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A bivalent COVID-19 vaccine booster targeting the omicron variant could be available next month for children as young as 12 years.
The Centers for Disease Control and Prevention (CDC) has released a guide to help clinicians and jurisdictions prepare for a fall booster campaign.
Both Pfizer-BioNTech and Moderna have created bivalent boosters in anticipation of a possible fall/winter virus surge. The Food and Drug Administration (FDA) advised the companies to use both the original SARS-CoV-2 strain and the omicron BA.4/5 spike protein. About 89% of the circulating strains are BA.5, and nearly all the rest are BA.4, according to the CDC.
The bivalent boosters could receive emergency use authorization from the FDA “in or around September 2022,” according to the planning guide. Following authorization, the CDC will convene its Advisory Committee on Immunization Practices to discuss recommended uses. The CDC expects the Pfizer-BioNTech vaccine will be authorized initially for people ages 12 and older, and the Moderna vaccine will be authorized for adults.
A bivalent booster for children under 12 years is expected “within a short time” after authorization for teens, the CDC said.
People would be eligible for a single-dose booster if they have completed a primary series regardless of how many boosters they have received, if enough time has passed since the last dose. About 60% of adolescents ages 12-17 years and 30% of children 5-11 years have completed a primary vaccine series.
The U.S. has procured 175 million doses of bivalent boosters, which jurisdictions and pharmacies can pre-order. The Pfizer-BioNTech bivalent booster will be packaged in six-dose vials in cartons of 10 vials each with a 300-dose minimum order, according to the planning guide. The Moderna bivalent booster will be in five-dose vials in cartons of 10 vials each with a 100-dose minimum order. Storage and handling rules are the same as the original products.
The CDC has outlined the following steps pediatricians and other vaccinators can take to prepare for the fall booster campaign:
- 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 to eligible recipients.
- If unable to offer COVID vaccination, be prepared to refer patients to other vaccine providers.
- CDC planning guide for bivalent COVID vaccine boosters
- CDC information on COVID-19 vaccine boosters
- CDC clinical considerations for administering COVID-19 vaccines
- Information from the CDC on COVID-19 vaccination of children and teens
- 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