Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland

Vaccine from Pfizer/BioNTech authorised in the rolling review procedure after close scrutiny of the risks and benefits Swissmedic has authorised the vaccine from Pfizer/BioNTech. According to the data assessed by the Swiss Agency for Therapeutic Products, the level of protection afforded seven days after the second injection of the vaccine is over 90 percent. This represents the world's first authorisation in the ordinary procedure.

Two months after receiving the application, Swissmedic, the Swiss Agency for Therapeutic Products, has granted authorisation for the coronavirus vaccine Comirnaty (BNT162b2) on the basis of a careful review of the documents submitted on an ongoing basis. The data available to date showed a comparable high level of efficacy in all investigated age groups, thus meeting the safety requirements.

"The safety of patients is an essential prerequisite, especially where the authorisation of vaccines is concerned", says Swissmedic Director Raimund Bruhin. "Thanks to the rolling procedure and our flexibly organised teams, we nevertheless managed to reach a decision quickly - while also fully satisfying the three most important requirements of safety, efficacy and quality." Given the consequences of the pandemic, this swift authorisation marks a milestone in public health.

Rapid and high level of protection
Anyone aged 16 and over can be vaccinated against the novel coronavirus (SARS-CoV-2), subject to compliance with the federal government’s official vaccination recommendations. Two intramuscular injections of the vaccine, spaced at least 21 days apart, are recommended for optimum protection. According to the study data assessed by Swissmedic, the level of protection afforded seven days after the second injection is over 90 percent in adults.

Since the start of the pandemic, Swissmedic has made intensive preparations for dealing with applications for the authorisation of COVID-19 medicines. It set up an internal working group at an early stage to advise companies and research groups on scientific and regulatory questions. The authorisation application for BNT162b2 (Comirnaty), an mRNA vaccine, submitted in mid-October, was reviewed on an ongoing basis ("rolling submission").

Green light also given by independent advisory body
After Swissmedic had received the latest key data and the replies to its questions from the manufacturer and had them assessed by its own experts, the external vaccine specialists of the independent Swissmedic advisory body (Human Medicines Expert Committee, HMEC) held an extraordinary meeting on Friday, 18 December 2020 at which they conducted an in-depth review and - in keeping with the internal assessment - recommended that the coronavirus vaccine Comirnaty be approved. As a result, Swissmedic granted the authorisation today.

After a meticulous review of the available information, Swissmedic concluded that the COVID-19 vaccine from Pfizer/BioNTech is safe and that its benefit outweighs the risks. Before the vaccine could be authorised, the experts at Swissmedic reviewed the available study data according to the following criteria: qualitative (composition and manufacture), non-clinical (pharmacology and toxicology) and clinical (immunogenicity, safety and efficacy).

Safety: Focus on side effects
As with all medicines that arrive on the market for the first time, Swissmedic will monitor the safety of the vaccine closely and, if necessary, take immediate measures if any safety signals arise. The side effects documented most frequently in the authorisation studies are comparable with those after a flu vaccination.

Swissmedic provides a special online system (ElViS) that allows healthcare professionals to report suspected adverse drug reactions. Recipients of vaccines will be advised to contact their vaccination centre, hospital, doctor or pharmacist if they experience any fairly severe or unusual symptoms after a vaccination.

As a condition of authorisation, Swissmedic will require the marketing authorisation holder to continue submitting information on the safety, efficacy and quality of its vaccine on an ongoing basis.

The authorisation applications for pandemic vaccines will continue to be processed with high priority using all the available resources. Swissmedic will report on further authorisations of pandemic vaccines as soon as new data become available, while also monitoring the international developments in this area.

Swiss Agency for Therapeutic Products
www.swissmedic.ch/?l­ang=2


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