COVID-19 Vaccine, mRNA (Pfizer-BioNTech) (Monograph)

Drug class: Vaccines

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Introduction

Nucleoside-modified mRNA (modRNA) vaccine used to stimulate active immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).^{1 609}

Uses for COVID-19 Vaccine, mRNA (Pfizer-BioNTech)

Prevention of Coronavirus Disease 2019 (COVID-19)

Used for active immunization to prevent COVID-19 caused by SARS-CoV-2.^{1 609}

The vaccine labeled as Comirnaty is used for prevention of COVID-19 in individuals ≥12 years of age.¹

Although efficacy and safety not definitely established, the Pfizer-BioNTech COVID-19 vaccine is also available under an FDA emergency use authorization (EUA) for prevention of COVID-19 in individuals 6 months through 11 years of age.⁶⁰⁹

The current COVID-19 vaccine, mRNA (Pfizer-BioNTech) has been specifically formulated for the 2023-2024 season.² Previous vaccine presentations, which included the intial monovalent formulation (Original strain) and the subsequent bivalent vaccines, are no longer authorized for use in the US; however, evidence of effectiveness and safety of the current vaccine are based principally on data from these previous formulations.^{1 2 59 68 609}

Consult the CDC's Advisory Committee on Immunization Practices (ACIP) interim recommendations and clinical considerations for use of COVID-19 vaccines, including dosage and administration, specific populations and situations, and cautionary information.¹³

ACIP recommends COVID-19 vaccination in all individuals ≥6 months of age in the US for prevention of COVID-19.¹³ There is currently no FDA-approved or FDA-authorized COVID-19 vaccine for children <6 months of age. ¹³ The current ACIP recommendations for COVID-19 vaccinations are available at [Web]

COVID-19 Vaccine, mRNA (Pfizer-BioNTech) Dosage and Administration

General

Pretreatment Screening

• Screen all individuals for contraindications and precautions to vaccination.¹³

Patient Monitoring

• Monitor all individuals who receive a COVID-19 vaccine for immediate adverse reactions according to CDC (ACIP) guidelines.¹ ACIP states that vaccination providers should consider observing the following individuals for 30 minutes after receiving the vaccine: those with a history of anaphylaxis to a non-COVID-19 vaccine or injectable therapy; those with an allergy-related contraindication to a different type of COVID-19 vaccine; those with a history of a non-severe, immediate (onset within 4 hours) allergic reaction to a previous dose of COVID-19 vaccine.¹³ Vaccination providers should consider observing all other individuals for 15 minutes because of the risk of syncope.¹³

Premedication and Prophylaxis

• Antipyretics or analgesics (e.g., acetaminophen, nonsteroidal anti-inflammatory agents) may be taken for the treatment of postvaccination local or systemic symptoms, if medically appropriate.¹³ However, these medications should not be used prophylactically for the purposes of prevention of post-vaccination symptoms.¹³

• Premedication with antihistamines prior to vaccination to prevent allergic reactions is generally not recommended; however, while antihistamines will not prevent anaphylaxis, some experts advise antihistamine use as a means of preventing milder allergic reactions in patients who might be at higher risk for allergic reactions.¹³

Dispensing and Administration Precautions

• Appropriate medications and supplies for managing immediate allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of COVID-19 vaccines.^{1 13}

• Syncope may occur following administration of parenteral vaccines, especially in adolescents.^{13 20} Patients should be seated or lying down during vaccination.¹³ Vaccination providers should consider observing vaccine recipients (especially adolescents) for 15 minutes after vaccination; if syncope develops, patients should be observed until symptoms resolve.¹³

Administration

IM Administration

Administer only by IM injection.^{1 609}

The Pfizer-BioNTech COVID-19 vaccine is supplied in various formulations and presentations.^{1 609} There are important differences between these formulations such as method of preparation, requirement for dilution, and storage requirements; consult the manufacturer's labeling (for the Comirnaty product) or the FDA EUA Fact Sheet (for the Pfizer-BioNTech COVID-19 vaccine authorized for use under an EUA) for specific instructions on each formulation.^{1 609} The various formulations and vial presentations are distinguished by different color vial caps and labels.^{1 609} As of September 11, 2023, the initial monovalent (Original strain) and bivalent Pfizer-BioNTech COVID-19 vaccine are no longer authorized for use in the US.²

