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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 

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Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
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The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

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HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

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Spain Beats England To Tevimbra Reimbursement Recommendations

 
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