Moderna’s COVID-19 vaccine – mRNA-1273 – has been approved by the US Food and Drug Administration (FDA), making it the second jab to gain an emergency use authorisation in the country after Pfizer/BioNTech.
The FDA has authorised the shot for use against COVID-19 in individuals aged 18 years or older, based in part on a data analysis from Moderna’s phase III study of mRNA-1273.
Results from a primary efficacy analysis of 196 cases in the phase III trial of the COVID-19 vaccine reflected a 94.5% efficacy rate.
Although Moderna will begin to immediately deliver doses of mRNA-1273 to the US government, it will continue to gather further data and plans to file a biologics license application (BLA) with the FDA requesting full approval in 2021.
The most common side effects after the two-dose regimen of mRNA-1273 included injection site pain (88.2%), erythema (8.6%), swelling (12.2%) and ipsilateral lymphadenopathy (14.2%).
“I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorisation, while advancing clinical development with a phase I, phase II and pivotal phase III study of 30,000 participants,” said Stéphane Bancel, chief executive officer of Moderna.
“It has been a ten-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” he added.
