Posted by Michael Wonder on 18 Mar 2022
Moderna submits amendment to the emergency use authorisation for an additional booster dose of its COVID-19 vaccine in the U.S.
17 March 2022 - Moderna today announced that it has submitted a request to the U.S. FDA for an amendment to the emergency use authorisation to allow for a fourth dose of its COVID-19 vaccine (mRNA-1273) in adults 18 years of age and older who have received an initial booster of any of the authorised or approved COVID-19 vaccines.
The request to include adults over 18 years of age was made to provide exibility for the U.S. Centers for Disease Control and Prevention and health care providers to determine the appropriate use of an additional booster dose of mRNA-1273, including for those at higher risk of COVID-19 due to age or co-morbidities.
This submission is based in part on recently published data generated in the United States and Israel following the emergence of Omicron.
