Johnson & Johnson's one-dose vaccine closes in on U.S. approval
Johnson & Johnson’s one-dose COVID-19 vaccine appeared safe and effective in trials, the U.S. Food and Drug Administration said Wednesday, paving the way for its approval for emergency use as soon as this week, according to Reuters.
The vaccine was 66% effective at preventing moderate to severe COVID-19 in a 44,000 person global trial, the FDA said in documents ahead of a Friday meeting of independent experts who will advise the agency on the emergency authorization.
New data provided by J&J to the FDA showed the vaccine was 64% effective at stopping moderate to severe cases of COVID-19 after 28 days in thousands of trial participants in South Africa where a worrying new variant has swept across the country.
Overall, the vaccine was 100% effective at stopping hospitalization 28 days after vaccination, compared with 85% at 14 days, and there were no COVID-19 deaths among those who received the shot rather than a placebo.
J&J also said the data suggested its vaccine cut down on asymptomatic infections, which experts said was another sign COVID-19 vaccines may indeed stop transmission of the disease.
The United States, where COVID-19 has killed more than half a million people, has been struggling to speed up its vaccination program because of the limited supply of the Pfizer-BioNTech and Moderna vaccines so far.
Worldwide, COVID-19 has infected 112 million people and killed more than 2.5 million and governments are racing to get their hands on any effective vaccines.