Johnson & Johnson Announces Submission of Application to the U.S. Food and drug administration for Unexpected emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Prospect

NEW BRUNSWICK, N.J., Feb. 4, 2021 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Business) today announced that Janssen Biotech, Inc., has submitted an software to the U.S. Food items and Drug Administration (Fda) requesting Emergency Use Authorization (EUA) for its investigational solitary-dose Janssen COVID-19 vaccine prospect. The Company’s EUA submission is primarily based on topline efficacy and basic safety details from the Phase 3 ENSEMBLE medical demo, demonstrating that the investigational one-dose vaccine fulfilled all primary and essential secondary endpoints. The Business expects to have products readily available to ship quickly subsequent authorization.

“Present-day submission for Unexpected emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal move towards cutting down the burden of sickness for people globally and placing an close to the pandemic,” explained Paul Stoffels, M.D., Vice Chairman of the Government Committee and Chief Scientific Officer at Johnson & Johnson. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to start shipping. With our submission to the Food and drug administration and our ongoing reviews with other wellbeing authorities all around the entire world, we are operating with wonderful urgency to make our investigational vaccine obtainable to the community as promptly as achievable.”

The Business has initiated rolling submissions with various well being organizations outdoors the U.S., and will submit a Conditional Promoting Authorisation Software (cMAA) with the European Medications Company in the coming weeks.

Production and Offer Chain Data

The Janssen investigational vaccine is appropriate with regular vaccine distribution channels. If approved, Janssen’s investigational solitary-dose vaccine is approximated to keep on being steady for two several years at -4°F (-20°C), at minimum a few months of which can be saved in most regular refrigerators at temperatures of 36°F–46°F (2°-8°C). The Enterprise will ship the vaccine applying the identical cold chain systems it works by using nowadays to transport other ground breaking medications.

Janssen’s Investigational COVID-19 Vaccine

The Janssen investigational COVID-19 vaccine leverages the Company’s AdVac® vaccine platform, which was also used to establish and manufacture Janssen’s European Commission-approved Ebola vaccine routine and construct its investigational Zika, RSV, and HIV vaccines. The protection profile observed was consistent with other investigational vaccines utilizing Janssen’s AdVac® technology among the much more than 200,000 men and women to date.

Phase 3 ENSEMBLE Analyze Structure

The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled scientific trial in grownups 18 a long time aged and more mature. The examine was made to assess the safety and efficacy of the Janssen investigational vaccine in preserving in opposition to equally average and critical COVID-19 illness, with evaluation of efficacy as of day 14 and as of day 28 as co-primary endpoints.

The demo, performed in eight countries throughout a few continents, consists of a varied and broad inhabitants.

Investigation and growth things to do for the investigational Janssen COVID-19 vaccine which includes the ENSEMBLE scientific demo and the shipping and delivery of doses for the U.S. has been funded in total or in portion with federal resources from the U.S. Office of Wellness and Human Companies, Office of the Assistant Secretary for Preparedness and Response, Biomedical Highly developed Exploration and Enhancement Authority (BARDA), less than Contract No. HHSO100201700018C, and in collaboration with the Countrywide Institute of Allergy and Infectious Disorders (NIAID), section of the Countrywide Institutes of Health and fitness (NIH) at the U.S. Section of Health and Human Services (HHS). 

Janssen has labored with BARDA since 2015 on revolutionary answers for influenza, chemical, organic, radiation and nuclear threats and rising infectious conditions this sort of as Ebola. In February 2020, Janssen and BARDA started function on the growth of a COVID-19 vaccine centered on Janssen’s AdVac® technological know-how.

For a lot more info on the Company’s multi-pronged strategy to encouraging beat the pandemic, check out:

About Johnson & Johnson
At Johnson & Johnson, we consider fantastic health and fitness is the basis of vibrant life, thriving communities and ahead development. Which is why for much more than 130 years, we have aimed to keep folks properly at each age and each individual phase of everyday living. Today, as the world’s largest and most broadly-based mostly healthcare business, we are fully commited to applying our reach and dimension for good. We try to strengthen accessibility and affordability, develop healthier communities, and put a balanced head, entire body and atmosphere in just arrive at of absolutely everyone, in all places. We are mixing our coronary heart, science and ingenuity to profoundly modify the trajectory of wellness for humanity. Study additional at Follow us at @JNJNews.

About the Janssen Pharmaceutical Corporations of Johnson & Johnson

At Janssen, we’re generating a upcoming where by ailment is a issue of the past. We’re the Pharmaceutical Businesses of Johnson & Johnson, performing tirelessly to make that potential a actuality for people almost everywhere by preventing sickness with science, improving upon access with ingenuity, and therapeutic hopelessness with heart. We target on parts of medication exactly where we can make the biggest variation: Cardiovascular & Rate of metabolism, Immunology, Infectious Illnesses & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Find out more at Follow us at @JanssenGlobal.

Recognize to Investors Relating to Ahead-On the lookout Statements

This press release includes “forward-on the lookout statements” as described in the Non-public Securities Litigation Reform Act of 1995 about improvement of a possible preventive vaccine for COVID-19. The reader is cautioned not to count on these ahead-hunting statements. These statements are based on recent anticipations of upcoming gatherings. If fundamental assumptions prove inaccurate or recognised or unidentified hazards or uncertainties materialize, precise final results could change materially from the expectations and projections of the Janssen Pharmaceutical Businesses, and/or Johnson & Johnson. Pitfalls and uncertainties include, but are not minimal to: challenges and uncertainties inherent in solution analysis and improvement, which include the uncertainty of scientific accomplishment and of getting regulatory approvals uncertainty of commercial achievement manufacturing issues and delays competitiveness, which includes technological advances, new solutions and patents attained by competition difficulties to patents solution efficacy or basic safety problems ensuing in product or service remembers or regulatory motion adjustments in actions and spending styles of purchasers of well being care items and products and services changes to applicable guidelines and laws, which include world-wide wellness care reforms and traits towards health and fitness treatment value containment. A additional listing and descriptions of these pitfalls, uncertainties and other aspects can be found in Johnson & Johnson’s Yearly Report on Variety 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Observe With regards to Ahead-Seeking Statements” and “Merchandise 1A. Risk Things,” and in the firm’s most lately submitted Quarterly Report on Type 10-Q, and the firm’s subsequent filings with the Securities and Trade Commission. Copies of these filings are obtainable on the net at, or on ask for from Johnson & Johnson. None of the Janssen Pharmaceutical Organizations nor Johnson & Johnson undertakes to update any ahead-seeking assertion as a end result of new facts or long term activities or developments.

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