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

NEW BRUNSWICK, NJ—(January 29, 2021)—today Johnson and Johnson  announced topline efficacy and safety data from the Phase 3 ENSEMBLE 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 ENSEMBLE 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. 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.

“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.”

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.

“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.”

Johnson and Johnson “over a  year ago, SARS-CoV-2 , the virus that causes COVID-19, began to infect a cluster of individuals in China. Since then, the virus has rapidly spread to every corner of the globe, causing more than 2 million reported deaths and nearly 100 million diagnosed cases, as well as impacting the economies and social fabric of societies around the world. “

With demand for COVID-19 vaccines outpacing the world’s supplies, a frustrated public and policymakers want to know: How can we get more? A lot more. Right away.

The problem: “It’s not like adding more water to the soup,” said vaccine specialist Maria Elena Bottazzi of Baylor College of Medicine.

Makers of COVID-19 vaccines need everything to go right as they scale up production to hundreds of millions of doses — and any little hiccup could cause a delay. Some of their ingredients have never before been produced at the sheer volume needed.

And seemingly simple suggestions that other factories switch to brewing new kinds of vaccines can’t happen overnight. Just this week, French drugmaker Sanofi took the unusual step of announcing it would help bottle and package some vaccine produced by competitor Pfizer and its German partner BioNTech. But those doses won’t start arriving until summer — and Sanofi has the space in a factory in Germany only because its own vaccine is delayed, bad news for the world’s overall supply.

“We think, ‘Well, OK, it’s like men’s shirts, right? I’ll just have another place to make it,’” said Dr. Paul Offit of Children’s Hospital of Philadelphia, a vaccine adviser to the U.S. government. “It’s just not that easy.”

Who Participated in the Study?

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.

The 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.

The Study 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 consistent 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.

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

 

Source: Johnson & Johnson and AP News wrote the original article

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