The Janssen Pharmaceutical Companies of Johnson & Johnson announced on Wednesday that Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on scientific evidence, including initial data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
“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,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “As vaccination rates continue to climb, a vaccine that prevents severe disease and protects against COVID-related hospitalization and death will help ease the strain on healthcare systems and is an important option for people in Canada and around the world.”
“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, 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,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer and Johnson & Johnson.
The Johnson & Johnson COVID-19 vaccine leverages the AdVac® vaccine platform, a unique and proprietary technology that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.
The Janssen COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine 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 to 8°C. The Company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines. The COVID-19 vaccine should not be re-frozen once thawed.
The Phase 3 ENSEMBLE study was a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older. The study was designed to evaluate the safety and efficacy of the Company’s vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The study enrolled a total of 43,783 participants.
The trial, conducted in eight countries across three continents, and included a diverse and broad population including 35 percent of participants over age 60. Forty percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.
The Janssen COVID-19 Vaccine (Ad26.COV2.S, recombinant) is indicated for active immunization for the prevention of coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 virus in individuals 18 years of age and older.