COVID-19 vaccine, mRNA-Moderna (Rx)

VAERS Reporting

Mandatory for vaccination providers to report to the vaccine adverse events reporting system (VAERS) all vaccine administration errors, serious adverse events, cases of myocarditis, cases of pericarditis, multisystem inflammatory syndrome in adults and children, and cases of COVID-19 that result in hospitalization or death

>10%

Aged 18-64 years

• Injection site pain (93.3%)
• Fatigue (71.9%)
• Headache (68.7%)
• Myalgia (64.8%)
• Arthralgia (48.6%)
• Nausea/vomiting (25.7%)
• Axillary swelling/tenderness (22.2%)
• Fever (17.3%)
• Injection site swelling (15.4%)
• Injection site erythema (10.5%)

Aged ≥65 years

• Injection site pain (88.3%)
• Fatigue (64.8%)
• Headache (53.3%)
• Myalgia (51.8%)
• Arthralgia (40.2%)
• Chills (32.7%)
• Nausea/vomiting (15%)
• Injection site swelling (13%)
• Axillary Swelling/tenderness (12.7%)

Post Authorization Experience

Cardiac disorders: Myocarditis, pericarditis

Immune system disorders: Anaphylaxis

Nervous system disorders: Syncope

Unsolicited Adverse Events During Clinical Trial

Lymphadenopathy related events: 1.7% vaccine; 0.8% placebo

Hypersensitivity: 6 participants with vaccine; none with placebo

Delayed injection site reactions >7 days postinjection: 1.4% vaccine; 0.7% placebo

Facial paralysis (including Bell palsy): 8 cases vaccine; 3 case placebo (data insufficient to determine causal relationship with vaccine)

Contraindications

Known history of severe allergic reaction (eg, anaphylaxis) to any component in 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 vaccine ingredient PEG)

Cautions

Appropriate treatment used to manage immediate allergic reactions must be immediately available if an acute anaphylactic reaction occurs following administration

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to vaccine

Syncope (fainting) may occur; procedures should be in place to avoid injury from fainting

Vaccine may not protect all vaccine recipients

Vaccination providers enrolled in the federal COVID-19

Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of multisystem inflammatory syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine

Myocarditis and pericarditis

• Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose
• Risk is higher among adolescent and adult males aged <40 yr than among females and older males; risk is highest in males aged 18-24 yr
• Some cases required intensive care support, although available data from short-term follow-up suggest most individuals had symptom resolution with conservative management
• The CDC has published clinical considerations relevant to myocarditis and pericarditis with mRNA COVID-19 vaccines

Pregnancy

A growing body of evidence on the safety and effectiveness of COVID-19 vaccination indicates that the benefits of vaccination outweigh any known or potential risks of COVID-19 vaccination during pregnancy

Recent studies have also shown that antibodies produced after COVID-19 vaccination during pregnancy are transferred to the newborn, and COVID-19 vaccination of people who are pregnant reduces the risk of COVID-19 hospitalization in infants younger than 6 months

CDC guidelines for vaccination of pregnant or lactating females

Animal data

• Vaccine administered IM to female rats 28 and 14 days prior to mating, and on gestation days 1 and 13
• No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported

Clinical considerations

• Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with nonpregnant individuals

Pregnancy registry

• Monitors pregnancy outcomes in women exposed to vaccine during pregnancy
• Encourage females who are vaccinated during pregnancy to enroll in the registry

Lactation

Unknown whether vaccine is excreted in human milk

Data are unavailable to assess the effects on breastfed infants or milk production/excretion

For preventive vaccines, underlying maternal condition is susceptibility to disease prevented by the vaccine

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; formulated in lipid particles, which enable delivery of RNA into host cells to allow expression of the SARS-CoV-2 S antigen

Elicits an immune response to the S antigen, which protects against COVID-19

IM Preparation

Thaw

• Refrigerator: Thaw for 45 hr; let each vial stand at room temperature for 15 minutes before administering
• Room temperature: Thaw for 15 minutes
• After thawing, do not refreeze

Inspect contents

• Suspension should appear white to off-white
• It may contain white or translucent product-related particulates
• Do not administer if vaccine is discolored or contains other particulate matter

Prepare dose

• Swirl vial gently after thawing and between each withdrawal
• Do not shake
• Do not dilute

Prefilled syringe

• Do not shake
• Do not dilute
• Use appropriate size sterile needle for IM injection
• With tip cap upright, remove tip cap by twisting counterclockwise until tip cap releases
• Remove tip cap in a slow, steady motion; avoid pulling tip cap while twisting
• Attach needle by twisting in clockwise direction until needle fits securely on syringe

IM Administration

For IM injection only

Monitor for immediate adverse reactions according to CDC guidelines

Storage

Minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light

Frozen storage

• Freeze between -50 to -15ºC (-58 to 5ºF)

Storage after thawing

• Do not refreeze once thawed
• Multiple dose vial: Record date and time of first use on vial label; discard after 12 hr
• Thawed vials can be handled in room light conditions
• Storage at 2-8ºC (36-46ºF): Refrigerate for up to 30 days before first use
• Storage at 8-25ºC (46-77ºF): Vials may be stored for up to 24 hr (total storage time at this temperature range)
• Vial storage during use: Store at 2-25ºC (36-77ºF); record date and time of first use on vial label

Transport

• If transport at -50 to -15ºC (-58 to 5ºF) is not feasible, may transport thawed vials for up to 12 hr at 2-8ºC (36-46ºF)
• Do not refreeze, continue storage at 2-8ºC (36-46ºF) until use