Pfizer and BioNTech requested the US Food and Drug Administration (FDA) on Friday for an amendment to its emergency use authorization of its Covid-19 vaccine, to expand its use for children ages 12 to 15 in the United States.
According to The Hill, the move would expand the FDA’s emergency approval for the vaccine, which is currently only available for those 16 and older. The two companies said they plan to request similar age extensions from other regulatory authorities worldwide in the coming days. Pfizer and BioNTech cited research unveiled last month that found its vaccine is 100 per cent effective in children ages 12 to 15.
“The companies plan to request similar rulings by other regulatory authorities worldwide in coming days. These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100 per cent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine, an official statement from the two companies read.
Topline results from an efficacy analysis on 12 to 15-year-old participants through cases accrued by March 31, 2021, from the Phase 3 trial were recently announced. In this analysis, the companies said that its vaccine “was well tolerated with side effects generally consistent with those observed in participants 16 to 25 years of age.”
It also stated that all participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Pfizer and BioNTech previously said they would file for emergency use authorization as soon as possible, and Pfizer CEO Albert Bourla said he hoped to start vaccinating 12- to 15-year-olds before the start of the next school year.
As per The Hill, last month, Moderna announced that it started testing its vaccine on children between the ages of six months and 12 years old in a study in the U.S. and Canada.
More than 90.2 million Pfizer-BioNTech vaccine doses have been administered in the U.S., more than the almost 80 million Moderna vaccine doses and the nearly 5 million Johnson & Johnson doses, according to Centers for Disease Control and Prevention (CDC) data.
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