Demanding More Data, Switzerland Delays Approval of AstraZeneca Covid-19 Vaccine
TEMPO.CO, Zurich – Switzerland has postponed approval for AstraZeneca’s Covid-19 vaccine to demand more data on efficacy and quality before granting permission for the EU-approved vaccine last week, drug regulator Swissmedic said Wednesday, February 3, 2021.
Read:
BioNTech Will Fulfill Demand for 144 Million Doses of Covid-19 Vaccine from Japan
Switzerland separately announced that it had ordered millions more doses of the Covid-19 vaccine from several other manufacturers.
Switzerland, which has ordered 5.3 million doses of the vaccine from AstraZeneca, said it was awaiting the results of the vaccine trials in North and South America involving tens of thousands of people, after previous trials had produced no clear data including on the level of efficacy in the elderly.
“As soon as the test results are received, a provisional authorization according to current procedures can be issued in a very short time,” Swissmedic said in a statement.
The Swiss drug regulator also said that for approval it is necessary to obtain additional data on the safety, efficacy and quality of the vaccine.
“The data currently available do not show positive results regarding the benefits and risks of vaccines,” Swissmedic said.
AstraZeneca did not immediately respond to a request for comment.
Pharmaceutical company AstraZeneca and its partner, the University of Oxford, have defended their vaccine, saying it has 76 percent efficacy against symptomatic coronavirus infections for three months after administration of a single dose, which increases if the second injection is delayed.
However, some European countries limit the use of the AstraZeneca vaccine to certain age groups, citing a lack of data on the effects of use, particularly in the elderly.
The Swiss government says it has signed deals with the German company Curevac and the Swedish government for the delivery of 5 million doses of the Covid-19 vaccine. Switzerland also made an initial agreement with US vaccine maker Novavax for 6 million doses, and will get another 6 million doses from Moderna.
The new orders bring the total Swiss vaccine orders to more than 30 million doses, which is enough to vaccinate its population of 8.6 million, or about twice as much for a two-dose rule.
Further talks with several other producers are underway for more supplies of the Covid-19 vaccine, the Swiss government said. “The idea behind procuring vaccines from different manufacturers is to ensure that sufficient doses of approved vaccines are available to the general public even if there are delivery problems,” said the Swiss Federal Ministry of Health.
BETWEEN | REUTERS