COVID-19 vaccine from Johnson & Johnson: Swissmedic approves the third vaccine against COVID-19

Application for authorisation submitted by Janssen-Cilag AG approved

Bern, 22 March 2021

Swissmedic has temporarily authorised the "Covid-19 vaccine Janssen" developed by the pharmaceutical corporation Johnson & Johnson for people aged 18 and over. This brings to three the number of vaccines officially authorised for distribution in Switzerland for the prevention of COVID-19. The vector vaccine based on a human adenovirus only needs to be administered as a single dose. The submitted study data show an average efficacy of 66.9 percent in the investigated age groups.

On 7 December 2020, Janssen-Cilag AG – a company in the Johnson & Johnson healthcare group – submitted an application to Swissmedic for the authorisation of its vaccine candidate (Ad26.COV2.S). Following a careful review of all the submitted documentation, Swissmedic has granted the "COVID-19 Vaccine Janssen" temporary authorisation. The HMEC (Human Medicines Expert Committee), Swissmedic's external advisory body, voiced its support for this decision during an extraordinary meeting.

The vaccine is administered once (as a single dose) and is authorised for people aged 18 and over. It is based on a human adenovirus (cold virus) containing the blueprint for the spike proteins of the coronavirus SARS-CoV-2, which in turn forms the basis for triggering the desired immune response to the virus in the human immune cells.

The submitted study data show efficacy rates between 64.2% (age group: 18 to 64 years) and 82.4% (65 years and older) 14 days after vaccination in all investigated age groups. Severe and critical forms of COVID-19 can be prevented with this vaccine (in almost 85% of cases). A positive effect was also demonstrated against the dominant mutations in Brazil and South Africa (SARS-CoV-2 variants).  

The side effects documented most frequently in the clinical trials were headache, fatigue, pain at the injection site and nausea. Most vaccine reactions appeared within 1 or 2 days after vaccination and were of short duration (1 to 2 days).

The vaccine can be stored frozen at -25 °C to -15 °C and can be transported either deep-frozen or after thawing at between 2 °C and 8 °C. Once removed from the freezer, the unopened vaccine can be stored in the refrigerator for up to 3 months.

Swissmedic reviewed this authorisation application, too, in the greatly accelerated rolling procedure. Results from ongoing studies and replies to questions were submitted continuously by the company and assessed by Swissmedic as soon as they were available.

With this authorisation of the COVID-19 vaccine from Johnson & Johnson, Swissmedic has now approved three of the four applications for COVID-19 vaccines submitted to date. The vaccines from Pfizer/BioNTech (Comirnaty) and Moderna have already been authorised. The application from AstraZeneca is still under review.

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