Switzerland seeks more data on AstraZeneca vaccine to give authorisationEuropost
Swiss regulators on Wednesday said that data submitted by AstraZeneca is not sufficient for them to authorise use of the company's Covid-19 vaccine and "new studies" are needed, news wires reported.
The Swissmedic regulatory authority said it had been examining information from AstraZeneca but that was "not yet sufficient to permit authorisation". "To obtain more information about safety, efficacy and quality, additional data from new studies are needed," it said in a statement, cited by AFP.
Switzerland has so far given the green light to Covid-19 vaccines made by Pfizer-BioNTech and Moderna. It had been expected to authorise the AstraZeneca jab soon, after the European Union last week gave the vaccine the go ahead. But while the EU granted approval for use in all people over the age of 18, several European countries have advised against giving the jabs to people over 65, citing lack of evidence that it was effective among the elderly.
"To obtain a conclusive assessment, the applicant will among other things have to submit additional efficacy data from a Phase 3 trial under way in North and South America, and these will have to be analysed, Swissmedic said.
Swiss Health Minister Alain Berset said on Wednesday that he did not expect the rejection of the AstraZeneca vaccine to have an impact on the country’s vaccine rollout.