COVID-19 vaccine, mRNA-Pfizer (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 5-11 years

• Dose 1

  • Pain at the injection site, mild-severe (0.3-58.9%)
  • Fatigue, mild-severe (0.3-22%)
  • Headache, mild-severe (0.1-16.5%)

• Dose 2

  • Pain at the injection site, mild-severe (0.3-52.8%)
  • Fatigue, mild-severe (0.7-21.4%)
  • Headache, mild-severe (0.2-18.7%)

Aged 12-15 years

• Dose 1

  • Pain at the injection site, mild-severe (1-43.7%)
  • Fatigue, mild-severe (1.3-34.1%)
  • Headache, mild-severe (1-32%)
  • Chills, mild-severe (0.4-17.3%)
  • New or worsened muscle pain, mild-severe (0.2-12.9%)

• Dose 2

  • Pain at the injection site, mild-severe (0.6-42.5%)
  • Fatigue, mild-severe (2.4-42.7%)
  • Headache, mild-severe (2-35%)
  • Chills, mild-severe (1.8-20.1%)
  • New or worsened muscle pain, mild-severe (0.5-18%)

Aged 16-55 years

• Dose 1

  • Pain at the injection site, mild-severe (1.3-50.5%)
  • Headache, mild-severe (1.1-27.1%)
  • Fatigue, mild-severe (1.4-26.2%)
  • New or worsened muscle pain, mild-severe (0.5-12.2%)
  • Chills, mild-severe (0.5-11.7%)

• Dose 2

  • Pain at the injection site, mild-severe (1.5-47.5%)
  • Fatigue, mild-severe (2.4-35.4%)
  • Headache, mild-severe (3.4-26.1%)
  • New or worsened muscle pain, mild-severe (2.3-20.6%)
  • Chills, mild-severe (2.6-17.8 %)
  • New or worsened joint pain, mild-severe (1-11.9%)

Aged ≥56 years

• Dose 1

  • Pain at the injection site, mild-severe (0.2-55.2%)
  • Fatigue, mild-severe (0.1-20.7%)
  • Headache, mild-severe (0.1-19%)
  • New or worsened muscle pain, mild-severe (1.1-15.5%)

• Dose 2

  • Pain at the injection site, mild-severe (0.5-46.9%)
  • Fatigue, mild-severe (0.1-26.7%)
  • Headache, mild-severe (0.7-24.9%)
  • Chills, mild-severe (1.1-12.3 %)

1-10%

Aged 5-11 years

• Dose 1

  • Injection site redness, mild-severe (5.2-9.5%)
  • New or worsened muscle pain, mild-severe (0.1-6.4%)
  • Injection site swelling, mild-severe (0.1-5.6%)
  • Diarrhea, mild-severe (0.7-5.2%)
  • Chills, mild-severe (1.1-3.6%)
  • New or worsened joint pain, mild-severe (1.1-2.3%)
  • Vomiting, mild-severe (0.5-1.7%)
  • Fever (≥38°C) (0.2-1.5%)

• Dose 2

  • Injection site redness, mild-severe (0.2-9.5%)
  • Injection site swelling, mild-severe (7.5-7.8%)
  • New or worsened muscle pain, mild-severe (0.1-7.7%)
  • Chills, mild-severe (0.1-7%)
  • Diarrhea, mild-severe (0.5-4.8%)
  • New or worsened joint pain, mild-severe (1.4-3.8%)
  • Fever (≥38°C) (0.1-3.4%)
  • Vomiting, mild-severe (0.1-1.8%)

Aged 12-15 years

• Dose 1

  • Diarrhea, mild-severe (1.2-6.8%)
  • Fever (≥38°C) (0.1-6.6%)
  • New or worsened joint pain, mild-severe (0.1-5.9%)
  • Diarrhea, mild-severe (0.5-5.4%)
  • Injection site redness, mild-severe (0.1-3.9%)
  • Injection site swelling, mild-severe (2-4.9%)
  • Vomiting, mild-severe (0.1-2.7%)

• Dose 2

  • Fever (≥38°C) (2.3-9.8%)
  • New or worsened joint pain, mild-severe (0.4-8.3%)
  • Injection site swelling, mild-severe (1.6-3.3%)
  • Injection site redness, mild-severe (2.4-2.6%)
  • Vomiting, mild-severe (0.4-2.3%)

