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.
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American Medical Association announces reimbursement codes for the COVID-19 vaccines being developed by Pfizer/BioNTech and Moderna.
US FDA plans to leverage large safety surveillance databases to make up for the fact that a vaccine authorized for emergency use likely would have only one-quarter to one-half as much safety data follow-up as a typical vaccine licensed under a BLA, says CBER director Peter Marks.
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.