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, multisystem inflammatory syndrome, and hospitalized or fatal cases of COVID-19 following vaccination

>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 participatns 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

Myocarditis and pericarditis

• Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose
• Observed risk is higher among 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

Data are insufficient to inform of vaccine-associated risks in pregnancy

Pregnancy registry: Women who are vaccinated with 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

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

Lactation

Data are not available to assess effects on breastfed infants or on milk production/excretion

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 frozen suspension before administering

Thaw in refrigerator: 2-8ºC (36-46ºF) for 2.5 hr (5.5-mL vial) or 3 hr (7.5-mL vial); after thawing, let vial stand at room temperature for 15 minutes before administering

Alternatively, thaw at room temperature of 15-25ºC (59-77ºF) for 1 hr (5.5-mL vial) or 1.5 hr (7.5-mL vial)

After thawing, do not refreeze

Do not shake; swirl vial gently after thawing and between each withdrawal

Do not dilute

Suspension is white to off-white and may contain white or translucent product-related particulates

Visually inspect for other particulate matter and/or discoloration administration; discard if either of these conditions exists

Syringes and needles

• Each primary series dose must contain 0.5 mL
• Each booster dose must contain 0.25 mL
• Primary series doses of 0.5 mL and booster doses of 0.25 mL may be extracted from either vial presentation, preferentially using low dead-volume syringes and/or needles

• Primary series doses/vial

  • Depending on syringes and needles used for each dose, there may be insufficient volume to extract >10 doses from the maximum of 11 doses vial and >13 doses from the maximum of 15 doses vial
  • Do not exceed 20 doses when extracting only booster doses or a combination of primary series and booster doses; do NOT puncture vial stopper >20 times

• Irrespective of syringe and needle type

  • Discard vial 12 hr after first puncture
  • If vial has been punctured 20 times, discard vial and contents
  • If amount remaining in vial cannot provide a full dose of 0.5 mL or 0.25 mL, discard vial and contents; do not pool excess vaccine from multiple vials
  • Pierce vial at different site each time drawing dose

IM Administration

For IM injection only

Storage

Does not contain preservatives

Vial stoppers are not made with natural rubber latex

Unopened vials

Store in original carton to minimize exposure to room light

• Frozen

  • Store frozen at -50ºC to -15ºC (-58ºF to 5ºF)
  • Do not store on dry ice or below -50ºC (-58ºF); dry ice may subject vials to temperatures colder than -50ºC (-58ºF)

• Refrigerated

  • Can be refrigerated at 2-8ºC (36-46ºF) for up to 30 days before first use
  • Do not refreeze

• Controlled room temperature

  • May be stored at 8-25ºC (46-77ºF) for up to 24 hr
  • Do not refreeze

After first dose withdrawn from vial

• Refrigerate or store at room temperature at 2-25ºC (36-77ºF)
• Discard vial after 12 hr
• Thawed vials can be handled in room light conditions
• Do not refreeze

Transportation of thawed vials

• If unable to transport at -50ºC to -15ºC (-58ºF to 5ºF), available data support transportation for up to 12 hr at 2-8ºC (35-46ºF) when shipped using shipping containers qualified to maintain this temperature under routine road and air transport conditions with shaking and vibration minimized
• After shipping, do not refreeze vials; refrigerate at 2-8ºC (35-46ºF) until use