Errors with COVID-19 Vaccines Outlined in ISMP Alert For Doctors

As the U.S. healthcare system attempts to immunize hundreds of millions nationwide with the recently approved COVID-19 vaccinations, a prominent medication safety group is warning healthcare providers about reports of various medication errors, and providing a series of recommendations designed to minimize the risk of problems.

The Institute for Safe Medication Practices (ISMP) issued an outline COVID-19 vaccination problems recorded throughout the first month of use, warning medical professionals about the importance of following safe vaccine administration practices, which will help avoid errors and potentially serious injuries.

To date, two mRNA vaccines from Pfizer and Moderna are approved for protection against COVID-19, after Emergency Use Authorization (EUA) was provided by the U.S. Food and Drug Administration (FDA) last month, with Moderna’s allowing use for adults age 18 and older, and Pfizer’s allowing use for children as young as 16 years of age.

The Pfizer vaccine requires two doses administered 21 days apart, and the Moderna vaccine requires two doses administered 28 days apart, meaning it will require nearly 700 million vaccine injections to protect the entire U.S. population.

Since the EUA’s were issued in December, allowing public vaccination to commence, the ISMP has been monitoring reports of several COVID-19 vaccination errors that were related to how the shots are administered.

The Institute reported the Pfizer-BioNTech’s COVID-19 vaccine requires dilution with preservative-free sodium chloride injection. According to multiple errors reported to date, healthcare professionals have added too little, resulting in patients receiving too much vaccine. Adverse health effects from these problems indicate recipients may experience potentially stronger side effects, which include temporary fatigue, headache, chills, fever, and joint and muscle pain.

As for Moderna’s mRNA vaccine, the Institute has become aware of 44 instances of patients receiving incorrect vaccines, due to improperly labeled vials and non-functioning barcodes, causing healthcare workers to confuse the product with the Regeneron monoclonal antibody and casirivimab; both of which are treatments for COVID-19, not vaccines.

The statement indicated COVID-19 vaccination mix-ups could result in patients receiving the first round of one brands vaccination, and the second coming from a different manufacturer, jeopardizing the efficacy of the vaccination schedule.

Healthcare professionals have also received reports of vaccine doses being wasted. Since both vaccines require use within six hours at room temperature, ISMP reported that some of the syringes being shipped are not efficient enough to extract a sixth dose from the Pfizer-BioNTech vaccine vials or an eleventh dose from the Moderna vaccine.

Among other dosing and scheduling errors, ISMP reported serious, but not life threatening, allergic reactions, errors in timing of appointments for second dose administration, and even administration of the vaccine to children not of the approved age to receive it.

The release reiterates the COVID-19 vaccine administration recommendations previously published on November 20, 2020, which were designed to help prepare the medical community and mitigate COVID-19 vaccine administration errors.

Those recommendations include planning ahead, safe storage, properly training and scheduling staff members, safely dispensing used syringes, and establishing a safety monitoring system to ensure vaccine side effects and errors are communicated to appropriate health authorities.

ISMP reported all side effects must be reported to the CDC’s Vaccine Adverse Event System (VAERS) and the ISMP National Vaccine Errors Reporting Program.