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Pediatricians should start preparing for a possible October rollout of bivalent COVID-19 vaccine boosters for children ages 5-11 years.
The Centers for Disease Control and Prevention (CDC) has released a guide for clinicians and jurisdictions anticipating that the Food and Drug Administration could grant emergency use authorization (EUA) in the next several weeks.
The Pfizer-BioNTech bivalent booster EUA that includes people 12 years and older could be expanded to include children ages 5-11 years. The Moderna bivalent booster authorization for those 18 years and older could be expanded to include children and adolescents ages 6-17 years.
The bivalent boosters were created to combat a possible fall/winter virus surge and contain both the original SARS-CoV-2 strain and the omicron BA.4/5 spike protein. About 85% of the circulating strains are BA.5, and the rest are other omicron variants, according to the CDC.
Only children who have completed a primary series would be eligible for a bivalent booster. About 61% of adolescents ages 12-17 years and 31% of children 5-11 years have completed a primary series.
The Pfizer-BioNTech bivalent booster for children ages 5-11 years will be a new product and is expected to require diluent. Preordering will be open from Sept. 26 to approximately Oct. 5, and vaccine delivery will begin after an EUA is issued. The minimum order for jurisdictions is 100 doses.
The Moderna bivalent booster for children and adolescents (6-17 years) will be the same product as for individuals 18 years and older. Adolescents ages 12-17 years are expected to receive the same dose as individuals 18 years and older. Children ages 6-11 years likely would get half the dose, according to the CDC. Because vaccinators already are using this product, there is no preorder period. However, sites ordering the vaccine will need to specify that they intend to use it for children ages 6-11 years, so they receive the appropriate ancillary kit. The minimum order for jurisdictions is 100 doses.
The CDC expects children will be allowed to receive a bivalent booster with a different brand than their primary series. As with people ages 12 and older, monovalent boosters would no longer be allowed for children ages 5-11 years if a bivalent booster is authorized.
The CDC has outlined the following steps pediatricians and other vaccinators can take to prepare:
- Enroll to be a vaccine provider.
- Ensure staff are equipped and trained to respond to possible allergic reactions.
- Be prepared to coadminister other routine vaccines including flu vaccine to eligible recipients.
- Be prepared to report certain adverse events to the Vaccine Adverse Event Reporting System and encourage patients to enroll in v-safe.
- If unable to offer COVID vaccination, be prepared to refer patients to other vaccine providers.
Bivalent COVID vaccine boosters for children ages 6 months to 4 years may be authorized in the coming months.
- CDC planning guide for bivalent COVID vaccine boosters
- CDC information on COVID-19 vaccine boosters
- CDC clinical considerations for administering COVID-19 vaccines
- AAP COVID vaccination resources
- AAP pediatric COVID-19 vaccine dosing quick reference guide
- AAP/Health and Human Services COVID vaccine toolkit
- Information from HealthyChildren.org on preparing children for a COVID-19 vaccine