COVID-19 bivalent vaccine, mRNA-Pfizer (Investigational)

Brand and Other Names:BNT162b2 OMI
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, frozen suspension concentrate

  • 30mcg/0.3mL
  • Each 0.3mL contains 15 mcg of original (wild-type spike protein) plus 15 mcg of omicron BA.4/BA.5 subvariants spike protein
  • Available as single-dose and multiple dose vials
  • Do not dilute

COVID-19 Disease Prevention

Emergency use authorization granted August 31, 2022

Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is indicated as a single booster dose

0.3 mL IM as a single dose

Administer at least 2 months after either

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, OR
  • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine

Dosing Considerations

Limitations of effectiveness: May not protect all vaccine recipients

Dosage Forms & Strengths

injection, frozen suspension concentrate

  • Aged 6 months through 4 years (maroon cap, must dilute): 3mcg/0.2mL (after dilution); contains 1.5 mcg of original (wild-type spike protein) plus 1.5 mcg of omicron BA.4/BA.5 subvariants spike protein; available as multiple dose vials
  • Aged 5-11 years (orange cap, must dilute): 10mcg/0.2mL (after dilution); contains 5 mcg of original (wild-type spike protein) plus 5 mcg of omicron BA.4/BA.5 subvariants spike protein; available as multiple dose vials
  • Aged ≥12 years (grey cap, no dilution): 30mcg/0.3mL; contains 15 mcg of original (wild-type spike protein) plus 15 mcg of omicron BA.4/BA.5 subvariants spike protein; available as single-dose and multiple dose vials

COVID-19 Disease Prevention

Emergency use authorization granted August 31, 2022 for aged 12-17 years, October 12, 2022 for 5-11 years, and December 8, 2022 for 6 months through 4 years

Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is indicated as a single booster dose for adolescents aged ≥6 months

<6 months: Safety and efficacy not established

6 months through 4 years (maroon cap vial, must dilute)

  • 3 mcg (0.2 mL) IM as a single dose
  • Administer at least 2 months after 2nd primary dose if eligible
  • Individuals who have not yet received 3-dose primary series of the Pfizer-BioNTech COVID-19 vaccine or have not yet received 3rd dose of their primary series may receive Pfizer-BioNTech COVID-19 bivalent vaccine as 3rd dose in their primary series following 2 doses of monovalent Pfizer-BioNTech COVID-19 vaccine
  • Individuals who already completed 3-dose primary series with original (monovalent) Pfizer-BioNTech COVID-19 vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time
  • Individuals turning from 4 years to 5 years between doses in primary series may receive either
    • 3-dose primary series of Pfizer-BioNTech COVID-19 vaccine (vials with maroon caps and labels with maroon borders) for Doses 1 and 2 and Pfizer-BioNTech COVID-19 bivalent vaccine (vials with maroon caps and labels with maroon borders) for Dose 3, OR
    • 2-dose primary series with the Pfizer-BioNTech COVID-19 vaccine authorized for use for individuals 5-11 years of age (vials with orange caps and labels with orange borders)

≥5 years

  • 5-11 years (orange cap vial, must dilute): 10 mcg (0.2 mL) IM as a single dose
  • ≥12 years (grey cap vial, no dilution): 30 mcg (0.3 mL) IM as a single dose
  • Administer at least 2 months after either
    • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, OR
    • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine

Dosing Considerations

Limitations of effectiveness: May not protect all vaccine recipients

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Adverse Effects

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 in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination

>10%

Injection site pain, mild (52.8%)

Fatigue, mild (29.2%)

Use of antipyretic/pain medication (29.2%)

Headache, mild (23.6%)

Fatigue, moderate (18.3%)

New/worsened muscle pain, mild (13.3%)

1-10%

Headache, moderate (9.6%)

New/worsened muscle pain, moderate (9%)

Chills, mild (8.3%)

New/worsened joint pain, mild (7.6%)

