Covid-19: further vaccine approved
Swissmedic has temporarily authorized the vaccine "COVID-19 Vaccine Janssen" developed by the pharmaceutical company Johnson & Johnson for people aged 18 and over. This means that three vaccines for the prevention of Covid-19 disease are now officially marketable in Switzerland. The vector vaccine, which is based on a human adenovirus, only needs to be administered once. The study data submitted show an average efficacy of 66.9% in the age groups examined.
On 7 December 2020, the company Janssen-Cilag AG of the healthcare group Johnson & Johnson submitted an application to Swissmedic for authorisation of its vaccine candidate (Ad26.COV2.S). Swissmedic approves the vaccine "COVID-19 Vaccine Janssen" for a limited period after a careful review of all the documents submitted. Swissmedic's external expert advisory body HMEC (Human Medicines Expert Committee) supported the decision at an extraordinary meeting.
Vaccine is administered only once
The vaccine is administered once (single dose) and is licensed for persons 18 years of age and older. It is based on a human adenovirus (human cold virus) that contains the blueprint of the spike proteins of the SARS-CoV-2 coronavirus, on the basis of which the desired immune response against the virus is triggered in human immune cells.
The submitted study data show efficacy 14 days after vaccination in all age groups studied ranging from 64.2 % (age group 18 to 64 years) to 82.4 % (65 years and older). Severe and critical courses of Covid-19 disease can be prevented with this vaccination (at almost 85 %). In addition, a good effect was demonstrated with the mutations that dominate in Brazil and South Africa (SARS-CoV-2 variants).
The most common adverse reactions documented in the clinical trials were headache, drowsiness, pain at the injection site or nausea. Most vaccine reactions occurred within 1 to 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 transported frozen or thawed at 2 °C to 8 °C. After removal from the freezer, the unopened vaccine can be stored in the refrigerator for up to 3 months.
Swissmedic also reviewed this marketing authorisation application at a greatly accelerated pace in a rolling procedure. Results of the ongoing studies and answers to questions posed were submitted by the company on an ongoing basis and reviewed by Swissmedic as soon as they were available.
With the approval of Johnson & Johnson's Covid-19 vaccine, Swissmedic has given a positive assessment to three of the four applications for Covid-19 vaccines submitted to date. The vaccines from Pfizer/BioNTech (Comirnaty) and Moderna have already been approved. The application from AstraZeneca is currently still under review.
It should be noted that the vaccine from Johnson & Johnson has not yet been ordered by the Federal Office of Public Health. For this reason, it is unlikely to be used in Switzerland due to time constraints.
Source: Swissmedic
