Moderna submitted a request to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) on a fourth dose of its COVID-19 vaccine for adults 18 years of age and older, who already received a booster dose of any approved or authorized shot.
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The request to include adults over 18 years of age was made to provide flexibility for the U.S. Centers for Disease Control and Prevention 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, said the company in a statement.
Currently a booster dose of the Moderna COVID-19 vaccine at the 50 microgram dose level is authorized by the FDA for emergency use in the United States for adults 18 years and older.
Moderna said it continues to collect and monitor real-world data on its COVID-19 vaccine. Clinical trials are ongoing for Moderna's Omicron-specific booster and a bivalent Omicron-specific booster.
Moderna's application followed the one filed by Pfizer and its German partner BioNTech earlier in the week, which requests FDA authorization for a second booster shot for adults 65 and older.
Pfizer said data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of Pfizer-BioNTech COVID-19 vaccine compared to individuals who received only an initial booster.
Both Pfizer and Moderna said their submission is based on real-world data sets from Israel analyzed at a time when the Omicron variant was widely circulating.
"These data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness," said Pfizer.
The applications by the two companies would intensify debate about the durability of the protection afforded by the coronavirus vaccines.
Emerging evidence, including data from Kaiser Permanente Southern California, suggests that effectiveness against both symptomatic COVID-19 and severe disease caused by Omicron wanes 3 to 6 months after receipt of an initial booster, the third dose, according to Pfizer.
Thus, additional booster doses may be needed to ensure individuals remain adequately protected, said the company.
The FDA is set to convene its advisory committee of vaccine experts in April to deliberate how to arrange COVID-19 booster shots, including whether and when those boosters may be needed and for which populations, based on the available data and latest science on circulating or emerging virus variants. ■