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

Dr. Anthony Fauci talks about the Omicron coronavirus variant during a press briefing at the White House in Washington on December 1, 2021.

Kevin Lamarque | Reuters

The White House Chief Medical Officer Dr. Anthony Fauci said Wednesday that the Food and Drug Administration could approve Pfizer and BioNTech's vaccine for children under 5 in the next month.

"My hope is that it will be within the next month or so and not much later than that, but I can not guarantee it," Fauci said in an interview with Blue Star Families, a nonprofit group that supports military families.

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

Pfizer plans to submit data to 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 did not identify any safety concerns with the 3-microgram vaccine doses in children six months to 4 years of age. Adults receive two doses of 30 micrograms each as part of their primary series of shots.

Children under the age of 5 are particularly vulnerable right now because they are the only age group that is not currently eligible for vaccination. Hospitalizations of children with Covid are rising as the highly contagious omicron variant has rapidly spread through communities across the United States over the past month.

"Unfortunately, we are seeing the number of admissions increase for children from zero to four, children who are not yet eligible for Covid-19 vaccination," said Dr. 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 the age of 5 were admitted to Covid on January 8, more than double the number in early December, before omicron became the dominant variant in the United States, according to CDC data collected from 250 hospitals in 14 states.

Walensky said earlier this month that there is no evidence that the omicron variant causes more serious illness in children. She said the delta variant also led to an increase in hospitalizations among children, but research later showed that the variant did not make children more ill compared to previous variants. Real-world data from the US, UK and South Africa have shown that omicron appears to cause less serious illness in adults.

Walensky said the unprecedented levels of virus transmission in the wider community are likely to be behind the increase in hospitalizations of children.

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