CAMDEN, N.J. (CBS/CNN) -- Johnson & Johnson officially asked the U.S. Food and Drug Administration for an emergency use authorization of its COVID-19 vaccine Thursday, taking forward the possibility of a third coronavirus vaccine for the American market. To help get the vaccine to this point, Rutgers was used as the second-largest Phase 3 clinical research trial site.
The site, based at Rutgers Robert Wood Johnson Medical School, enrolled 840 participants from the university community and throughout New Jersey.
Through trial, the vaccine was found to be 85% effective in preventing severe disease and demonstrated complete protection against COVID-19-related hospitalization as of 28 days. It was also found to be 72% effective in the United States and 66% effective overall.
"We all hope that after careful review of the trial results by the FDA that emergency use authorization is justified. This vaccine has the potential to reduce mortality, hospitalizations for serious infections and vaccinate up to 100 million Americans by the summer," said principal investigator Jeffrey Carson, a provost at Rutgers Biomedical and Health Sciences and Distinguished Professor of Medicine at Rutgers Robert Wood Johnson Medical School.
Rutgers served as a clinical trial site for the Moderna Phase 3 vaccine trial, which was led at Rutgers New Jersey Medical Center.
"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," Dr. Paul Stoffels, Chief Scientific Officer at Johnson & Johnson, said in a statement.
The FDA has scheduled a public meeting of its Vaccines and Related Biological Products Advisory Committee for Feb. 26. The independent group of experts will look at the data and make a recommendation that the agency takes into consideration when it makes a decision.
This means an EUA will not come before the end of the month, if the FDA decides to grant one. But adding a third vaccine to the mix would add both supply and flexibility to the struggling US efforts to vaccinate the population.
If the FDA decides to authorize the vaccine, the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will meet to discuss whether the vaccine should be given to Americans and if so, who should get it first.
The Johnson & Johnson vaccine is a little different than the two authorized Covid-19 vaccines. The vaccine, made through a collaboration of J&J's vaccine division, Janssen Pharmaceutical, and Beth Israel Deaconess Medical Center in Boston, is delivered in a single shot. Pfizer and Moderna's require two.
Janssen's is considered versatile since it is considered stable for up to three months kept in regular refrigerated temperatures and doesn't need the deep freeze like Pfizer's.
Johnson & Johnson's Covid-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, according to the company. The vaccine is 85% effective overall at preventing hospitalization and death in all regions where it was tested.
Its efficacy against moderate and severe disease ranged from one country to another: 72% in the US, 66% in Latin America and 57% in South Africa. This was measured starting one month after the shot.
In the South African arm of the clinical trial, the majority of the cases were due to a variant known as B.1.351, which is more transmissible and which carries mutations that make it less susceptible to the antibody immune response -- including antibodies that would be prompted by vaccination. People who did get a moderate case of Covid-19 in the trial tended to develop a milder course of the disease with fewer symptoms, according to the company.
The J&J vaccine works a little differently than the Moderna and Pfizer vaccines. Those two use messenger RNA, genetic instructions delivered in a fat droplet that prompt the body to make what looks like a piece of the virus. With the J&J vaccine, the genetic material is delivered in a common cold virus called an adenovirus, which has been disabled so it doesn't replicate itself or make people sick.
The US government has ordered 100 million doses and J&J says it can meet this commitment by June. "Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping," Stoffels said.
(©Copyright 2021 CBS Broadcasting Inc. All Rights Reserved.The-CNN-Wire™ & © 2021 Cable News Network, Inc., a Time Warner Company contributed to this report.)
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