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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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EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

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

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

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.

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Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.