Switzerland declines to approve Oxford/AstraZeneca vaccine, citing insufficient data
Switzerland's drugs regulator has declined to authorize a COVID-19 vaccine developed by England's University of Oxford and British-Swedish pharmaceutical giant AstraZeneca because the data that’s been submitted and analyzed so far "are not yet sufficient."
"To obtain more information about safety, efficacy and quality, additional data from new studies are needed," the Swiss Agency for Therapeutic Products, also known as Swissmedic, said in a statement Wednesday.
"The data currently available do not point to a positive decision regarding benefits and risks," the agency added. "To obtain a conclusive assessment, the applicant will among other things have to submit additional efficacy data from a Phase III trial under way in North and South America, and these will have to be analysed. As soon as the results have been received, a temporary authorisation according to the rolling procedure could be issued at very short notice."
Switzerland joins a growing list of European countries expressing skepticism over the amount of available trial data and the vaccine efficacy among older age groups. On Tuesday, health officials in both Belgium and France announced that, pending additional data, their countries won't recommend the Oxford/AstraZeneca vaccine to anyone over the age of 55. Last week, Germany's vaccine commission said the shot should not be administered to people older than 65, citing "insufficient data."
Meanwhile, the U.S. Food and Drug Administration has said it wants to see the results from a large, ongoing trial in the United States before authorizing the Oxford/AstraZeneca vaccine.