COVID-19 Vaccine Should Demonstrate At Least 50% Effectiveness, US FDA Says
Guidance on COVID-19 vaccine development and licensure appears to set a precedent in specifying the clinical efficacy rate for a product approval; agency also takes accelerated approval off the table for now and says emergency use authorization may be granted only after safety and efficacy have been demonstrated.
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J&J CEO Gorsky says the agency is working with sponsors to ensure the proper data is gathered to make the vaccine available in children.
Modified vaccines targeted at new SARS-CoV-2 variants must generate immune response rates not more than 10% below those of the original vaccine, agency says in one of a suite of guidances on medical product development to address variants.
Although differences in how sponsors have publicly disclosed demographic data for their enrolled trials make cross-study comparisons difficult, in general trial enrollment of Black and Hispanic participants has ranged from 10%-19% and 11%-45%, respectively, with one-quarter to one-third of study subjects falling into older age groups.