Johnson & Johnson (JNJ) - Get Report said Thursday it has submitted an application seeking emergency use authorization for its investigational single-dose COVID-19 vaccine candidate to the U.S. Food and Drug Administration.
The company said its EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the Janssen investigational single-dose vaccine met all primary and key secondary endpoints. JNJ said it expects to have product available to ship immediately following authorization.
"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, M.D., 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."
Johnson & Johnson's global 'Ensemble' trial indicated a 66% efficacy rate in preventing moderate to severe forms of COVID-19 but a 100% effectiveness rate against hospitalization and death in the 43,783 patients that participated in the study.
Trial data also showed that the one-shot vaccine, which doesn't require excessively low temperatures to keep in storage, produced an 85% rate of protection against patients with more severe forms of COVID-1, and a 57% rate of efficacy against the new strain of the virus recently identified in South Africa.
JNJ also said it has begun rolling submissions with several health agencies outside the U.S., and will submit a Conditional Marketing Authorization Application (cMAA) with the European Medicines Agency in the coming weeks.
Shares of Johnson & Johnson closed up .93% in regular trade Thursday, and were up another 1.86% to $165.26 in after-hours trade.
On Wall Street Thursday, stocks finished higher for a fourth day, with the S&P 500 closing at a record, as sentiment got a boost from a drop in weekly jobless claims to below 800,000 for the first time since November.