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

 
• By Sarah Karlin-Smith
  
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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...

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COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
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GSK’s Bexsero Dangles No More: Meningococcal B Vaccine Converts To Regular Approval

 
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WHO To Finalize Preferred & Critical Characteristics Of New Mpox Human Vaccines

 
• By Vibha Sharma

To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.

WHO Urges Countries To Curb Spread Of Mpox With Vaccines, Therapeutics & Other Actions

 
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The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.

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