Pfizer-BioNTech COVID-19 Vaccine

Generic name: COVID-19 Vaccine, MRNA
Brand names: Comirnaty
Dosage form: suspension for intramuscular injection
Drug class: Viral vaccines

Usage of Pfizer-BioNTech COVID-19 Vaccine

The Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula (COVID-19 Vaccine, mRNA) is a vaccine made by Pfizer and BioNTech that may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. The Pfizer-BioNTech COVID-19 Vaccine is an FDA-approved vaccine for adults and adolescents aged 12 years and also has emergency use authorization (EUA) for children aged 6 months to 11 years.

This updated vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 and trials have shown it shows substantially improved responses against multiple Omicron XBB-related sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent vaccine. Pre-clinical data also demonstrate that serum antibodies induced by the 2023-2024 updated vaccine effectively neutralize the recently emerged Omicron BA.2.86 (Pirola) and the globally dominant Omicron-related EG.5.1 (Eris) subvariant when compared to the previous bivalent vaccine.

For individuals previously vaccinated with any COVID-19 vaccine, administer the Pfizer-BioNTech COVID-19 Vaccine at least 2 months after the last dose of the COVID-19 vaccine.

The Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula is indicated as a single dose for most adults and children 5 years of age and older. Children aged less than 5 may be eligible to receive additional doses of this vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.

The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) was FDA-approved and granted EUA on September 11, 2023.

Pfizer-BioNTech COVID-19 Vaccine side effects

The Pfizer-BioNTech COVID-19 vaccine may cause severe side effects including allergic reactions. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination.

Signs of a severe allergic reaction may include:

  • Difficulty breathing
  • Swelling of your face and throat
  • A fast heartbeat
  • A bad rash all over your body
  • Dizziness and weakness.

    • Myocarditis and pericarditis

    Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) are rare side effects that have occurred in some people who have received the vaccine. In most, symptoms began within a few days following the vaccine, and symptoms resolved with conservative management. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine:

  • Chest pain
  • Shortness of breath
  • Feelings of having a fast-beating, fluttering, or pounding heart.

    • Other common side effects include:

  • Pain at the injection site (up to 91%)
  • Tiredness (up to 78%)
  • Headache (up to 76%)
  • Chills (up to 49%)
  • Muscle pain (up to 46%)
  • Joint pain (up to 28%)
  • Fever (up to 24%)
  • Injection site swelling (up to 12%)
  • Injection site redness (up to 10%).

    • These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur.

    If you experience a severe allergic reaction, call 911, or go to the nearest hospital.

    Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

    Report vaccine side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html.

    Before taking Pfizer-BioNTech COVID-19 Vaccine

    You should not get the Pfizer-BioNTech COVID-19 Vaccine if you have had a severe allergic reaction to a previous dose of the Pfizer-BioNTech COVID-19 Vaccine (also called Comirnaty) or any of the components of the vaccine (see "Ingredients' below).

    There is insufficient data to inform women about vaccine-associated risks during pregnancy, but very limited animal studies have revealed no evidence of harm to the fetus. Pregnant women infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant women.

    It is not known whether the Pfizer-BioNTech COVID-19 Vaccine is excreted in human milk or its effects on the breastfed infant or milk production/excretion. Consider the benefits versus the risks.

    Safety and effectiveness have not been established in children less than 12 years of age. Evidence from clinical studies strongly suggests that a single dose of the Pfizer-BioNTech COVID-19 Vaccine is ineffective in individuals younger than 6 months of age.

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    How to use Pfizer-BioNTech COVID-19 Vaccine

    The Pfizer-BioNTech COVID-19 Vaccine is given to you as an injection into a muscle, usually the deltoid muscle of the upper arm.

  • The usual dosage is 0.3mL

    • Warnings

    Contraindicated in people who have had a severe allergic reaction (such as anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

    Postmarketing data has revealed there is an increased risk of myocarditis and pericarditis, particularly within the first week following vaccination. The highest observed risk for the Pfizer-BioNTech COVID-19 Vaccine is in males aged 12 years through 17 years of age.

    Fainting may occur in association with vaccine administration, including the Pfizer-BioNTech COVID-19 Vaccine. Tell your healthcare provider if you are prone to fainting and take measures to protect yourself from injury (such as lying down).

    Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have less of a response to the Pfizer-BioNTech COVID-19 Vaccine.

    What other drugs will affect Pfizer-BioNTech COVID-19 Vaccine

    Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Tell your healthcare provider if you take:

  • a blood thinner
  • a medicine that affects your immune system.

    • Also, tell your healthcare provider if you have received any other COVID-19 vaccines.

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