New Brunswick-based Johnson & Johnson announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.
Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.
The data also demonstrated the vaccine was 85% effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death across countries with different variants, beginning 28 days after vaccination.1 Variants observed in an ongoing analysis in the ENSEMBLE study included the B.1.351 variant which was identified in 95% of the COVID-19 cases in South Africa.
“From the beginning of the pandemic, we have worked to develop and deliver a vaccine that could protect the health of people everywhere, and today’s milestone represents significant progress toward ensuring global access to our single-shot vaccine,” said Alex Gorsky, chairman and chief executive officer at Johnson & Johnson. “We are moving forward with urgency and purpose to meet our commitments to the global community as we do all we can to help end the pandemic.”
The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and United Nations 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.
“The WHO listing of our single-shot COVID-19 vaccine advances our pledge to help stem this pandemic and our unwavering commitment to equitable access,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “Achieving this important prerequisite for distributing our vaccine through the COVAX Facility which is co-led by Gavi is a major step forward in making our vaccine accessible for all.”
In December 2020, Johnson & Johnson entered into an agreement in principle with Gavi, the Vaccine Alliance (Gavi) in support of the COVAX Facility. Johnson & Johnson and Gavi expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Company’s vaccine to COVAX through 2022.2
“A single-shot COVID-19 vaccine that can be distributed and stored using established supply chains has the potential to be very meaningful in the face of this global pandemic,” said Mathai Mammen, M.D., Ph.D., global head, Janssen Research & Development at Johnson & Johnson. “In addition, the clinical data shared with WHO that informed the Emergency Use Listing demonstrated protection against disease across countries with multiple variants.”
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