The federal agency’s Advisory Committee on Immunization Practices (ACIP) recommendation was to authorize and approve the updated 2023-2024 (monovalent, XBB containing) COVID-19 vaccines for persons 6 months of age and older.
The CDC's ACIP voted today to recommend the COVID-19 vaccines with updated protection for the circulating Omicron variants.
Specifically, the ACIP committee voted on the following question:
Should the 2023-2024 (monovalent, XBB containing) COVID-19 vaccines authorized under EUA or approved by BLA be recommended for use in persons ≥6 months of age?
The vote was 13-1 in favor of recommending the vaccines.
Yesterday, the FDA approved the vaccines for individuals 12 years of age and older and authorized them under emergency use for individuals 6 months through 11 years of age.
Here are some highlights from today's meeting.
During the early part of the meeting, a CDC representative reviewed the variants circulating throughout the United States, noting that the most prevalent strain was EG5 with it accounting for 21.5% of cases. Other findings showed that 90% of the circulating viruses were part of the XBB lineage.
In its reporting, CDC mentioned the newer BA286 strain. As previously reported by Contagion, this variant has over 30 mutations, which is much higher than others circulating.
CDC also reported the preliminary pseudovirus neutralization data generated by multiple labs didn’t indicate a large reduction in neutralizing activity against this variant. In addition, CDC generated BA286 isolates, and is working on titrations before neutralization and will distribute to external laboratories for further examination. The BA286 strain has not evolved into an emerging strain yet and has a very small prevalence in the United States with approximately 100 cases.
One of the presenters stated the hospitalization rates increased in all age groups since mid-July and that rates were highest in seniors and infants less than 6 months of age.
For children younger than 5 years of age, most patients did not have underlying medical conditions; conversely, a higher proportion of hospitalized children and adolescents who were 5-17 years did have underlying medical conditions.
For adults, most who were hospitalized had multiple underlying medical conditions, and the presenter noted that most children and adults hospitalized since January 2023 had not received an updated bivalent booster.
Vaccine Manufacturer Data
The 2 mRNA vaccine manufacturers as well as Moderna presented data on their updated vaccines.
Moderna: As part of its presentation, Moderna said its study demonstrated their updated vaccine showed, “consistent cross neutralization demonstrated for newer variants including BA286.” The variants they referenced were the following: XBB15, XBB116, EG51, and FL151.
Novavax: The company did its preclinical work with macaques and the company representative said its booster vaccine induced robust neutralizing responses against XBB subvariants including all the aforementioned strains.
Pfizer: The company reported their booster vaccine was equally immunogenic against XBB15, EG51, and BA286 in a COVID-19 vaccine-experienced preclinical study.
With both the FDA and CDC in agreement, this paves the way for finalizing the approval and authorization for these updated vaccines.
In terms of availability, both Moderna and Pfizer-BioNTech have said they will be prepared for distribution of the updated vaccines this fall. The Novavax vaccine has not yet been approved, but their updated XBB version of its COVID vaccine is currently under review by the FDA for emergency use authorization to prevent COVID-19 in individuals aged 12 and older. The company has said it has doses ready for distribution upon the FDA decision.