Diarrhea, mild (6%)

Injection site pain, moderate (5%)

Fever ≥38ºC (5%)

Swelling, mild (4.7%)

Chills, moderate (4.7%)

Redness, mild (4.3%)

Fever 38-38.4ºC (3.7%)

New/worsened joint pain, moderate (3.7%)

Redness, moderate (2.7%)

Swelling, moderate (2%)

Fatigue, mild (1.7%)

Vomiting, mild (1.7%)

Diarrhea, moderate (1.7%)

Diarrhea, severe (1.3%)

Fever >38.9-40ºC (1.3%)

<1% H3

Injection site pain, severe (0.3%)

Headache, severe (0.3%)

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Warnings

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
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Pregnancy & Lactation

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

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.

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Pharmacology

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

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Administration

IM Preparation

Gray top vial (30mcg/0.3mL, no dilution)

  • For aged ≥12 years
  • Thaw in refrigerator for 2 hr (carton of single dose vials), 6 hr (carton of multiple dose vials), and then sit at room temperature for 30 minutes
  • Suspension should appear white to off-white; do not administer if discolored or contains particulate matter
  • Before use, mix by inverting vaccine vial gently 10 times
  • Do not shake
  • Before gently mixing, the thawed vaccine may contain white to off-white opaque amorphous particles; after mixing, it should appear as a white to off-white suspension with no visible particles

Orange top vial (must dilute)

  • For aged 5-11 years
  • Thaw vials in refrigerator for 2 hr (carton of single dose vials), 4 hr (carton of multiple dose vials), and then sit at room temperature for 30 minutes
  • Suspension should appear white to off-white; do not administer if discolored or contains particulate matter
  • Before dilution, mix by inverting vaccine vial gently 10 times
  • Do not shake
  • Before gently mixing, the thawed vaccine may contain white to off-white opaque amorphous particles; after mixing, it should appear as a white to off-white suspension with no visible particles
  • Dilute vial contents with 1.3 mL of sterile nonbacteriostatic 0.9% NaCl (not provided); again, mix by gently inverting vial 10 times (do not shake) After dilution, 1 vial contains 10 doses of 0.2 mL

Maroon top vial (must dilute)

  • For aged 6 months to 4 years
  • Allow vials to thaw in refrigerator for 2 hr (carton of single dose vials) and then sit at room temperature for 30 minutes
  • Before dilution, gently invert vaccine vial 10 times to mix
  • Do not shake
  • Before gently mixing, the thawed vaccine may contain white to off-white opaque amorphous particles; after mixing, it should appear as a white to off-white suspension with no visible particles
  • Dilute vial contents with 2.2 mL of sterile 0.9% NaCl (not provided); again, mix by gently inverting vial 10 times (do not shake)
  • Suspension should appear white to off-white; do not administer if discolored or contains particulate matter
  • After dilution, 1 vial contains 10 doses of 0.2 mL

IM Administration

For IM injection only

Monitor for immediate adverse reactions according to CDC guidelines

Storage

Once received, frozen vials may be immediately transferred to refrigerator or frozen in ultra-low temperature freezer

Vial storage before use

  • Refrigerate at 2-8ºC (3-46ºF), thaw and store for up to 10 weeks; record expiry date on carton
  • Ultra-low temperature freezer at -90 to -60ºC (-130 to -76ºF) for up to 12 months from the date of manufacture
  • Do NOT store vials in conventional freezer at -25 to -15ºC (-13 to 5ºF)
  • Once vials are thawed, do not refreeze

Vial storage during use

  • Before first puncture: May store at room temperature (8-25ºC [46-77ºF]) up to 12 hr
  • After first puncture (multiple dose vial): Store at 2-25ºC (35-77ºF); discard 12 hr after first puncture

Transportation of vials

  • If local redistribution needed, vials may be transported at -90 to -60ºC (-130 to -76ºF) or at 2-8ºC (35-46ºF)
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Images

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.