COVID-19 vaccine, mRNA-Pfizer

Dosing & Uses

ADULT Dosage Forms & Strengths injection, frozen suspension concentrate

• 30 mcg/0.3mL (multiple-dose vial)

COVID-19 Disease Prevention December 11, 2020: Emergency use authorization (EUA) issued by FDA for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged ≥16 years 0.3 mL IM x2 doses administered 3 weeks apart Dosing Considerations Limitations of effectiveness: May not protect all vaccine recipients There are no data available on interchangeability of this vaccine with other COVID-19 vaccines; individuals who have received 1 dose should receive a second dose with the same vaccine to complete vaccination series EUA in adolescents aged 16-17 years is based on extrapolation of safety and effectiveness from adults aged >18 years

PEDIATRIC

Dosage Forms & Strengths injection, frozen suspension concentrate

• 30 mcg/0.3mL (multiple-dose vial)

COVID-19 Disease Prevention December 11, 2020: Emergency use authorization (EUA) issued by FDA for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged ≥16 years <16 years: Safety and efficacy not established ≥16 years: 0.3 mL IM x2 doses administered 3 weeks apart Dosing Considerations Limitations of effectiveness: May not protect all vaccine recipients There are no data available on interchangeability of this vaccine with other COVID-19 vaccines; individuals who have received 1 dose should receive a second dose with the same vaccine to complete vaccination series EUA in adolescents aged 16-17 years is based on extrapolation of safety and effectiveness from adults aged >18 years

Adverse Effects

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 (84.1%) Fatigue (62.9%) Headache (55.1%) Muscle pain (38.3%) Chills (31.9%) Joint pain (23.6%) Fever (14.2%) Injection site swelling (10.5%) 1-10% Injection site redness (9.5%) Nausea (1.1%) <1% Malaise (0.5%) Lymphadenopathy (0.3%) Frequency Not Defined Severe allergic reactions reported following mass vaccination outside of clinical trials

Warnings

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 the vaccine ingredient PEG)

Cautions Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to the vaccine Vaccine may not protect all vaccine recipients Allergic reactions

• Appropriate medical treatment used to manage immediate allergic reactions must be immediately available following vaccination

• Do not administer second dose to anyone experiencing a severe reaction (ie, requiring epinephrine or hospitalization) to the first dose

• Individuals with histories of severe allergic reaction to vaccines should consult their doctors about the COVID-19 vaccine

• People with severe allergies to food, pets, latex, oral medications, or environmental conditions may be vaccinated according to interim CDC clinical considerations for mRNA COVID-19 vaccines

• Vaccine Adverse Event Reporting System (VAERS)
  

  • December 14-23, 2020: 21 cases of anaphylaxis detected after administration of 1,893,360 first doses (11.1 cases per million doses) reported in MMWR

  • 71% of these occurred within 15 minutes of vaccination

  • 17 of 21 anaphylaxis cases occurred in people with a known history of allergies or allergic reactions (eg, medications, foods, insect stings), including 7 with prior anaphylactic reactions

Drug interaction overview

• Data are not available to assess concomitant administration with other vaccines

Pregnancy & Lactation

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

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

Administration

IM Preparation 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 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 Do not use if discolored or if other particles observed Dilute vial contents using 1.8 mL of 0.9% NaCl; equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe 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 IM Administration For IM injection only Storage Frozen vials prior to use

• Does not contain preservatives

• Vial stoppers are not made with natural rubber latex

• 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 -80ºC to -60ºC (-112ºF to -76ºF); vials must be kept frozen at this temperature range and protected from light in the original cartons until ready to use

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

  • Do not refreeze thawed vials

• 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 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 5 days (120 hr)

  • 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