Deauthorization of 2023-2024 COVID-19 Vaccines and Administration Error Clarity

Dear COVID-19 Vaccine Providers,

Thank you for continuing to elevate your questions and concerns regarding the Center for Disease Control and Prevention's (CDC) recent deauthorization of the 2023-2024 COVID-19 vaccine, including questions about administration errors. We hope this email clears up any confusion and clarifies immediate action to take, as well as next steps to prepare for.

The 2023-2024 mRNA COVID-19 vaccines are no longer authorized and should NOT be administered even if they are not expired.

Administration of any 2023-2024 mRNA doses on or after August 23 after FDA authorization and approval of the 2024-2025 mRNA vaccines is considered a vaccine administration error.

Some of the questions we received from you include:

• Do we need to contact patients who received a dose on/after August 23rd about revaccination?
• What is the timing interval for administering the new formula to affected patients once we receive it?

We are actively communicating with the CDC on potential next steps to address these questions and will follow up when confirming guidance is received. For now, here are important steps all providers should take as we navigate the transition to the new formula.

To minimize risk of vaccine administration error, providers should:

• Remove all 2023-2024 mRNA COVID-19 vaccines from storage units immediately, even if they are not expired.
• Once all inventory is fully accounted for, delete 2023-2024 mRNA COVID-19 vaccine listings from the available vaccine inventory in your Immunization Information System (IIS), as applicable.
• Return all unused 2023-2024 mRNA COVID-19 vaccines to CDC's centralized distributor using the normal process for returning spoiled/expired vaccines.
  • Providers must use the category "Spoiled" and the reason "Expired BUD" to reconcile and submit the return of these vaccines in the IIS. Please do not use the "Recall" category.

A Vaccine Adverse Event Reporting System (VAERS) report is required for COVID-19 vaccines under Emergency Use Authorization (EUA). VAERS reporting is strongly encouraged for licensed COVID-19 vaccines.

For licensed COVID-19 vaccines (Moderna and Pfizer-BioNTech in people ages 12 years and older), healthcare providers are strongly encouraged to report the following to VAERS:

• Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether or not it is clear that a vaccine caused the adverse event. 
• Vaccine administration errors, whether or not associated with an adverse event.

For COVID-19 vaccines given under EUA, vaccination providers are required to report the following to VAERS:

• Vaccine administration errors, whether or not associated with an adverse event.
• Serious adverse events regardless of causality. Serious adverse events per the FDA are defined as:
  • Death.
  • A life-threatening adverse event.
  • Inpatient hospitalization or prolongation of existing hospitalization.
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
  • A congenital anomaly/birth defect.
  • An important medical even that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.
• Cases of Multisystem Inflammatory Syndrome (MIS) in children and adults.
• Cases of myocarditis.
• Cases of pericarditis.
• Cases of COVID-19 that result in hospitalization or death.

Reporting is also encouraged for any other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov or by calling 1-900-822-7967. Please refer to additional details in the CDC's Clinical Guidance for COVID-19 Vaccination web page.

Preparation/next steps for 2024-2025 COVID-19 vaccine:

COVID-19 vaccine for the 2024-2025 season is expected to be available to order starting Tuesday, September 3, 2024. Some things to remember as you prepare for the fall/winter respiratory season:

• It can take up to two weeks from the approval date to receive your shipment.
• All respiratory products can be ordered at any time. You do not need to wait for your assigned ordering window to place an order for these products.
• Place smaller orders more frequently, rather than large orders.
• Orders may be reduced to meet allocation and product availability. The goal is to ensure all providers receive some product.
• Providers are required to carry and offer all Advisory Committee on Immunization Practices (ACIP) recommended vaccines for the population they serve.

We know you all have been working diligently to protect thousands of people in Washington state every day from getting sick with COVID-19. We apologize for any confusion and messaging delays that deauthorization may have caused you and your patient population.

Please stay tuned for more updates and thank you for your continued vaccination efforts during this time.

In partnership,

Office of Immunization
Washington State Department of Health
COVID.vaccine@doh.wa.gov