Swiss regulators said Wednesday that data submitted by AstraZeneca were not yet sufficient for it to authorise use of the Anglo-Swedish firm’s COVID-19 vaccine and “new studies” were needed.
The Swissmedic regulatory authority said it had been examining information from AstraZeneca but that it 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.
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 neighbouring 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.
Swissmedic said a meeting of its external advisory body on Tuesday had confirmed its interim assessment of the AstraZeneca vaccine data.
“The data currently available do not point to a positive decision regarding benefits and risks,” it said.
“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.
“As soon as the results have been received, a temporary authorisation according to the rolling procedure could be issued at very short notice,” it added.
A spokesperson for AstraZeneca meanwhile stressed in an email that the company’s jab had already been granted emergency use authorisation “in close to 50 countries, spanning four continents, including most recently in the European Union.”
“We are confident that our vaccine is effective, well-tolerated, and can have a real impact on the pandemic.”
The spokesperson said the company would “continue to share new data as it becomes available and work with Swissmedic to make Covid-19 vaccine AstraZeneca available in Switzerland as soon as possible.”
– 17 mn more doses –
Switzerland, which kicked off vaccination against the coronavirus in late December, meanwhile announced Wednesday that it had signed three more contracts to acquire another 17 million vaccine doses.
The country of 8.5 million people said it had reached an agreement with Germany’s Curevac, whose vaccine is in Phase 3 trials, and the Swedish government for the delivery of five million doses.
It said it had also signed a preliminary agreement with US firm Novavax for six million doses.
These will add two new vaccines to the Swiss portfolio, if they are approved by regulators.
At the same time, the Swiss government had also signed a deal to acquire an additional six million doses of the Moderna vaccine, bringing the total number of those jabs available in Switzerland to 13.5 million.
In addition, the government has signed deals for access to around three million Pfizer-BioNTech doses and 5.3 million AstraZeneca doses.