Pfizer/Biontech COVID-19 vaccine wins Swiss regulatory approval

ZURICH (Reuters) – Swiss drugs regulator Swissmedic has authorised the COVID-19 vaccine from Pfizer and partner BioNTech, the agency said on Saturday, calling it the world’s first such approval under a standard procedure.

Pharmacy manager Larren Suh displays the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine at Massachusetts General Hospital in Boston, Massachusetts, U.S., December 16, 2020. Craig F. Walker/Pool via REUTERS

Two months after receiving the application, Swissmedic granted authorisation for the vaccine for people aged 16 and older after 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,” Swissmedic said.

“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 nevertheless 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,” 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”.

The vaccine has been authorised or approved for emergency use in more than 15 countries, the partners said. Swissmedic’s Bruhin said he expected EU regulators to approve it soon.

Swiss vaccinations will start within days, Health Minister Alain Berset said on Twitter. The first priority for the voluntary jabs will be vulnerable people, including the elderly and those with medical conditions.

The Swiss health agency said on Saturday a nationwide vaccination programme could start from Jan. 4 with an initial batch of around 100,000 doses.

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

“We will take immediate action if necessary should safety signals emerge,” Bruhin told a news conference.

Switzerland has a contract with Pfizer and BioNTech to deliver 3 million doses of the vaccine, it has said, enough for 1.5 million people to get two jabs three weeks apart.

COVID-19 cases in Switzerland and neighbouring Liechtenstein have surpassed 400,000 and the death toll has topped 6,000, prompting the government on Friday to close restaurants for a month and urge people to stay home.

Source: Read Full Article