Swiss Medical Regulator Does Not Authorize Oxford/AstraZeneca Vaccine

Swiss medical regulator Swissmedic said on Feb. 3 that it has not yet authorized the COVID-19 vaccine developed by Oxford/AstraZeneca for use due to insufficient data on safety, efficacy, and quality.

“The data currently available do not point to a positive decision regarding benefits and risks,” Swissmedic said in a press release, claiming that more data from new studies is necessary “to obtain more information about safety, efficacy, and quality” of the Oxford/AstraZeneca COVID-19 vaccine.

Swissmedic specified that it wants to see data from large-scale human trials of the vaccine being conducted in North America and South America, after previous trials did not show clear efficacy data in older people.

“As soon as the results have been received, a temporary authorization according to the rolling procedure could be issued at very short notice,” Swissmedic said.

AstraZeneca said that Swissmedic was reviewing its vaccine on a rolling basis to speed up the approval process and that it would share information with Swissmedic as soon as it becomes available.

Some European countries have also cited lack of data for using the vaccine on older people, causing them to limit it to certain age groups.

Though the European Medicines Agency also cited insufficient efficacy data for people aged over 55, the agency recommended it for use last week, noting that it generates an immune response in older populations.

Switzerland, which has already ordered 3.5 million doses from AstraZeneca, announced that it had ordered more COVID-19 vaccines from other developers, including 6 million from Moderna, 5 million from Curevac, and 6 million from Novax. This brings the total vaccine orders to over 30 million doses, which is enough to vaccinate its population of 8.6 million.

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