Europe’s medical regulator, the European Medicines Agency (EMA), recommended the approval of Moderna’s COVID-19-flu vaccine. According to the agency, the vaccine, called mCombriax, “triggered the production of adequate amounts of antibodies” against both COVID-19 and influenza.
The mRNA vaccine is designed for those aged 50 and older against both viruses.
The agency’s recommendation stems from a study involving 8,000 people age 50 and older that demonstrated that those who received the vaccine had “levels of antibodies against influenza and SARS-CoV-2 that were statistically non‑inferior to those seen in people who received both Spikevax (an authorised COVID-19 mRNA vaccine) and either Fluzone HD or Fluarix (authorised influenza vaccines),” the entity explained.
Side effects linked to the mRNA vaccine include pain, tiredness, muscle pain, joint pain, headache, chills, swollen lymph nodes, nausea, vomiting, and fever.
“The [Committee for Medicinal Products for Human Use] CHMP positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world’s first flu plus COVID combination vaccine,” Moderna CEO Stéphane Bancel said of the vaccine’s recommendation. “If approved, this would be Moderna’s fourth marketed product in Europe. Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA’s rigorous scientific review.”
Meanwhile, the FDA has agreed to review Moderna’s updated application concerning its mRNA vaccine after previously denying the proposal. The U.S. agency initially argued that Moderna’s study design was inadequate. The Center for Biologics Evaluation and Research (CBER) “does not consider the application to contain a trial ‘adequate and well-controlled,’ and the application is therefore, on its face, inadequate for review,” the original letter of refusal read. “This is because your control arm does not reflect the best-available standard of care in the United States at the time of the study.”
