Johnson & Johnson submits its one-shot COVID-19 vaccine for FDA authorization

Diana Swiga
Posted at 6:11 PM, Feb 04, 2021

Johnson & Johnson submitted its one-shot coronavirus vaccine for an emergency use authorization to the FDA on Thursday.

While not fully as effective as the two-shot Pfizer and Moderna vaccines, Johnson & Johnson’s vaccine candidate was 85% effective against death and severe coronavirus cases after 28 days, according to a double-blind placebo study. The vaccine is considered 66% effective against the coronavirus after 28 days overall.

The Johnson & Johnson coronavirus vaccine is easier to transport than the Pfizer and Moderna vaccines, as it can be stored at standard refrigerator temperatures for up to three months.

“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.”

Dr. Anthony Fauci said earlier this week that the Johnson & Johnson vaccine can still be beneficial to the public despite it being less effective at stopping mild cases of the coronavirus.

“I think you have to point out the fact that what the J & J has shown to be and the study that just came out is that it is quite effective in preventing severe disease, including hospitalizations and deaths,” Fauci said during an interview with CNN’s Wolf Blitzer. “So, it's a single-dose vaccine.

“And if you want to not get seriously ill or die, that is a good vaccine and its value. So you don't want to get hung up on the differences of the numbers of the total efficacy in it. If you're focusing on not wanting to get seriously ill and getting to the hospital, this is a vaccine, as I mentioned, that's value added to the entire effort of multiple vaccine candidates that are available now.”