Comirnaty

The COVID-19 vaccine, mRNA (Pfizer-BioNTech)(2023-2024 Formula) labeled as Comirnaty is supplied as a frozen suspension in single-dose vials and prefilled syringes that must be thawed prior to administration; see manufacturer's prescribing information for specific instructions.¹ The Comirnaty vaccine does not need to be diluted before use.¹

Prior to use of the vial, gently invert 10 times; do not shake.¹ The vaccine should appear as a white to off-white suspension; do not use if vaccine is discolored or if particulate matter is observed.¹ To administer a dose, withdraw 0.3 mL of the vaccine from the vial using aseptic technique and an appropriate syringe and needle, and administer immediately.¹

Do not shake the prefilled syringe prior to use.¹ Remove the tip cap and attach a sterile needle to administer a dose.¹

Pfizer BioNTech COVID-19 Vaccine (2023–2024 Formula) Vials with Blue Cap

The Pfizer-BioNTech COVID-19 vaccine, mRNA (2023-2024 Formula) authorized for use under an FDA EUA for children 5–11 years of age is supplied in single-dose vials with a blue cap and label.⁶⁰⁹ The vaccine does notneed to be diluted prior to use.⁶⁰⁹

Each 0.3 mL dose of the vaccine is formulated to contain 10 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).⁶⁰⁹

The vaccine is supplied as a frozen suspension that must be thawed prior to use; see EUA fact sheet for specific instructions.⁶⁰⁹

Prior to use, gently invert the vial 10 times; do not shake.⁶⁰⁹ The vaccine should appear clear to slightly opalescent with no visible particulates.⁶⁰⁹ Do not use if liquid is discolored or if particles are observed.⁶⁰⁹

To administer a dose, withdraw 0.3 mL of the vaccine from the vial using aseptic technique and an appropriate syringe and needle, and administer immediately.⁶⁰⁹

Pfizer BioNTech COVID-19 Vaccine (2023-2024 Formula) Vials with Yellow Cap

The Pfizer-BioNTech COVID-19 vaccine (2023–2024 Formula) authorized for use under an FDA EUA for children 6 months through 4 years of age is supplied in multiple-dose vials with a yellow cap and label.⁶⁰⁹ Dilution is required prior to administration.⁶⁰⁹

Each 0.3 mL dose is formulated to contain 3 mcg of nucleoside-modified messengerRNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5). ⁶⁰⁹

The multiple dose vials contain a frozen suspension that must be thawed prior to administration; see EUA fact sheet for specific instructions.⁶⁰⁹

Prior to dilution, gently invert the vial 10 times; do not shake.⁶⁰⁹ Using aseptic technique, dilute the vaccine with 1.1 mL of 0.9% sodium chloride injection.⁶⁰⁹ The vaccine should appear clear to slightly opalescent with no visible particulates.⁶⁰⁹ Do not use if liquid is discolored or if particles are observed.⁶⁰⁹

To administer a dose, withdraw 0.3 mL of the vaccine from the vial using aseptic technique and an appropriate syringe and needle, and administer immediately.⁶⁰⁹ If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.⁶⁰⁹

Dosage

Pediatric Patients

Prevention of COVID-19

Adolescents ≥12 Years of Age

IM

Unvaccinated:Administer a single 0.3 mL dose (Comirnaty, gray caps).^{1 13}

Previously vaccinated with 1 or more doses of any mRNA vaccine or Novavax or Janssen COVID-19 vaccine (including in combination with any original monovalent or bivalent COVID-19 vaccine doses): Administer a single 0.3 mL dose (Comirnaty, gray caps).^{1 13}

Administer the updated 2023-2024 vaccine at least 2 months after the last dose of a COVID-19 vaccine for previously vaccinated individuals.^{1 13}

Children 5-11 Years of Age

IM

Unvaccinated: Administer a single 0.3 mL dose (Pfizer-BioNTech 2023-2024 Formula, blue caps).^{13 609}

Previously vaccinated with 1 or more doses of any mRNA vaccine: Administer a single 0.3 mL dose (Pfizer-BioNTech 2023-2024 Formula, blue caps).^{13 609}

Administer the updated 2023-2024 vaccine at least 8 weeks after the last dose of mRNA COVID-19 vaccine for previously vaccinated individuals.^{13 609}

