Reimbursement Challenges Await COVID-19 Vaccines Given Emergency Use Authorization
CARES Act appears to have overlooked Medicare coverage of a vaccine not granted traditional approval by US FDA. Meanwhile, other patient and provider vaccine reimbursement issues still need to be addressed by HHS and Congress to ensure widespread, affordable access to COVID-19 vaccines cleared by FDA under any pathway.
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US FDA drug center is evaluating how to handle the end of the coronavirus public health emergency, which would mean unapproved products would no longer be available, but officials likely have plenty of time to consider options.
Real-World Evidence: CDC Prioritizing Populations, Outcomes For COVID-19 Vaccine Effectiveness Studies
Strategy for assessing how the earliest vaccines to reach market perform beyond clinical trials includes leveraging existing surveillance and data platforms, and employing a diversity of study approaches, CDC epidemiologist says; high-priority areas for study include protection against symptomatic illness among health care workers and prevention of severe disease in the elderly.
Governor Cuomo will establish two panels, one examining safety and efficacy and another considering distribution and pricing, to advise the state on how to approach use of coronavirus vaccines once one is approved.