Pfizer and its German partner BioNTech have applied to amend their emergency use authorization with Food and Drug Administration (FDA) on Friday to obtain approval to administer the COVID-19 vaccine to children aged 12 to 15 years.
The measure would extend the FDA’s emergency approval for the vaccine, which is currently only available to those 16 years of age and older. The two companies said they intend to request similar age extensions from other regulators around the world in the coming days.
Pfizer and BioNTech cited research revealed last month who found that his vaccine is 100% effective in children between the ages of 12 and 15.
“These filings are 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 look forward to working closely with the US Food and Drug Administration (FDA) and other global regulators as part of companies’ efforts to extend the emergency or conditional authorization of COVID-19 vaccine to 12-15 year olds as soon as possible “, the statement continued.
As of March 31, the companies said the third phase study with 2,260 adolescents did not lead to cases of COVID-19 among those vaccinated, with 18 cases identified in the placebo group. Side effects among adolescents who received the vaccine were “generally consistent” with those seen in participants aged 16 to 25 years.
At the time, Pfizer and BioNTech said they would file the emergency use permit as soon as possible, and Pfizer CEO Albert Bourla said he hoped to start vaccinating children between the ages of 12 and 15 before it began. the following school year.
The Pfizer-BioNTech vaccine was the first vaccine to obtain emergency use in the United States in December, followed shortly by the Moderna vaccine. But the Pfizer-BioNTech vaccine is the only permitted immunization for 16- and 17-year-olds, while the Moderna and Johnson & Johnson vaccines are restricted to those 18 years of age and older.
Last month, Moderna announced that it has started testing its vaccine on children aged between six months and 12 years in a study in the US 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 Centers for Disease Control and Prevention ( CDC).
As of Thursday, more than a quarter of US adults over the age of 18 have been completely vaccinated.
Although children can spread the virus to others, they are less likely to develop a severe illness or die from COVID-19. Less than 12 percent of COVID-19 confirmed cases and less than 0.2 percent of deaths were among those 17 years of age and younger, according to CDC data.