Children 6 Months through 4 Years of Age

IM

Unvaccinated: Administer 3 doses, 0.3 mL each (Pfizer-BioNTech 2023-2024 Formula, yellow caps); dose 1 and 2 should be given 3–8 weeks apart, and dose 3 should be given at least 8 weeks after dose 2.^{13 609} For children turning from 4 to 5 years of age during the initial vaccination series, refer to ACIP recommendations at [Web].¹³

Previously vaccinated with 1 dose of original monovalent or bivalent Pfizer-BioNTech COVID-19 vaccine: Administer 2 doses, 0.3 mL each (Pfizer-BioNTech 2023-2024 Formula, yellow caps); dose 1 should be administered 3–8 weeks after receipt of the last dose of Pfizer-BioNTech COVID-19 vaccine, and dose 2 should be administered at least 8 weeks after dose 1.^{13 609}

Previously vaccinated with 2 or more doses of original monovalent or bivalent Pfizer-BioNTech COVID-19 vaccine: Administer a single 0.3 mL dose (Pfizer-BioNTech 2023-2024 Formula, yellow caps) at least 8 weeks after receipt of the last dose of Pfizer-BioNTech COVID-19 vaccine.^{13 609}

Per FDA authorization, all COVID-19 vaccine doses in this age group should ideally be from the same manufacturer.¹³

Immunocompromised Children 6 Months through 4 Years of Age

IM

Unvaccinated:Administer a 3-dose series, each dose 0.3 mL (Pfizer-BioNTech 2023-2024 Formula, yellow caps).^{13 609} Dose 1 and 2 should be given 3 weeks apart, and dose 3 should be given at least 8 weeks after dose 2.^{13 609} For children turning from 4 to 5 years of age during the initial vaccination series, refer to ACIP recommendations at [Web].¹³

Previously vaccinated with 1 or 2 dose(s) of original or bivalent Pfizer-BioNTech COVID-19 vaccine: Complete the 3-dose series with two or one 0.3 mL dose(s) (Pfizer-BioNTech 2023-2024 Formula, yellow caps), respectively, using the same dosing interval as above.^{13 609}

Previously vaccinated with 3 or more doses: Administer a single 0.3 mL dose (Pfizer-BioNTech 2023-2024 Formula, yellow caps) at least 8 weeks following the last dose. ^{13 609}

One or more additional doses may be administered based on clinicial discretion.¹³

Per FDA authorization, all COVID-19 vaccine doses in this age group should ideally be from the same manufacturer.¹³

Immunocompromised Children 5-11 Years of Age

IM

Unvaccinated: Administer a 3-dose series, each dose 0.3 mL (Pfizer-BioNTech 2023-2024 Formula, blue caps); ideally all doses from the same manufacturer.^{13 609} Dose 1 and 2 should be given 3 weeks apart, and dose 3 should be given at least 4 weeks after dose 2.^{13 609} For children turning from 11 to 12 years of age during the initial vaccination series, refer to ACIP recommendations at [Web].¹³

Previously vaccinated with 1 or 2 dose(s) of original or bivalent Pfizer-BioNTech COVID-19 vaccine: Complete the 3-dose series with two or one 0.3 mL dose(s) (Pfizer-BioNTech 2023-2024 Formula, blue caps), respectively; ideally from the same manufacturer, using the same dosing interval as above.^{13 609}

Previously vaccinated with 3 or more doses of any mRNA vaccine: Administer a single 0.3 mL dose (Pfizer-BioNTech 2023-2024 Formula, blue caps) at least 8 weeks after the last COVID-19 vaccine dose.^{13 609}

One or more additional doses may be administered based on clinician discretion.¹³

Immunocompromised Adolescents ≥12 Years of Age

IM

Unvaccinated: Administer a 3-dose series, each dose 0.3 mL (Comirnaty, gray caps); ideally all doses from the same manufacturer.^{1 13} Dose 1 and 2 should be given 3 weeks apart, and dose 3 should be given at least 4 weeks after dose 2.^{1 13}

Previously vaccinatedwith 1 or 2 doses of original monovalent or bivalent Pfizer-BioNTech COVID-19 vaccine: Complete the 3-dose series with two or one 0.3 mL dose(s)(Comirnaty, gray caps), respectively; ideally from the same manufacturer, using the same dosing interval as above.^{1 13}

