ZURICH (Reuters) – Switzerland’s drug regulator is still awaiting data needed to consider whether to approve AstraZeneca’s COVID-19 vaccine, a Swissmedic official said on Tuesday, adding the information “unfortunately” had yet to be submitted.
AstraZeneca was the first vaccine maker to seek Swiss approval in early October 2020, but has since been overtaken by three vaccines that have won Swissmedic’s blessing from Pfizer, Moderna and Johnson & Johnson. Another candidate, from Germany’s CureVac, this week submitted a rolling application, in hopes of a speedy OK.
Claus Bolte, Swissmedic’s head of approvals, said AstraZeneca’s approval process had dragged on as part of a “curious” situation, marked by the company’s release of initial efficacy data in March that drew U.S. officials’ rebuke, before days later issuing slightly worse numbers.
“We’re waiting, just like the U.S. Food and Drug Administration, for the results of clinical trials in Latin America and North America,” Bolte said during a press conference from Bern.
“It was announced four weeks ago, but it has unfortunately not yet been submitted,” he said. “We want to decide on an approval. Right now, however, it’s not possible.”
With AstraZeneca’s vaccine associated with very rare blood clots in Europe, Bolte added Switzerland could eventually make recommendations on limits about who should get the shot, if data supported such a move. First, however, it must be approved.
AstraZeneca did not immediately respond to an emailed request for comment. The European Medicines Agency said earlier this month the risk of dying from COVID-19 was “much greater” than the risk of mortality from rare side effects.
Also at the press conference, Swiss vaccines czar Nora Kronig said Moderna’s COVID-19 vaccine deliveries had experienced some hiccups and delays, but the government still anticipated the U.S. company would meet its second-quarter commitments.
Moderna told Reuters last week its second-quarter deliveries to Britain and Canada faced delays, but that Swiss and European Union shipments would hit target ranges.
Switzerland expects eight million doses combined from Moderna and Pfizer and its German partner BioNTech in April, May and June.
