One week after announcing its single-dose vaccine was 66% effective overall in preventing COVID-19 in a global clinical trial, Johnson & Johnson submitted an application requesting the US Food and Drug Administration grant emergency use authorization for the vaccine on Thursday.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” Paul Stoffels, chief scientific officer at Johnson & Johnson, said in a statement. “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 FDA has called a meeting to discuss authorizing the vaccine on Feb. 26. Their discussion “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 Janet Woodcock, M.D., acting FDA commissioner on Wednesday.
“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,” Woodcock said.
The FDA granted emergency use authorization to both Pfizer and Moderna for their coronavirus vaccines in December, with vaccinations beginning just days later. Those vaccines are said to be 95% and 94% effective, respectively.
Johnson & Johnson says in addition to that 66% stat, its vaccine is 85% effective in preventing severe disease. Authorization of the vaccine could come as soon as this month, CNBC says.
Unlike the Pfizer and Moderna vaccines, Johnson & Johnson’s vaccine only requires a single shot. It can also be stored at normal refrigeration temperatures for around three months, which is significantly longer than the Pfizer and Moderna vaccines.