Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of investigational single-shot Janssen COVID-19 vaccine candidate

Johnson & JohnsonJohnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The data package delivered includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The Company’s rolling submission of clinical data to WHO is now complete.

"Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our unwavering commitment to equitable access," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson. "If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries."

The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and UN procurement agencies. The EUL process expedites access to such products in many countries around the world and is also a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

In December 2020, the Company entered into an agreement in principle with Gavi, the Vaccine Alliance (Gavi) in support of the COVAX Facility. The Company and Gavi expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Janssen vaccine to COVAX through 2022.

Commitment to Equitable Access

Equitable access is at the forefront of Johnson & Johnson’s COVID-19 response. The Company's single-dose vaccine candidate and its compatibility with standard vaccine distribution channels align with WHO's recommendations for medical interventions in a pandemic setting, which emphasize ease of distribution, administration and compliance.

The Company is committed to ensuring global access to its COVID-19 vaccine candidate on a not-for-profit basis during the acute phase of the pandemic. In September 2020, Johnson & Johnson joined other life sciences companies and the Bill & Melinda Gates Foundation in signing an unprecedented communiqué which outlined a steadfast commitment to facilitating equitable access to the innovations being developed to fight the pandemic.

Regulatory Filings

The Company filed for Emergency Use Authorization (EUA) in the United States on February 4, 2021 and submitted a Conditional Marketing Authorisation Application (cMAA) in the European Union on February 15, 2021. In addition, rolling submissions for the investigational single-dose COVID-19 vaccine have been initiated in several countries worldwide. The Company will continue to provide data on an ongoing basis in support of WHO prequalification for the Janssen COVID-19 vaccine candidate.

Manufacturing and Supply Chain Information

The Janssen investigational vaccine is compatible with standard vaccine distribution channels. If authorized, Janssen's investigational single-dose vaccine is estimated to remain stable for two years at -20°C (-4°F), at least three months of which can be stored in most standard refrigerators at temperatures of 2°-8°C (36°F-46°F).

About Janssen's Investigational COVID-19 Vaccine

The Janssen investigational COVID-19 vaccine leverages 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.

About Phase 3 ENSEMBLE Study Design

The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in adults 18 years old and older. The trial, conducted in eight countries across three continents, includes a diverse and broad population. The study was designed to evaluate the safety and efficacy of the Janssen investigational vaccine 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 Company announced topline efficacy and safety data from ENSEMBLE on January 29, 2021.

For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Most Popular Now

Moderna announces emergency use authorization for …

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the government of India has issued a...

Sanofi launches dedicated vaccines mRNA Center of …

Sanofi will invest approximately €400 million annually in a first-of-its kind vaccines mRNA Center of Excellence. The Center will work to accelerate the development and d...

GSK and Alector announce global collaboration in i…

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical...

Roche's Actemra/RoActemra receives U.S. FDA Emerge…

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemr...

Positive new data for Johnson & Johnson single…

Johnson & Johnson (NYSE: JNJ) (the Company) announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly sp...

Tezepelumab granted Priority Review by U.S. FDA

Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelu...

Cancer cells eat themselves to survive

It is the membrane of cancer cells that is at the focus of the new research now showing a completely new way in which cancer cells can repair the damage that can otherwis...

mRNA vaccines slash risk of COVID-19 infection by …

People who receive mRNA COVID-19 vaccines are up to 91 percent less likely to develop the disease than those who are unvaccinated, according to a new nationwide study of ...

Anti-tumor agent from the intestine

It is believed to be involved in the development of chronic inflammatory intestinal diseases, to trigger diabetes, to be responsible for obesity, even neurological diseas...

Moderna and Pfizer-BioNTech vaccines prime T cells…

Researchers at La Jolla Institute for Immunology (LJI) have found that T cells from people who have recovered from COVID-19 or received the Moderna or Pfizer-BioNTech vac...

Mefloquine: A promising drug 'soldier' in the batt…

Early 2020 saw the world break into what has been described as a "war-like situation": a pandemic, caused by the severe acute respiratory syndrome-related coronavirus 2 (...

Artificial intelligence could be new blueprint for…

Writing in the July 12, 2021 online issue of Nature Communications, researchers at University of California San Diego School of Medicine describe a new approach that uses...