By Judy Recker, MHA, RPh, CPHQ, CPHRM
On December 18, 2020, the Food and Drug Administration (FDA)
issued an emergency use authorization (EUA) for Moderna’s COVID-19 vaccine, mRNA-1273 (the “vaccine”). Moderna’s mRNA-1273 joins Pfizer’s COVID-19 vaccine, mRNA-BNT162b2, which was granted EUA on December 11, 2020. Both vaccines were developed by a genetic technology called synthetic messenger RNA (mRNA). These new mRNA vaccine types
do not use the live virus that causes COVID-19. Instead, they give instructions for cells to make the harmless “spike proteins” that are located on the COVID-19 virus surface. The immune system recognizes the foreign protein and builds an immune response by making antibodies. In clinical trials, the vaccine was shown to be 94.1% effective against COVID-19 and 100% effective against severe COVID-19.
is a pathway to make unapproved medical products available during public health emergencies, provided there are no adequate, approved, and available alternatives. For the FDA to issue an EUA for a vaccine, there must be adequate manufacturing information to ensure quality and consistency, and the FDA must determine whether the vaccine’s known and potential benefits outweigh its known and potential risks. Even though an EUA has been issued, vaccine manufacturers are continuing their clinical trials to obtain additional safety and effectiveness information and will eventually apply for FDA approval. Therefore, mRNA-1273 is still considered investigational.
Consider the following recommendations to mitigate risks associated with the COVID-19 mRNA 1273 vaccine:
- Ensure readiness. Assemble a vaccine workgroup composed of representatives from multiple disciplines: physicians, advanced practice providers, pharmacists, infection prevention nurses, risk managers, attorneys, materials managers, human resource managers, information technology managers, facility managers, security managers, and employee health professionals.
- Develop a policy and procedure. Develop a written policy and procedure for the COVID-19 mRNA 1273 vaccine. Consider using the organization’s influenza vaccine policy and procedure as a guide.
- Follow your state and local health department guidelines. The Centers for Disease Control and Prevention (CDC) has posted links to individual state COVID-19 vaccination plans in its COVID-19 Vaccination Program Operational Guidance.
- Store the vaccine properly. Be familiar with vaccine storage requirements. Ensure that appropriate freezers and refrigerators are working properly and that temperature monitoring is in place. The American Society for Health Care Engineering (ASHE) published Selection and Preparation for Cryogenic Vaccine Storage, which provides basic information to help discern which type of system will work best for your organization, given its existing infrastructure. According to the CDC’s Vaccine Storage and Distribution Tool Kit, a healthcare organization should follow the proper storage and handling crucial to an effective vaccine cold chain.
- Provide patient education. Prior to administering the vaccine, give patients the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and answer any questions they may have. Document that the patient received the Fact Sheet for Recipients and Caregivers. This may be included on the informed consent form.
- Obtain informed consent. Prior to administering the vaccine, obtain written informed consent from the patient and incorporate the consent document into the medical record. The informed consent discussion should include the fact that the vaccine is investigational, the vaccine’s risks and benefits, and alternatives to receiving the vaccine.
- Know the vaccine. Familiarize staff and providers with the vaccine prior to administering it at your facility. In particular, train staff and providers on its method/route of administration, dosing schedule, patient selection criteria, side effects, warnings and contraindications, and storage considerations. For information regarding the vaccine, see the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).
- Adhere to the dosing schedule. Like many other vaccines, this vaccine requires administration of two doses three to four weeks apart. Develop a process to schedule the second vaccine dose and send appointment reminders.
- Consider alternate care sites for vaccine administration to accommodate large groups. When the vaccine is administered in a non-traditional or alternative setting, organizations should anticipate and prepare for vaccine related adverse reactions and emergencies by securing additional supplies, designating waiting/observations areas, and hiring additional staff if necessary. In some cases, organizations may need to employ security officers to ensure patient and healthcare worker safety. For additional guidance on alternative vaccination sites, see Guidance for Planning Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations and/or Considerations for Planning Curbside/Drive-Through Vaccination Clinics.
- Report adverse events. Report all vaccination errors and serious adverse effects related to the vaccine to the Vaccine Adverse Event Reporting System (VAERS) and to the extent feasible, the manufacturer. For more information about reporting adverse events, refer to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).
No legal or medical advice intended. This content includes general guidelines. Such materials are for informational purposes only and may not reflect the most current legal or medical developments. These informational materials are not intended, and must not be taken, as legal or medical advice on any particular set of facts or circumstances.
- For a comprehensive CDC resource list regarding COVID-19 vaccines, see: The Centers for Disease Control and Prevention. Vaccines & Immunizations. COVID-19 Vaccination. https://www.cdc.gov/vaccines/covid-19/index.html. Updated December 11, 2020. Accessed December 17, 2020.