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Health officials approved a plan to simplify COVID-19 vaccination on Wednesday, while acknowledging complexities remain for vaccinating young children.
The changes approved by the heads of the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) include using only bivalent versions of mRNA COVID-19 vaccines. In addition, most children and adults will need just one bivalent dose regardless of their vaccination history.
Officials have said the changes will reduce the number of different mRNA COVID-19 vaccine vials from 11 to five and eliminate look-alikes that cause confusion. They 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 0.5% in both the 2-4 years age group and under 2 years group, according to CDC data.
The changes come as most people already have some antibodies either from vaccination or infection. However, officials said young children still will need multiple vaccine doses. Children under 5 years who are unvaccinated may receive a two-dose series of the bivalent Moderna vaccine or a three-dose series of the bivalent Pfizer-BioNTech vaccine. Unvaccinated children who are 5 years of age may receive two doses of the bivalent Moderna vaccine or one dose of the Pfizer-BioNTech bivalent vaccine.
Children 6 months through 5 years who have received one, two or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, but the number of doses will depend on the vaccine and previous doses.
The CDC’s Advisory Committee on Immunization Practices (ACIP) discussed the changes Wednesday but did not take a formal vote. Members generally were supportive, although several expressed concerns about the complexities for young children.
ACIP member Sarah S. Long, M.D., FAAP, professor of pediatrics at Drexel University College of Medicine in Philadelphia, called the recommendations for young children “really defeating for a pediatrician.”
“Immunologically there is not a difference between a 4, a 5, and a 6-year-old,” she said. “ … So there isn’t a reason to have all this unnecessary drama around those ages.”
The CDC’s Sara Oliver, M.D., M.S.P.H., who leads ACIP’s COVID-19 vaccines work group, acknowledged the changes are “less than ideal” for young children. Several flow charts are available in the CDC’s meeting slides. In the coming days, the CDC will provide detailed charts on dosing on its interim clinical considerations webpage. There also is a webinar planned for May 11, with details to come at https://emergency.cdc.gov/coca/calls/index.asp.
“We’ve taken big steps for the 6 and over population,” Dr. Oliver said. “We fully acknowledge there’s additional steps that need to be taken for the pediatric age group. We look forward to hopefully being able to take those steps based on solid, evidence-based decisions in the coming future. We hope that’s in the next several months as we think toward fall recommendations.”
Officials have approved an additional bivalent dose for several additional groups. People 65 years and older who have received one bivalent dose may receive one more dose at least four months after their initial bivalent dose.
Most people who are immunocompromised and have received a bivalent dose can receive a single additional dose at least two months later and additional doses at the discretion of their health care provider. Eligibility for additional doses for immunocompromised young children will depend on their vaccination history.
ACIP member Camille N. Kotton, M.D., FIDSA, FAST, clinical director, transplant and immunocompromised host infectious diseases at Massachusetts General Hospital, expressed concern about children under 5 years who are immunocompromised and had Pfizer-BioNTech vaccines but are not eligible for additional bivalent doses. The FDA said it did not have enough data for this group but hopes to have more in the fall.
“Are you saying for the next six months these immunocompromised children would not be eligible?” Dr. Kotton asked. “That sounds potentially devastating for a high-risk immunocompromised population for a fairly prolonged period.”
FDA officials said they would take her concerns under consideration. In June, the FDA’s Vaccines and Related Biological Products Advisory Committee will discuss strain composition for the fall, and the FDA also will consider whether the general population needs additional doses.
Other likely developments in the fall include commercial markets likely playing a greater role in vaccine distribution. Jesse M. Hackell, M.D., FAAP, chair of the AAP Committee on Practice and Ambulatory Medicine, spoke Wednesday on behalf of the AAP about the potential impact of this change.
“Recognizing many pediatric practices operate on razor-thin margins, our fear is that few practices are going to be able to invest $10,000-$13,000 up front in purchasing the vaccines, especially because we have no indication how we will be paid for the vaccine or for the administration,” he said. “If we lose those providers of the COVID vaccine our impact on the vaccine rates will only get worse.”
He urged officials to ensure providers would be paid adequately and have the flexibility to return unused vaccines for credit.
- The CDC’s clinical considerations and the AAP’s dosing guide are being updated in the coming days and will provide detailed guidance on dosing by age and product.
- FDA press release on COVID-19 vaccine authorization changes
- Detailed information on changes to the Moderna COVID-19 vaccine authorization
- Detailed information on changes to the Pfizer-BioNTech COVID-19 vaccine authorization