(GNB Desk): Late Thursday, Johnson & Johnson is filing with the FDA for emergency use authorization approval for its one-dose vaccine.
Johnson & Johnson, a third coronavirus vaccine candidate has requested emergency use authorization from the Food and Drug Administration. Johnson & Johnson submitted its application Thursday for the company’s single-dose inoculation.
In a statement released on late Thursday, the company said, Johnson & Johnson (NYSE: JNJ) (the Company) 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.
“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,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. 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”, J & J said in a statement.
If emergency use is granted, it aims to supply 100 million doses in the first half of 2021.
Unlike Pfizer and Moderna, Johnson & Johnson’s Janssen vaccine can be stored for at least three months at 36-46 degrees Fahrenheit, compatible with standard vaccine distribution channels, the company said.
This comes as COVID restrictions ease and hospitalizations and new COVID cases decline. However, the concern grows among several top infectious disease doctors.
Dr. Michael Osterholm said, “Within six to 12 weeks, we could be seeing the very worst to the pandemic to date.”
Dr. Celine Gounder, an epidemiologist at New York University who advised the Biden transition team, said she’s concerned about pandemic fatigue and that it’s crucial to vaccinate as many as possible.
“My biggest concern right now is that people are fatigued, they’re frustrated, they just want life to go back to normal,” Gounder said. “These variants will continue to spread, continue to mutate and at the end of the day, we could end up having vaccines that no longer work.”
A global media for the latest news, entertainment, music fashion, and more.
