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A COVID-19 vaccine for children under 5 years could be available later this month, but it must undergo a rigorous review from two federal agencies.
Pfizer and BioNTech announced Tuesday they have started the process of requesting emergency use authorization (EUA) for the first two doses of vaccine in this age group so vaccination could begin while they continue to study a planned third dose.
“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. “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.”
The Food and Drug Administration’s (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 Centers for Disease Control and Prevention (CDC) will decide whether to recommend the vaccine for young children.
“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we're committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement. “Furthermore, children are not small adults. Because they're still growing and developing, it's critical that these vaccines are evaluated in well-designed and well-conducted clinical trials.”
Children under 5 years would receive doses of 3 micrograms (µg). It is a lower dose than the 10-µg doses used for children ages 5-11 years and 30-µg doses used for those 12 years and older.
In December, Pfizer said the two-dose series with a 3-µg 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.
The companies said they plan to submit trial data on third doses in the coming months. They submitted an EUA application for the first two doses at the request of the FDA so that vaccination could begin sooner. Nearly 1.7 million children under 5 years have been diagnosed with COVID-19, according to CDC data.
The American Medical Association announced Tuesday it has assigned provisional Current Procedural Terminology codes for vaccinating children under 5 years with the Pfizer-BioNTech vaccine. They will go into effect once federal officials authorize the vaccine.
91308 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use
0081A Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; first dose
0082A Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; second dose
- 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