Johnson & Johnson has submitted an application to the US FDA for emergency use authorization of its investigational single-shot Janssen COVID-19 Vaccine candidate.
The company intends to distribute vaccine to the US government immediately following authorization, and expects to supply 100 million doses to the US in the first half of 2021, J&J said in a press release.
The EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial. The study found that the vaccine was 85% effective in preventing severe COVID-19 and a 66% overall efficacy rate in preventing moderate-to-severe COVID-19.
“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,” said Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “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.”
According to J&J, the company has initiated rolling submissions with several health agencies outside the US and will submit a Conditional Marketing Authorization Application (cMAA) with the European Medicines Agency in the coming weeks.
In response, the FDA will convene a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb 26, 2021 to discuss the EUA request.
“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,” said Acting FDA Commissioner Janet Woodcock, MD. “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.