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

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, multisystem inflammatory syndome in adults and children, and cases of COVID19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent

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

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

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

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 vials before dilution

• Allow vials to thaw in refrigerator (may take up to 3 hr) or at room temperature for 30 minutes
• Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hr

• Thawed under refrigeration

  • Thaw and then store undiluted vials in refrigerator at 2-8ºC (35-46ºF) for up to 1 month
  • A carton of 25 vials or 195 vials may take up to 2-3 hr, respectively, to thaw in refrigerator, whereas fewer vials will thaw in less time

• Thawed at room temperature

  • For immediate use, thaw undiluted vials at room temperature up to 25ºC (77ºF) for 30 minutes
  • Thawed vials can be handled in room light conditions

Dilution

• Before dilution, invert vial gently 10 times; do NOT shake
• Inspect contents; should appear white to off-white suspension and may contain white to off-white opaque amorphous particles
• Discard if discolored or if other particles observed
• Gently invert diluted vial contents 10 times to mix; do NOT shake
• Record date and time of dilution on vial label
• Store diluted vial at 2-25ºC (35-77ºF); discard any unused vaccine 6 hr after dilution

• Aged ≥12 years

  • Select purple vial cap and label border
  • Dilute vial contents using 1.8 mL of 0.9% NaCl (do NOT use bacteriostatic 0.9% NaCl or any other diluent); equalize vial pressure before removing needle from vial by withdrawing 1.8 mL air into empty diluent syringe
  • After dilution, 1 vial contains 6 doses of 0.3 mL (30 mcg); vial labels and cartons may state vial contains 5 doses, however, the latest EAU information supersedes the number of doses stated on vial labels

• Aged 5-11 years

  • Select orange vial cap and label border
  • Dilute vial contents using 1.3 mL of 0.9% NaCl (do NOT use bacteriostatic 0.9% NaCl or any other diluent); equalize vial pressure before removing needle from vial by withdrawing 1.3 mL air into empty diluent syringe
  • After dilution, 1 vial contains 10 doses of 0.2 mL (10 mcg)

• Aged 6 months through 4 years

  • Select maroon vial cap and label border
  • Dilute vial contents using 2.2 mL of 0.9% NaCl (do NOT use bacteriostatic 0.9% NaCl or any other diluent); equalize vial pressure before removing needle from vial by withdrawing 2.2 mL air into empty diluent syringe
  • After dilution, 1 vial contains 10 doses of 0.2 mL (3 mcg)

IM Administration

For IM injection only

Do not pool excess vaccine from multiple vials

Monitor for immediate adverse reactions according to CDC guidelines

Storage

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

Do not refreeze thawed vials

Does not contain preservatives

Vial stoppers are not made with natural rubber latex

Frozen vials prior to use

• Ultra-low freezer

  • Vials arrive in thermal containers with dry ice
  • Once received, remove vial cartons immediately from the thermal container and store in an ultra-low-temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF); vials must be kept frozen at this temperature range and protected from light in the original cartons until ready to use

• Short-term storage in pharmaceutical freezer

  • Alternatively, vials may be stored at -25ºC to -15ºC (-13ºF to 5ºF) for up to 2 weeks
  • Vials must be kept frozen and protected from light until ready to use
  • Vials may be returned 1 time to the recommended storage condition of -90ºC to -60ºC (-130ºF to -76ºF)
  • Track total cumulative storage time at -25ºC to -15ºC (-13ºF to 5ºF); do not exceed 2 weeks
  • May transport under these conditions, but it counts against the total storage time of 2 weeks at this temperature

• Ultra-low-temperature freezer unavailable

  • If an ultra-low-temperature freezer is unavailable, the thermal container in which the vaccine arrives may be used as temporary storage when consistently refilled to the top of the container with dry ice
  • Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage
  • The thermal shipping container maintains a temperature range of -90ºC to -60ºC (-130ºF to -76ºF); storage within this temperature range is not considered an excursion from the recommended storage condition

Thawed vials before dilution

• Thawed under refrigeration

  • Thaw and then store undiluted vials in refrigerator at 2-8ºC (35-46ºF) for up to 1 month
  • Carton of 25 vials or 195 vials may take up to 2 or 3 hr, respectively, to thaw in refrigerator; whereas, fewer number of vials will thaw in less time

• Thawed at room temperature

  • For immediate use, thaw undiluted vials at room temperature up to 25ºC (77ºF) for 30 minutes
  • Thawed vials can be handled in room light conditions
  • Vials must reach room temperature before dilution
  • Undiluted vials may be stored at room temperature for no more than 2 hr

Vials after dilution

• After dilution, store vials at 2-25ºC (35-77ºF) and use within 6 hr from time of dilution
• During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light
• Discard any vaccine remaining in vials after 6 hr
• Do not refreeze