Johnson & Johnson on Thursday asked U.S. regulators to approve its single-dose COVID-19 vaccine for emergency use.
The vaccine, if approved, would be an efficient weapon in the fight against the coronavirus. States are putting messenger-RNA shots from Pfizer/BioNTech and Moderna into arms, but they must arrange to give a second dose of both versions.
Approval of the J&J shot would add a third vaccine in the U.S. arsenal that doesn’t require a return visit. Also, the vials can be stored for up to three months in a normal refrigerator.
The Food and Drug Administration will pore over human-trial data from J&J that say the shots were 72% effective at staving off moderate-to-severe disease in the U.S. and 66% effective across all participating countries.
That’s less powerful than the 95% efficacy demonstrated by the mRNA shots in U.S. circulation, though J&J’s adenovirus vector was able to stave off severe disease, meaning recipients didn’t die or land in the hospital.
J&J called Thursday’s FDA request “a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.”
The company is ready to provide 100 million doses of its vaccine to the U.S. through June.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” said Paul Stoffels, chief scientific officer at J&J. “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.”
