Usual Adult Dose for COVID-19

Monovalent formulations are no longer available for use in the US. The US Centers for Disease Control and Prevention (US CDC) recommend that patients should receive the corresponding bivalent vaccine in place of this vaccine.

Primary Series: 0.3 mL IM for 2 doses, administered 21 days apart

• Third primary series dose (if indicated): 0.3 mL IM at least 28 days after the second primary series dose

Comments:

• A third dose administered at least 28 days following the first 2 doses of this vaccine is authorized for patients who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
• This is a monovalent vaccine formulation.
• For information on dosing of the bivalent vaccine(s), please see the appropriate product information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: For active immunization to prevent coronavirus disease 2019 (COVID-19) due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Usual Pediatric Dose for COVID-19

Monovalent formulations are no longer available for use in the US. The US CDC recommend that patients should receive the corresponding bivalent vaccine in place of this vaccine.

12 years and older:

• Primary Series: 0.3 mL IM for 2 doses, administered 21 days apart

Comment:

• No data are available regarding interchangeability of COVID-19 vaccine products; the same vaccine product should be used for both doses.

Use: For active immunization to prevent COVID-19 due to SARS-CoV-2

FOR INVESTIGATIONAL USE ONLY

12 years and older:

• Third primary series dose (if indicated): 0.3 mL IM at least 28 days after the second primary series dose

Comments:

• The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this unapproved product for active immunization to prevent COVID-19 due to SARS-CoV-2 (third primary series dose).
• A third dose administered at least 28 days following the first 2 doses of this vaccine is authorized for patients who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
• This is a monovalent vaccine formulation.
• For information on dosing of the bivalent vaccine(s), please see the appropriate product information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: Active immunization for the prevention of COVID-19 due to SARS-CoV-2

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Monovalent formulations of this drug were voluntarily withdrawn from the US market by the manufacturer in May 2023 due to an increased risk of administration error between these formulations and bivalent boosters used in the same patient population at the same dosage. Specifically, the US CDC recommend that all monovalent vaccine inventory should be removed from storage and discarded in accordance with local, state, and federal regulations, even if they are not expired.

CONTRAINDICATIONS:

• Known history of severe allergic reaction (e.g., anaphylaxis) to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 12 years; an EUA is in effect for the use of an experimental vaccine to prevent COVID-19 in patients 12 through 15 years of age; this drug is not authorized for use in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IM administration only. Do not inject IV, intradermally, or subcutaneously.
• After dilution, vials contain six-0.3 mL doses of vaccine.
• Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial; if standard syringes/needles are used, the volume may not be sufficient to extract 6 doses from the vial.
• Each dose must contain 0.3 mL of vaccine.
• If the vaccine remaining in the vial cannot provide a full 0.3 mL dose, discard the vial; do not pool excess vaccine from multiple vials.

Storage requirements:

• Vials prior to dilution: The manufacturer product information should be consulted regarding storage and subsequent thawing of frozen vials.
• Vials during storage: Minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light.
• Vials after dilution: Store between 2C to 25C (35F to 77F) and use within 6 hours from time of dilution; discard any vaccine remaining in vial after 6 hours; do not freeze diluted vaccine (discard if frozen).

Reconstitution/preparation techniques:

• Requires dilution with sterile 0.9% Sodium Chloride Injection, USP, before administration
• The manufacturer product information should be consulted.

General:

• This information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a grey cap and label with a grey border, which is:
• approved for use as a 2-dose primary series in patients 12 years and older AND
• authorized for emergency use as a third primary series dose (if appropriate) in patients 12 years and older.
• After preparation, each 0.3 mL dose contains 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2.

Patient advice:

• Read the US FDA-approved patient labeling and/or the Vaccine Information Fact Sheet for Recipients and Caregivers.
• To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS): https://vaers.hhs.gov

Frequently asked questions

• Can you take Ibuprofen after the COVID booster vaccine?