Pfizer and BioNTech requested on Friday that the Food and Drug Administration extend the emergency use authorization for their coronavirus vaccine so that it can be used in children aged 12 to 15 years. If it widens, young adolescents may begin vaccinating before returning to school in the fall.
The companies plan to seek similar approvals from health care institutions around the world in the coming days, they said in a joint statement.
“These submissions are a critical step in Pfizer and BioNTech’s ongoing efforts to support governments in expanding their global vaccination efforts,” the statement said. The results of clinical trials found that the vaccine is very effective in that age group, the companies said last month.
The Pfizer BioNTech vaccine has been approved for emergency use in people 16 years of age and older. The approval for its use in the younger age group will also speed up the country’s efforts to achieve herd immunity, which depends on the vaccination of children.
More than 2,000 young adolescents participated in the third phase of the vaccine trial. Among those who received it, no one developed symptomatic coronavirus infections or showed serious side effects, the companies said last month. The vaccinated 12- to 15-year-olds also produced, on average, higher levels of antibodies than older adolescents and young adults did.
The trial results have not yet been published in a scientific journal.
The Covid-19 vaccine trials for children started slowly, in part because it took time to find participants. Vaccinators initially focused on adults, in part because children would die much less from Covid-19. The biology of a child differs from that of an adult, which can affect the action of vaccines.
Moderna is also testing its vaccine in children. Results of the study from 12 to 17-year-olds, which began in December, are expected soon. A separate trial consisting of children under 12 began last month.
In March, Pfizer began testing its vaccine in children under 12, with results expected during the second half of the year.