Bypassing booster shot review not an option, says medicines regulator

Just over 60% of the population in Switzerland has been vaccinated against Covid-19. Keystone / Alexandra Wey

The head of Swissmedic has dismissed criticism that the agency has been hesitant to approve booster shots, noting that the pharmaceutical companies submitted applications later in Switzerland than the European Union.

“Swissmedic is anything but slow,” Swissmedic director Raimund Bruhin toldExternal link the German-language paper NZZamSonntag. “The assessment [of booster shot applications] is well advanced.”

The medicines regulator has faced criticism over the timeline for authourising so-called boosters or third jabs. The European Medicines Agency approved the Pfizer/BioNtech booster in early October, and several countries including the United States, Israel and Austria have already started administering third shots. Calls for booster shots have grown louder over the last few weeks as more vaccinated individuals wind up in hospitals in Switzerland.

The companies decide when to submit their applications in different countries, said Bruhin. “We have no influence here. The Americans and the EU received the applications earlier than we did and maybe with slightly different dates.”

Some countries have also bypassed the review process for booster shots, allowing their public health ministries to bear the responsibility. This isn’t an option in Switzerland, indicated Bruhin. “Anyone who bypasses these processes can quickly lose a lot of trust and cause damage.”

He added that they also can’t rely on the European Medicines Agency decision because Swissmedic has responsibility for the Swiss legal area and surveillance after approval. The agency needs “hard facts” not just “soft signs” and Swiss citizens trust Swissmedic more than they trust a foreign drug authority.

In an interview on Swiss public television, SRF, earlier this week, Swissmedic’s head of regulatory affairs Claus Bolte said that booster shots could be approved by the end of the month. Bruhin confirmed that the agency is waiting for companies to answer remaining open questions.

Outlook

The number of new corona cases have risen in recent days as many people return from autumn holidays and the weather turns colder, bringing more people inside. Public health experts have cautioned that the winter months could be difficult, urging people to get vaccinated as quickly as possible.

Lukas Engelberger, the head of the conference of cantonal health directors, toldExternal link the SonntagsZeitung that he is optimistic that the corona crisis will be behind us next spring under two conditions. Firstly, vaccinations have to continue a pace and secondly, no dangerous virus mutations can emerge.

The Federal Office of Public Health appears less optimistic, points out the NZZamSonntag. The public health office has budgeted CHF 1.5 billion in 2022 for corona testing alone. This is despite the government no longer covering the cost of testing except in suspected cases. This is double what was spent on Covid-19 testing from the third quarter 2020 to the second quarter 2021. Invoices can be submitted later, says the public health office, so the budget numbers may not correspond with when tests were carried out.