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.



Russian War Bloggers Report New Ukrainian Attack in Kursk Region

People wait at a bus stop next to a reinforced concrete bomb shelter installed in a street in the course of Russia-Ukraine conflict, in Kursk, Russia August 28, 2024. The sign on the construction reads: "Shelter". REUTERS/Maxim Shemetov/File Photo Purchase Licensing Rights
People wait at a bus stop next to a reinforced concrete bomb shelter installed in a street in the course of Russia-Ukraine conflict, in Kursk, Russia August 28, 2024. The sign on the construction reads: "Shelter". REUTERS/Maxim Shemetov/File Photo Purchase Licensing Rights
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Russian War Bloggers Report New Ukrainian Attack in Kursk Region

People wait at a bus stop next to a reinforced concrete bomb shelter installed in a street in the course of Russia-Ukraine conflict, in Kursk, Russia August 28, 2024. The sign on the construction reads: "Shelter". REUTERS/Maxim Shemetov/File Photo Purchase Licensing Rights
People wait at a bus stop next to a reinforced concrete bomb shelter installed in a street in the course of Russia-Ukraine conflict, in Kursk, Russia August 28, 2024. The sign on the construction reads: "Shelter". REUTERS/Maxim Shemetov/File Photo Purchase Licensing Rights

Ukrainian forces have launched a major new attack in Russia's western Kursk region, Russian military bloggers reported on Sunday.
Ukrainian troops broke across the border in a surprise incursion on Aug. 6, and for the past five months have resisted Russian attempts to expel them.
Reports from the Russian bloggers, who support Moscow's war in Ukraine but have often reported critically on failings and setbacks, indicated that the latest Ukrainian assault had put Russian forces on the defensive.
"Despite strong pressure from the enemy, our units are heroically holding the line," the Operativnye Svodki (Operational Reports) channel said.
It said artillery and small-arms battles were taking place, and Ukraine was using Western-armored vehicles to bring in large numbers of infantry.
The reports, which Reuters could not independently verify, said fighting was concentrated near the town of Bolshoye Soldatskoye.
But one influential blogger, Yuri Podolyak, said this was most likely a Ukrainian distraction manoeuvre, possibly to prepare a strike on Glushkovo, further west. He recommended civilians there and in another town, Korenevo, to evacuate.
Ukrainian and Western assessments say that some 11,000 troops from Russia's ally North Korea have been deployed in the Kursk region to support Moscow's forces. Russia has neither confirmed nor denied their presence.
Ukrainian President Volodymyr Zelenskiy said on Saturday that Russian and North Korean forces had suffered heavy losses.
"In battles yesterday and today near just one village, Makhnovka, in Kursk region, the Russian army lost up to a battalion of North Korean infantry soldiers and Russian paratroops," Zelenskiy said. "This is significant."
The president provided no specific details. A battalion can vary in size but is generally made up of several hundred troops.
Russian President Vladimir Putin said in response to a question at his marathon annual phone-in last month that Russia would definitely drive Ukrainian forces out of Kursk but declined to set a date for when this would happen.
Russia's defense ministry did not mention Kursk in its latest battlefield update on Sunday.
BARGAINING CHIP
Ukraine's unexpected success in biting off a slice of Russian territory and holding on to it since last August could provide it with an important bargaining chip as both sides gear up for possible peace talks this year.
Both have been striving to improve their battlefield positions before US President-elect Donald Trump is sworn in on Jan. 20. Trump has repeatedly said he will bring a quick end to the war, but without saying how.
By committing some of its most effective units to the Kursk offensive, Ukraine has, however, weakened the defense of its own eastern regions where Russian forces have advanced since August at their most rapid pace since 2022.
The Ukrainian military said on Saturday that the "hottest" front was near Pokrovsk, an important road and rail hub towards which Russia has been pressing for months.
On Sunday, Ukraine's air defenses shot down 61 out of 103 drones launched by Russia in an overnight attack, the air force said. Russia said it had destroyed five Ukrainian drones over Russian territory.