Swiss Delay Approval of Astra’s Covid Shot to Seek More Data
(Bloomberg) -- Switzerland wants AstraZeneca Plc to provide more data on its Covid-19 vaccine before deciding whether to authorize the shot, taking a more cautious stance than its neighbors.
“The data currently available do not point to a positive decision regarding benefits and risks,” the country’s regulator, Swissmedic, said in a statement Wednesday.
The request comes less than a week after the European Union gave the shot the green light. Still, France and Germany have restricted its use in the elderly, citing a lack of trial data in older age groups. The U.K. approved the vaccine in December.
In Switzerland, AstraZeneca will have to submit additional efficacy data from a Phase III trial underway in North and South America, among other information.
AstraZeneca’s vaccine has faced questions over its efficacy since the company reported early trial results. Those showed 70% protection, on average, but the results came from two groups: one that delivered 62% effectiveness, and the other 90%, with the higher level coinciding with a mistake in dosing.
When the U.K. approved the vaccine, the country’s regulators signaled that the discrepancy was more likely linked to the interval between shots than the dosing level.
Further analysis of trial data showed the inoculation to be 82% effective when the two shots are given three months apart, according to the University of Oxford, AstraZeneca’s partner in developing the vaccine. The shot may also significantly reduce transmission of the virus, according to the new findings.
©2021 Bloomberg L.P.