Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorization for the Moderna COVID-19 vaccine (mRNA-1273) to include a third dose for immunocompromised individuals 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 recognize 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, 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 placebo. In the study, the third dose of mRNA-1273 was generally well tolerated.
About the Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).
The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.
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