Aged 18-55 years

• Dose 1

  • Diarrhea, mild-severe (0.1-8.7%)
  • New or worsened joint pain, mild-severe (0.2-6.9%)
  • Injection site swelling, mild-severe (0.2-4.3%)
  • Injection site redness, mild-severe (0.2-3.9%)
  • Fever (≥38°C) (0.3-3%)
  • Vomiting, mild-severe (0.2-1%)

• Dose 2

  • Fever (≥38°C) (1.5-9.5%)
  • Diarrhea, mild-severe (0.2-8.2%)
  • Injection site swelling, mild-severe (0.3-4.1%)
  • Injection site redness, mild-severe (0.4-3.4%)
  • Vomiting, mild-severe (0.1-1.6%)

Aged >56 years

• Dose 1

  • New or worsened muscle pain, mild-severe (4.5-9.1%)
  • Diarrhea, mild-severe (0.2-6.8%)
  • New or worsened joint pain, mild-severe (0.1-5.9%)
  • Chills, mild-severe (1.4-5.1 %)
  • Injection site swelling, mild-severe (0.1-4.3%)
  • Injection site redness, mild-severe (0.2-3.5%)
  • Fever (≥38°C) (0.1-1.1%)
  • Vomiting, mild-severe (0.4%)

• Dose 2

  • New or worsened joint pain, mild-severe (0.5-9.8%)
  • Fever (≥38°C) (0.4-8.5%)
  • Diarrhea, mild-severe (0.1-6.7%)
  • Injection site swelling, mild-severe (0.2-4.3%)
  • Injection site redness, mild-severe (0.5-3.5%)

<1%

Malaise (0.5%)

Lymphadenopathy (0.3%)

>56 years

• Dose 1

  • Vomiting, mild-severe (0.4%)

• Dose 2

  • Vomiting, mild-severe (0.1-0.5%)

Postmarketing Experience

Cardiac disorders: Myocarditis, pericarditis

Gastrointestinal disorders: Diarrhea, vomiting

Immune system disorders: Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema)

Musculoskeletal and connective tissue disorders: Pain in extremity (arm)

Contraindications

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

Cautions

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

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

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

May not protect all vaccine recipients

Myocarditis and pericarditis

• May increase risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
• Risk is higher among adolescent and adult males aged <40 years than among females and older males, and the observed risk is highest in males aged 12-17 years
• Available data suggest that majority of symptoms resolved 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

Pregnancy registry

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

Clinical considerations

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

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

IM Preparation

Multiple-dose vials

• Yellow caps and labels
• Add 1.1 mL of sterile 0.9% NaCl into vial
• Before removing needle from vial, equalize vial pressure by withdrawing air into the empty diluent syringe
• Record date and time of dilution on vial label
• Store at 2-25ºC (35-77ºF) and discard after 12 hr
• After dilution, multiple-dose vials contain 3 doses of 0.3 mL each
• If the amount of vaccine in vial cannot provide a full dose of 0.3 mL, discard vial and any excess volume; do not pool excess vaccine from multiple vials

Single-dose vials

• Do not dilute
• Thaw vial in refrigerator at 2-8ºC (35-46ºF) or at room temperature (up to 25ºC [77ºF])
• Before use, mix by inverting vial gently 10 times; do not shake
• Discard vial and any excess volume

Single-dose prefilled syringes

• Thaw syringe in carton in refrigerator at 2-8ºC (35-46ºF) or at room temperature (up to 25ºC [77ºF])
• Do not remove syringe from carton to thaw
• Do not shake
• Remove tip cap and attach a sterile needle

Inspect vial/syringe

• Inspect visually for particulate matter and discoloration before administration
• Vaccine will be a white to off-white suspension
• Discard if discolored or contains particulate matter

IM Administration

Administer by IM injection

Storage

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light

Do not refreeze thawed vials or prefilled syringes

Frozen vials or syringes before use

• Vials may arrive frozen at ultra-cold conditions in thermal containers with dry ice
• Once received, remove vial cartons immediately from the thermal container and transfer to refrigerator at 2-8C (35-46F), thawed and stored for up to 10 weeks
• Alternatively, may store in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF)
• Do not store vials and syringes at vials may be stored at -25ºC to -15ºC (-13ºF to 5ºF)

Refrigerated vials or syringes before use

• If vials and prefilled syringes are received refrigerated at 2-8ºC (35-46ºF), they should be stored refrigerated
• Check that the carton has been previously updated to reflect the 10-week refrigerated expiry date