Upcoming Emergency Approval: Vaccine Overcomes Major Hurdle in US, What Does That Mean for Switzerland?



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The United States should begin vaccinations against Covid this year. Two questions arise for Switzerland: Will this speed up the process here and will there still be enough doses of vaccine left?

The US has already reserved 100 million cans - the first production at Pfizer / Biontech.

The US has already reserved 100 million cans – the first production at Pfizer / Biontech.

Photo: EPA / Keystone

After the UK, Covid vaccines are likely to start in the US next week – the Pfizer / Biontech vaccine is about to launch for emergency purposes. The FDA’s independent vaccine advisory committee voted 17-4 Thursday. The agent’s proven benefits outweigh the risks in people over the age of 16. One member abstained. The FDA is expected to approve the product based on this recommendation in the coming days.

The FDA had already stated in a document released Tuesday that it had no concerns about the use of the vaccine. Research has not revealed any new problems regarding its safety and efficacy.

Pfizer will supply the US and the EU first

Now nothing stands in the way of final approval by the FDA. Delivery of the first doses of the vaccine to the US will begin in a few hours, as Pfizer had announced in advance. The United States had already signed a preliminary contract for the express delivery of 100 million cans in July. They also managed to deliver another 500 million.

What does that mean for Switzerland? She only got up last week 3 million doses of the vaccine contractually insured with Pfizer / Biontech. With this amount, 1.5 million people can be vaccinated here, because each vaccinated person needs two injections every three weeks. Only after the second vaccination does full protection against Covid disease begin.

However, serum is extremely scarce and manufacturer Pfizer, one of the world’s largest pharmaceutical companies, cannot keep up with production. “There are always bottlenecks in both the equipment and the active ingredients,” Pfizer chief Albert Bourla said this week at an IFPMA World Pharmaceutical Association press conference. However, Pfizer plans to produce 50 million cans this year. In the next year it should be 1.3 billion. “We are working to improve that even more,” emphasized Bourla.

Pfizer will deliver to the US and the European Union first, leaving no cans for Switzerland at first. That is not a problem, because the serum should not be used here at all. Emergency release for vaccines is not possible, Switzerland is one of the few countries that does not allow early release at all. That is the crucial difference between Switzerland and the United States and the EU and other Western countries. Millions of healthy people can only be vaccinated once complete data from clinical studies on a vaccine are available. The emergency communication is only based on provisional results.

Obviously, to avoid political pressure, Swissmedic even issued a press release on Friday to explain the situation: “In Switzerland there is no legal basis for the emergency use of Covid-19 vaccines while authorization requests are still being processed. . »Applicants would now have to submit sufficient and meaningful data on the safety, efficacy and quality of their vaccines. “We hope to get the answers quickly,” says Raimund Bruhin, director of Swissmedic. “As soon as the data allow an initial risk-benefit assessment, Swissmedic will decide very quickly on approval.”

Approval in the first half of 2021

The Swiss licensing authority Swissmedic is in close contact with the FDA about Covid vaccines; is one of its associated authorities. Scientists discuss so-called expert evaluations. In this way, Swissmedic will also get a detailed insight into the Pfizer / Biontech vaccine review. That should support your judgment, but not speed it up.

Approval in Switzerland is not expected until the first half of 2021. The announcement by the Federal Office of Public Health that it could already be in Starting in January was a “hypothesis”. With the comparatively small quantity, Pfizer / Biontech should again have enough cans to supply Switzerland as well.

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