Moderna Announces European Medicines Agency Authorizes Third Dose of COVID-19 Vaccine for Immunocompromised Individuals Aged 12 Years and Older

Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the European Medicines Agency (EMA) has authorized a third dose of the Moderna COVID-19 vaccine (Spikevax) given at least 28 days after the second dose to severely immunocompromised individuals 12 years of age or older.

“We recognize the need to protect immunocompromised individuals who are at the highest risk of severe COVID-19 disease. It is promising to see recent trials demonstrating that a third dose of the Moderna COVID-19 vaccine may enhance immune response in this important population,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We remain committed to helping to end the COVID-19 pandemic with our mRNA vaccine.”

A growing number of studies have shown the benefit of a third dose of COVID-19 vaccine in immunocompromised subjects. In particular, a recent double-blind, randomized controlled trial of 120 individuals who had undergone solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) demonstrated that a third dose of the Moderna COVID-19 vaccine improved immune response compared to placebo¹. In the study, the third dose was generally well tolerated.