(Reuters) – The European Medicines Agency (EMA) said on Thursday it would not impose a 50% efficacy threshold for COVID-19 vaccines, adding full trial data was necessary for it to make a sound assessment on the benefits and risks of a shot.
German biotech CureVac NV said on Wednesday its COVID-19 vaccine was only 47% effective in a late-stage trial, missing the study’s main goal and throwing into doubt the potential delivery of hundreds of millions of doses to the European Union.
“We will need to collect all the final data from this clinical trial, and have a good analysis of the outcome throughout different regions, age groups and according to different variants,” Marco Cavaleri, head of Biological Health Threats and Vaccines Strategy at the EMA, told reporters.
“So I think it is premature to enter into what this means … We always felt it was difficult to define upfront a threshold,” he said, adding that EMA would pay particular attention to variants circulating that may be more infectious.
Cavaleri said EMA had been asking drugmakers to design studies to enable them to demonstrate a minimum efficacy of 50%.
“But we make clear right from the start that this does not mean that we will not look into the entirety of the evidence,” he said.
In the United States, the Food and Drug Administration has said COVID-19 vaccines needed to reach a 50% efficacy threshold in pivotal studies in order to be approved.
In November, before the first data from vaccine trials were released, the EMA said it would not set a minimum level of efficacy for potential COVID-19 vaccines.
Source: Read Full Article