COVID-19 Vaccines: Lost Placebo Control Could Mean Lost Approval, US FDA Officials Say
Getting an EUA is not a reason to vaccinate all placebo patients, US FDA officials write in NEJM article.
You may also be interested in...
Although US FDA wants sponsors to maintain blinded Phase III follow-up as long as possible after emergency use authorization or licensure, vaccine researcher Larry Corey says it will become ‘untenable’ to keep individuals in placebo arm once they qualify for vaccine access under the allocation framework.
Advisory Committee on Immunization Practices work group also says previous infection with SARS-CoV-2 should not exclude someone from receiving vaccine if they are in one of the early groups recommended for prioritization; ACIP group unveils updated ethical principles intended to guide vaccine allocation decisions.
US FDA must rethink guidance on maintaining placebo-control in COVID-19 trials after any vaccine gets an EUA, companies say, arguing current proposal may not be ethical or feasible. Disease organizations who agree with the hurdles to preserving placebo-control maintain this is a reason why any EUA must meet a very high standard.