BERLIN , AstraZeneca announced Thursday that it has withdrawn its application for approval in Switzerland of its COVID-19 vaccine. This was because Switzerland's medical regulator wanted to limit its use to those over 50.
The BioNTech-Pfizer Moderna, Johnson & Johnson and BioNTech-Pfizer vaccines have been cleared for use in Switzerland. Swissmedic, the national medical regulator, has not yet given marketing authorization for AstraZeneca.
According to the British-Swedish pharmaceutical firm, the company has been in close contact with Swiss regulators since October 2020 when it began rolling submissions for authorization in Switzerland.
AstraZeneca stated that it had "decided not pursue the marketing authorization of its COVID-19 vaccination in Switzerland." This decision was based on Swissmedic’s requirement that the indication be restricted to persons 50 years of age or older.
The AstraZeneca vaccine was approved earlier this year by the Swiss medical regulator. Switzerland is not a member country of the European Union. After it was linked to rare blood clots in younger people, authorities in several European countries recommended it be used only in older age groups.
AstraZeneca stated in its statement that there are "established treatment protocols for the optimal managing" of such cases. It also noted that COVID-19 has been granted conditional marketing authorization or emergency use authorization in over 80 countries.
The company stated that the vaccine is generally well tolerated by adults aged 18 and over and has been proven to be effective against all forms of COVID-19.
AstraZeneca has not yet been approved for US use. In July, the drugmaker stated that it would ask the U.S. Food and Drug Administration to approve the full regulatory approval of the vaccine rather than the emergency use authorization on a fast track.