On Thursday, Johnson & Johnson applied for the Emergency Use Authorization (EUA) to the Food and Drug Administration (FDA) for its COVID-19 vaccine candidate.
The drug regulatory body is expected to grant that authorization within weeks.
If approved, it would be the United States’ third COVID-19 vaccine, along with the FDA-approved vaccines from Pfizer/BioNTech and Moderna.
In a press release, Dr. Paul Stoffels, Chief Scientific Officer, Johnson & Johnson, said, “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.”
If the FDA approves the EUA, Dr. Stoffels said the company would be ready to begin shipping vaccines.
However, it is unclear how many vaccine doses would be readily available. Previously, Johnson & Johnson said it expects to supply 100 million doses to the nation by June 2021.
The Johnson & Johnson vaccine is made in association with Janssen Pharmaceuticals. It only requires basic refrigeration and is a single-dose regimen, unlike other vaccines that need two doses for immunization.
In Phase 3 trials, the Johnson & Johnson vaccine prevented all hospitalizations and deaths in people four weeks after they received the shot, according to the company. Notably, these effects were seen in people infected with the new strains of the virus, which have been detected in the U.K. and South Africa.
Based on the Phase 3 trial findings, the vaccine was found to be 72% effective at preventing moderate to severe disease in the United States, while it was 57% effective in South Africa.
Globally, the vaccine was found to be 85% effective when researchers looked just at the shot’s effect on severe COVID disease.
Last week, Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, said that “the most important thing” is to keep people out of the hospital and prevent severe illness.
He said, “If you can prevent severe disease in a high percentage of individuals, that will alleviate so much of the stress” on the health care system.
The Johnson & Johnson vaccine uses an inactivated common cold virus, called an adenovirus, to train the immune system to recognize and fight off the new coronavirus.
This is a different approach than the Pfizer and Moderna vaccines, which are based on messenger RNA (mRNA) to train the immune system. The story appeared on NBC News and Today.