The usual route to marketing authorization of a medicinal product with a new active substance in Switzerland is to submit an application as set out in Article 11 of the therapeutic products act (TPA) [13, 14], before which a complete dossier, including read-outs of clinical trials and details on validated manufacturing processes, must be prepared. A standard timeline of 540 calendar days from submission is foreseen for the authorization of a new therapeutic product. On 18th September 2020, based on the COVID-19 ordinance 3 article 21, the Swiss medicines regulator Swissmedic clarified significantly faster, alternative routes for medicinal products targeting COVID-19, utilizing novel “rolling review” concepts [15, 16]. In a regular review, the applicant must submit all relevant data at formalized milestones, at which point activity switches to Swissmedic, who review the dossier and issue a consolidated list of questions to which the submitting company responds within a certain timeframe. Rolling review does away with this structure—the company submits data and dossier components as they become available and Swissmedic responds with queries as they arise [16]. In addition, TPA Article 9a [13] allows Swissmedic to temporarily authorize medicinal products, provided that a series of preconditions are met regarding the severity of the disease in question and anticipated effectiveness of the medicinal product and assumes that the company will provide the required data to convert the authorization into an ordinary authorization before the temporary authorization expires [16].

While the aforementioned pivotal trial was still ongoing, and on the strength of the Phase 1/2 data, Pfizer AG submitted BNT162b2 into a rolling submission process with Swissmedic in mid-October 2020, which was placed on a track towards temporary authorisation via Article 9b by Swissmedic [13, 14, 16]. As the Phase 3 data became available in December, an intense period of correspondence between Pfizer’s regulatory affairs department and Swissmedic ensued, with both parties working long and irregular hours. At this time, Switzerland was recording more than 600 COVID-19-related deaths per week[3], and as in other Swiss businesses, the vast majority of Pfizer AG staff were working from home, further complicating this exceptional workload. On 19th December, 64 days after the submission of the first data was submitted, Swissmedic granted temporary authorisation to Comirnaty® for active immunisation in persons aged 16 and over for prevention of COVID-19. This represented the world’s first approval of a COVID-19 vaccine outside of emergency use programs [15].

A few weeks later, on 12th January 2021, mRNA-1273 (Spikevax®) was similarly granted temporary authorisation for use in those aged 18 and over for protection against COVID-19 [17].

This process of rolling review, while undoubtably key to the unprecedentedly rapid timelines achieved for mRNA vaccines in the pandemic setting, presented significant challenges to the usual internal processes established by pharmaceutical companies and regulatory authorities. Workforce and resource planning was complicated by timelines dictated primarily by the availability of data, ultimately tied to event occurrence in clinical trials.