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Pfizer Inc. said Tuesday it asked the Food and Drug Administration to authorize its COVID-19 booster shots for all individuals ages 18 and older.
"The amendment request is based on results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the vaccine, which enrolled more than 10,000 participants during a period when the Delta variant was the prevalent strain," the companies said in a joint press release.
The first coronavirus booster shots – also Pfizer's – were granted for emergency use authorization (EUA) in September.
That same month, an external advisory board voted to recommend booster shots on an emergency basis only for those with high-risk jobs, medical conditions or people 65 and older.
COVID-19 VACCINATION AND YOUNG CHILDREN: WHAT TO KNOW
FILE - In this Oct. 5, 2021, file photo a healthcare worker fills a syringe with the Pfizer COVID-19 vaccine at Jackson Memorial Hospital in Miami. (AP Photo/Lynne Sladky, File)
Since then, the FDA and U.S. Centers for Disease Control and Prevention (CDC) have also approved the Pfizer/BioNTech vaccine for emergency use for children ages 5-11.
Approximately 28 million kids in that age range are eligible for the shots and the White House says the federal government has procured enough of the two-dose vaccine for all of them.
GOP, DEM SENATORS PUSH FOR 9/11-STYLE COVID-19 COMMISSION
A Pfizer study of 2,268 children found the vaccine was nearly 91% effective at preventing symptomatic COVID-19 infections.
Additionally, the FDA studied the shots in 3,100 vaccinated kids in concluding the shots are safe.
At least 94 children ages 5-11 have died from COVID-19 since the start of the pandemic, more than 8,300 have been hospitalized and more than 5,000 have developed a serious inflammatory condition linked to the virus.
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CDC data shows that 194 million Americans, ages 12 and above, are currently fully vaccinated against the infectious disease.
The Associated Press contributed to this report
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