The US Food and Drug Administration (FDA) is likely to approve Pfizer’s Covid vaccine for children under 5 years of age in February, White House chief medical advisor Anthony Fauci has said.
According to Fauci, younger children will likely need three doses, because two shots did not induce an adequate immune response among kids between 2-4 yeas of age in Pfizer’s clinical trials, CNBC reported.
“My hope is that it’s going to be within the next month or so and not much later than that, but I can’t guarantee that,” Fauci was quoted as saying.
Pfizer had in December 2021 announced plans to submit data to the FDA in the first half of 2022 if the three-dose study proves successful.
The US drug major said it did not identify any safety concerns with the 3-microgram vaccine doses in children six months to 4 years old. Adults receive two doses of 30 micrograms apiece as part of their primary series of shots.
Children under 5 are particularly vulnerable right now because they are the only age group that is not currently eligible for vaccination.
Hospitalisations of children with Covid are rising as the highly contagious Omicron variant has rapidly spread through communities across the US over the past month.
“Sadly, we are seeing the rates of hospitalisation increasing for children zero to four, children who are not yet currently eligible for Covid-19 vaccination,” Rochelle Walensky, director of the Centers for Disease Control and Prevention, told reporters during a conference call earlier this month.
Nearly 8 out of every 100,000 children under 5 years of age were hospitalised with Covid as of January 8, more than double the rate in early December before the Omicron became the dominant variant in the US, according to CDC data collected from 250 hospitals across 14 states.
However, the World Health Organization (WHO) has maintained that it is not necessary for healthy children to receive Covid boosters.
“The aim is to protect the most vulnerable, to protect those at highest risk of severe disease and dying, those are our elderly population, immunocompromised with underlying conditions and also health care workers,” WHO Chief Scientist Soumya Swaminathan said during a recent briefing.