Pfizer and its German partner BioNTech requested to change their emergency use authorization with the Food and Drug Administration (FDA) on Friday to receive approval to give their COVID-19 vaccine to 12 to 15 year olds.
The move would expand the FDA’s emergency approval for the vaccine, which is currently only available to people 16 and older. The two companies said they plan to apply for similar age extensions from other regulatory agencies around the world in the coming days.
Pfizer and BioNTech cited research revealed last month who found the vaccine to be 100 percent effective in children ages 12 to 15.
“These entries represent a critical step in Pfizer and BioNTech’s ongoing efforts to support governments in broadening global vaccination efforts,” the companies said in a press release.
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 expand the emergency or conditional approval of their COVID-19 vaccine in 12 to 15. oldies as soon as possible, ”the statement continued.
On March 31, the companies stated that the third phase of the study involving 2,260 adolescents yielded no COVID-19 cases among the vaccinees, with 18 cases identified in the placebo group. The side effects in the adolescents who received the vaccine were “generally consistent” with the side effects seen in participants aged 16 to 25 years.
At the time, Pfizer and BioNTech said they would apply for emergency use authorization as soon as possible, and Pfizer CEO Albert Bourla said he hoped to begin vaccinating 12-15 before the start of the next school year. year olds.
The Pfizer BioNTech vaccine was the first vaccine to be licensed for emergency use in the US in December, followed shortly after by the Moderna vaccine. But the Pfizer-BioNTech vaccine is the only immunization allowed for 16 and 17 year olds, while Moderna and Johnson & Johnson vaccines are limited for those 18 and older.
Last month, Moderna announced it has started testing its vaccine on children between the ages of six months and 12 years in a study in the US and Canada.
According to data from Centers for Disease Control and Prevention (CDC), more than 90.2 million doses of Pfizer-BioNTech vaccines have been administered in the US, more than the nearly 80 million doses of Moderna vaccines and the nearly 5 million doses of Johnson & Johnson.
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 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 under 17 and younger, according to CDC data.