Previously vaccinated with 3 or more doses of any mRNA vccine or 1 or more doses of Novavax or Janssen COVID-19 vaccine (including in combination with any original monovalent or bivalent COVID-19 vaccine doses): Administer a single 0.3 mL dose (Comirnaty, gray caps) at least 8 weeks after the last COVID-19 vaccine dose.^{1 13}

Adolescents ≥12 years of age who are moderately or severely immunocompromised may receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 2 months after the last dose of updated (2023–2024 Formula) COVID-19 vaccine.¹³ Further additional doses may be administered based on clinical judgement.¹³ Any further additional doses should be administered at least 2 months after the last updated (2023–2024 Formula) COVID-19 vaccine dose.¹³

Adults

Prevention of COVID-19

IM

Unvaccinated:Administer a single 0.3 mL dose (Comirnaty, gray caps).^{1 13}

Previously vaccinated with 1 or more doses of any mRNA vaccine or Novavax or Janssen COVID-19 vaccine (including in combination with any original monovalent or bivalent COVID-19 vaccine doses): Administer a single 0.3 mL dose (Comirnaty, gray caps). ^{1 13}

Administer the updated 2023-2024 vaccine at least 2 months after the last dose of a COVID-19 vaccine for previously vaccinated individuals.^{1 13}

Adults ≥65 years of age: Administer 1 additional dose of any updated (2023-2024 formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 4 months following the previous dose of an updated COVID-19 2023–2024 vaccine.¹³ If Pfizer-BioNTech is used, administer a 0.3 mL dose.¹³

Immunocompromised Adults:

Unvaccinated:Administer a 3-dose series, each dose 0.3 mL (Comirnaty, gray cap); ideally all doses from the same manufacturer.^{1 13} Dose 1 and 2 should be given 3 weeks apart, and dose 3 should be given at least 4 weeks after dose 2.^{1 13}

Previously vaccinatedwith 1 or 2 doses of original monovalent or bivalent Pfizer-BioNTech COVID-19 vaccine: Complete the 3-dose series with two or one 0.3 mL dose(s) (Comirnaty, gray caps), respectively; ideally from the same manufacturer, using the same dosing interval as above.^{1 13}

Previously vaccinated with 3 or more doses of any mRNA vaccine or 1 or more doses of Novavax or Janssen COVID-19 vaccine (including in combination with any original monovalent or bivalent COVID-19 vaccine doses): Administer a single 0.3 mL dose (Comirnaty, gray caps) at least 8 weeks after the last COVID-19 vaccine dose. ^{1 13}

Adults up to 64 years of age who are moderately or severely immunocompromised may receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 2 months after the last dose of updated (2023–2024 Formula) COVID-19 vaccine.¹³ Further additional doses may be administered based on clinical judgement.¹³ Any further additional doses should be administered at least 2 months after the last updated (2023–2024 Formula) COVID-19 vaccine dose.¹³

Adults ≥65 years of age who are moderately or severely immunocompromised should receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 2 months after the last dose of updated (2023–2024 Formula) vaccine.¹³ Further additional doses may be administered based on clinical judgement.¹³ Any further additional doses should be administered at least 2 months after the last updated (2023–2024 Formula) COVID-19 vaccine dose.¹³

Cautions for COVID-19 Vaccine, mRNA (Pfizer-BioNTech)

Contraindications

• • Known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.¹

  ACIP considers the following to be contraindications to vaccination with both mRNA COVID-19 vaccines (Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine):

  • Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or severe allergic reaction to a component of the vaccine (e.g., polyethylene glycol [PEG]).¹³

  • Known (diagnosed) allergy to a component of the vaccine (e.g., PEG).¹³

Warnings/Precautions

Hypersensitivity Reactions

Severe allergic reactions including anaphylaxis reported rarely outside of clinical trials.^{1 3 13 17 22 23 26 37 40}

Delayed-onset local reactions (e.g., erythema, induration, pruritus, tenderness) around the injection site area reported in some vaccine recipients.^{13 38} ACIP states that delayed-onset local reaction after the first dose of an mRNA COVID-19 vaccine is not a contraindication or precaution to administration of a second dose.¹³

