FDA Commissioner Stephen Hahn, MD, appeared before the Senate Health, Education, Labor and Pensions Committee June 30 to explain the agency’s vaccine approval requirements. Here are four things to know about what he said:
- To receive full approval, a COVID-19 vaccine will have to prevent the disease or lessen its severity in at least 50 percent of people who receive it.
- Vaccine developers will need to closely monitor their vaccine’s effectiveness and safety after winning approval.
- The FDA expects vaccine developers to involve trial participants who are diverse in race and age.
- The agency still considers emergency use authorizations, and any decisions made regarding temporary approvals will be made on a case-by-case basis.
More articles on pharmacy:
Coalition of drugmakers to unveil $1B venture to pursue antibiotics
Gilead’s remdesivir pricing could set a disruptive industry precedent
CVS Health reportedly launching a GPO called Zinc
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
