Johnson & Johnson plans to submit an application to the US Food and Drug Administration for emergency use authorization for its coronavirus vaccine next week.
The company will apply for an EUA "middle to late next week," Dr. Mathai Mammen, Janssen’s global head of research and development, said during a call with reporters on Friday morning. The call was held along with officials from the National Institutes of Health. Janssen is the vaccine arm of Johnson & Johnson.
Once an application is submitted, "The FDA really looks very, very carefully at the data in each age group and in each demographic group," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during the call.
If the vaccine is authorized for emergency use, Mammen said, "Our plan is to have supply immediately upon launch."
About the vaccine: Johnson & Johnson’s single-shot Covid-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, but 85% effective against severe disease, the company announced Friday.
The vaccine was 72% effective against moderate and severe disease in the US, the company said.