COVID-19 Vaccine (Moderna)

Warning

Special Alerts:

Emergency Use Authorization (EUA) Changes for COVID-19 Vaccine (Moderna): On March 29, 2022, the EUA for the Moderna 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 ≥18 years of age (i.e., those who are solid organ transplant recipients or diagnosed with conditions considered to have an equivalent level of immunocompromise). A booster only presentation of the Moderna COVID-19 vaccine is also available in multiple dose vials with dark blue caps and labels with a purple border. The booster dose only presentation of the Moderna COVID-19 vaccine is not authorized for use as the primary vaccination series. For additional information, consult the EUA at [Web] and the fact sheets at [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 errors were reported by consumers, details about the contributing factors were not provided in many cases. However, possible contributing factors include increased demand for vaccination services, the ability to administer the flu and COVID-19 vaccines during the same visit, syringes located next to each other, unlabeled syringes, distractions, and staffing shortages. The alert provides recommendations for preventing such vaccine mix-ups. For additional information, consult the NAN alert at [Web].

On January 31, 2022, COVID-19 Vaccine (Moderna) received full FDA approval for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age or older. An emergency use authorization (EUA) for the Moderna COVID-19 vaccine is still in effect and authorizes use of the vaccine as an additional (third) primary dose in certain immunocompromised individuals, and as a single homologous booster dose in individuals who have completed the primary series of this vaccine or as a single heterologous booster dose in individuals who have completed primary vaccination with another authorized or approved COVID-19 vaccine.

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monog...