Europe – EMA sets 50% efficacy goal – with flexibility – for COVID vaccines

The European Medicines Agency (EMA) has released its planned framework for issuing marketing authorizations for vaccines against COVID-19, as the agency continues its rolling reviews of candidate vaccines. Rather than setting hard-and-fast efficacy standards, the guidance lays out EMA’s expectations, while allowing room for a balanced evaluation for conditional marketing authorization of a vaccine during the pandemic.

In terms of efficacy, EMA is expecting to see at least one “well-designed large-scale phase 3 efficacy trial” to support marketing authorization of a COVID-19 vaccine. For pivotal trials, laboratory-confirmed COVID-19 disease of any severity is the primary endpoint, with efficacy analysis limited to those participants who were seronegative at the time of their baseline assessment “as it is important to show that the vaccine protects subjects not likely to have been exposed to the virus before.”…