BERN – Swissmedic has temporarily approved the Covid-19 vaccine “COVID-19 Vaccine Janssen” developed by the pharmaceutical giant Johnson & Johnson for people aged 18 and over. This means that three vaccines to prevent the disease are officially marketable in Switzerland (this in addition to Pfizer and Moderna).
This vaccine is given once (single dose). The vector is a human adenovirus (human variant of the cold virus) that contains the spike protein structure of the SARS-CoV-2 coronavirus, on the basis of which the desired immune response against the virus in human immune cells is activated.
The study data presented show efficacy in all age groups tested between 64.2% (18-64 years) and 82.4% (over 65) 14 days after vaccination. This vaccine allows to avoid the serious and critical courses of Covid-19 disease (up to almost 85%). Furthermore, it has also been shown to be effective against mutations found in Brazil and South Africa.
The most common side effects reported in clinical trials (within 1-2 days of vaccination and temporary) were headache, fatigue, arm pain or nausea.
The vaccine can be stored frozen at -25 ° C to -15 ° C and transported frozen or thawed at 2 ° C to 8 ° C. Once removed from the freezer, the unopened vaccine can be stored in the refrigerator for up to 3 months.
On 7 December 2020, Janssen-Cilag AG of the Johnson & Johnson healthcare group submitted an application for approval for the candidate vaccine (Ad26.COV2.S) to Swissmedic. Application examined as quickly as possible through the rolling review procedure. The answers to the questions asked and the results of the ongoing studies were presented by the company on an ongoing basis and verified by Swissmedic as soon as they were available. The Human Medicines Expert Committee (HMEC), which collaborates with Swissmedic, supported the decision at an extraordinary meeting.
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