New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which met all of its primary and key secondary endpoints, according to a news release.
EUL submission is a step forward in the process for a new or unlicensed product to be assessed for use during public health emergencies by governments and UN procurement agencies. Such listing would offer the single-dose vaccine in many countries and is a prerequisite to supply vaccines to the new COVAX Facility for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.
Previously, J&J agreed in principle with Gavi, the Vaccine Alliance, to support the COVAX Facility, with plans to enter into an advance purchase agreement for up to 500 million doses of the vaccine to be provided to COVAX through 2022.
“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,” J&J vice chairman & chief scientific officer Dr. Paul Stoffels said in the release. “If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries.”
Earlier this week, J&J submitted a conditional marketing authorization application (cMAA) with the European Medicines Agency (EMA) for its COVID-19 vaccine, having initiated a rolling submission with the EMA to enable the EMA to review data as it becomes available in December.
Additionally, the company earlier this month applied for FDA emergency use authorization (EUA) in the U.S., with a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) scheduled for Feb. 26, 2021, to discuss the EUA request.
In previous announcements, J&J has said it expects to have product available to ship immediately following authorization. The company set its target to produce 1 billion doses in 2021 and expand production after that. The company has committed to not-for-profit pricing during the pandemic assuming its single-dose vaccine is authorized by FDA and other regulators. J&J is also investigating a two-dose regimen for its vaccine.