AstraZeneca pulls request for Swiss approval of COVID shot
ABC News
AstraZeneca says it is withdrawing its application for approval of its COVID-19 vaccine in Switzerland because the country’s medical regulator wanted to restrict its use to people over age 50
BERLIN -- AstraZeneca said Thursday that it is withdrawing its application for approval of its COVID-19 vaccine in Switzerland because the country's medical regulator wanted to restrict its use to people over age 50.
Switzerland has cleared the BioNTech-Pfizer, Moderna and Johnson & Johnson vaccines for use. However, national medical regulator Swissmedic hadn't yet granted marketing authorization for the AstraZeneca vaccine.
The British-Swedish pharmaceutical company said that, since it started rolling submissions for authorization in Switzerland in October 2020, it “has been in close communication with the regulator and has continuously provided the requested study results and other pertinent information and documents.”
AstraZeneca said it has now “decided not to pursue the marketing authorization for its COVID-19 vaccine in Switzerland. This decision is based on Swissmedic’s requirement to restrict the indication to people 50 years and above.”