The Advisory Committee on Immunization Practices (ACIP) recently issued updated recommendations on the use of vaccines to protect against COVID-19.1 In addition, 3 new COVID-19 vaccine products have been approved for use in the United States since September. Before we discuss both of these items, it’s important to understand why we’re still talking about COVID-19 vaccines.
The impact of vaccination can’t be understated. Vaccines to protect against COVID-19 have been hugely successful in preventing mortality and morbidity from illness caused by SARS-CoV-2. It is estimated that in the first year alone, after vaccines became widely available, they saved more than 14 million lives globally.2 By the end of 2022, they had prevented 18.5 million hospitalizations and 3.2 million deaths in the United States.3 However, waning levels of vaccine-induced immunity and the continuous mutation of the virus have prompted the need for booster doses of vaccine and development of new vaccines.
Enter this year’s vaccines. The new products include updated (2023-2024 formula) COVID-19 mRNA vaccines from Moderna and Pfizer-BioNTech, for use in those ages 6 months and older, and Novavax COVID-19 vaccine for use in those ages 12 years and older. All 3 provide protection against the currently circulating XBB variants, which by September 2023 accounted for > 99% of circulating SARS-CoV-2 strains in the United States.1
Novavax is an option for those who are hesitant to use an mRNA-based vaccine, although the exact recommendations for its use are still pending. Of note, the previously approved bivalent vaccines and the previous Novavax monovalent vaccine are no longer approved for use in the United States.
Current recommendations. For those ages 5 years and older, the recommendation is for a single dose of the 2023-2024 COVID-19 vaccine regardless of previous vaccination history—except for those who were previously unvaccinated and choose Novavax. (Those individuals should receive 2 doses, 3 to 8 weeks apart.) For those ages 6 months through 4 years, the recommended number of doses varies by vaccine and previous vaccination history1; a table can be found at www.cdc.gov/mmwr/volumes/72/wr/mm7242e1.htm.
Those who are moderately to severely immunocompromised should receive a 3-dose series with one of the 2023-2024 COVID-19 vaccines and may receive 1 or more additional updated doses.1 These recommendations are more nuanced, and a full description of them can be found at www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.
Major changes in this year’s recommendations,4 compared to those previously made on the use of the bivalent vaccines, include:
- Eliminating complex recommendations for 5-year-olds, who are now included in the standard recommendation
- Reducing the number of COVID-19 vaccine products in use by standardizing the dose (25 mcg) for those ages 6 months to 11 years
- Choosing to monitor epidemiology and vaccine effectiveness data to determine whether an additional dose of this year’s vaccine will be needed for those ages 65 years and older, rather than making a recommendation now.
Who’s paying? Another change is how COVID-19 vaccines are paid for. The United States is moving from a system of federal procurement and distribution to the commercial marketplace. This may lead to some disruption and confusion.
All commercial health plans, as well as Medicare and Medicaid, must cover vaccines recommend by the ACIP with no out-of-pocket cost. The Vaccines for Children program provides free vaccine for uninsured and underinsured children up to age 19 years.
However, that leaves no payer for uninsured adults. In response, the CDC has announced the establishment of the Bridge Access Program, which is a private/government partnership to provide the vaccine to this age group. Details about where an adult can obtain a free COVID-19 vaccine through this program can be found by visiting www.cdc.gov/vaccines/programs/bridge/index.html or by calling 800-CDC-INFO.
A dynamic situation. COVID-19 vaccines and associated recommendations are likely to change with time, as we learn how best to formulate them to adjust to virus mutations and determine the optimal intervals to adjust and administer these vaccines. The result may (or may not) eventually resemble the approach recommended for influenza vaccines, which is annual assessment and adjustment of the targeted antigens, when needed, and annual universal vaccination.