Switzerland starts 'rolling review' of Moderna COVID-19 vaccine

So-called rolling reviews allow drug companies to submit applications for COVID-19 medicinal products before development work is concluded and prior to the availability of complete supporting documentation. U.S. drugmaker Moderna said this week that it has enough data for a first interim analysis of its late-stage COVID-19 vaccine trial, raising hopes that initial results will be released soon.

Switzerland has begun a rolling review of Moderna's, COVID-19 vaccine candidate so it can give it a speedy approval should it pass muster in clinical trials, the country's drug regulator said on Friday.

Regulator Swissmedic is already scrutinizing the progress of experimental vaccines being developed by AstraZeneca as well as Pfizer and BioNTech SE in similar rolling reviews. So-called rolling reviews allow drug companies to submit applications for COVID-19 medicinal products before development work is concluded and prior to the availability of complete supporting documentation.

U.S. drugmaker Moderna said this week that it has enough data for a first interim analysis of its late-stage COVID-19 vaccine trial, raising hopes that initial results will be released soon. Interim trial data from Pfizer and BioNTech released on Monday indicated that its vaccine candidate was more than 90% effective.

"Swissmedic can thus obtain an initial picture of the benefit-risk profile of the vaccine candidates before the authorisation studies are completed," Swissmedic said in a statement about the rolling review. "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."

As part of the review, Swissmedic said it was working with other drug regulators around the world. Switzerland has already set aside 400 million Swiss francs ($437 million) to buy COVID-19 vaccines and reserved a total of about 16 million doses of the shots being developed by Moderna, AstraZeneca and Pfizer/BioNTech. ($1 = 0.9148 Swiss francs)

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