Health Canada has granted full approval to Janssen Pharmaceutical Companies of Johnson & Johnson’s single-dose Covid-19 vaccine for the disease prevention in people aged 18 years and above.
The approval is supported by scientific evidence submitted by the company, including the primary data from the Phase III ENSEMBLE clinical trial, which was conducted in 43,783 subjects.
The double-blind, randomised, placebo-controlled trial assessed the efficacy and safety of the single-shot vaccine against severe and moderate Covid-19.
Data showed that the vaccine candidate has provided 85% effectiveness in severe Covid-19 disease prevention.
It has also provided protection against the disease-associated risk of hospitalisation and death, after 28 days of vaccination.
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 recognise the dedication of everyone involved in our Covid-19 vaccine development, our partners, the regulators and clinical study participants.
“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.”[SV1]
The company has developed the single-dose vaccine using its AdVac vaccine platform, which was previously used for the development and production of its Ebola vaccine regime.
The platform was also used in constructing the company’s experimental Zika, respiratory syncytial virus (RSV), and human immunodeficiency virus (HIV) vaccines.
Johnson & Johnson’s vaccine is expected to remain stable at -25°C to -15°C for a period of two years, and a maximum of six months at routine refrigeration at 2 to 8°C temperatures.