Future Health Pharma GmbH represents Novavax in Switzerland and is considered to be the marketing authorisation holder for the Nuvaxovid vaccine. The company submitted an application for an indication extension for the vaccine to adolescents aged 12 to 18 years. It also applied for authorisation of a new dosage recommendation for a booster dose for persons aged 18 years and over.
COVID-19 vaccine from Novavax: application for indication extension to 12 to 18-year-olds and booster dose submitted
Swissmedic is reviewing applications from Future Health Pharma GmbH for Nuvaxovid
The COVID-19 vaccine Nuvaxovid has been authorised in Switzerland for basic immunisation of people aged 18 years and over since 12 April 2022. The two applications should extend the indication to people aged 12 to 18 years and enable a booster dose for people aged 18 years and over.
Swissmedic is reviewing the application documentation received in an accelerated process without compromising on the scientific review. When a decision on the benefit/risk profile in this age group and on the booster dose will be possible depends on any necessary additional information on safety, efficacy and quality.