Increasing COVID-19 Vaccine Safety

As of March 2022, more than 557 million COVID-19 vaccines have been administered in the United States. Among these are several high-profile reports of COVID-19 vaccination errors, including administration of an incorrect vaccine in a pediatric population and administration of an adult COVID-19 vaccine to children.

To minimize the risk of future mix-ups and possible resultant vaccine hesitancy, the Institute for Safe Medication Practices (ISMP) has released recommendations for safety protocols surrounding COVID-19 vaccine dispensing and administration. These recommendations apply equally to the Pfizer-BioNTech, Moderna, and Johnson & Johnson’s Janssen vaccines. However, they should be especially considered for the Pfizer-BioNTech vaccine, as this vaccine has an Emergency Use Authorization for both pediatric and adult populations. ISMP recommendations include:

• Prior to verification and dispensing, store adult and pediatric COVID-19 vaccines separately, such as in separate labeled bins. This separate storage should be present in both refrigerators and freezers.
• During verification and dispensing, use barcode scanning to verify that the correct product is being used. Do not rely on different vial cap colors, as the caps can be removed, making it hard to tell the vials apart.
• During dispensing, clearly label all individual syringes that contain vaccines. Labels should be printed for each patient. Alternatively, vaccine preparers should be given strips of preprinted labels which differentiate adult and pediatric doses.
• Before administration, when possible, use barcode scanning to confirm the correct vaccine is being administered.
• Before administration, only bring a single patient’s intended vaccine(s) into the vaccination area at a time.
• Before administration, verbally verify with the patient or caregiver/parent to verify the vaccine by reading the label to them out loud.
• Before administration, document the vaccine’s lot number and date of manufacture. Immediately following administration, document this in the patient’s profile, on vaccination records, and via the state-appropriate immunization registry.
• If any vaccine error is noted during any part of the dispensing, verification, or administration process, report it internally as well as to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) and to the ISMP National Vaccine Errors Reporting Program (VERP).

Further complicating the risk of COVID-19 vaccine mix-ups, in the United States, the Pfizer-BioNTech vaccine has undergone recent formulation changes in its adult versions of the COVID-19 vaccine. These changes make the adult vaccine more stable after preparation but can complicate safety protocols. The new differences in the Pfizer-BioNTech adult vaccines are as follows:

In addition, the Centers for Disease Control and Prevention (CDC) regularly updates its Vaccine Storage and Handling Toolkit with an addendum specific to storage and handling best practices for COVID-19 vaccines. Although some of the CDC recommendations are similar to the ISMP recommendations, they recommend additional safety protocols and best practices, specifically with regards to the COVID-19 vaccine cold chain and developing policies and procedures for addressing errors and emergencies. This is in contrast to the ISMP recommendations, which focus primarily on dispensing and administration protocols. As the CDC vaccine toolkit is regularly updated as additional COVID-19 formulations become available, it is important to regularly review the toolkit website. As of March 2022, recommended CDC best practices specific to COVID-19 vaccines include:

• Developing and maintaining clearly written, detailed, and up-to-date storage and handling standard operating procedures (SOPs) for COVID-19 vaccines. The benefit of an SOP is to ensure proper procedures are followed. Further, an SOP outlines procedures by which problems are identified, reported, and corrected. Lastly, SOPs provide instruction for how to handle emergencies like equipment malfunctions, power failures, and natural disasters.
• Never store COVID-19 vaccines in dormitory-style or combined refrigerator/freezer units. This is because such units have a single door and a single evaporator plate or cooling coil. As this is usually located in a freezer compartment, these kinds of units carry a high risk of freezing vaccines, even when used temporarily.
• If using a household-grade refrigeration unit, place water bottles on the top shelf, floor, and in the door racks to help temperature stability that might otherwise be disrupted by frequent opening and closing of refrigerator doors. Do not place items other than water bottles, vaccines, or diluents (if applicable) in the unit.
• Place vaccines and diluents two to three inches from the refrigeration unit walls, ceiling, floor, and door.
• Store COVID-19 vaccines and diluents (if applicable) in their original packaging.
• If using a household-grade refrigeration unit, do not store vaccines and diluents in any part of the unit that does not provide temperature stability or adequate air flow.
• Within a refrigeration unit, place vaccines and diluents (if applicable) in rows and allow space between rows to facilitate air flow.
• Regularly double-check COVID-19 vaccine expiration dates in the refrigeration unit, and always double-check before dispensing. Place vaccines that are soonest to expire at the front of the refrigeration unit.
• Avoid predrawing COVID-19 vaccines as this can compromise the required cold chain.

Maintaining COVID-19 vaccine safety though the entire medication use process is vital to not only ensuring proper patient care, but also maximizing patient trust in COVID-19 vaccines. By following both the ISMP and CDC best practices for COVID-19 vaccine storage, dispensing, and administration, pharmacy can optimize patient safety.