Washington, Sept. 26 (U.S.): Pfizer Inc. has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children as it nears seeking approval for expanded use of the injection.
The drugmaker and its partner, Germany’s BioNTech, say they expect to request authorization for emergency use of the vaccine in children aged 5 to 11 “in the coming weeks.”
The AP report said the companies also plan to provide the data to the European Medicines Agency and other regulators.
The two-shot Pfizer vaccine is currently available to those 12 years of age or older. An estimated 100 million people in the United States have been fully vaccinated, according to the Centers for Disease Control and Prevention.
Pfizer has tested a lower dose of the injection in children. The drug company said last week that researchers found that the vaccine developed levels of antibodies to fight the coronavirus in children that were just as strong as those in teens and young adults who get regular doses of strength.
Earlier this month, the head of the Food and Drug Administration, Dr. Peter Marks, told the Associated Press that once Pfizer turns over the results of its study, his agency will evaluate the data “hopefully within weeks” to determine if the shots are safe and effective enough for children. the youngest.
The US company, Moderna, which makes other vaccines, is studying its shots on children of primary school age. Results are expected later in the year.
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