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
'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
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
Manufacturing and Supply Chain Information
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-degreeC to -15-degreeC, and a maximum of six months at routine refrigeration at temperatures of 2 to 8-degreeC. 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.
Phase 3 ENSEMBLE Study Design
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.
Authorized Use
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.
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Learn more at www.janssen.com/canada. Follow us at @JanssenCanada.
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
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