Health Canada has authorised an Interim Order (IO) to the Janssen Pharmaceutical (JPI) Companies of Johnson & Johnson’s (J&J) single-shot vaccine preventing Covid-19 for people aged 18 above.
The vaccine leverages J&J’s AdVac vaccine platform for developing Ebola Zika, RSV, and HIV vaccines.
The latest development is based on scientific evidence, including data from the Phase III ENSEMBLE study, which show that the vaccine was 85% effective in preventing severe disease.
The vaccine also demonstrated protection against Covid-19 related hospitalisation and death, starting from 28 days after vaccination.
The company expects to deliver the ten million doses included in the Advance Purchase Agreement (APA) with the Government of Canada by the end of the third quarter this year.
Janssen Canada Medical Affairs vice-president Dr Ebele Ola said: “A vaccine that prevents severe disease and protects against Covid-related hospitalisation and death will help ease the burden on Canadians and the strain on our healthcare systems. Our single-shot Covid-19 vaccine is a critical tool for fighting this global pandemic.”
J&J noted that the IO would aid in the use of the vaccine while more data are collected.
Later this year, the company intends to file for a Notice of Compliance with Health Canada.
The US Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) to its single-dose Covid-19 vaccine.
On another note, Reuters reported that Austria had suspended vaccinations with a batch of AstraZeneca’s Covid-19 vaccine as a precautionary measure following a person’s death and another’s illness.
The Austrian Federal Office for Safety in Health Care (BASG) received two reports temporally connected to vaccines from the same batch (ABV 5300) in Zwettl.
The agency said there is no evidence of a causal relationship with vaccination at present, adding that the affected vaccine batch’s left overstocks will not be distributed and used for inoculating people.