The submission is based on data from the phase 3 ENSEMBLE clinical trial that showed the investigational single-dose vaccine met all primary and key secondary endpoints.
“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, chief scientific officer, Johnson & Johnson, in a February 4, 2021 company press release. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping.”
The EUA submission is based on results from the phase 3 ENSEMBLE clinical trial that showed the investigational vaccine met all primary and key secondary endpoints. The clinical trial was a randomized, double-blind, placebo-controlled trial in >43 000 adults aged ≥18 years accruing 468 symptomatic cases of COVID-19.
The results showed that the level of protection against moderate-to-severe COVID-19 was 72% in the US, 66% in Latin America, and 57% in South Africa, 28 days post-vaccination. Also, the vaccine was found to be 85% effective overall in preventing severe disease and demonstrated complete protection against COVID-19-related hospitalization and death 28 days post-vaccination.
Johnson & Johnson plans to distribute the vaccine to the US government immediately after receiving authorization, and the company expects to supply 100 million doses of the vaccine in the first half of 2021.
“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,” added Stoffels in the same press release.