What Healthcare Providers Should Know About Administering the Moderna COVID-19 Vaccine
Key takeaways:
The FDA has issued the emergency use authorization for the Moderna COVID-19 vaccine for patients 18 years and older.
The Moderna vaccine works similarly to the Pfizer-BioNTech vaccine, but doesn’t require a diluent and may be stored in the refrigerator.
Moderna’s vaccine is a 2-dose series (0.5mL each) intramuscular shot given 28 days apart.
The FDA issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11. The EUA for Moderna’s vaccine followed a week later on December 18, widening the immunization efforts across the nation.
Moderna’s COVID-19 vaccine works similarly to the Pfizer-BioNTech vaccine, with 94.1% efficacy and less stringent storage requirements. Both vaccines are novel messenger RNA (mRNA) vaccines that use fat bubbles to deliver genetic code to cells to produce proteins that fight the virus.
As a provider, here’s what you need to know about the Moderna mRNA COVID-19 vaccine and how to administer it.
How does Moderna’s COVID-19 vaccine differ from Pfizer’s?
The chart below shows the main differences between the two vaccines, including indication, doses, storage, and shelf life. We’ll go into more detail about these differences below.
| Moderna | Pfizer-BioNTech | |
|---|---|---|
| Indication | 18 years and older | 16 years and older |
| Dose | 0.5mL | 0.3mL |
| Dose per vial | 10 doses | 5 doses* |
| Time between doses | 28 days | 21 days |
| Route | Intramuscular | Intramuscular |
| Diluent | No diluent needed | 1.8mL of 0.9% of sodium chloride |
| Storage of frozen vial | -13℉ to 5℉ (-25℃ to -15℃) | -112℉ to -76℉ (-80℃ to -60℃) |
| Storage of thawed vial under refrigeration | 36℉ to 46℉ (2℃ to 8℃) for 2.5 hours | 35℉ to 46℉ (2℃ to 8℃) for up to 5 days |
| Storage of thawed vial under room temperature | 59℉ to 77℉ for 1 hour | Up to 77℉ (25℃) for 30 minutes |
| Shelf-life in refrigerator | 30 days | 5 days |
*Some vials may deliver up to 6 or 6 doses instead of 5.
Who can safely receive the Moderna COVID-19 vaccine?
The Moderna vaccine is indicated for patients 18 years and older, whereas the Pfizer-BioNTech vaccine is indicated for patients 16 years and older. The difference is related to the clinical trial participants. Moderna’s inclusion criteria was 18 years and older. Of note, the effectiveness for Moderna dropped to about 86% for participants above the age of 65.
Pregnant people
None of the vaccines in development have been studied in pregnant people. But a recent FDA review noted that 13 pregnancies were reported after vaccination in the clinical trials for Moderna’s vaccine. Data will continue to be collected in these study participants. Also, a reproductive toxicity study in rats that delivered mRNA prior to mating and during gestation showed no adverse events.
The Centers for Disease Control and Prevention’s interim clinical recommendation for pregnant people is that they may choose to get vaccinated if they like as the CDC sees limited risks, the vaccine is not live, and studies show the vaccine degrades rather quickly.
Immunocompromised populations
Immunocompromised patients are likely at a higher risk to contract COVID-19; however, there’s limited data available to understand the vaccine’s effects in these vulnerable populations. They may still receive the vaccine, but it’s important to counsel on the unknown safety risks, along with diminished immune response to the vaccine.
Patients with allergies
Additionally, the CDC clinical considerations list that patients with these conditions may be vaccinated:
Family history of anaphylaxis
History of allergy to oral medications
History of food, pet, insect, environmental, latex, venom, or other allergies not related to vaccines or injectables
These patients should be observed for 30 minutes if they have a history of anaphylaxis and 15 minutes if they have a history of allergic reactions (not severe).
Overall, immunocompromised, lactating, and pregnant people may choose to get vaccinated although there is limited to no data available on these populations in the studies.
