WHO Grants Janssen COVID-19 Vaccine Emergency Listing

New Jersey-based Johnson & Johnson (JNJ) announced today that the World Health Organization (WHO) had issued Emergency Use Listing (EUL) for the Janssen COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.

Data from the Phase 3 ENSEMBLE study showed that the Janssen COVID-19 vaccine was well tolerated and demonstrated a 67% reduction in symptomatic COVID-19 disease in participants who received the vaccine compared to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination.

The study 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.

Alex Gorsky, Chairman and CEO at JNJ, stated in a press release, “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 how 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. It 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.

“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,” added Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development at JNJ.