Moderna Withdraws Application For Combination COVID-19–Influenza Vaccine

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

Moderna on May 21 said it withdrew its application for a license for its combination vaccine against COVID-19 and influenza.

The move came “in consultation with” the Food and Drug Administration, which decides on licensing applications, the Massachusetts-based pharmaceutical company said in a brief statement.

The combination shot is known as mRNA-1083.

“The Company plans to resubmit the [application] later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available,” Moderna stated. “Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer.”

Moderna and some other vaccine makers began testing combination COVID-19–flu shots during the COVID-19 pandemic. The company said in 2024 that its combination vaccine performed well in a phase 3 clinical trial. Moderna researchers said in May that in the trial, the vaccine elicited immune responses that were at least as good as those from standard influenza vaccines and its COVID-19 vaccine.

Moderna had asked for licensure for its combination vaccine for people aged 50 and older, a population that is among the most susceptible to both influenza and COVID-19.

There are no combination COVID-19 vaccines on the market.

Pfizer and BioNTech reported in 2024 that their combination COVID-19–influenza vaccine in a phase 3 trial triggered immune responses against an influenza A strain and COVID-19 that were at least as good as those seen after flu and COVID-19 vaccination, but that the antibody levels were lower against influenza B for people who received the combination shot than the levels triggered by standard flu vaccination.

“We are committed to developing vaccines that will reduce the burden of respiratory diseases and believe that combination vaccines are the most efficient way to do this,” Annaliesa Anderson, a Pfizer senior vice president, said at the time. “Today’s results provide insight and direction towards achieving this goal, and we remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps.”

Moderna’s announcement came one day after FDA officials said they would not approve COVID-19 vaccines for many Americans without trial data showing that the benefits of the shots outweigh the risks.

“We want to know more about what the products are doing, especially as we enter the seventh, eighth, ninth doses,” Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, said at a town hall.

He also noted that the FDA plans to approve vaccines based only on antibody data for people older than 65 and for younger people who have at least one factor that places them at higher risk of severe COVID-19, as determined by the Centers for Disease Control and Prevention, such as obesity. FDA officials estimate that 100 million to 200 million Americans fall into one of those groups.

Just 13 percent of children and 23 percent of adults, according to CDC data, have received one of the currently available COVID-19 vaccine formulations.