Vaccine demonstrates protection against COVID-19 related hospitalization and death, and across different variants
The Janssen Pharmaceutical Companies of Johnson & Johnson blazoned moment that Health Canada has approved its single- shot COVID-19 vaccine to help COVID-19 in individualities 18 times of age and aged.
This decision was grounded on scientific substantiation, including original data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in precluding severe complaint, and showed protection against COVID-19 affiliated hospitalization and death, beginning 28 days after vaccination.
“ We’re pleased by Health Canada’s decision to authorize the Johnson & Johnson COVID-19 vaccine grounded on Phase 3 clinical data that proves the vaccine’s robust safety and efficacity,” 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 complaint 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.”
“ Moment marks the first major nonsupervisory blessing for the Johnson & Johnson COVID-19 vaccine and an important moment to fete the fidelity of everyone involved in our COVID-19 vaccine development, our mates, the controllers and clinical study actors. We’re proud to have a COVID-19 vaccine available to cover people around the world and will continue to work to insure 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
The Johnson & Johnson COVID-19 vaccine leverages the AdVac ® vaccine platform, a unique and personal technology that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine authority and construct its investigational Zika, RSV, and HIV vaccines.
Manufacturing and Supply Chain Information
The Janssen COVID-19 single- cure vaccine is compatible with standard vaccine storehouse and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two times at-25 °C to-15 °C, and a outside of six months at routine refrigeration at temperatures of 2 to 8 °C. The Company will transport the vaccine using the same cold chain technologies it uses moment to transport treatments for cancer, immunological diseases and other drugs. The COVID-19 vaccine shouldn’t bere-frozen formerly fused.
Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE study was a randomized, double-eyeless, placebo- controlled clinical trial in individualities 18 times of age and aged. The study was designed to estimate the safety and efficacity of the Company’s vaccine seeker in guarding against both moderate and severe COVID-19 complaint, with assessment of efficacity as of day 14 and as of day 28 asco-primary endpoints. The study enrolled a aggregate of actors.
The trial, conducted in eight countries across three mainlands, and included a different and broad population including 35 percent of actors over age 60. Forty percent of actors in the study had comorbidities associated with an increased threat for progression to severe COVID-19.
Authorized Use
The Janssen COVID-19 Vaccine (Ad26.COV2.S, recombinant) is indicated for active immunization for the forestallment of coronavirus complaint-2019 (COVID-19) caused by SARS-CoV-2 contagion in individualities 18 times of age and aged.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we ’re creating a future where complaint is a thing of the history. We ’re the Pharmaceutical Companies of Johnson & Johnson, working lifelessly to make that future a reality for cases everyplace by fighting sickness with wisdom, perfecting access with imagination, and healing forlornness with heart. We concentrate on areas of drug where we can make the biggest difference Cardiovascular & Metabolism, Immunology, Infectious Conditions & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
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