What are the ingredients in the Moderna COVID-19 vaccine?
The vaccine is broken down into three components:
Genetic component
Genetic code for the SARS-CoV2 spike protein
Lipid bubbles
SM-102
PEG2000-DMG
1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
Cholesterol
Saline solution
Tromethamine (tris)
Sodium acetate
Sucrose (sugar)
Water
The lipid bubbles act like a coating to protect the genetic material on its way into the patient’s body, while the saline solution is used for pH maintenance.
There’s a lot of vaccine hesitancy among patients with the vaccine rolling out “early.” So it may be helpful to highlight that these ingredients are not toxic or dangerous and remind patients that the vaccine cannot cause COVID-19.
How is the vaccine stored before use?
The FDA fact sheet has information about storage and handling that the vials and product may not contain. It’s important to have all the updated information, especially since the product is not FDA approved yet.
The ultra low temperatures needed to store the Pfizer vaccine are not required for the Moderna vaccine, which makes it easier to handle. The Moderna COVID-19 vaccines are multiple-dose vials that should be stored between -13℉ to 5℉ (-25℃ to -15℃).
How long do you have to thaw the vaccine?
The vaccine must remain frozen before use, so proper thawing will be needed prior to administration. There are two ways to thaw the vaccine:
Thaw in the refrigerator for 2.5 hours between 36℉ to 46℉, then leave the vial at room temperature for an additional 15 minutes before using.
Thaw it between 59℉ to 77℉ for 1 hour.
You may use either method to thaw the vaccine, which may be helpful depending on storage availability, mobile clinics, and scheduling of appointments.
How is the Moderna COVID-19 vaccine dosed?
The vaccine is a two-dose series containing 0.5mL for each dose. The doses are given 1 month apart (28 days) intramuscularly.
Both doses should be of the Moderna vaccine. If you administer the Pfizer-BioNTech first, then the second dose must also be Pfizer.
How do you prepare doses?
Along with easier storage requirements, preparing the Moderna COVID-19 vaccine is slightly easier as well. There is no need to dilute the vaccine — simply withdraw the dose needed to administer it.
What are the storage requirements after use?
The storage requirements differ once you make the first puncture into the multiple dose vial. Once you draw the first dose, you will need to store the vaccine vial between 36℉ to 77℉ (2℃ to 25℃) and toss it out after 6 hours. Diligently tracking the times withdrawn and used will be important to prevent wasting of the vaccine.
Like the Pfizer vaccine, you may not refreeze the vial for the Moderna vaccine once it’s been thawed or used. So it may be good practice to have enough patients scheduled or on roster during a given time to maximize all doses and avoid any wasting of the vaccine.
What are some side effects of the vaccine?
Some adverse reactions to counsel your patients on may include:
Injection site pain or swelling
Fatigue
Headache
Muscle
pain
Chills
Nausea/vomiting
However, these side effects are mild to moderate in most people and should go away on their own.
If the patient experiences serious side effects, refer them to their provider or to the emergency room for immediate attention and report the effects to the FDA.
Is there anything else I should know about the vaccine?
Like most vaccines, if you are administering it you must:
Communicate to the patient receiving the Moderna COVID-19 vaccine or to their caregiver the information on the vaccine fact sheet, including the following:
This vaccine is not FDA-approved yet.
The patient or caregiver is not mandated to get this vaccine.
The extent of the risks and benefits are unknown.
There are alternative vaccines available.
Report any of the following to the Vaccine Adverse Event Reporting System (VAERS):
Serious adverse events
Errors in administration
Cases of multisystem inflammatory syndrome
Cases of COVID-19 that cause death or result in hospitalization
Report vaccination information to the patient’s local jurisdiction’s immunization information system.
These considerations and facts to note are key to vaccination providers. More information for healthcare professionals on administering the COVID-19 vaccine is available from the FDA and the CDC.
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