This week, the marketing authorisation holder Moderna Switzerland GmbH submitted further data on the booster dose of its COVID-19 vaccine (Spikevax®). Swissmedic has assessed the benefits and risks of a booster dose for adults in general, and has amended the product information. This means that all adults can now receive a booster with a half-dose of the vaccine at least six months after their second vaccination.
Indication extension for booster with Spikevax® approved from 18 years
Swissmedic has reviewed the documents on the booster submitted by the marketing authorisation holder, and has amended the product information for Moderna's COVID-19 mRNA vaccine. A booster dose can now be administered to anyone aged 18 or over with immediate effect. As stipulated in the Swissmedic decision of 26 October 2021, high-risk individuals can still obtain the booster from age 12. In both cases, however, the second dose must have been administered at least six months previously.
Booster vaccine with half-dose
Basic immunisation with Spikevax involves two doses of 0.5 ml administered at an interval of one month. For a booster given at least 6 months after the second vaccination, a half-dose (0.25 ml) is administered. The immune response data from ongoing clinical trials shows that a booster dose can increase the body’s immune response, which declines over time.
Use and safety of COVID-19 vaccines
Vaccines are used in accordance with the official recommendations from the Federal Commission for Vaccination (FCV). The marketing authorisation holders must continue to provide information on the safety, efficacy and quality of their products on an ongoing basis. Swissmedic continues to closely monitor the benefits and risks of all vaccines for preventing COVID in Switzerland and internationally.