Pfizer and BioNTech have asked the Food and Drug Administration for emergency use authorization of their COVID-19 booster targeting omicron subvariants BA.4 and BA.5 and the original strain of the virus from 2020 for children 6 months through 4 years.
Children within that age group would receive the omicron boosters as the third shot in their primary series if approved, the vaccine manufacturers said.
The primary series for children younger than 5 currently includes three doses of the original COVID-19 vaccine, while the primary series for those over 5 only involves two doses.
“With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization,” Pfizer and BioNTech said Monday.
The request comes as a surge in respiratory illnesses, including the flu and respiratory syncytial virus, or RSV, has led to overcrowding in some children’s hospitals across the country.
Pfizer and BioNTech’s omicron booster has already been authorized for people 5 and older in the United States and the European Union.
Even if omicron boosters are authorized for the younger age group, uptake for the updated shots could be low, as only 10% of children 6 months through 4 years have received their first COVID-19 vaccine dose, according to the Centers for Disease Control and Prevention.
Meanwhile, the emergence of new coronavirus subvariants BQ.1 and BQ.1.1 might affect the effectiveness of the updated boosters. Pfizer-BioNTech said last month that its updated booster still offers more protection against newer omicron subvariants, including BQ.1.1, than its original COVID-19 vaccine.