If a hypersensitivity reaction occurs following COVID-19 vaccination, report the case to VAERS.¹³

History of severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components (e.g., PEG): ACIP considers this a contraindication to vaccination with the mRNA COVID-19 vaccines.¹³ Consideration may be given to using an alternative COVID-19 vaccine (Novavax COVID-19 vaccine) in such individuals.¹³

Known (diagnosed) allergy to a component of the vaccine (e.g., PEG): ACIP considers this a contraindication to vaccination with the mRNA COVID-19 vaccines.¹³ Consideration may be given to using an alternative COVID-19 vaccine (Novavax COVID-19 vaccine) in such individuals.¹³

History of any immediate allergic reaction to any other vaccine or injectable therapy (i.e., IM, IV, or sub-Q vaccines or therapies): ACIP considers this a precaution, but not a contraindication, to COVID-19 vaccination.¹³

History of immediate allergic reaction to a vaccine or injectable therapy that contains multiple components (one or more of which is a component of a COVID-19 vaccine), but it is not known which component elicited the reaction: ACIP considers this a precaution, but not a contraindication, to the COVID-19 vaccine.¹³

History of allergic reactions (including severe allergic reactions) not related to COVID-19 vaccines, other vaccines, or injectable therapies: ACIP states that food, pet, insect, venom, or environmental allergies and allergic reactions to oral medications (including the oral equivalents of injectable medications) are not a contraindication or precaution to COVID-19 vaccination.¹³ Latex allergy is not a contraindication or precaution since vial stoppers of COVID-19 vaccines are not made with natural rubber latex.¹³ Allergies to eggs or gelatin are not a contraindication or precaution since COVID-19 vaccines do not contain eggs or gelatin.¹³ In addition, a family history of allergies is not a contraindication or precaution to COVID-19 vaccination.¹³

ACIP states to observe the following individuals for 30 minutes after vaccination: those with a history of an immediate allergic reaction of any severity to any other vaccine or injectable therapy, those with a contraindication to a different type of COVID-19 vaccine (i.e., viral vector), those with a history of a non-severe, immediate allergic reaction to a previous dose of COVID-19 vaccine, and those with a history of anaphylaxis due to any cause not considered a contraindication; observe all other individuals for 15 minutes.¹³ Instruct vaccine recipients to seek immediate medical care if they develop signs or symptoms of an allergic reaction after their observation period ends and they have left the vaccination site.¹³

Appropriate medications and supplies to manage immediate allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of a COVID-19 vaccine.¹³

ACIP interim guidance regarding management of anaphylaxis are available at the CDC website at [Web].¹³

Lymphadenopathy

Lymphadenopathy, lymphadenitis, lymph node pain, injection-site lymphadenopathy, axillary swelling/tenderness, and axillary mass reported in clinical trials evaluating COVID-19 vaccine (Pfizer-BioNTech).^{1 3 10}

Unilateral axillary adenopathy, including palpable axillary mass, identified through self-detection or incidentally on breast imaging in individuals who received an mRNA COVID-19 vaccine outside of clinical trials.^{30 44} Consider vaccine-induced hyperplastic axillary adenopathy in differential diagnosis if unilateral axillary adenopathy identified on breast imaging in individuals who recently received an mRNA COVID-19 vaccine.^{30 44}

Myocarditis and Pericarditis

Rare reports of acute myocarditis or pericarditis in recipients of mRNA COVID-19 vaccines.^{1 3 13 53 54 55 56 57 58} Symptom onset typically within 0–7 days (range: 0–40 days) after receipt of a dose of an mRNA COVID-19 vaccine.^{2 53 54 57}

Has occurred predominantly in males <40 years of age.^{13 54 55 56 58} In some cases, patients were hospitalized and responded to medications and rest with rapid improvement or resolution of symptoms.^{1 54 55 56 57}

Consider possibility of myocarditis and pericarditis in the differential diagnosis for any individual who develops acute chest pain, shortness of breath, or palpitations after receipt of an mRNA COVID-19 vaccine.^{53 54 58} Consider expert consultation regarding diagnosis, management, and follow-up.⁵³

If myocarditis or pericarditis occurs after receipt of a COVID-19 vaccine, report the case to VAERS.¹³

