New Brunswick, N.J.-based J&J’s Janssen Biotech subsidiary submitted the application for its investigational single-dose Janssen COVID-19 vaccine candidate, based on safety and efficacy data from its Phase 3 Ensemble clinical trial that met all of its primary and key secondary endpoints, according to a news release.
The company expects to have product available to ship immediately following FDA authorization, as well. Johnson & Johnson 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.
Additionally, the company said it has initiated rolling submissions with multiple health agencies outside the U.S., with plans to submit a Conditional Marketing Authorization Application (cMAA) with the European Medicines Agency in the coming weeks.
“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” Johnson & Johnson vice chairman of the executive committee and chief scientific officer Dr. Paul Stoffels said in the release. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
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.
FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine, which would become the third authorized candidate in the U.S., following those developed by Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE).
The administration said in a news release that the timing for the meeting will allow it to thoroughly evaluate the data submitted by J&J before a public discussion. The FDA can’t predict how long the evaluation of the data will take after the meeting to make a decision on the EUA request, but said it will review the request “as expeditiously as possible” while still doing so in a thorough manner.
“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” Acting FDA Commissioner Dr. Janet Woodcock said. “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease