New Brunswick, N.J.-based J&J’s cMAA application with the European Medicines Agency (EMA) is seeking authorization for the investigational, single-dose COVID-19 vaccine candidate developed by its Janssen subsidiary, according to a news release. The submission is based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its primary and key secondary endpoints.
The Janssen single-dose COVID-19 vaccine is estimated to remain stable for two years at -4°F (-20°C), at least three months of which can be stored in most standard refrigerators at temperatures of 36°F–46°F (2°-8°C). J&J plans to ship it using the same cold chain technologies it uses to transport other medicines.
Earlier this month, the company 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 December, J&J initiated a rolling submission with the EMA to enable the EMA to review data as it becomes available.
Upon announcing its submission for EUA, J&J 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.
“Throughout Europe, there remains an urgent need for additional COVID-19 vaccines, and today’s submission is a significant step forward in ensuring the European Union has another option to help reduce the impact the pandemic has had in Europe and around the world,” J&J vice chairman of the executive committee and chief scientific officer Dr. Paul Stoffels said in the release. “We stand ready to begin distributing our vaccine within the European Union in the second quarter of 2021.”