The Swiss therapeutics products agency Swissmedic has started a review of another anti-Covid 19 vaccine – this time from United States biotech firm Moderna - in the rolling submission procedure.This content was published on November 13, 2020 - 14:03
This is the third authorisation procedure submitted in Switzerland for a vaccine against the novel coronavirus.
“The rolling submission procedure for mRNA-1273 is based on the initially submitted data packages on the preclinical situation and quality, as well as on preliminary clinical data. In a rolling review, the data can be evaluated as soon as they become available. The companies can then submit the latest data continuously without having to wait for the conclusive results from all studies,” Swissmedic said on Friday.
Swissmedic can thus obtain an initial picture of the benefit-risk profile of the vaccine candidates before the authorisation studies are completed (Phase III studies). This accelerates the review process while at the same time “preserving the same level of careful checking of all requirements relating to safety, efficacy and quality”, it explained.
The agency is already reviewing authorisation applications for Covid-19 vaccines from the companies AstraZeneca and Pfizer/BioNTech.
On Wednesday Swiss government announced that it had earmarked an additional CHF100 million ($111 million) to buy an anti-Covid vaccine.
Interior Minister Alain Berset said the aim was to provide a “safe and efficient product of high-quality” for the population in Switzerland. The allocation of funds comes on top of CHF300 million approved earlier this year.
So far, Switzerland has assured reservations for about 13 million doses of prospective vaccines from AstraZeneca and Moderna and an international programme by the World Health Organization (WHO). It is also in negotiations with Pfizer/BioNTech about assuring delivery. Swissmedic has to examine and approve any product before it is distributed.
Health officials estimate about 60-70% of the population must be inoculated against the new coronavirus to get the pandemic under control.
Coronavirus infections in Switzerland rose by 6,739, the federal health authorities said on Friday. The death toll increased by 97.