COVID-19 Vaccine (Pfizer-BioNTech)

Warning

Special Alerts:

Emergency Use Authorization (EUA) Changes for COVID-19 Vaccine (Pfizer BioNTech): On March 29, 2022, the EUA for the Pfizer BioNTech COVID-19 vaccine was reissued to permit use of the vaccine as a second booster dose at least 4 months after receipt of a first booster dose of any FDA-authorized or approved COVID-19 vaccine product to individuals ≥50 years of age and certain immunocompromised individuals ≥12 years of age (i.e., those who are solid organ transplant recipients or diagnosed with conditions considered to have an equivalent level of immunocompromise). For additional information, consult the EUA at [Web] and the fact sheet for healthcare providers at [Web]

National Alert Network (NAN) Alert Regarding Age-Related COVID-19 Vaccine Mix-ups: On December 6, 2021, the National Alert Network (NAN) issued an alert to make vaccine providers aware of reports of accidental mix-ups between the pediatric formulation of the Pfizer BioNTech COVID-19 vaccine intended for children 5–11 years of age (10 mcg/0.2 mL with an orange cap) and the adult formulation of the Pfizer BioNTech COVID-19 vaccine intended for individuals ≥12 years of age (30 mcg/0.3 mL with a purple cap). Multiple cases of such errors have been report to the ISMP National Vaccine Errors Reporting Program (ISMP VERS). In some cases, children ≥12 years of age received the formulation intended for children 5–11 years of age, resulting in underdoses; in other cases, children 5–11 years of age received the formulation intended for individuals ≥12 years of age, resulting in overdoses. Possible causes include vial and syringe mix-ups and incorrect assumption that the formulations are interchangeable. The pediatric vaccine is specifically formulated to be less concentrated to ensure accurate dose measurement; use of the adult formulation to prepare doses for children 5–11 years of age is likely to result in delivery of an inaccurate volume of vaccine to the patient. The NAN alert provides recommendations for preventing such vaccine mix-ups, which include segregate storage, proper labeling of syringes, and vaccine verification at the time of administration. For additional information, see [Web].

National Alert Network (NAN) Alert Regarding Influenza and COVID-19 Vaccine Mix-ups: On October 15, 2021, the National Alert Network (NAN) issued an alert to make vaccine providers aware of reports of accidental mix-ups between the influenza (flu) and COVID-19 vaccines. The alert is based on 16 cases reported to the Institute for Safe Medication Practices (ISMP) error reporting programs. Most of the reports ISMP has received involve administration of one of the COVID-19 vaccines instead of an influenza vaccine; in 3 cases, patients received an influenza vaccine instead of a COVID-19 vaccine. Because most of the ...