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Moderna COVID Vaccine’s Myocarditis Risk Has Improved With Time, US FDA Says

 
• By Sue Sutter

‘Robust results’ from recent US surveillance studies show slight decreases in the myocarditis risk differential between the Moderna and Pfizer/BioNTech vaccines, agency says in briefing documents for panel review of Moderna’s pediatric EUA request.

Hour glass
The myocarditis risk differential for Moderna's vaccine relative to Pfizer/BioNTech's is looking better with the passage of time and more surveillance data. • Source: Shutterstock

The US Food and Drug Administration appears more comfortable with the myocarditis risk of Moderna, Inc.’s COVID-19 vaccine relative to that of Pfizer Inc./BioNTech SE’s competing mRNA product in adolescent males and young men than it did in the second half of 2021.

Briefing

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More from US FDA Performance Tracker

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

More from Regulatory Trackers

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

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.

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