AstraZeneca has withdrawn its request for vaccine approval in Switzerland because the country's medical regulator wanted to restrict it to people aged 50 and older.
The British-Swedish pharmaceutical company said the vaccine "is generally well tolerated in adults 18 years and above," but some European countries recommended it only be given to older adults due to its link to blood clots, according to the Associated Press.
AstraZeneca said their vaccine "has been shown to be effective against all severities of COVID-19, across current variants of concern and all adult age groups."
Despite AstraZeneca's confidence in the vaccine, the company said it has "decided not to pursue the marketing authorization for its COVID-19 vaccine in Switzerland."
AstraZeneca noted in a statement that the choice was based on Swissmedic's "requirement to restrict the indication to people 50 years and above."
After AstraZeneca pulled their application, Swissmedic confirmed in a statement that "there are currently no new authorization applications pending for COVID-19 vaccines in Switzerland."
However, Swissmedic has cleared BioNTech-Pfizer, Moderna and Johnson & Johnson vaccines for citizens.
For more reporting from the Associated Press, see below.
Since AstraZeneca started rolling submissions for authorization in Switzerland in October 2020, it said it "has been in close communication with the regulator and has continuously provided the requested study results and other pertinent information and documents."
Switzerland is not a member of the European Union, whose medical regulator approved the AstraZeneca vaccine earlier this year. Authorities in some European countries later recommended that it be used primarily in older age groups after it was linked to extremely rare blood clots, mostly in younger people.
The AstraZeneca vaccine hasn't yet been approved for use in the United States. The drugmaker said in July that it had decided to ask the U.S. Food and Drug Administration for full regulatory approval, rather than the fast-track emergency use authorization originally anticipated.
In an earlier study of 30,000 people, the AstraZeneca vaccine was 79% effective at preventing symptomatic cases of COVID-19 — including in older adults. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received dummy shots — a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.
AstraZeneca also said the study's independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations earlier this year.
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