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines.^{1 609} Procedures should be in place to avoid injury from fainting.¹ ACIP states to consider observing individuals receiving the vaccine, especially adolescents, for 15 minutes after vaccination.¹³

Concomitant Illness

Base decision to administer or delay vaccination in an individual with a current or recent febrile illness on the severity of symptoms and etiology of the illness.²⁰

ACIP states that a moderate or severe acute illness is a precaution for administration of vaccines and recommends that a risk assessment be performed with potential deferral of vaccination.¹³ Deferring vaccination until an individual has recovered avoids superimposing adverse effects of the vaccine on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccination.²⁰

Data not available to date regarding safety and efficacy of COVID-19 vaccines in adults or children with a history of multisystem inflammatory syndrome.¹³ ACIP recommends weighing theoretical concerns about a dysregulated immune response against the known risks of COVID-19 following reinfection and the benefits of protection following COVID-19 vaccination.¹³

Individuals with Underlying Medical Conditions

ACIP states that individuals with altered immunocompetence or certain underlying medical conditions may receive any COVID-19 vaccine approved or authorized by FDA, unless they have a contraindication to the vaccine.¹³ Current FDA-approved or FDA-authorized COVID-19 vaccines are not live vaccines, so they may be safely administered to immunocompromised individuals.¹³

US healthcare providers and health departments can request a clinical consultation from the Clinical Immunization Safety Assessment COVIDvax project ([Web]) if they have concerns about vaccinating individuals with certain underlying medical conditions.¹³

Although a causal relationship not established, several cases of Bell's palsy reported in COVID-19 vaccine trials.¹

Advise individuals who have bleeding disorders or are receiving anticoagulant therapy about the risk of hematoma from IM injections.²⁰

Specific Populations

Pregnancy

Data insufficient to date to inform vaccine-associated risks during pregnancy.¹

Developmental toxicity studies in rats did not reveal evidence of vaccine-related adverse effects on female fertility, fetal development, or postnatal development.¹

Available data suggest that, while absolute risk is low, pregnant women with COVID-19 are at increased risk of severe illness, preterm birth and possibly increased risk of adverse pregnancy complications and outcomes.^{13 16 34}

FDA states pregnancy is not a contraindication to use of the Pfizer-BioNTech COVID-19 vaccine; pregnant women should discuss potential benefits and risks of vaccination with their healthcare providers.¹⁹

ACIP states vaccination against COVID-19 is recommended for pregnant women.¹³ Evidence indicates that benefits of vaccination against COVID-19 during pregnancy outweigh any known or potential risks.¹³

ACOG recommends that pregnant women be vaccinated against COVID-19.¹⁶ ACOG suggests that clinicians review available data on risks and benefits of vaccination, including risks of not getting vaccinated, in the context of the individual's current health status and risk of exposure.¹⁶

Encourage women who receive a COVID-19 vaccine during pregnancy and those who become pregnant within 30 days after receiving a COVID-19 vaccine to participate in CDC's v-safe program.¹⁶

Lactation

Not known whether Pfizer-BioNTech COVID-19 vaccine is distributed into milk.¹ Data not available to assess whether the vaccine administered to a woman who is breast-feeding has any effects on breast-fed infant or milk production.¹ FDA states that breast-feeding is not a contraindication to use of the Pfizer-BioNTech COVID-19 vaccine; breast-feeding women should discuss benefits and risks of vaccination with their healthcare providers.¹⁹

ACIP states that vaccination against COVID-19 recommended for lactating women.¹³ FDA-authorized COVID-19 vaccines administered to breast-feeding women cannot cause SARS-CoV-2 infection in women or their infants; therefore, breast-feeding women can receive COVID-19 vaccination.¹³

ACOG recommends that lactating women be vaccinated against COVID-19.¹⁶ ACOG also states that theoretical concerns regarding safety of vaccinating lactating women do not outweigh potential benefits of the vaccine; there is no need for individuals who receive a COVID-19 vaccine to avoid initiating breast-feeding or to discontinue breast-feeding.¹⁶

Females and Males of Reproductive Potential

ACIP recommends vaccination against COVID-19 in women currently trying to become pregnant and those who might become pregnant in the future.¹³ Women trying to become pregnant do not need to avoid pregnancy after COVID-19 vaccination.¹³ There is no evidence that any FDA-approved or FDA-authorized COVID-19 vaccines affect current or future fertility.¹³

