Swissmedic examines application for COVID-19 booster vaccination from Johnson & Johnson

Bern, 22.12.2021 - Johnson & Johnson has submitted an application in Switzerland for the authorisation of booster vaccinations with its “COVID-19 Vaccine Janssen”. Swissmedic is examining the submitted data in the rolling review process.

On 22 March 2021, Swissmedic authorised “COVID-19 Vaccine Janssen” from Johnson & Johnson. This vector-based vaccine is administered as a single dose to persons aged 18 years and over.

The pharmaceutical company has now submitted an application to Swissmedic to have booster vaccinations authorised. The clinical data for the booster are being examined in respect of safety and efficacy.

The time taken for the rolling procedure until Swissmedic’s decision is influenced chiefly by the applicant company itself. It depends primarily on the completeness of the data submitted by Johnson & Johnson and the results of the clinical trials. To date, Swissmedic has authorised booster vaccinations with the vaccines from Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax).

Booster vaccination
A "booster vaccination" is a further dose of vaccine administered after a certain period to fully vaccinated people with a basic level of immunisation in order to boost the immunological memory. Booster vaccinations are indicated as soon as the protection after complete basic immunisation is no longer sufficient for preventing severe cases of COVID-19.

Duration of vaccination protection
The protection resulting from COVID-19 vaccination against infection or mild symptomatic disease is achieved by means of neutralising antibodies located in the blood or the mucous membranes of the respiratory tract. In the event of any subsequent contact with the pathogen, the latter is then recognised, thereby averting an outbreak of the illness or a severe case of the disease. The amount of these antibodies slowly decreases following basic immunisation. Consequently, the protection against asymptomatic or mild infection/illness also declines, although the protection against serious cases of the disease, including hospitalisations, is maintained for a longer period. This is because complete vaccination results in the formation not only of antibodies, but also memory B cells and T cells, which basically afford protection against serious illness by being reactivated after contact with the virus and secreting large amounts of antibodies which, in turn, fight the pathogen quickly and efficiently.

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