Pfizer seeks FDA authorization for omicron vaccine in kids under 5

Pfizer and its German partner BioNTech have submitted an application asking the Food and Drug Administration for emergency use authorization of their omicron-adapted bivalent COVID-19 vaccine as the third shot in a three-dose series for children ages 6 months through 4 years, the companies announced Monday. 

If authorized, the children would still receive two doses of the original vaccine, and then a third dose that specifically targets the omicron variant of the coronavirus. 

The bivalent omicron vaccine targets the BA.4/BA.5 omicron strains, as well as the original strains of COVID-19. The vaccine is authorized for use as a booster dose only in adults and children over the age of 5.

“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,” the companies said in a statement.

Respiratory illnesses like flu, RSV and COVID-19 are spiking early this year, overwhelming hospitals across the United States.

The monovalent shot, which the FDA still requires as the primary series before getting the omicron-specific shot, targets the original strain of the virus. 

BA.5 was the dominant strain of COVID-19 in the U.S. over the summer, but is now fading away.