Johnson & Johnson Requests Emergency Authorization From FDA for Covid Vaccine

Johnson & Johnson yesterday announced that the company has requested Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. 

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Just yesterday, Johnson & Johnson (NYSE: JNJ) revealed that Janssen Biotech, Inc., has applied to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate.

The EUA submission of the company is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which showed that the investigational single-dose vaccine met all primary and key secondary endpoints.

Therefore, as soon as it is authorized, the experts of the company expect their product to be available to be distributed. They intend to supply 100 million doses to the U.S. in the first half of 2021.

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

 “Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic. 

Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”

Later in the evening, the FDA announced that its advisory committee will meet Feb. 26 to discuss the application. It is expected that the vaccine will be authorized within a few days, and it will thus become the third available to the American public.

Johnson & Johnson has started rolling submissions with several health agencies outside the United States., and in the next several weeks, it intends to submit a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency.

The J&J vaccine is meant to be delivered as a single dose, but the company conducted a separate trial to check if a second dose is worthwhile.

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Being compatible with standard vaccine distribution channels, in case it gets authorized, it is estimated that the Janssen’s investigational single-dose vaccine will remain stable for two years at -4°F (-20°C), at for at least three months, it can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C). The vaccine will be shipped via the same cold chain technologies the company uses to transport other innovative medicines these days.

This vaccine supports the Company’s AdVac® vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines. Its safety profile was found to be consistent with other investigational vaccines using Janssen’s AdVac® technology among over 200,000 people to the present day.

To evaluate its safety and efficacy in protecting against both moderate and severe COVID-19 disease, a randomized, double-blind, placebo-controlled clinical trial was conducted.

The study, called Phase 3 ENSEMBLE study involves a diverse and broad population from eight countries across three continents, all adults 18 years old and older.

Moreover, it has an assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.

Research and development activities for the vaccine, including this trial and the delivery of doses for the U.S. have been funded in whole or 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).

In the last six years, Janssen has worked with BARDA on developing innovative solutions for influenza, emerging infectious diseases like Ebola, as well as chemical, biological, radiation, and nuclear threats.

Last February, they started working on the development of a COVID-19 vaccine based on Janssen’s AdVac® technology.

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