ACOG recommends vaccination for all eligible individuals, including those who may consider future pregnancy.¹⁶

Pediatric Use

Pfizer-BioNTech COVID-19 vaccine, mRNA (2023-2024 Formula) is authorized for use in children 6 months through 11 years of age.⁶⁰⁹

The Comirnaty COVID-19 vaccine (2023-2024 Formula) is FDA-labeled for use in adolescents ≥12 years of age.¹

Geriatric Use

Individuals ≥65 years of age have been included in clinical trials evaluating the original Pfizer-BioNTech COVID-19 monovalent vaccine (no longer authorized for use in the US), and data from such individuals contribute to the overall assessment of safety and efficacy of the vaccine.¹

Common Adverse Effects

Most common adverse reactions (≥10%) after a dose of COMIRNATY: pain at the injection site, fatigue, headache, chills, muscle pain, joint pain, fever, injection site swelling, injection site redness.¹

Solicited adverse effects in individuals 6 months through 23 months of age receiving the COVID-19 vaccine, mRNA (Pfizer-BioNTech): Injection site redness, swelling and tenderness, decreased appetite drowsiness, fever, irritability.⁶⁰⁹

Solicited adverse effects in individuals 2 through 11 years of age receiving the COVID-19 vaccine, mRNA (Pfizer-BioNTech): Injection site pain, redness and swelling, chills, diarrhea, fatigue, fever, headache, new or worsened joint pain, new or worsened muscle pain, vomiting.⁶⁰⁹

Drug Interactions

Vaccines

Data not available to date to assess safety and immunogenicity of concomitant administration of COVID-19 vaccine (Pfizer-BioNTech) with other vaccines.^{1 13} Immunogenicity and adverse event profiles are generally similar whether vaccines are administered concomitantly or alone.¹³ Base decisions to administer a COVID-19 vaccine concomitantly with other vaccine(s) on whether routine immunizations with the other vaccines have been delayed or missed, the individual's risk of vaccine-preventable disease (e.g., during an outbreak or occupational exposures), and reactogenicity profiles of the vaccines.¹³

ACIP states that COVID-19 vaccines may be administered without regard to timing of other vaccines, including simultaneous administration on the same day.¹³ If a COVID-19 vaccine is administered concomitantly with other vaccines, administer at a different injection site and, if possible, separate injection sites by ≥1 inch.¹³

Specific Drugs

Stability

Storage

Suspension for Injection

Consult prescribing information or EUA fact sheet for information on storage, handling, and stability of the vaccine.^{1 609} Various documents that describe the shipping, storage, and handling requirements and procedures for the Pfizer-BioNTech COVID-19 vaccine, including specifics about temperature requirements and temperature monitoring, thermal shipping containers, ultra-low-temperature freezers, and safe handling of dry ice, are available at [Web].

Actions

• Nucleoside-modified mRNA (modRNA) vaccine formulated in lipid nanoparticles (LNPs).^{1 3 6 7 10 11}

• The modRNA contained in the Pfizer-BioNTech COVID-19 vaccine encodes a membrane-anchored, full-length spike (S) glycoprotein receptor-binding domain (RBD) antigen of SARS-CoV-2 with 2 proline modifications that lock the S protein in an antigenically preferred prefusion conformation.^{1 3 10 11} Following IM injection, the LNPs in the vaccine enable delivery of the modRNA into host cells where it is released and translated to the encoded S antigen of SARS-CoV-2.^{1 3 11} The S antigen is then incorporated into cellular membranes and elicits an immune response to provide protection against SARS-CoV-2.^{1 3 11}

Advice to Patients

• Advise the vaccine recipient or caregiver to read the FDA-approved patient labeling or FDA Fact Sheet.^{1 609}

• Inform the vaccine recipient or caregiver of the potential benefits and risks of vaccination.^{1 609}

• Instruct the vaccine recipient or caregiver to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967 and www.vaers.hhs.gov.¹

• The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system.⁶⁰⁹ Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.⁶⁰⁹

• Advise patient to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.^{1 609}

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.^{1 609}

• Inform patients of other important precautionary information.^{1 609}

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Frequently asked questions

• Can you take Ibuprofen after the COVID booster vaccine?

Medical Disclaimer