Coronavirus: Moderna seeks FDA authorization for 4th COVID-19 vaccine dose for all adults

WASHINGTON — Moderna is seeking authorization from the U.S. Food and Drug Administration for a fourth dose of its COVID-19 vaccine for all adults – a broader request than rival vaccine maker Pfizer-BioNTech made earlier this week, The Associated Press is reporting.

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In a news release posted Thursday evening, Moderna said it has requested that the FDA amend its emergency use authorization for the company’s mRNA vaccine, branded as Spikevax, to allow a fourth dose for “adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.”

The drugmaker added that it included all adults in the request “to provide flexibility for the U.S. Centers for Disease Control and Prevention (CDC) and health care providers to determine the appropriate use of an additional booster dose,” such as in higher-risk patients.

The news comes two days after Pfizer and BioNTech asked the FDA to approve an additional COVID-19 vaccine booster dose for adults age 65 and older.

“The submission is based on two real-world data sets from Israel analyzed at a time when the omicron variant was widely circulating,” the companies said in a news release Tuesday. “These data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness.”

Moderna also based its submission on the Israeli data, along with data generated in the United States, the company said.

According to The New York Times, the rates of new coronavirus cases and deaths appear to be declining in the United States. As of Wednesday, the country averaged 31,152 new cases and 1,268 deaths per day, down 43% and 31%, respectively, in the past two weeks.

The CDC reported Thursday that 65.3% of the U.S. population is considered fully vaccinated against COVID-19. About 44.4% of fully vaccinated residents have received a booster dose of a coronavirus vaccine, the agency said.

The Associated Press contributed to this report.

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