Moderna COVID-19 Vaccine Emergency Use Authorization (EUA)
On December 18, 2020 the Food and Drug Administration (FDA) authorized the Moderna COVID‑19 Vaccine for emergency use in individuals 18 years of age and older to prevent COVID‑19.
This week shipments of Moderna vaccine will begin to arrive in Wisconsin. DHS is prioritizing hospitals and clinics as initial vaccination sites so as to reach front-line healthcare workers, as recommended both by the Advisory Committee on Immunization Practices and the State Disaster Medical Advisory Committee.
The Advisory Committee on Immunization Practices’ (ACIP) Recommendation
On December 19th and 20th of 2020, the expert committee members of the Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the vaccine in persons aged ≥18 years. The director of the Centers for Disease Control and Prevention (CDC) accepted those recommendations.
Clinical Resources
Ensure that your staff are familiar with the EUA fact sheet for clinicians and give each vaccine recipient the EUA Fact Sheet for Recipients and Caregivers. The patient factsheet is given in lieu of a vaccine information statement. FDA will be updating its website with translations of the Fact Sheet for Recipients.
In the near future, the FDA will provide answers to Frequently Asked Questions about the Moderna COVID19 vaccine at this website.
Additional Storage Information Not Displayed on the Vial Labels and Cartons
- Do not store on dry ice or below -40ºC (-40ºF).
- Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.
- Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours.
- Do not refreeze once thawed.
To find the expiration date for any vial:
1. Go to the Moderna COVID‑19 Vaccine webpage
2. On the vial, find the lot number, printed on both the carton and vial.
3. Enter the lot number in the website search field and press "Submit."
Contraindications
Please review the EUA information and ACIP recommendations and become familiar with all clinical guidelines including contraindications. Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine (see Full EUA Prescribing Information).
Ensure that appropriate medical treatment for managing immediate allergic reactions is immediately available in the event of an acute anaphylactic reaction occurring following COVID-19 vaccine administration.
Pfizer and Moderna COVID-19 vaccine products are not interchangeable; the same product must be administered for both doses of the vaccine series.
Product-specific Resources
Moderna recently launched a website for the Moderna COVID-19 vaccine. It discusses details of Moderna COVID-19 vaccine’s EUA, contraindications, warnings and precautions, adverse reactions, reporting of adverse events and vaccine administration errors, considerations for pregnancy and lactation, dosing, and schedule. Moderna intends to post translations (Spanish, Chinese, Vietnamese, Tagalog, Arabic, and French) of its EUA fact sheets for clinicians and patients on its website in the near future.
Moderna has a 24/7 call center, 1-866-MODERNA (1-866-663-3762). Based on their questions, callers will be routed to one of four areas:
- General Moderna Questions
- Healthcare Provider Questions (clinical)
- Product Quality or Technical Questions
- Pregnancy Registry
Monitoring Vaccine Safety
Review What Every Clinician Should Know about COVID-19 Vaccine Safety.
Ensure all of your patients are aware of and receive a QR code for the V-Safe program.
Remember to submit all vaccine administration errors and adverse events to VAERS. Be sure to familiarize yourself with the specific EUA reporting requirements including:
- Vaccine administration errors whether or not associated with an adverse event
- Serious adverse events (irrespective of attribution to vaccination)
- Cases of Multisystem Inflammatory Syndrome (MIS) in adults
- Cases of COVID-19 that result in hospitalization or death.
Communications
We know that your staff may have many questions about the COVID-19 vaccine. Please take a moment to review CDC’s COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians and find answers to many frequently asked questions on CHOP’s Vaccine Education Center website.
CDC has also posted COVID-19 vaccine information for patients, including:
Reminder: Continuing COVID-19 Precautions
We are many months away from having enough COVID-19 vaccine supply and reaching high vaccination coverage. In the meantime, please continue to encourage your patients and stakeholders to continue wearing masks, physical distancing, washing their hands, and getting tested and isolating if they have signs and symptoms of COVID-19.
Even after the first people get vaccinated, it is important to continue using all these COVID-19 precautions so that we stand the best chance of getting our families, communities, schools, and workplaces “back to normal” sooner.
Thank you for your continued work as we move to implement an important tool in the fight against COVID-19.
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