WHO Issues EUL for Janssen COVID-19 Vaccine

The World Health Organization (WHO) announced today it issued EUL for the Janssen Pharmaceutical Companies of Johnson & Johnson single-shot COVID-19 vaccine, Ad26.COV2.S.

The EUL applies to individuals 18 years of age and older.

Phase 3 data demonstrated the COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The one-shot adenovirus prophylaxis provided 66.1% efficacy in preventing COVID-19 versus placebo ≥28 days after vaccination.

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,” Johnson & Johnson Vice Chairman of the Executive Committee and Chief Scientific Officer Paul Stoffels, MD, said. “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.”