Johnson & Johnson Announces Single-Shot COVID-19 Vaccine
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Canada Approves Johnson & Johnson Single Shot COVID-19 Vaccine

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Johnson & Johnson becomes the latest COVID-19 vaccine provider to be added to Canada’s approved list for authorized use

TDS News – On January 29, 2021, Johnson & Johnson announced topline efficacy and safety data from its Phase 3 clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.

The Phase 3 study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination.

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The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.

“Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” said Alex Gorsky, Chairman Chief Executive Officer, Johnson & Johnson.

Today, Health Canada approved the Johnson & Johnson’s single shot vaccine for emergency authorization of use. Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. This decision was based on scientific evidence, including 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.

Johnson & Johnson anticipates fulfilling the 10 million doses included in the Advance Purchase Agreement with the Government of Canada by the end of Q3 2021.

The Janssen COVID-19 vaccine candidate demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO)), with no reported cases among participants who had received the Janssen COVID-19 vaccine, 28 days post-vaccination.

“These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.

Trial participants of the phase 3 clinical study continue to be followed for up to two years for assessments of safety and efficacy. Therefore, these data may be updated based on ongoing analysis. The comprehensive available data set will be submitted to a peer-reviewed journal in the coming weeks.

If authorized, Janssen’s single-dose vaccine candidate is estimated to remain stable for two years at -20°C (-4°F), at least three months of which can be at temperatures of 2-8°C (36°F–46°F). The Company will ship the vaccine using the same cold chain technologies it uses today to transport other innovative medicines.

Johnson and Johnson’s now becomes the fifth vaccine in production to treat COVID-19 along with Pfizer, Astra Zeneca, Moderna and Russia’s Sputnik V.

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