J&J’s single-shot vaccine showed 85% protection against Covid-19 related hospitalisation and death, and across different variants
Janssen, the pharmaceutical company of Johnson & Johnson (J&J), has received Health Canada full approval for use of its single-shot Covid-19 vaccine in people aged 18 years and above.
Health Canada approval was supported by scientific evidence, including initial data from the Phase 3 ENSEMBLE clinical trial, conducted in eight countries across three continents.
The study evaluated the safety and efficacy of the J&J vaccine candidate against both moderate and severe Covid-19 disease, in 43,783 participants.
The assessment of vaccine efficacy by the 14th day and 28th day include the co-primary endpoints.
In the Phase 3 trial, the vaccine showed 85% efficacy in preventing severe disease, and showed protection against Covid-19 risk, 28 days after vaccination.
Janssen R&D global head Mathai Mammen said: “We are delighted by Health Canada’s decision to approve the Johnson & Johnson Covid-19 vaccine based on Phase 3 clinical data that proves the vaccine’s robust safety and efficacy.
“As vaccination rates continue to climb, a vaccine that prevents severe disease and protects against Covid-related hospitalisation and death will help ease the strain on healthcare systems and is an important option for people in Canada and around the world.”
J&J is developing the recombinant Covid-19 vaccine candidate through Janssen, which leverages its AdVac vaccine technology.
Janssen previously used its AdVac vaccine platform to develop and manufacture an EC-approved Ebola vaccine regimen, and create potential Zika, RSV, and HIV vaccines.
The company claims that its single-dose Covid-19 vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas.
It is estimated to remain stable for two years at -25°C to -15°C, and a maximum of six months at routine refrigeration at temperatures of 2°C to 8°C.
The vaccine will be shipped using the same cold chain technologies used for transporting medicines for cancer, immunological disorders and other diseases.
Johnson & Johnson executive committee vice chairman and chief scientific officer Paul Stoffels said: “Today marks the first major regulatory approval for the Johnson & Johnson Covid-19 vaccine and an important moment to recognize the dedication of everyone involved in our Covid-19 vaccine development.
“We are proud to have a Covid-19 vaccine available to protect people around the world and will continue to work to ensure global access.”