WHO Grants Emergency Use Listing for Johnson & Johnson’s Single-Dose COVID-19 Vaccine

NEW BRUNSWICK, N.J., March 12, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) (the “Company”) announced today that the World Health Organization (WHO) has granted Emergency Use Listing (EUL) approval for the single-dose COVID-19 vaccine developed by Janssen Pharmaceuticals, Inc. (“Janssen”), a subsidiary of Johnson & Johnson, for the prevention of COVID-19 in adults aged 18 years and older.

Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated, with a 67% reduction in the incidence of symptomatic COVID-19 among vaccinated participants compared to those in the placebo group. Protective efficacy was observed starting from day 14 and persisted through day 28 post-vaccination.

Alex Gorsky, Chairman of the Board and Chief Executive Officer of Johnson & Johnson, stated, “From the very outset of the pandemic, we have been committed to developing and providing a vaccine that safeguards public health across nations. Today’s milestone marks significant progress in ensuring global access to the single-dose Johnson & Johnson vaccine. Driven by a sense of urgency, we remain steadfast in our commitment to society, doing everything in our power to help bring this pandemic to an end.”

The Emergency Use Listing (EUL) procedure simplifies the process for governments and United Nations procurement agencies to evaluate new or unapproved products for use during public health emergencies. The EUL procedure accelerates access to such products in many countries worldwide and is a prerequisite for supplying vaccines to the COVAX Facility, a global mechanism for the centralized procurement and distribution of COVID-19 vaccines with 190 participating countries, including 92 low-income countries.

Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, stated: “The inclusion of our single-dose COVID-19 vaccine on the World Health Organization’s list is a tremendous encouragement to our resolve to help curb the current pandemic, as well as to our steadfast commitment to equitable vaccine access. The distribution of our vaccine through the COVAX Facility, co-led by Gavi, the Vaccine Alliance, represents a critical prerequisite; fulfilling this requirement marks a significant step forward in ensuring equitable global access to the Johnson & Johnson vaccine.”

In December 2020, Johnson & Johnson reached an agreement in principle with Gavi to support the COVAX Facility. Johnson & Johnson and Gavi expect to sign an Advance Purchase Agreement (APA), under which up to 500 million doses of the Johnson & Johnson vaccine will be supplied to COVAX by the end of 2022.

Dr. Mathai Mammen, Global Head of Janssen Research & Development, a subsidiary of Johnson & Johnson, stated, “A single-dose COVID-19 vaccine that can be distributed and stored using established supply chains may hold significant implications for the current global pandemic. Furthermore, clinical data submitted to the World Health Organization for inclusion on the Emergency Use Listing demonstrates that the Johnson & Johnson vaccine prevents COVID-19 in countries with multiple circulating variants.”

Commitment to Equitable Access

Equitable access is central to Johnson & Johnson’s response to the COVID-19 pandemic. The company’s single-dose candidate vaccine, along with its compatibility with standard vaccine distribution channels, aligns with the World Health Organization’s recommendations for medical interventions during pandemics, emphasizing ease of distribution, administration, and adherence.

The Company is committed to ensuring the global availability of Johnson & Johnson’s single-dose COVID-19 candidate vaccine, adhering to non-profit principles for emergency use. In September 2020, Johnson & Johnson, together with other life sciences companies and the Bill & Melinda Gates Foundation, signed an unprecedented joint statement firmly committing to promote equitable access to innovative products under development to combat the pandemic.

Registration and Filing

Following the unanimous vote by the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on February 26, 2021, Johnson & Johnson received Emergency Use Authorization (EUA) for its vaccine in the United States on February 27. The company’s single-dose COVID-19 vaccine was granted an Interim Order Authorization in Canada on March 5, 2021, and received Conditional Marketing Authorization (CMA) in the European Union on March 11, 2021.

Production and Supply Chain Information

Johnson & Johnson’s single-dose COVID-19 vaccine is compatible with standard vaccine storage and distribution channels, enabling delivery to remote areas. The vaccine is estimated to remain stable for two years at temperatures between -25°C and -15°C, and for up to three months under conventional refrigeration conditions at 2°C–8°C. The company will utilize the same cold-chain technologies currently employed for transporting other pharmaceuticals and vaccines to distribute this vaccine.

Johnson & Johnson COVID-19 Vaccine

Johnson & Johnson’s COVID-19 vaccine utilizes the proprietary AdVac® vaccine platform, a technology also employed in the development and production of the Janssen Ebola vaccine approved by the European Commission, as well as in the construction of investigational candidate vaccines for Zika virus, respiratory syncytial virus (RSV), and human immunodeficiency virus (HIV).

Phase 3 ENSEMBLE Study Design

The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and protective efficacy of the Janssen candidate vaccine in preventing moderate to severe COVID-19 among adults aged 18 years and older, with efficacy assessments at 14 days and 28 days post-vaccination as co-primary endpoints. A total of 43,783 participants were enrolled in the study.

This trial was conducted in eight countries across three continents, encompassing a diverse and broad population, with 34% of participants aged over 60 years. In the study, 41% of participants had comorbidities associated with an increased risk of progression to severe COVID-19.

Responsible Editor: Liu Li

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