Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Demonstrates 66% Efficacy Against Moderate to Severe Disease in Phase 3 Trial

January 30, 2021/BioValleyBIOON/-- Johnson & Johnson (JNJ) recently announced the top-line efficacy and safety data from the Phase 3 ENSEMBLE study, indicating that its single-dose COVID-19 vaccine, under development by Janssen Pharmaceuticals, met all primary and key secondary endpoints. The top-line safety and efficacy data were based on 43,783 participants, with a cumulative total of 468 symptomatic COVID-19 cases reported.

The Phase 3 ENSEMBLE study aimed to evaluate the efficacy and safety of the Janssen COVID-19 candidate vaccine in protecting against moderate to severe COVID-19, with co-primary endpoints assessed at 14 days and 28 days post-vaccination. Among all participants from diverse regions, including those infected with emerging viral variants, the Janssen COVID-19 candidate vaccine demonstrated, at 28 days post-vaccination,The overall efficacy in preventing moderate to severe COVID-19 was 66%.It is worth mentioning that,Protective effects were observed as early as 14 days after vaccination.。Twenty-eight days after vaccination, the efficacy against moderate to severe COVID-19 was 72% in the United States, 66% in Latin America, and 57% in South Africa.

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, stated: “These results from our single-dose COVID-19 candidate vaccine represent a promising moment. By providing an effective and well-tolerated vaccine that requires only one immunization, we have the potential to significantly reduce the burden of severe disease, which is a critical component of the global public health response. The World Health Organization considers single-dose vaccines the optimal choice in a pandemic setting, as they enhance access, distribution, and compliance. With an efficacy rate of 85% in preventing severe COVID-19 disease and COVID-19-related medical interventions, this vaccine has the potential to protect hundreds of millions of people from the severe and fatal consequences of COVID-19. It also offers hope for helping to alleviate the tremendous burden on healthcare systems and communities.”

Twenty-eight days after vaccination with the Janssen COVID-19 Vaccine in adults aged 18 years and older, efficacy against severe disease was 85% across all study regions. Efficacy against severe disease increased over time, with no severe cases reported among vaccinated participants after Day 49.

The Janssen COVID-19 vaccine was shown to provide complete protection against COVID-related hospitalization and death 28 days after vaccination.. The vaccine demonstrated significant efficacy in preventing COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, or extracorporeal membrane oxygenation [ECMO]); no cases were reported among participants who received the Janssen COVID-19 vaccine 28 days post-vaccination.

In this study, severe COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by one or more of the following: signs consistent with severe systemic illness, admission to the intensive care unit, respiratory failure, shock, organ failure, or death. Moderate COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by one or more of the following: pneumonia, deep vein thrombosis, shortness of breath or abnormal oxygen saturation (>93%), abnormal respiratory rate (≥20 breaths per minute), or two or more systemic symptoms suggestive of COVID-19.

Protection was consistent across races, age groups (including adults aged ≥60 years [N=13,610]), and all studied variants and regions, including South Africa, where nearly all COVID-19 cases (95%) were caused by infection with the SARS-CoV-2 variant of the B.1.351 lineage.

The overall study results include efficacy against emerging coronavirus strains, including some highly transmissible variants present in the United States, Latin America, and South Africa. The Phase 3 ENSEMBLE trial was conducted across eight countries and three regions at the height of the COVID-19 pandemic, when the accelerated global spread of the disease led to increased exposure to the virus.

Dr. Mathai Mammen, Global Head of Janssen Research & Development, stated, “These results demonstrate the extraordinary efforts of everyone involved in our COVID-19 candidate vaccine clinical program, and we are deeply grateful.”Clinical Trialthe valuable contributions of personnel and trial participants. Altering the trajectory of the pandemic will require large-scale vaccination to establish herd immunity, and single-dose regimens offer rapid onset of protection along with convenient delivery and storage, providing a potential solution for reaching as many people as possible. In the fight against the pandemic, the ability to prevent hospitalizations and deaths will change outcomes.”

The analysis included a concurrent review of the available safety data from the Phase 3 ENSEMBLE study by the Data and Safety Monitoring Board (DSMB), an independent expert panel, which reported no significant vaccine-related safety concerns. A review of adverse events indicated that the single-dose Janssen COVID-19 vaccine was generally well tolerated.

To date, the safety profile in over 200,000 individuals has been consistent with that of other candidate vaccines utilizing Janssen’s AdVac® technology. The overall incidence of fever was 9%, with Grade 3 fever occurring in 0.2% of cases. The overall rate of serious adverse events (SAEs) reported by subjects receiving placebo was higher than that reported by subjects receiving the active candidate vaccine. No anaphylactic reactions were observed.

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

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

Furthermore, the Janssen candidate vaccine is compatible with standard vaccine distribution channels. If approved, the single-dose Janssen candidate vaccine is expected to remain stable for two years at -20°C (-4°F), including at least three months at 2–8°C (36–46°F). The company will utilize existing cold-chain technologies currently employed for transporting other innovative medicines to deliver the vaccine.

The company plans to apply for Emergency Use Authorization (EUA) in the United States in early February and hopes to deliver the product for use immediately upon authorization. As authorization is obtained and contracts are finalized, the company will share more information on deployment details. The company’s projected production timeline will enable it to fulfill its supply commitments for 2021, including those signed with national governments and global organizations. (Bioon.com)

Original Source: Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial