Public Health

Fauci says FDA could approve Pfizer’s Covid vaccine for children under 5 next month

dr Anthony Fauci speaks about the Omicron variant coronavirus during a press conference at the White House in Washington December 1, 2021.

Kevin Lamarque | Reuters

White House Medical Advisor Dr. Anthony Fauci said Wednesday the Food and Drug Administration could approve Pfizer and BioNTech’s vaccine for children under 5 years old next month.

“I’m hoping it will be within the next month or so and not much later, but I can’t guarantee that,” Fauci said during an interview with Blue Star Families, a nonprofit group that supports military families.

Fauci said younger children will likely need three doses because two shots in Pfizer’s clinical trials in 2- to 4-year-olds did not elicit an adequate immune response.

Pfizer plans to file data with the Food and Drug Administration in the first half of 2022 if the three-dose study proves successful, the company announced in December. Pfizer said it has not found any safety concerns with the 3 microgram doses of vaccine in children aged 6 months to 4 years. Adults receive two doses of 30 micrograms each as part of their first series of vaccinations.

Children under the age of 5 are currently at particular risk as they are the only age group not currently eligible for vaccination. Hospitalizations of children with Covid are on the rise as the highly contagious Omicron variant has spread rapidly in communities across the US over the past month.

“Unfortunately, we are seeing hospitalization rates increasing for children aged 0 to 4, children who are not currently eligible for a Covid-19 vaccine,” said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, told reporters during a conference call earlier this month.

Nearly 8 in every 100,000 children under the age of 5 were hospitalized with Covid as of Jan. 8, more than doubling the number in early December before omicron became the dominant variant in the US, according to CDC data collected from 250 hospitals in 14 states were collected.

Walensky said earlier this month that there is no evidence the Omicron variant causes more serious illnesses in children. She said the Delta variant also led to an increase in hospitalizations among children, but later research showed that the strain did not make children sicker than earlier variants. Field data from the US, UK and South Africa have shown that Omicron appears to cause less severe disease in adults.

Walensky said the unprecedented level of virus transmission in the wider community is likely behind the increase in child hospitalizations.

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