Washington: Pfizer and BioNTech said Tuesday they are seeking emergency authorization from US health regulators for use of their Covid vaccine for children aged under five years.
If the Food and Drug Administration (FDA) authorizes, it will become the first Covid vaccine available to this age group in the United States.
The request for emergency authorization comes as the highly contagious Omicron variant has led to record numbers of infections. The under-5 group includes more than 19 million children, the only Americans not yet eligible for vaccination.
The companies said that they started submitting their formal application after federal regulators pressed them to submit the request even though two doses failed to produce the hoped-for immune response among children 2 to 4 years old in a clinical trial.
“Having a safe and effective vaccine available for children in this age group is a priority,” acting FDA Commissioner Janet Woodcock said. She said the agency asked for the application because of the recent Omicron surge.
In a tweet soon after the announcement, the FDA said it will hold a meeting in two weeks, on February 15, to consider the request.
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