. • Source: Shutterstock

A lively vaccine pipeline has helped to smooth and speed the transition between US Food and Drug Administration approval and the Centers for Disease Control and Prevention’s subsequent recommendations for use, with recent approvals of three vaccine applications neatly meeting the CDC’s expectations for the 26-28 June session of its Advisory Committee on Immunization Practices.

Key Takeaways

  • FDA approvals of Merck’s Capvaxive, Moderna’s mResvia and a new claim for GSK’s Arexvy came in time for votes at CDC vaccine committee’s 26-28 June meeting.

The FDA approvals came in the well-trod fields of pneumococcal and respiratory syncytial virus vaccines, where CDC recommendations are already...

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More from Approvals

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.

New EU Filings

 
• By Neena Brizmohun

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Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 
• By Neena Brizmohun

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 
• By Bridget Silverman

The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.