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Federal officials say they will start shipping COVID-19 vaccines for children under 5 years immediately after the Food and Drug Administration (FDA) authorizes them, which could happen later this month.
The Biden administration has enough doses, needles and other supplies for the 18 million children who would become eligible, according to Jeff Zients, White House COVID-19 response coordinator.
“We’re doing everything we can to prepare now,” Zients said during a press conference Wednesday. “We’re taking all the best practices and applying all the lessons learned over the last 12 months to ensure getting kids under 5 the protection of the vaccine is easy and convenient, and we will be ready to start … soon after FDA and CDC (Centers for Disease Control and Prevention) make their decisions.”
In December, Pfizer and BioNTech said their two-dose series with a 3-microgram dosage did not meet non-inferiority criteria for those ages 2-4 years, leading the company to begin studying a third dose for all young children that would be given eight weeks after the second dose. However, at the FDA’s request, it submitted an application for emergency use authorization (EUA) for the first two doses this week so vaccination could begin sooner.
“With many children in particular as well as adults being infected and in the hospital during the omicron surge, it turns out that has actually facilitated the collection of … additional clinical data that we didn’t have in December,” Surgeon General Vivek H. Murthy, M.D., M.B.A. said Wednesday. “Whether that changes the risk-benefit profile is what the FDA will be assessing.”
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet Feb. 15 to discuss the use of two doses of the Pfizer-BioNTech vaccine in children 6 months through 4 years. The FDA will decide whether to grant an EUA, and the CDC will decide whether to recommend the vaccine for young children.
“Pfizer’s application will now undergo the same independent, rigorous and transparent review process that was used to authorize the vaccine that now more than 250 million Americans have received, including millions of children ages 5 and up,” Dr. Murthy said.
Officials acknowledged they also will have to address misinformation and hesitation and said they are prepared to answer parents’ questions. Vaccines have been available for children ages 5-11 years for three months, but only 29% of children in this age group have received a dose and 20% are fully vaccinated, CDC data show.
Among children under 5 years, about 1.7 million have been diagnosed with COVID-19 since the start of the pandemic, according to CDC data.
“Pediatricians have seen firsthand the fear, stress and hardship that so many families of young children have endured as they await a vaccine,” AAP President Moira A. Szilagyi, M.D., Ph.D., FAAP, said in a statement Tuesday. “We urge a transparent and data-driven process to evaluate this vaccine for this age group and look forward to offering its protection to our youngest children.”
- AAP resources on becoming a vaccinator, preparing a pediatric practice for COVID-19 vaccination and getting paid
- CDC clinical considerations for administering COVID-19 vaccines
- Information from the FDA about the Pfizer-BioNTech COVID-19 vaccine
- Information from HealthyChildren.org on preparing children for a COVID-19 vaccine