Swissmedic approves booster dose with the COVID-19 vaccine from Janssen-Cilag AG

Bern, 27.12.2021 - This week, Janssen-Cilag AG submitted data on the booster dose of its "COVID-19 Vaccine Janssen" to Swissmedic. The Agency has approved the authorisation application, which means that persons aged 18 years and older can now receive a booster dose after a first vaccination.

On 22 March 2021, Swissmedic authorised "COVID-19 Vaccine Janssen" from Janssen-Cilag AG. This vector-based vaccine is administered as a single dose to persons aged 18 and older.

At the request of the applicant, Johnson & Johnson, Swissmedic has reviewed and approved the clinical data on safety and efficacy submitted for the booster. The second dose of the vaccine can be administered, at the earliest, two months after the first dose.

Mixed vaccination authorised

The authorisation application also included clinical data on mixed vaccinations. Johnson & Johnson combined the mRNA vaccines from Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) with its own vaccine. For a mixed vaccination, Swissmedic approved an interval for the booster dose of six months after the second mRNA vaccination. This period is the same as that for a booster with mRNA vaccines. This is the first time in Switzerland that an applicant has submitted clinical data on a mixed vaccination.

The data for the authorisation of the booster vaccination with COVID-19 Vaccine Janssen will be included in the updated product information.

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