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Swiss achieve first full-blown vaccine approval

Switzerland announced it has become the first government in the world to approve a coronavirus vaccine using a standard process of regulatory approval.

BERN, Switzerland (AN) — Switzerland announced on Saturday that it has become the first government in the world to approve a new coronavirus vaccine by adhering to a standard non-emergency process for granting regulatory approval.

Swiss medical regulator Swissmedic said it authorized the Pfizer-BioNTech two-shot vaccine and found the level of protection afforded seven days after the second injection of the vaccine is more than 90% effective against COVID-19.

"This represents the world's first authorization in the ordinary procedure," Swissmedic said in a statement.

"The data available to date showed a comparable high level of efficacy in all investigated age groups, thus meeting the safety requirements," it said. "After a meticulous review of the available information, Swissmedic concluded that the COVID-19 vaccine from Pfizer-BioNTech is safe and that its benefit outweighs the risks."

The "ordinary procedure" refers to Swissmedic's full-blown review of Pfizer-BioNTech's coronavirus vaccine Comirnaty® (BNT162b2), in contrast to the U.S. Food and Drug Administration's emergency approval process for two vaccines: Pfizer-BioNTech's and a second from Moderna in partnership with the U.S. National Institute of Allergy and Infectious Diseases.

FDA announced it granted emergency authorization use to Moderna's shot on Friday. Earlier in the week, health workers in the United States began receiving Pfizer-BioNTech's shot that won FDA's emergency authorization use on December 12.

An independent advisory committee to Swissmedic held an in-depth review and recommended Comirnaty® be approved on Friday. As a result, Swissmedic granted the authorization on Saturday but will keep monitoring for adverse side effects, which so far are comparable to those after a flu shot. Pfizer-BioNTech must also keep submitting data on the vaccine.

A week earlier, just as FDA was considering emergency approval, Swissmedic made a point of publicly clarifying this kind of emergency authorization use is not a legal option in Switzerland. But it noted that it works closely with partner agencies such as FDA and reviews all applications for COVID-19 vaccines "as a matter of urgency" as part of a “rolling” procedure.

Unlike in Switzerland, laws in nations such as Britain and the United States permit an emergency use authorization of drugs and other medical products that are still in development if there is a health crisis that might warrant their use.

Such an authorization is based on the notion that an experimental drug, or, in this case, a vaccine, can help vulnerable populations even before all of the scientific studies into the vaccine's safety and effectiveness have been completed. Normally, ordinary approval is contingent on studies involving thousands of people in a process that can last a decade.

This year, the rapid development and approval of coronavirus vaccines since the World Health Organization declared the world's first coronovirus pandemic on March 11 is an extraordinary achievement for science. WHO Director-General Tedros Adhanom Ghebreyesus said that from the beginning of the pandemic, the world knew it would need vaccines to end it."Images of people receiving vaccines are giving us hope, but it must be hope for all, not hope for some," he told a news briefing on Friday. "For most of the past year we have been talking to world leaders and vaccine developers to ensure that once vaccines were available, they were available equitably to all countries."

'Safety, efficacy and quality'

The Swiss medical regulator, which has a staff size equal to only about 3% of FDA's 15,000 employees, said nonetheless that its two-month approval process for the Pfizer-BioNTech vaccine was based on a careful review of the documents that were submitted on an ongoing basis since the application was first received in mid-October.

It said the vaccine, best administered with two shots at least 21 days apart, is suitable for anyone who is 16 or older. The vaccine has already received emergency authorization use in Bahrain, Britain, Canada and the United States.

But Switzerland's fast-tracked "ordinary" approval process represented a milestone in public health, Swissmedic said, given the consequences of a pandemic that remains out of control and has infected 75 million people and killed 1.67 people million worldwide — including almost 404,000 people infected and more than 6,500 people killed in Switzerland.

"The safety of patients is an essential prerequisite, especially where the authorization of vaccines is concerned," Swissmedic's director, Dr. Raimund Bruhin. "Thanks to the rolling procedure and our flexibly organized teams, we nevertheless managed to reach a decision quickly — while also fully satisfying the three most important requirements of safety, efficacy and quality."Switzerland is among the nations that signed deals with drug makers to assure its 8.6 million population gets early access to coronavirus vaccines. It has agreements with Pfizer-BioNTech, Moderna and AstraZeneca to receive 15.8 million doses of vaccines, pending approval from Swissmedic, which said that it also is evaluating a vaccine application from Janssen-Cilag.