Bivalent Boosters approved down to 6 months old!
By: Joseph Mechak, MD
The FDA and CDC have granted emergency use authorization (EUA) for both the Pfizer/BioNTech and Moderna COVID-19 Bivalent booster vaccines for children as young as 6 months.
This comes as hospitalizations for Flu, RSV and COVID are all surging. Specifically, pediatric COVID hospitalizations have increased by 68% over the past 2 months and have nearly doubled in the 0 to 4 year age group during that same time. It is more important than ever to stay up to date with all of your seasonal vaccinations.
As with the other COVID vaccine recommendations, we at Potomac Pediatrics recommend that all children stay up-to-date with available COVID-19 vaccination. We are scheduled to receive both Moderna and Pfizer/BioNTech bivalent booster doses for this youngest age group this week (Week of Dec 12, 2022). Information about clinic dates and how to sign up will be provided in subsequent communications.
The FDA has released the following information about these booster vaccines. Read carefully as the recommendations differ slightly from other age groups and depending on which vaccine your child received for their primary series.
- Regarding children who have complete or are planning to complete a Moderna primary series – Children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 Vaccine two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine.
- Regarding children who have NOT yet completed their 3-dose Pfizer primary series – Children 6 months through 4 years of age who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine or have not yet received the third dose of their primary series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine.
- Regarding children who have completed their 3-dose Pfizer primary series – Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will NOT be eligible for a booster dose of an updated bivalent vaccine at this time. Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant. The data to support giving an updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating those data as quickly as possible.
- The Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component corresponding to the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.
- Individuals who receive the updated (bivalent) vaccines may experience similar side effects reported by individuals who received previous doses of the original (monovalent) mRNA COVID-19 vaccines.
The CDC has also provided the following recommendations and clarifications
- Regarding children that have turned 5 during or following their primary Pfizer vaccine series: The child should receive 1 bivalent Pfizer-BioNTech booster dose when they turn age 5 years, and it has been at least 2 months since completing their primary series. A child can get the bivalent booster dose regardless of whether the third primary series dose was a monovalent or bivalent Pfizer-BioNTech vaccine.
- Regarding children 6mo to 5 years that received a mixed primary series – Currently, children in this age group who receive a mixed 3-dose primary series with any combination of Moderna and Pfizer-BioNTech vaccines are not authorized to receive any booster dose.
- Current booster recommendations by age and primary series:
- Ages 6 months – years and completed the Moderna primary series: 1 bivalent Moderna booster dose.
- Ages 6 months – 4 years and completed Pfizer-BioNTech primary series: No booster dose is recommended at this time.
- Age 5 years and completed Moderna primary series: 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech)
- Age 5 years and received Pfizer-BioNTech primary series: 1 bivalent Pfizer-BioNTech booster dose.
- Ages 6 years and older: 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) regardless of which vaccine they received for their primary series.
For more information about the FDA and CDC EUA, please see the releases below.
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