Alex Azar touts biomedical teamwork to combat coronavirus
Health and Human Services Secretary Alex Azar on developing potential coronavirus therapeutics and when he expects a vaccine to become available.
WASHINGTON—The Food and Drug Administration plans to release guidance Tuesday outlining its conditions for approving a Covid-19 vaccine, including a requirement that any vaccine be at least 50% more effective than a placebo in preventing the disease.
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The FDA said that no vaccine would be approved unless a vaccine company had “clearly demonstrated” proof of a vaccine’s safety and effectiveness through a clinical study, according to a summary of the guidance viewed by The Wall Street Journal.
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According to the summary, the FDA also said a vaccine wouldn’t be approved simply if it leads to antibodies in the bloodstream of patients, on grounds that it is not known what level of antibodies will confer protection to patients.
The FDA said it would also require a vaccine maker to conduct further monitoring of safety after any approval and recommended that people getting the vaccine be followed for a year after treatment. The summary document said that such “post-market studies” may be necessary to “further assess known or potential serious risks.”
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