Olivia C. Welter, PharmD
While COVID-19 continues to evolve, recommendations for vaccinating against it are changing as well. From initial anticipation for vaccine development in 2020 to new booster dose indications in 2023, CDC and other national regulatory agencies have released multiple updates to ensure the various COVID-19 vaccines remain as safe, accessible, and efficacious as possible.
Highlights include blanket recommendations of bivalent vaccines from CDC, allowing older adults and immunocompromised patients to receive additional bivalent booster doses for added protection, and HHS announcing continued vaccine accessibility for uninsured patients.
Primary vaccination
In the beginning of the pandemic, the primary vaccine series included one dose of the Janssen viral vector vaccine or two doses of either the Pfizer or Moderna monovalent mRNA vaccine.
Vaccine technology developed quickly and, as of May 2023, CDC recommends only bivalent mRNA vaccines for completing the primary vaccination. Just one dose of either the Pfizer or Moderna bivalent COVID-19 vaccine completes the primary vaccination for adults and children aged 12 years and older who are not immunocompromised. These bivalent mRNA vaccines are currently available under an EUA and offer greater protection against COVID-19. Their monovalent counterparts from Pfizer and Moderna have received full approval by FDA but are no longer recommended for use. The Novavax protein subunit vaccine remains available under EUA as an alternative to mRNA vaccines. Though monovalent, this vaccine expands patients’ choices.
CDC has a notice on their Novavax-specific webpages that some doses may have expired or may be expiring soon. They are directing vaccine providers to check expiration dates weekly and never administer an expired dose.
All doses of the Janssen single-dose vaccine expired on May 7, 2023. CDC has issued an announcement directing vaccine providers to dispose of any remaining doses they may have on hand.
Booster doses
The bivalent Pfizer and Moderna vaccines were originally developed as booster doses intended to supplement coverage of monovalent primary series doses.
Now, they can be used both to complete the primary vaccination and for booster doses.
In April 2023, FDA authorized adults aged 65 and older to receive a second booster dose of bivalent vaccine. This demographic, as well as immunocompromised patients, are the only populations who are currently able to receive additional bivalent booster doses.
The Novavax vaccine may serve as a booster dose in addition to being an option for primary series completion.
Cost of vaccines
When the first COVID-19 vaccines were developed, the federal government partnered with vaccine manufacturers to purchase bulk vaccine supply. These doses have been distributed to states, allocated to vaccine providers, and given to patients at no cost. Now, some COVID-19 vaccines are commercialized, and the government is no longer universally covering costs for vaccine ordering and administration.
Kaiser Family Foundation released an analysis in early 2023 detailing how much commercial doses of COVID-19 vaccine could cost. They anticipated that $110–130 per dose would be standard, compared to the federal purchase rate of around $20–26 per dose.
Insured patients can still expect to receive the vaccine for free. COVID-19 vaccine manufacturers have previously stated that the vaccine will remain free for those without insurance, although they have not released any details or plans for achieving this.
In April 2023, HHS announced their Bridge Access Program For COVID-19 Vaccines and Treatments. This program creates a public–private partnership that will maintain access to COVID-19 vaccines for uninsured patients. The federal government intends to partner with a network of pharmacies, both chains and independents, to provide per-dose payments for each vaccine administered to a qualifying patient.
The Biden administration expects that the Bridge Access Program will launch in fall 2023. Limited funds are available to support this program through December 2024. ■