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Swiss regulator seeks more data on AstraZeneca vaccine

AstraZeneca vaccine submitted insufficient data on COVID-19 jab for approval, says Swissmedic

Peter Kenny   | 03.02.2021
Swiss regulator seeks more data on AstraZeneca vaccine


Switzerland's health regulator said Wednesday that data submitted by the British-Swedish drug company AstraZeneca were insufficient to authorize the use of its COVID-19 vaccine.

Declaring that "new studies" on the vaccine are needed, Swissmedic said in a statement: "With regard to the AstraZeneca vaccine, the data submitted and analyzed so far are not yet sufficient to permit authorization."

"To obtain a conclusive assessment, the applicant will, among other things, have to submit additional efficacy data from a Phase III trial underway in North and South America, and these will have to be analyzed," it said.

Switzerland had approved two novel coronavirus vaccines -- one made by Pfizer and BioNTech, as well as another by Moderna -- both based on mRNA technology, Swissmedic said on Jan. 29.

The country began vaccinations against the disease late in December, and the Health Ministry says it received 517,625 vaccines, 315,033 of which have been administered.

The regulator said the most common side effects in its approval studies were similar to those of flu vaccinations, including pain at the point of injection, headaches, chills and muscle pain.

"After approval, the safety of the vaccines is continuously monitored by Swissmedic, with a particular focus on serious and previously unknown reactions."

More than 8,800 people have died in connection with the novel coronavirus, with 528,524 cases confirmed in the Alpine country of 8.6 million.

"The epidemiological situation is improving in terms of figures, but the evolution of cases of the more contagious variant is worrying," said Health Minister Alain Berset on Wednesday.

He said on the Swiss national broadcaster, RSR, that the Swiss federal authorities are not considering any easing to the current national lockdown measures.

Switzerland has concluded three new contracts for vaccines, with German company Curevac for 5 million doses of its vaccine candidate in its Phase 3 trials, Novavax of the US for 6 million doses and Moderna for an additional 6 million.

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