coronavirus vaccine

J&J Submits COVID-19 Vaccine Candidate for Emergency Use Listing

Johnson & Johnson 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 today 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 Feb. 4, 2021 and submitted a Conditional Marketing Authorisation Application (cMAA) in the European Union on Feb. 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).

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.

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 Jan. 29, 2021.

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