NEW YORK, February 5. /TASS/. US corporation Johnson & Johnson has sent a request to the regulatory body under the US Department of Health and Human Services to approve the use of its vaccine against coronavirus in an emergency, the corporation wrote on its website.
"Johnson & Johnson today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The company expects to have product available to ship immediately following authorization," the statement said.
According to the company, "The company has initiated rolling submissions with several health agencies outside the U.S., and will submit a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency in the coming weeks."
Johnson & Johnson released data on the third phase of trials of its vaccine in the United States and beyond in late January. More than 43,000 people took part in the research, in particular, in the United States, Latin America, South Africa. According to the obtained data, during the tests in the United States, the effectiveness of the drug was 72%, in Latin America - 66%, and in South Africa - 57%. Johnson & Johnson also cited 85% vaccine efficacy estimate for trial participants over 18 years old.
FDA dedicated committee of the US Department of Health and Human Services will consider an application from Johnson & Johnson’s Janssen for the approval of use her emergency coronavirus vaccine on February 26. According to the statement, the committee includes independent experts in science and public health from all over the country. Their opinion is advisory and the final decision will be made by the FDA.
In December 2020, FDA approved coronavirus vaccine developed by the American company Pfizer and its German partner BioNTech. Also, the drug produced by the US company Moderna was certified.
According to Johns Hopkins University, which uses information from federal and local authorities, more than 26.6 mln coronavirus cases have been detected in the United States, more than 455,200 people have died. The country ranks first in the world for both indicators.