Vaccination 1 shot to prevent COVID-19! Johnson and Johnson single-dose new crown vaccine large-scale phase 3 clinical: prevention of moderate to severe COVID-19, total efficiency of 66%!

Jan. 30, 2021 // -- JNJ recently announced top-line efficacy and safety data for the Phase 3 ENSEMBLE study, indicating that the single-dose COVID-19 vaccine being developed by Janssen Pharmaceuticals has reached all major and critical secondary endpoints.
safety and ability data based on 43,783 participants, a total of 468 cases of COVID-19 symptoms occurred.
3 ENSEMBLE study aims to assess the effectiveness and safety of Jansen COVID-19 candidate vaccines in protecting moderate to severe COVID-19, with the common primary endpoint being 14 and 28 days after vaccination.
among all participants from different regions, including those infected with emerging virus variants, the overall effectiveness of the Jansen COVID-19 vaccine candidate vaccine in the prevention of moderate to severe COVID-19 was 66% 28 days after vaccination.
note that protective effects were observed as early as the 14th day of vaccination.
28 days of vaccination, the protection rates for moderate to severe COVID-19 infections were 72%, 66% and 57%, respectively, in the United States, Latin America and South Africa.
. Paul Stoffels, M.D., vice chairman and chief scientific officer of johnson and Johnson's executive committee, said, "These results represent a promising moment with a single dose of the COVID-19 candidate vaccine.
by providing an effective and well-to-resistant vaccine, it is possible to significantly reduce the burden of serious diseases with just one immunization, which is a key component of the global public health response.
world health organization believes that a one-shot vaccine is the best option in a pandemic environment and enhances access, distribution and follow-up.
85 per cent effectiveness in preventing serious COVID-19 diseases and preventing COVID-19-related medical interventions will have the potential to protect hundreds of millions of people from the serious and deadly consequences of COVID-19.
it also offers hope of helping to ease the enormous burden on the health care system and the community.
" - Prevention of serious diseases, protection against COVID-19-related hospitalizations and deaths: 28 days after all adults aged 18 and over were vaccinated, the effective rate of the Jansen COVID-19 vaccine in preventing serious diseases was 85% in all study areas.
effectiveness of vaccines against serious diseases increased over time, and no serious cases were reported after the 49th day of vaccination participants.
28 days after vaccination, the Jansen COVID-19 vaccine was shown to have full protective effect on COVID-related hospitalization and death.
vaccine has a significant preventive effect on COVID-19 cases requiring medical intervention (hospitalization, entry into the ICU, mechanical aeration, in vitro pulmonary oxygenation (ECMO)), and no cases were reported 28 days after vaccination among subjects receiving the Jansen CVID-19 vaccine.
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, access to intensive care units, respiratory failure, shock, organ failure, or death.
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 oxygen saturation of more than 93%, abnormal respiratory frequency (≥20), or two or more systemic symptoms that indicate COVID-19.
The protection is consistent in race, age group, including adults over 60 years of age (N=13610), as well as in all variants and regions studied, including South Africa (almost all COVID-19 cases in the region (95 per cent) are due to SARS-CoV-2 variants infected with the B.1.351 linee.
Photo Source: nasdaq.com - Multi-continental studies provide clinical data on a variety of emerging virus mutations: the overall results include efficacy for emerging coronavirus strains, including some highly contagious variants found in the United States, Latin America and South Africa.
ENSEMBLE trial was conducted at the height of the COVID-19 pandemic in eight countries and three regions, when the spread of the disease accelerated worldwide, leading to increased exposure to the virus. Dr. Mathai Mammen, Global Head of research and development at
Jansen, said, "These results demonstrate the extraordinary efforts of everyone involved in our CLINICALD-19 candidate vaccine clinical program, and we are very grateful to the clinical trial staff and trial participants for their valuable contribution.
changing the trajectory of a pandemic will require mass vaccination to create group immunity, while single-dose programs offer fast-start protection and convenient delivery and storage, providing a potential solution for as many people as possible.
ability to avoid hospitalization and death in the fight against pandemics will change outcomes.
2 years of follow-up to assess their safety and effectiveness in the "Ensemble" Phase 3 study.
, the data may be updated based on ongoing analysis.
these comprehensive available data sets will be presented to peer-reviewed journals in the coming weeks.
- Phase 3 ENSEMBLE Research Safety Data: The analysis included a simultaneous review of available 3-phase ENSEMBLE Study Safety Data by the Data and Security Monitoring Committee (DSMB, an independent expert group) without reporting any major vaccine-related safety issues.
review of adverse events showed that the single dose of Janssen COVID-19 vaccine was generally well- resistant.
, the safety profile is consistent with other candidates using Jansen AdVac technology in more than 200,® 200,000 people.
rate of 9% and 0.2% for level 3.
subjects who received placebo treatment reported higher overall severe adverse events (SAEs) than those who received active candidate vaccine therapy.
no allergic reactions were observed.
Jansen COVID-19 vaccine (Photo: arynews.tv) - Access to and distribution of Jansen's candidate vaccine: With regulatory approval, the company is committed to providing an affordable COVID-19 vaccine in a non-profit manner for emergency pandemics.
addition, Janssen candidate vaccines are compatible with standard vaccine distribution channels.
if approved, Janssen's single dose candidate vaccine is expected to remain stable at -20C (-4F) for two years, with a temperature of 2-8C (36F-46F) for at least three months.
company will use 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 as soon as it is licensed.
the company will share more details about the deployment as the authorization is obtained and the contract is finalized.
company's projected production schedule will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.
origin: Johnson and Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in In Analysis of its Phase 3 ENSEMBLE Trial<!--/ewebeditor:page->