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Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
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Vote based on totality of scientific evidence provided by the Company including safety and efficacy data
https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-u-s-fda-advisory-committee
NEW BRUNSWICK, N.J., February 26, 2021 - Johnson & Johnson (NYSE: JNJ) (the Company) today announced that 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.
"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," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. "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 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.
"We are grateful to everyone who has contributed to the wealth of data we presented today, including study participants, site investigators and teams, collaborators and everyone who has worked so hard to bring us to this moment. We are confident our COVID-19 vaccine candidate will have a significant impact in protecting people around the world," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.
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.
Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.
Manufacturing and Supply Chain Information
The Johnson & Johnson COVID-19 single-dose vaccine candidate is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C). The Company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines. The COVID-19 vaccine should not be re-frozen if distributed at temperatures of 36°F-46°F (2°-8°C).
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.
Phase 3 ENSEMBLE Study Design
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).
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.
For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.
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