A while ago TrialSite predicted that the other vaccine makers in the lead had to keep an eye out for Johnson and Johnson and now that day has come as the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for the Company’s single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial.
The Vaccine Candidate
Johnson & Johnson’s COVID-19 Vaccine Candidate
The Company’s Janssen COVID-19 Vaccine leverages the AdVac® vaccine platform, a unique and proprietary technology that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.
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.
What are the Next Steps
The next step in the process is for the FDA to decide whether to grant an EUA for Janssen’s COVID-19 vaccine candidate. The recommendation of the FDA Advisory Committee is non-binding, and the final decision on authorization is made by the FDA. Under an EUA, the FDA has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency. If authorized by the FDA, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will then provide a recommendation on the use and roll-out of the Janssen COVID-19 vaccine candidate.
Committed to Reasonable Economic Model
Johnson & Johnson is committed to making its COVID-19 vaccine candidate available on a not-for-profit basis for emergency pandemic use. The Company is prepared to supply its vaccine immediately upon EUA and expects to deliver enough single-dose vaccine candidate by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-dose vaccines to the U.S. during the first half of 2021.
Heavy Hitting Executive
As TrialSite reported in the past, when Johnson and Johnson assigned the vaccine development to Paul Stoffels, MD, they were putting the best in the industry on this critical mission. An MD, the Vice Chairman of the Executive Committee and Chief Scientific Officer, declared today, “We are extremely grateful to the VRBPAC members for their extensive review of the data supporting emergency use of Johnson & Johnson’s single-shot COVID-19 vaccine candidate.” The executive continued, “We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible.”
The ENSEMBLE Study
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older. The study was designed to evaluate the safety and efficacy of the Company’s 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 enrolled a total of 43,783 participants.
The trial, conducted in eight countries across three continents, includes a diverse and broad population, including 34% of participants over age 60.
The study enrolled 44% of participants in the United States. Seventy-four percent of participants in the U.S. 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.
Research and development activities for the Janssen COVID-19 vaccine candidate, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., have been funded with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, 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).
Call to Action: Next steps
Now the FDA needs to decide whether to grant an EUA for Janssen’s COVID-19 vaccine candidate. We are fairly certain this will occur.