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CDC Data More Positive on Myocarditis Benefit-Risk Than FDA’s Assessment of Pfizer’s Vaccine

 
• By Sarah Karlin-Smith

Updated modeling on heart events in young adults presented to CDC’s vaccine advisors points towards much lower rates of the adverse event from mRNA vaccines than some of FDA’s modeling.

cardio-covid scales (nielsen hobbs)
In weighing the risks of myocarditis versus the risks of COVID-19, one key difference between CDC’s modeling and FDA’s “worst-case” scenario is that CDC relied on VAERS, while FDA’s used Optum’s US claims database. • Source: Nielsen Hobbs

The benefit of Pfizer Inc.’s COVID-19 vaccine compared to the risk of myocarditis/pericarditis looks stronger for young males in new data released by the US Centers for Disease Control and Prevention on 30 August, potentially offsetting some concern that might have been raised after a “worst-case scenario” analysis conducted as part of the US Food and Drug Administration’s biologics license application approval predicted excess cases of myocarditis/pericarditis could potentially exceed COVID-19 hospitalizations and deaths in the 16-17 age group.

CDC presented an updated benefit-risk assessment of Pfizer/BioNTech SE’s mRNA vaccine Comirnaty to the Advisory Committee on Immunization Practices 30 August, adjusting methods used in its previous analysis...

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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
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Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

More from Pink Sheet

US FDA Meeting Drought Ends … With A Vengeance

 
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The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
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The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

Could EU Collective Procurement Counter US Most Favored Nation Policy?

 
• By Francesca Bruce

Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.