Swiss Drugs Regulator Authorizes Pfizer/Biontech COVID-19 Vaccine

FILE PHOTO: Syringes are seen in front of displayed Biontech and Pfizer logos in this illustration taken November 10, 2020. REUTERS/Dado Ruvic
FILE PHOTO: Syringes are seen in front of displayed Biontech and Pfizer logos in this illustration taken November 10, 2020. REUTERS/Dado Ruvic
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Swiss Drugs Regulator Authorizes Pfizer/Biontech COVID-19 Vaccine

FILE PHOTO: Syringes are seen in front of displayed Biontech and Pfizer logos in this illustration taken November 10, 2020. REUTERS/Dado Ruvic
FILE PHOTO: Syringes are seen in front of displayed Biontech and Pfizer logos in this illustration taken November 10, 2020. REUTERS/Dado Ruvic

Swiss drugs regulator Swissmedic has authorized 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.

Two months after receiving the application, Swissmedic granted authorization 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 authorization of vaccines is concerned," Swissmedic Director Raimund Bruhin said, Reuters reported.

"Thanks to the rolling procedure and our flexibly organized 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.



China Discovers Cluster of New Mpox Strain

A woman walks on the Youyi Bridge at the Liangmahe river in Beijing, China on Thursday, Jan. 9, 2025. (AP Photo/Aaron Favila)
A woman walks on the Youyi Bridge at the Liangmahe river in Beijing, China on Thursday, Jan. 9, 2025. (AP Photo/Aaron Favila)
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China Discovers Cluster of New Mpox Strain

A woman walks on the Youyi Bridge at the Liangmahe river in Beijing, China on Thursday, Jan. 9, 2025. (AP Photo/Aaron Favila)
A woman walks on the Youyi Bridge at the Liangmahe river in Beijing, China on Thursday, Jan. 9, 2025. (AP Photo/Aaron Favila)

Chinese health authorities said on Thursday they had detected the new mutated mpox strain clade Ib as the viral infection spreads to more countries after the World Health Organization declared a global public health emergency last year.
China's Center for Disease Control and Prevention said it had found a cluster outbreak of the Ib subclade that started with the infection a foreigner who has a history of travel and residence in the Democratic Republic of the Congo, Reuters reported.
Four further cases have been found in people infected after close contact with the foreigner. The patients' symptoms are mild and include skin rash and blisters.
Mpox spreads through close contact and causes flu-like symptoms and pus-filled lesions on the body. Although usually mild, it can be fatal in rare cases.
WHO last August declared mpox a global public health emergency for the second time in two years, following an outbreak in the Democratic Republic of Congo (DRC) that spread to neighboring countries.
The outbreak in DRC began with the spread of an endemic strain, known as clade I. But the clade Ib variant appears to spread more easily through routine close contact, including sexual contact.
The variant has spread from DRC to neighboring countries, including Burundi, Kenya, Rwanda and Uganda, triggering the emergency declaration from the WHO.
China said in August last year it would monitor people and goods entering the country for mpox.
The country's National Health Commission said mpox would be managed as a Category B infectious disease, enabling officials to take emergency measures such as restricting gatherings, suspending work and school, and sealing off areas when there is an outbreak of a disease.