J&J’s single-dose COVID-19 vaccine offers 100% protection against hospitalisation

Johnson & Johnson announced today that the single-dose COVID-19 vaccine candidate developed by Janssen Pharmaceuticals showed 66% efficacy overall in preventing moderate to severe COVID-19 disease, 85% efficacy overall in preventing severe disease and complete protection against COVID-19 related hospitalisation and death, 28 days after vaccination, according to data from its late-stage clinical trial.

Janssen’s COVID-19 vaccine 85% effective in preventing severe disease and 100% effective against hospitalisation and death

According to the efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, the single-dose injection COVID-19 vaccine met all primary and key secondary endpoints, based on 43,783 trial participants accruing 468 symptomatic cases of COVID-19.

The Janssen COVID-19 vaccine also showed evidence of protection against multiple virus variants, including the SARS-CoV-2 variant from the B.1.351 lineage identified in South Africa.

Alex Gorsky, Chairman, Board of Directors and Chief Executive Officer, Johnson & Johnson said:

“Johnson & Johnson embarked on the global effort to combat the COVID-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine. 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. We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”

Janssen’s COVID-19 vaccine platform

The investigational Janssen COVID-19 vaccine candidate leverages the company’s patented AdVac® vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates.

The Janssen AdVac® viral vector technology can induce potent and long-lasting humoral and cellular immune responses, enabling the pursuit of vaccines for disease targets that are currently unpreventable or untreatable.

The Phase 3 ENSEMBLE clinical trial results

The Phase 3 ENSEMBLE study is aimed at evaluating 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. Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination amongst all participants from different geographies and including participants infected with an emerging viral variant. Protection onset was observed as early as day 14 after vaccination. 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.

The Janssen COVID-19 vaccine candidate was 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49.

No cases of hospitalisation 28-days post-vaccination

The first single injection COVID-19 vaccine candidate also demonstrated 100% 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. No cases of hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO) were reported among trial participants who received the Janssen COVID-19 vaccine, 28 days post-vaccination.

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson commented:

“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. A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance. Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.”

In the study, the definition of severe COVID-19 disease included laboratory-confirmed SARS-CoV-2 and one or more of the following: signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death, among other factors. Moderate COVID-19 disease was defined as laboratory-confirmed SARS-CoV-2 and one or more of the following: evidence of pneumonia, deep vein thrombosis, shortness of breath or abnormal blood oxygen saturation above 93%, abnormal respiratory rate (≥20); or two or more systemic symptoms suggestive of COVID-19.

Multi-continent clinical trial data on new virus mutations

Protection was generally consistent across race, age groups, including adults over 60 years of age (N= 13,610), and across all variants and regions studied, including South Africa where nearly all cases of COVID-19 (95%) were due to infection with a SARS-CoV-2 variant from the B.1.351 lineage.

The ENSEMBLE study results include efficacy against newly emerging strains of coronavirus, including some highly infectious variants present in the US, Latin America and South Africa. The Phase 3 ENSEMBLE trial is being conducted at the peak of the COVID-19 pandemic in eight countries and three regions, at a time when disease spread has accelerated throughout the world resulting in people having increased exposure to the virus.

Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development said:

“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions. Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible. The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”

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

Phase 3 ENSEMBLE trial safety data

The analysis included a concurrent review of the available Phase 3 ENSEMBLE study safety data by the Data and Safety Monitoring Board (DSMB), an independent group of experts, that did not report any significant safety concerns relating to the vaccine. A review of adverse events indicated that a single-dose of Janssen’s COVID-19 vaccine candidate was generally well-tolerated.

The safety profile was in line with other vaccine candidates using Janssen’s AdVac® technology among more than 200,000 people to date. Overall fever rates were 9% and Grade 3 fever 0.2%. Overall serious adverse events (SAEs) reported were higher in participants who received placebo as compared to the active vaccine candidate. No anaphylaxis was observed.

Janssen’s COVID-19 Vaccine candidate access and distribution

Janssen Pharmaceuticals is committed to bringing an affordable COVID-19 vaccine on a not-for-profit basis for emergency pandemic use, pending regulatory authorizations. The Company intends to file for U.S. Emergency Use Authorization (EUA) in early February. With the announcement of the positive trial results, EUA application filing could happen as early as next week.

Janssen expects to have vaccines available to ship immediately upon gaining regulatory authorization. The pharma company expects to share more information on specifics of deployment as authorizations are secured and contracts are finalised. The anticipated manufacturing timeline will enable Janssen to meet its 2021 supply commitments, including those signed with governments and global organizations.

Janssen’s COVID-19 vaccine can be supplied trough standard cold chain distribution channels

The Janssen COVID-19 vaccine candidate is compatible with standard vaccine distribution channels. If authorized, Janssen’s one-shot vaccine 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). Janssen plans to ship the vaccine using the same cold chain technologies it uses currently to transport other innovative therapeutics.

The Phase 3 ENSEMBLE Study Design

The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older.

The ENSEMBLE study was designed to evaluate the safety and efficacy of the Janssen vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.

Janssen’s COVID-19 vaccine program has been designed to be thorough and driven by science. As such, the Company is also investigating immune responses for different doses and dosing regimens as well as studying a two-dose regimen of its COVID-19 vaccine candidate for efficacy in the Phase 3 ENSEMBLE 2 study.

The Phase 3 ENSEMBLE study demographics

The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34% (N= 14,672) of participants over age 60.

The study enrolled 44% (N=19,302) of participants in the United States, 41% (N=17,905) in Central and South America (Argentina, Brazil, Chile, Colombia, Mexico, Peru) and 15% (N=6,576) in South Africa.

Forty-five percent of participants are female, 55% male.

Among participants globally, 59% are White/Caucasian; 45% are Hispanic and/or Latinx; 19% are Black/African American; 9% are Native American and 3% are Asian. In the United States, 74% are White/Caucasian; 15% are Hispanic and/or Latinx; 13% are Black/African American; 6% are Asian and 1% are Native American.

Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19 (overall 41%), obesity (28.5%), type 2 diabetes (7.3%), hypertension (10.3%), HIV (2.8%); also other immunocompromised participants were in the study.

COVID-19 Study Funding

Johnson & Johnson continues to develop and test its COVID-19 vaccine candidate in accordance with ethical standards and sound scientific principles. J&J is committed to transparency and sharing information related to its ongoing clinical studies – including the ENSEMBLE study protocol.

ENSEMBLE has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).

Janssen has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola. In February 2020, Janssen and BARDA began work on the development of a COVID-19 vaccine based on Janssen’s AdVac® technology.

The Janssen Pharmaceutical Companies entered into a collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of the preventive vaccine candidate for COVID-19.

For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus .

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