Pfizer and its German partner BioNTech applied to modify their emergency use authorization with the Food and Drug Administration (FDA) Friday for approval to administer the COVID-19 vaccine to 12- to 15-year-olds.
The measure would extend FDA emergency approval for the vaccine, which is currently only available to those over 16 years of age. The two companies said they plan to apply for similar age extensions to other regulators around the world in the coming days.
Pfizer and BioNTech cited the research presented last month who found their vaccine to be 100% effective in children ages 12 to 15.
“These presentations represent a critical step in Pfizer and BioNTech’s ongoing efforts to support governments in expanding global vaccination efforts,” the companies said in a statement.
“Companies hope to work closely with the U.S. Food and Drug Administration (FDA) and other global regulatory authorities as part of companies’ efforts to extend the emergency or conditional authorization of their COVID-vaccine. 19 in a period of 12 to 15 years. Old as soon as possible, “the statement continued.
On March 31, the companies stated that the third phase trial with 2,260 adolescents did not result in COVID-19 cases among the vaccinated, with 18 cases identified in the placebo group. Side effects among adolescents who received the vaccine were “generally consistent” with those observed among participants aged 16–25 years.
At the time, Pfizer and BioNTech said they would present the emergency use permit as soon as possible, and Pfizer CEO Albert Bourla said he hoped to start vaccinating young people 12 to 15 years before the start. of the next school year.
The Pfizer-BioNTech vaccine was the first vaccine to obtain emergency use authorization in the U.S. in December, followed shortly after by the Moderna vaccine. But the Pfizer-BioNTech vaccine is the only vaccine authorized for 16- and 17-year-olds, while Moderna and Johnson & Johnson vaccines are restricted to those over 18 years of age.
Last month, Moderna announced that it began testing its vaccine on children between the ages of six months and 12 in a study in the United States and Canada.
More than 90.2 million doses of Pfizer-BioNTech vaccine have been administered in the United States, more than nearly 80 million doses of Modern vaccine and nearly 5 million doses of Johnson & Johnson, according to data from the Center for Disease Control and Prevention (CDC).
As of Thursday, more than a quarter of adults over the age of 18 in the United States have been fully vaccinated.
Although children can spread the virus to other people, they are less likely to develop a serious illness or die from COVID-19. According to CDC data, less than 12% of confirmed cases of COVID-19 and less than 0.2% of deaths were between the ages of 17 and under.