COVID-19 vaccine, mRNA-Moderna (Investigational)

COVID-19 vaccine, mRNA-Moderna (Investigational) is used for active immunization to prevent COVID-19 in individuals aged 18 years or older. 

• COVID-19 vaccine, mRNA-Moderna (Investigational) is available under the following different brand names: mRNA-1273 (Moderna).

Adult dosage

Injection, suspension

• Primary series or third dose for immunocompromised individuals: 100mcg/0.5mL
• Booster: 50mcg/0.25mL
• 2 multiple-dose vial sizes (5.5mL, 7.5mL)

COVID-19 Disease Prevention

Adult dosage

• 2-dose primary series: 0.5mL (100mcg) IMx2 doses administered 1 month apart
• Third dose for severely immunocompromised individuals: 0.5mL (100mcg) administered at least 28 days following the 2-dose regimen of an mRNA vaccine
• Booster dose: 0.25 mg (50 mcg) IM to be administered at least 6 months after completing the primary series for all individuals aged 18 years or older.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of COVID-19 vaccine, mRNA-Moderna (Investigational) include:

• injection site reactions (pain, swelling, or redness), 
• fatigue, 
• headache, 
• headache, 
• muscle pain, 
• chills, 
• joint pain, 
• fever, 
• nausea, 
• vomiting, and
• swollen lymph nodes in the armpits 

Serious side effects of COVID-19 vaccine, mRNA-Moderna (Investigational) include:

• hives, 
• difficulty breathing, 
• swelling in the face, lips, tongue, or throat, 
• chest pain or pressure, 
• stabbing chest pain that may travel to the left shoulder and neck,
• abnormal heartbeat, and
• shortness of breath

Rare side effects of COVID-19 vaccine, mRNA-Moderna (Investigational) include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• COVID-19 vaccine, mRNA-Moderna (Investigational) has severe interactions with no other drugs.
• COVID-19 vaccine, mRNA-Moderna (Investigational) has serious interactions with no other drugs.
• COVID-19 vaccine, mRNA-Moderna (Investigational) has moderate interactions with no other drugs.
• COVID-19 vaccine, mRNA-Moderna (Investigational) has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Known history of a severe allergic reaction (eg, anaphylaxis) to any component in the vaccine

CDC listed contraindications

CDC has listed the following contraindications:

• Severe allergic reaction after previously receiving mRNA COVID-19 vaccine or its components
• Allergic reaction (of any severity) immediately after receiving mRNA COVID-19 vaccine or its components, including polyethylene glycol (PEG)
• Immediate allergic reaction (of any severity) to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using COVID-19 vaccine, mRNA-Moderna (Investigational)?”

Long-Term Effects

• See “What Are Side Effects Associated with Using COVID-19 vaccine, mRNA-Moderna (Investigational)?”

Cautions

• Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to the vaccine
• The vaccine may not protect all vaccine recipients

Allergic reactions

• Appropriate medical treatment used to manage immediate allergic reactions must be immediately available following vaccination
• Do not administer a second dose to anyone experiencing a severe reaction (ie, requiring epinephrine or hospitalization) to the first dose
• Individuals with histories of severe allergic reaction to vaccines should consult their doctors about the COVID-19 vaccine
• People with severe allergies to food, pets, latex, oral medications, or environmental conditions may be vaccinated according to interim CDC clinical considerations for mRNA COVID-19 vaccines
• Vaccine Adverse Event Reporting System (VAERS)
• December 21, 2020 – January 10, 2021: 10 cases of anaphylaxis detected after administration of 4,041,396 first doses (2.5 cases per million doses) reported in MMWR
• 90% of these occurred within 15 minutes of vaccination
• 9 of 10 anaphylaxis cases occurred in people with a known history of allergies or allergic reactions (eg, medications, foods, contrast media0, including 5 with prior anaphylactic reactions, none of which was associated with receipt of a vaccine

Myocarditis and pericarditis

• Reports of adverse events following the use of mRNA COVID-19 vaccines suggest increased risks of myocarditis and pericarditis, particularly following the second dose
• Symptom onset is typically within a few days after vaccine administration
• Instruct patients to seek immediate medical attention if they experience chest pain, shortness of breath, or feelings of a fast-beating, fluttering, or pounding heart after receiving the vaccine
• Available data from short-term follow-up (as of June 2021) suggest that most individuals have had resolution of symptoms, but the information is not yet available about potential long-term sequelae
• The decision to administer an mRNA vaccine to individuals with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances
• The CDC has published clinical considerations relevant to myocarditis and pericarditis with mRNA COVID-19 vaccines

Drug interaction overview

• Data are not available to assess concomitant administration with other vaccines

Pregnancy and Lactation

• Data are insufficient to inform of vaccine-associated risks in pregnancy
• Pregnancy registry: Women who are vaccinated with the Moderna COVID-19 vaccine during pregnancy are encouraged to enroll in the registry by calling 1-866-MODERNA (1-866-663-3762)
• A smartphone app, v-safe, is also available to report adverse effects to the CDC following vaccination with a COVID-19 vaccine
• CDC guidelines for vaccination of pregnant or lactating women
• Data is not available to assess effects on breastfed infants or milk production/excretion.