Johnson & Johnson single-dose COVID-19 vaccine 66% effective

Johnson & Johnson single-dose COVID-19 vaccine 66% effective.  Get 1 shot to prevent COVID-19! Johnson & Johnson single-dose COVID-19 vaccine large-scale Phase 3 clinical: prevention of moderate to severe COVID-19, the total effective rate is 66%!

Johnson & Johnson (JNJ) recently announced the efficacy and safety data of the Phase 3 ENSEMBLE study, indicating that the single-dose COVID-19 vaccine being developed by its subsidiary Janssen Pharmaceuticals has reached all primary and key secondary endpoints. The safety and effectiveness data is based on 43783 participants, and a total of 468 symptomatic cases of COVID-19 have occurred.

The Phase 3 ENSEMBLE study aims to evaluate the effectiveness and safety of Janssen’s COVID-19 candidate vaccine in protecting moderate to severe COVID-19. The common primary endpoints are 14 days and 28 days after vaccination. Among all participants from different regions, including those infected with newly emerging virus variants, 28 days after vaccination, the total effective rate of Janssen COVID-19 candidate vaccine in preventing moderate to severe COVID-19 was 66% .

It is worth mentioning that the protective effect was observed as early as the 14th day of vaccination. 28 days after vaccination, the protection rates against moderate to severe COVID-19 infections in the United States, Latin America, and South Africa were 72%, 66%, and 57%, respectively.

Paul Stoffels, MD, Vice Chairman and Chief Scientific Officer of Johnson & Johnson’s Executive Committee, said: “These results of a single injection of the COVID-19 candidate vaccine represent a promising moment. By providing an effective and well-tolerated vaccine, only A single immunization may greatly reduce the burden of serious diseases, which is a key component of the global public health response.

The World Health Organization believes that a single shot of vaccine is the best option in a pandemic environment and can enhance access, distribution and compliance. In terms of prevention of severe COVID-19 disease and prevention of COVID-19 related medical interventions, an 85% effective rate will potentially protect hundreds of millions of people from the severe and deadly consequences of COVID-19. It also offers hope of helping reduce the huge burden on the healthcare system and the community. “

Prevent serious diseases; protect against hospitalization and death related to COVID-19:

At 28 days after all adults 18 years and older were vaccinated, the Janssen COVID-19 vaccine was 85% effective in preventing serious diseases in all study areas. The effectiveness of preventing serious diseases has increased over time. Among the vaccinated participants, no serious cases were reported after the 49th day.

At 28 days after vaccination, the Janssen COVID-19 vaccine was proven to have complete protection against hospitalization and death related to COVID. The vaccine has a significant preventive effect on COVID-19 cases that require medical intervention (hospitalization, entry into ICU, mechanical ventilation, extracorporeal membrane oxygenation [ECMO]). In subjects who received Janssen CVID-19 vaccine, vaccinate No cases were reported in the next 28 days.

In this study, the definition of severe COVID-19 disease includes laboratory-confirmed SARS-CoV-2 and one or more of the following factors: signs consistent with severe systemic disease, entering the intensive care unit, respiratory failure, shock, Organ failure or death, etc. Moderate COVID-19 disease is defined as laboratory-proven SARS-CoV-2 and one or more of the following diseases: pneumonia, deep vein thrombosis, shortness of breath or abnormal blood oxygen saturation exceeding 93%, abnormal respiratory frequency (≥ 20); or two or more systemic symptoms suggesting COVID-19.

In race, age group, including adults over 60 years old (N=13610), and all the variants and regions studied, including South Africa (almost all COVID-19 cases [95%] in this region are due to B infection .1.351 SARS-CoV-2 variant of the pedigree), the protection obtained is consistent.

Image source: nasdaq.com

Multi-continental studies provide clinical data on multiple emerging virus mutations:

The overall results of the study include the efficacy of emerging coronavirus strains, including some highly infectious variants that exist in the United States, Latin America and South Africa. Phase 3 of the ENSEMBLE trial was conducted at the height of the COVID-19 pandemic in 8 countries and 3 regions. At that time, the spread of the disease accelerated around the world, resulting in increased exposure to the virus.

Dr. Mathai Mammen, Global Head of R&D Department of Janssen, said: “These results prove the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program. We are very grateful for the valuable contributions of clinical trial personnel and trial participants. Changing the pandemic Trajectory will require large-scale vaccination to create herd immunity, and the single-dose regimen has quick-start protection and convenient transportation and storage, providing a potential solution for as many people as possible. In the fight against the pandemic, The ability to avoid hospitalization and death will change the outcome.”

Participants in the Phase 3 ENSEMBLE study will continue to be followed up for up to 2 years to assess their safety and effectiveness. Therefore, these data may be updated based on ongoing analysis. These comprehensive available data sets will be submitted to peer-reviewed journals in the coming weeks.

Safety data of Phase 3 ENSEMBLE study:

The analysis included a simultaneous review of the available Phase 3 ENSEMBLE safety data by the Data and Safety Monitoring Board (DSMB, an independent expert group), without reporting any major safety issues related to the vaccine. A review of adverse events shows that a single dose of Janssen COVID-19 vaccine is generally well tolerated.

So far, among more than 200,000 people, the safety profile is consistent with other vaccine candidates using Janssen AdVac® technology. The total fever rate was 9%, and the grade 3 fever rate was 0.2%. The overall serious adverse events (SAE) reported by subjects who received placebo was higher than those who received active vaccine candidates. No allergic reactions were observed.

Janssen COVID-19 vaccine (Image source: arynews.tv)

Acquisition and distribution of Janssen vaccine candidates:

Subject to regulatory approval, the company is committed to providing an affordable COVID-19 vaccine in a non-profit manner for use in an emergency pandemic.

In addition, Janssen vaccine candidates are compatible with standard vaccine distribution channels. If approved, Janssen’s single-dose vaccine candidate is expected to remain stable at -20°C (-4°F) for 2 years, of which at least three months can be at 2-8°C (36°F–46°F) Temperature. The company will use the cold chain technology currently used to transport other innovative drugs to deliver vaccines.

The company intends to apply for a U.S. Emergency Use Authorization (EUA) in early February and hopes to deliver the product for use immediately after obtaining the authorization. As the authorization is obtained and the contract is finalized, the company will share more information about deployment details. The company’s projected production schedule will enable it to fulfill its 2021 supply commitments, including commitments signed with governments and global organizations.

(source:internet, reference only)

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