Johnson & Johnson officially asked the US Food and Drug Administration for an emergency use authorization of its Covid-19 vaccine Thursday.
"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.
As the FDA looks at the results, it will schedule a public meeting of its Vaccines and Related Biological Products Advisory Committee, an independent group of experts who will also look at the data and make a recommendation that the agency takes into consideration when it makes a decision.
What's next: If the FDA decides to authorize the vaccine, next the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meets to discuss whether the vaccine should be given to Americans and if so, who should get it first.
This same regulatory process for Pfizer took a little over three weeks; for Moderna it was a little more than two.
The Johnson & Johnson vaccine is a little different than the other Covid-19 vaccines. The vaccine, made through a collaboration with the company's vaccine division, Janssen Pharmaceutical, and Beth Israel Deaconess Medical Center, is delivered in a single shot. Pfizer and Moderna’s require two. It’s 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.
The US government has ordered 100 million doses and Johnson & Johnson said 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.