Moderna has announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorisation for the Moderna Covid-19 vaccine (mRNA-1273) to include a third dose for immunocompromised individuals.
The third dose will available to people 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
“We recognise the need to protect immunocompromised individuals who are at the highest risk of severe Covid-19 disease,” said Stéphane Bancel, Chief Executive Officer of Moderna. “It is promising to see recent studies demonstrating that a third dose of the Moderna Covid-19 vaccine may enhance immune response in immunocompromised populations. We will continue to generate data on protection against SARS-CoV-2 variants and we remain committed to helping to end the Covid-19 pandemic with our mRNA vaccine.”
A recent double-blind, randomised controlled trial of 120 individuals who had undergone solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung or pancreas) demonstrated that a third dose of the Moderna Covid-19 vaccine improved immune response compared to placebo. In the study, the third dose of mRNA-1273 was generally well tolerated.