J&J’s COVID-19 single-shot jab approved by the FDA for Emergency Use

The U.S. FDA has approved the first single-shot COVID-19 jab, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for emergency use to help fight the global pandemic.

Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, to prevent COVID-19 in individuals 18 years of age and older.

J&J’s COVID-19 vaccine 85% effective in preventing severe disease

The EUA authorisation was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that showed the vaccine was 85% effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson said:

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public. We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

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

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide. We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”

Johnson & Johnson highlights they are committed to making the COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use.

20 million people in the U.S. to be vaccinated by the end of March

The pharmaceutical giant has already started shipping the COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March 2021 to enable the full vaccination of more than 20 million people in the United States. J&J plans to deliver 100 million single-shot vaccines to the U.S. during the first half of this year under the U.S. government’s management allocation and distribution. The supply will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines.

Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization (WHO) for its COVID-19 vaccine candidate. Moreover, rolling submissions for the single-shot COVID-19 vaccine candidate have been commenced in several countries around the world.

The EUA follows a unanimous vote by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021.

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

“We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single-shot COVID-19 vaccine to protect people around the world”.

Johnson & Johnson’s COVID-19 vaccine technology

J&J’s COVID-19 vaccine leverages the AdVac® vaccine platform, a unique and patented technology further used for the development and production of Janssen’s European Commission-approved Ebola vaccine and its investigational Zika, RSV, and HIV vaccines.

The cutting-edge AdVac® technology is based on the development and production of adenovirus vectors (gene carriers). The AdVac® vectors are based on a specific type of adenovirus which has been genetically modified so that it can not replicate in humans and cause disease.

J&J’s COVID-19 vaccine suitable for standard storage conditions

The Johnson & Johnson single-dose COVID-19 vaccine is suitable for standard vaccine storage and distribution channels, making easy delivery to remote areas possible. The vaccine is thought 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).

J&J plans to ship the vaccine using the same cold chain technologies it uses currently to transport treatments for cancer, immunological disorders and other therapeutics. The COVID-19 vaccine should not be re-frozen if distributed at temperatures of 36°F–46°F (2°-8°C).

The Emergency Use Authorization

To date, there is no FDA-approved vaccine to prevent COVID-19. The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. FDA but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

The EUA terms allow the use of the vaccine while more data are collected. J&J plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

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, which involved 43,783 participants. The study was designed to evaluate the safety and efficacy of the J&J’s vaccine candidate in protecting against both moderate and severe COVID-19 disease, with an assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.

The trial, carried out in eight countries across three continents, includes a diverse and broad population including 34% of the participants over age 60. Forty-four percent of the study participants were enrolled in the United States, out of which 74% are White/Caucasian, 15% are Hispanic and/or Latinx, 13% are Black/African American, 6% Asian and 1% Native American. Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19.

The R&D activities for the COVID-19 vaccine, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., was 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), 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).

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

About Johnson & Johnson and Janssen Pharmaceutical Companies

Johnson & Johnson is the world’s largest and most broadly-based healthcare company. Founded 1886, J&J develops medical devices, pharmaceutical, and consumer packaged goods. The company aims to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of all people, everywhere.

Janssen the Pharmaceutical Companies of Johnson & Johnson, work tirelessly to fight sickness with science, improving access with ingenuity, and healing hopelessness with heart. Janssen has a focus on areas of medicine where the company can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com.

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