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US FDA Tags Moderna COVID-19 Vaccine With Higher Myocarditis Risk Than Pfizer/BioNTech

 
• By Sue Sutter

In expanding authorization of booster doses for both mRNA vaccines, the agency updated Moderna’s fact sheet to state the vaccine appears to pose a higher risk of myocarditis/pericarditis in males under age 40 years after the second dose, although data are ‘not yet dispositive.’

Risk increase
The FDA updated Moderna's COVID-19 vaccine fact sheet to reflect an increased myocarditis risk relative to other mRNA vaccines. • Source: Alamy

Lost amid the fanfare of the US Food and Drug Administration’s recent decision to broadly authorize COVID-19 mRNA vaccine boosters for everyone 18 years and older was a quiet, but still notable, change in language on the myocarditis risk with Moderna, Inc.’s vaccine.

In conjunction with the expanded authorization, the Moderna health care provider fact sheet was updated to state that the...

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• By Alaric DeArment

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• By Eliza Slawther

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.

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• By Lisa Takagi

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

 
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Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.