Johnson & Johnson Applies For Emergency Use Authorization For COVID-19 Vaccine

 

 

By DUSTIN JONES

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 Thursday, the company said 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.

It has shown to be 66% effective overall in preventing moderate to severe COVID-19 four weeks after the shot is administered. Johnson & Johnson said the vaccine was 72% effective in the United States, compared to 66% in Latin America and 57% in South Africa.

However, the vaccine is 85% effective in preventing severe forms of COVID-19. And the efficacy of the treatment increased over time, the company said, with no cases in vaccinated participants after 49 days.

"The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response," said Paul Stoffels, Johnson & Johnson vice chairman of the executive committee and chief scientific officer. "Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19."

The FDA is expected to hold the first meeting of outside advisers on the application on Feb. 26. If the advisers favor the vaccine, a decision authorize its use could come very soon afterwards.