FDA urges Pfizer to apply for authorization of Covid vaccine for children under five

US regulators are urging Pfizer to apply for emergency authorization for a two-dose regimen of its Covid-19 vaccine for children six months to five years old, according to sources.

The move could clear the way for the shots as soon as the end of February, while the companies await data on a three-dose course.

The additional data from the third dose study is reportedly expected in March. The two-step authorization process could mean that young children could be vaccinated more than a month earlier than previous estimates, assuming the FDA and the Centers for Disease Control and Prevention greenlight the shots.

Young children are the last remaining age group without approval of Covid-19 shots. They are far less likely than adults to develop serious complications or to die from Covid-19, but incidences of illness have risen amid the nationwide spike in cases from the omicron variant. Most cases and deaths occur among older people, especially those who are unvaccinated.

Vaccines for kids ages five to 12 were approved by US regulators in November, though uptake of shots has been slower than US officials hoped.