Johnson & Johnson COVID-19 Vaccine Fully Approved by Health Canada to Prevent COVID-19 in Individuals 18 years and Older
Vaccine demonstrates protection against COVID-19 related hospitalization and death, and
TORONTO, Nov. 24, 2021 /CNW/ - The Janssen Pharmaceutical Inc. Companies of Johnson & Johnson announced today 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.
Johnson & Johnson's COVID-19 Vaccine
Manufacturing and Supply Chain Information
Phase 3 ENSEMBLE Study Design
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.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com/canada. Follow us at @JanssenCanada. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of a potential preventive vaccine for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
SOURCE Janssen Inc.