Swiss drugs regulator authorises Pfizer-BioNtech Covid-19 vaccine

The authorisation comes after a two-month rolling review. PHOTO: AFP

GENEVA (REUTERS) - Swiss drugs regulator Swissmedic has authorised the Covid-19 vaccine from Pfizer and partner BioNTech, the agency said on Saturday (Dec 19), calling it the world's first such approval under a standard procedure.

Two months after receiving the application, Swissmedic granted authorisation for the vaccine in a rolling review of documents being submitted.

Other countries have already approved it for emergency use to help curb the global coronavirus pandemic.

"The data available to date showed a comparable high level of efficacy in all investigated age groups, thus meeting the safety requirements," it said on its website.

"The safety of patients is an essential prerequisite, especially where the authorisation of vaccines is concerned", Swissmedic Director Raimund Bruhin said.

"Thanks to the rolling procedure and our flexibly organised teams, we ... managed to reach a decision quickly - while also fully satisfying the three most important requirements of safety, efficacy and quality."

Swissmedic is also reviewing applications for Covid-19 vaccines made by Moderna and AztraZeneca.

"We commend Swissmedic for its careful assessment of our Covid-19 vaccine and timely action to help protect the people of Switzerland," Ms Sabine Bruckner, Pfizer's head of Swiss operations, said in a statement, calling Swiss approval "a historic moment in the fight against this deadly disease".

Swiss vaccinations will start within days, Health Minister Alain Berset said in a video posted on Twitter.

First priority for the voluntary jabs will be vulnerable people, including the elderly and those with medical conditions.

Swissmedic will require Pfizer to continue submitting information on the safety, efficacy and quality of its vaccine on an ongoing basis, it said.

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