Pfizer requested the FDA authorize a booster dose of its mRNA COVID-19 vaccine, developed with BioNTech, for 16- and 17-year-olds Nov. 30, The New York Times reports.
The official emergency use authorization request came hours after people familiar with the situation, who spoke on the condition of anonymity because they were not authorized to discuss the matter, told The Washington Postt that the drugmaker was planning to submit the request within a few days.
"It is our hope to provide strong protection for as many people as possible, particularly in light of the new variant," Pfizer's CEO, Albert Bourla, PhD, said in a Nov. 30 tweet, referring to the B.1.1.529 strain, known as omicron, which has been detected in at least 20 countries. Health officials around the world are investigating how the strain, which has more than 30 mutations in the spike protein, may affect illness severity or the effectiveness of vaccines and treatments.
The FDA is expected to reach a decision on Pfizer's request within a week, the Times reports. If approved, it would become the first booster shot available for use in people younger than 18.
The CDC on Nov. 29 strengthened its booster guidance, urging all Americans aged 18 and older to get their booster shots at least six months after receiving their second dose of the Pfizer-BioNTech or Moderna vaccines, or two months after the Johnson & Johnson shot.
More than 41.1 million U.S. adults had received booster doses as of Nov. 30, CDC data shows.