Atlanta—Pharmacists should prepare. The more than 23 million Americans aged 65 years and older who received a bivalent booster dose at least 4 months ago are now eligible for an additional one.

In the wake of regulatory action by the FDA, the CDC has updated COVID-19 vaccine recommendations. The goal was to allow more flexibility for those at higher risk who want the option of added protection from additional COVID-19 vaccine doses, according to a recent press release.

The recommendations, which were supported by the CDC’s Advisory Committee on Immunization Practices, include:

• Allowing an additional updated (bivalent) vaccine dose for adults aged 65 years and older and additional doses for people who are immunocompromised
• Ending the use of monovalent (original) mRNA COVID-19 vaccines
• Urging everyone aged 6 years and older to receive an updated (bivalent) mRNA COVID-19 vaccine, regardless of whether they previously completed their (monovalent) primary series.

Public health officials emphasized that those aged 6 years and older who have already received an updated mRNA vaccine do not need to take any action unless they are aged 65 years or older or immunocompromised. Also, multiple doses continue to be recommended for young children and will vary by age, vaccine, and which vaccines were previously received.

In addition, the CDC advised that alternatives to mRNA COVID-19 vaccines remain available for people who cannot or will not receive an mRNA vaccine. The CDC’s recommendations for use of (monovalent) Novavax or Johnson & Johnson’s Janssen COVID-19 vaccines were not affected by the recent changes.

“CDC and ACIP will continue to monitor COVID-19 disease levels and vaccine effectiveness in the months ahead and look forward to additional discussion around potential updates this fall,” according to the press release.

Those changes followed FDA action to amend the emergency use authorizations of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines.

“This action includes authorizing the current bivalent vaccines (original and Omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States,” the FDA wrote in an announcement.

The changes allow adults aged 65 years and older who have received a single dose of a bivalent vaccine to get one additional dose at least 4 months following their initial bivalent dose. “A second bivalent dose for individuals 65 years of age and older is supported by data showing the waning of immunity in this population over time and its restoration by an additional dose,” the FDA pointed out. “Additionally, based on evidence from studies conducted previously, immunocompromised individuals may require additional doses.”

That refers to the decision that patients with certain types of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose of a bivalent COVID-19 vaccine at least 2 months following a dose of a bivalent COVID-19 vaccine. Unlike the over-age-65-year cohort, those with immunocompromise are authorized to receive additional doses at the discretion of, and at intervals determined by, their healthcare provider. For immunocompromised individuals aged 6 months through age 4 years, eligibility for additional doses will depend on the vaccine previously received, according to the FDA.

The never-vaccinated now will receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.

In terms of pediatrics, the FDA states that children aged 6 months through age 5 years who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine (age 6 months through age 5 years) OR a three-dose series of the Pfizer-BioNTech bivalent vaccine (age 6 months through age 4 years). Children who are aged 5 years may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.

As for children aged 6 months through 5 years who have received one, two, or three doses of a monovalent COVID-19 vaccine, they are allowed to receive a bivalent vaccine, but the number of doses recommended depends both on the type of vaccine and their vaccination history.

“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Evidence is now available that most of the U.S. population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes COVID-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines. COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine. The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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