Posted by Michael Wonder on 26 Oct 2020
European Union would apply lower threshold in assessing COVID-19 vaccine
25 October 2020 - The EU’s drug regulator is willing to approve a vaccine even if it were effective in less than half of people taking it, a lower threshold than the FDA is likely to apply.
The European Union’s chief drug regulator would approve a vaccine against COVID-19 even if trials showed that it was effective in less than half the people who take it, lower than the threshold the U.S. Food and Drug Administration is likely to apply in assessing vaccine candidates for the U.S. population.
According to officials at the EMA, the body would be willing to approve a COVID-19 vaccine even if it showed a so-called efficacy rate below 50%, as long as the shot were safe enough to justify the benefits.
