J&J gets US CDC Advisory Committee Recommendation for single-shot COVID-19 vaccine

"For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis, and we believe recommendation from the CDC to begin use of our vaccine as part of the U.S. national immunization program will add a critical tool in the fight against COVID-19," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. "This recommendation follows the FDA's decision to grant an Emergency Use Authorization for our single-shot vaccine, which has the potential to play a pivotal role in helping to end the COVID-19 pandemic."

Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines 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-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S.

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.

The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by the FDA through an Emergency Use Authorization (EUA).

The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34 percent of participants over age 60.

The study enrolled 44 percent of participants in the United States. Seventy-four percent of participants in the U.S. are White/Caucasian; 15 percent are Hispanic and/or Latinx; 13 percent are Black/African American; 6 percent are Asian and 1 percent 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 Company's COVID-19 vaccine, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., have been funded in part 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).

Johnson & Johnson has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola.