The Swiss drugs regulator will delay its approval of the two Covid-19 vaccines developed by AstraZeneca and Johnson & Johnson until it receives more data on their efficacy at preventing the virus, the agency said on Wednesday.
Swissmedic, the country’s regulator, said the current data for the AstraZeneca jab is “not yet sufficient for approval” and it has now called for more information on the vaccine’s “safety, effectiveness and quality.”
Specifically, the Swiss agency has asked for efficacy data from the ongoing phase III trial being carried out in North and South America, where the AstraZeneca vaccine is being tested on 30,000 people.
Swissmedic is currently conducting “rolling reviews” of both the AstraZeneca and Johnson & Johnson vaccines, meaning in theory that a quick decision can be made once the relevant data is available and reviewed.
“When the AstraZeneca and Johnson & Johnson vaccines can be approved depends on the quality of the missing documents. A prognosis is difficult,” Swissmedic said in a statement.
The AstraZeneca vaccine, which was developed with the University of Oxford, has already been approved by drug regulators in the UK and the EU, and is now being rolled out.
The US and some European nations have been cautious about the jab however, after a dosing mistake during clinical trials saw some participants under the age of 55 accidentally given half doses of the vaccine, followed by full second doses.
