London, March 18 : US drug maker Moderna has announced that it has submitted a request to the US Food and Drug Administration (FDA) for an amendment to the emergency use authorisation (EUA) to allow for a fourth dose of its Covid-19 vaccine to all adults.
This week, rival Pfizer had also applied to the FDA, however, it was for an additional booster dose to adults aged 65 and above.
Moderna, in a statement, said its request to include adults above 18 years of age was made “to provide flexibility for the US Centers for Disease Control and Prevention (CDC) and healthcare providers to determine the appropriate use of an additional booster dose, including for those at higher risk of Covid-19 due to age or comorbidities.”
The submission is also based in part on recently published data generated in the US and Israel following the emergence of Omicron.
“Moderna continues to collect and monitor real-world data on its Covid-19 vaccine.Real-world evidence continues to confirm the effectiveness and robust safety profile of the Moderna Covid-19 vaccine,” the drug maker said in a statement.
It is also undertaking clinical trials for an Omicron-specific booster dose.Pfizer is also working on a vaccine targeting all variants and aims to provide protection for at least a year.
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