Johnson and Johnson (NYSE: JNJ) has requested emergency use authorization from the Food and Drug Administration for its single-dose COVID19 vaccine. The company recently shared data demonstrating its vaccine was 66% effective in combating the virus.
Preliminary results from an international study proved that J&J’s vaccine was secure and served to protect against the virus. However it is believed that the vaccine is not as effective as the two-dose option made by Pfizer and Moderna.
If approved, it will be the third Covid-19 vaccine authorized for emergency use within the U.S.
“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,” J&J’s chief scientific officer, Dr. Paul Stoffels, said in a statement.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” he said. “With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
The FDA has requested that its independent advisers publicly deliberate all of the information regarding the single-dose shot. The panel will convene on February 26.
“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” acting FDA Commissioner Janet Woodcock said in a statement. “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines.”
According to infectious disease experts, J&J’s vaccine results can not be compared to those of Pfizer and Moderna, which proved to be 95% and 94% effective. They state that J&J’s vaccine is a single dose shot and was tested when infections were at their worst with multiple contagious variants.