Swissmedic Grants Marketing Authorization for COVID-19 Vaccine

Swissmedic in Switzerland announced it had granted a Conditional Marketing Authorization for the COVID-19 mRNA vaccine Comirnaty®, also known as BNT162b2. 

Comirnaty is the name under which Pfizer AG and BioNTech SE developed the COVID-19 vaccine marketed in Switzerland. And Pfizer AG stated it is the Marketing Authorization Holder in Switzerland.

Pfizer and BioNTech previously announced an agreement with Switzerland to supply the vaccine. Deliveries are scheduled for late 2020 and will occur throughout 2021.

The companies have also submitted the final Conditional Marketing Authorization Application following rolling submissions with the European Medicines Agency and several other regulatory agencies worldwide.

“It is encouraging to see that our mRNA vaccine is now approved in Switzerland. The number of countries authorizing the use of our vaccine is steadily increasing. This is important to support addressing this pandemic,” said Sean Marett, Chief Business Officer and Chief Commercial Officer at BioNTech, in a press release.

The Swissmedic decision is based on a rolling submission, including data from the Phase 3 clinical study. That study demonstrated a vaccine efficacy rate of 95 percent in participants without prior SARS-CoV-2 infection and also in participants with and without previous SARS-CoV-2 infection, in each case measured from 7 days after the second vaccine dose. 

The BNT162b2 vaccine is authorized or approved for emergency use in more than 15 countries, including the USA.

Pfizer and BioNTech continue to collaborate with governments and Ministries of Health around the world to distribute the vaccine, subject to country authorization or approval, to help ensure it can reach those most in need as quickly as possible. 

Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network can supply up to 1.3 billion doses by the end of 2021.

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