The main medical regulator of Switzerland has rejected the Oxford-AstraZeneca Wuhan coronavirus (COVID-19) vaccine. According to the regulator, there is a lack of available trial data to prove that the vaccine is safe to use.
“With regard to the AstraZeneca vaccine, the data submitted and analyzed so far are not yet sufficient to permit authorization,” said the Swiss Agency for Therapeutic Products (SwissMedic) in a statement released on Wednesday, Feb. 3.
“To obtain more information about safety, efficacy and quality, additional data from new studies are needed.”
The Human Medicines Expert Committee, an external and independent advisory panel that double-checks SwissMedic’s findings on medicines for human use, arrived at the same conclusion during a meeting on Tuesday.
“The data currently available do not point to a positive decision regarding benefits and risks,” said the panel. SwissMedic concluded its statement by demanding more data.
“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. As soon as the results have been received, a temporary authorization according to the rolling procedure could be issued at very short notice.”
AstraZeneca responded by saying it will continue to share new data with SwissMedic “as it becomes available,” and will comply with every requirement to make sure its vaccine is approved.
“AstraZeneca has now been granted a conditional marketing authorization or emergency use in close to 50 countries, spanning four continents, including most recently in the European Union,” said the company in a statement. “We are confident that our vaccine is effective, well-tolerated and can have a real impact on the pandemic.”
Meanwhile, other countries have set cut-off ages for people who wish to take the vaccine. For example, Ireland has set its cut-off age at 70, while Belgium has it at 55.
The European Medicines Agency said there is not enough data to provide a faithful estimate of the vaccine’s efficacy for people over the age of 55. Therefore, it cannot reliably justify its use for people over 55. (Related: Aussie scientists cast doubt on low-efficacy AstraZeneca coronavirus vaccine.)