Swiss regulator approves Pfizer/BioNTech booster for 16 and up

The extension of the Covid-19 booster only applies to the Pfizer/BioNtech vaccine. Keystone / Christophe Archambault / Pool

Swissmedic has approved the extension of Covid-19 boosters for the Pfizer/BioNTech vaccine to all people aged 16 and over. This now "clears the way" for wider use of the booster vaccination, it said.

On Tuesday, the Swiss Agency for Therapeutic Products said that it was “adapting the product information” for the Pfizer/BioNTech so that a booster can be administered to people 16 years and up. In all cases, the third dose must be administered at least six months after the second dose.

Swissmedic reached the decision based on, among other things, a study involving 10,000 participants aged 16 to 87 years. The interim results of this study did not reveal any evidence of “new risk aspects” with the third vaccine dose, Swissmedic said.

Swissmedic “continues to monitor very closely the benefits and risks of the vaccine” for preventing Covid-19. The extension of boosters doesn’t apply to the Moderna vaccine.

The Federal Commission for Vaccination is now specifying detailed vaccination recommendations for the extension.

Booster doses of both the Pfizer/BioNTech and Moderna vaccines are currently being administered to specific groups, namely people over 65 and “people with a weakened immune system” from the age of 12. This followed Swissmedic’s approval of boosters at the end of October. A booster campaign for the rest of the population is expected to start soon.

Expanding treatment options

The Swiss government also announced on Tuesday that it has reserved around 8,000 packages of the antiviral drug Molnupiravir to treat Covid-19. A clinical trial has demonstrated efficacy in non-hospitalised Covid-19 patients at high risk of severe disease progression, said the Swiss National Scientific Taskforce.

With this deal, the government saidExternal link the country has access to another “promising” Covid-19 drug, in addition to casirivimab/imdevimab (developed by Roche and Regeneron) and sotrovimab (sold by GSK). In contrast to these monoclonal antibodies, molnupiravir is an antiviral treatment and can be administered orally. According to the Federal Office of Public Health, the government will cover the cost of treatment in the outpatient setting until it is reimbursed by mandatory health insurance.

Molnupiravir is expected to be available by January 2022 at the latest but it has not been approved in Switzerland. However, it can already be used to treat Covid-19 patients during the ongoing approval process after “an adaptation of Covid-19 Regulation 3, which has yet to take place,” the statement added.

The contract, the amount of which is confidential, was signed with the company MSD Merck Sharp & Dohme Switzerland.