The Covid-19 vaccine has been granted emergency use authorisation after evaluation of safety, effectiveness and manufacturing quality by FDA
Johnson & Johnson (J&J) has secured the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its single-dose Covid-19 vaccine.
Developed by J&J’s pharmaceutical subsidiary Janssen, the vaccine has been authorised to prevent Covid-19 in individuals aged 18 years and above.
The single-dose Covid-19 vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas, said the company.
It would remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration temperatures of 36-46°F (2 to 8°C).
The vaccine leverages AdVac vaccine platform, a unique technology previously used in developing and manufacturing Janssen’s Ebola vaccine regimen and in creating its investigational Zika, RSV, and HIV vaccines.
Johnson & Johnson chairman and CEO Alex Gorsky said: “This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world, all of whom shared a goal of bringing a single-shot vaccine to the public.
“We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”
The FDA EUA was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE, a randomised, double-blind, placebo-controlled clinical trial.
The study enrolled a total of 43,783 participants, aged 18 years and above, to evaluate the safety and efficacy of the company’s vaccine candidate.
Phase 3 ENSEMBLE trial showed that the vaccine was 85% effective in preventing severe Covid-19 disease, and protection against Covid-19 related hospitalisation and death, post 28 days of the vaccination.
The US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA), and National Institute of Allergy and Infectious Diseases (NIAID), partly funded the research and development of the Covid-19 vaccine.
Janssen said that its Covid-19 vaccine has not been approved in the US, but has been authorized by FDA through an Emergency Use Authorization for active immunization in people aged 18 years and older.
Johnson & Johnson chief scientific officer and executive committee vice-chairman Paul Stoffels said: “We believe the Johnson & Johnson single-shot Covid-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants.
“A vaccine that protects against Covid-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide.”