The Food and Drug Administration (FDA) has authorized additional doses of the bivalent Pfizer-BioNTech COVID-19 vaccine for children under 5 years who are immunocompromised, under the emergency use authorization (EUA).
Children ages 6 months through 4 years with certain types of immunocompromise who received three 0.2 milliliter doses of Pfizer-BioNTech COVID-19 vaccine or bivalent Pfizer-BioNTech COVID-19 vaccine can now receive:
- a fourth dose administered at least one month following the most recent dose and
- additional doses that may be administered at the discretion of the health care provider, taking into consideration the individual’s clinical circumstances.
The FDA also revised its EUA fact sheets for Pfizer-BioNTech COVID-19 bivalent vaccine to reflect the changes (see resources below).
The changes to the EUA would come upon approval by the director of the CDC.
The changes come after health officials recently approved a plan to simplify COVID-19 vaccination while acknowledging complexities remain for vaccinating young children. Those changes include using only bivalent versions of mRNA COVID-19 vaccines, with most children and adults now needing just one bivalent dose regardless of their vaccination history.
The previous changes, approved in mid-April by the Centers for Disease Control and Prevention (CDC) and FDA, are aimed at reducing the number of different mRNA COVID-19 vaccine vials from 11 to five and eliminating look-alikes that cause confusion. Officials hope the new guidance will reduce errors and improve uptake.
Less than 17% of people have received a bivalent vaccine, including just under 8% of adolescents ages 12-17 years, less than 5% of children ages 5-11 years and 0.6% of both 2- to 4-year-olds and those younger than 2 years, according to CDC data.
- CDC’s Clinical Considerations for Use of COVID-19 Vaccines
- AAP's Pediatric COVID-19 Vaccine Dosing Guide is being updated in the coming days and will provide detailed guidance on dosing by age and product.
- FDA Health Care Professional Fact Sheet – Pfizer BioNTech Vaccine
- FDA Recipient and Caregiver Face Sheet – Pfizer BioNTech Vaccine