Increasing COVID-19 Vaccine Safety

By Jessica Pyhtila, PharmD

March 18, 2022

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:

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:


Dilute before use

Do not dilute

Age group

12 years and older

12 years and older

Vial cap color






Dose volume



Amount of diluent needed per vial



Doses per vial



Stability in ultra-low-temperature freezer (-90°C to -60°C)

9 months

6 months

Stability in freezer (-25°C to -15°C)

2 weeks

Should not be stored in freezer

Stability in refrigerator (2°C to 8°C)

1 month

10 weeks

Stability at room temperature

2 hours prior to dilution, including thaw time

12 hours prior to puncture, including thaw time

Stability after puncture

6 hours

12 hours

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:

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. 

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Our World In Data. “Coronavirus (COVID-19) Vaccinations.” Accessed March 8, 2022.

Centers for Disease Control and Prevention. “Pfizer-BioNTech COVID-19 Vaccine (Purple Cap) Age 12 and Over.” March 2, 2022. Accessed March 8, 2022.

NBC Chicago. “Walgreens COVID Vaccine Mix-Up: Family Says Kids Mistakenly Given Vaccine Instead of Flu Shot.” October 15, 2021. Accessed March 8, 2022.

Lonas, Lexi. “Indiana parents say children having adverse reactions after mistaken adult dose of COVID-19 vaccine.” The Hill, October 14, 2021. Accessed March 8, 2022.

Institute for Safe Medication Practices. “Adult and Pediatric Coronavirus Disease 2019 (COVID-19) Vaccine Mix-Ups are Predictable.” November 4, 2021. Accessed March 8, 2022.

Centers for Disease Control and Prevention.

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Jessica Pyhtila, PharmD

Jessica Pyhtila is a Clinical Pharmacy Specialist practicing at the top of her license in primary and palliative care at the Department of Veterans Affairs. She is board-certified in geriatrics (BCGP) and pharmacotherapy (BCPS). She received her PharmD from the University of Maryland; PGY1 Pharmacy Practice and PGY2 Ambulatory Care trained at the VA Maryland Health Care System. She additionally writes and edits interdisciplinary continuing education presentations and medical content.