Pfizer and its German partner BioNTech have requested their emergency use authorization with the Food and Drug Administration (FDA) Friday to get approval to administer their COVID-19 vaccine to 12- to 15-year-olds.
The move will expand the FDA’s emergency approval for the vaccine, which is currently only available to those 16 and older. The two companies said they plan to request similar age extensions from other regulators worldwide in the coming days.
Pfizer and BioNTech cite research released last month which found that the vaccine is 100 percent effective in children aged 12 to 15 years.
“These submissions are a critical step in the ongoing efforts of Pfizer and BioNTech to support governments in expanding global vaccination efforts,” the companies said in a statement.
The companies look forward to working closely with the US Food and Drug Administration (FDA) and other global regulatory authorities as part of the companies’ efforts to obtain the emergency or conditional authorization of their COVID-19 vaccine within 12 to 15 years to extend. old as fast as possible, ”the statement continued.
On March 31, the companies stated that the third phase of 2,260 adolescents had no COVID-19 effects among those vaccinated, with 18 cases identified in the placebo group. The side effects among the adolescents who received the vaccine were ‘generally’ consistent with the observations among participants aged 16 to 25 years.
At the time, Pfizer and BioNTech said they would have to apply for emergency clearance as soon as possible, and Pfizer CEO Albert Bourla said he hoped to vaccinate 12- to 15-year-olds before the next school year.
The Pfizer-BioNTech vaccine was the first vaccine to obtain an emergency permit in the US in December, shortly thereafter by Moderna’s vaccine. But the Pfizer BioNTech vaccine is the only vaccine allowed for 16- and 17-year-olds, while the Moderna and Johnson & Johnson vaccines are limited to 18-year-olds.
Last month, Moderna announced that it had begun testing its vaccine on children between the ages of six months and 12 years in a study in the US and Canada.
More than 90.2 million Pfizer-BioNTech vaccine doses have been administered in the US, more than the nearly 80 million doses of Moderna vaccine and the nearly 5 million doses of Johnson & Johnson, according to the Centers for Disease Control and Prevention (CDC).
As of Thursday, more than a quarter of American adults over the age of 18 have been fully vaccinated.
Although children can spread the virus to others, they are less likely to develop a serious illness or die from COVID-19. Less than 12 percent of confirmed COVID-19 cases and less than 0.2 percent of deaths were among those 17 and younger, according to CDC data.