Moderna applied for a so-called "biologics license" for its COVID-19 vaccine on June 1, a step up from its current emergency-use authorization, which would open the shot to interstate commerce and allow the drugmaker to market it directly to consumers.
Moderna's vaccine received a nod for emergency use in people aged 18 and older amid the pandemic on the basis of safety data from a large clinical trial involving about 30,000 people. The trial showed a 94.1 percent reduction in the number of symptomatic COVID-19 cases in people who had received the vaccine, compared to people who received dummy injections.
Approval of a biologics license will allow Moderna to keep its vaccine on the market once the public health emergency is over, and will allow the company to advertise its product to the public, which isn't permitted under emergency use.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans in collaboration with the U.S. government,” Albert Bourla, chairman and CEO of Pfizer, said in a statement. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
The three COVID-19 vaccines currently available in the United States are those made by Johnson & Johnson, Moderna, and Pfizer-BioNTech.
"Although the vaccines currently authorized by the U.S. Food and Drug Administration offer strong protection against COVID-19, we need to prepare for the possibility of needing booster shots to counter waning immunity and to keep pace with an evolving virus,” National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said in a statement.
“The results of this trial are intended to inform public health policy decisions on the potential use of mixed vaccine schedules should booster doses be indicated."
The NIH said initial trial results are expected by late summer.