Expert advisors for the Food and Drug Administration met Thursday to discuss which virus strain this year's updated COVID-19 vaccines should target. The advisors have been meeting around this time each year for such a strain selection, a routine decision in the process of updating the life-saving vaccines.
But this year's meeting was awkward and even a little tense. Earlier this week, new FDA leaders under health secretary and anti-vaccine advocate Robert F. Kennedy Jr. announced a sweeping new framework that would restrict access to the shots, making them available only to people 65 and older and those with medical conditions that put them at risk of severe illness. For updated COVID-19 vaccines to be approved for healthy children and adults, vaccine makers would need to repeat large, randomized, placebo-controlled trials, which are expensive, ethically debatable at this point, and could easily take too much time to complete before the shots would need to be ready for fall vaccinations. The advisors weren't consulting on the new framework, and there is much uncertainty about its implementation.
Just thirty minutes into yesterday's nearly seven-hour meeting, one committee member broached one of the largest looming questions, saying, "If a different strain was selected for this season, would that require additional clinical trials, etc.?"
Fonte: Ars Technica - Leia mais