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Class: Biological Therapy

Generic Name: BNT162b2

Name: Pfizer-BioNTech COVID-19 Vaccine

For which conditions is this drug used? The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for immunization to prevent COVID-19 in individuals 16 and older. The EAU permits the emergency use of the vaccine although it has not been FDA approved. There are currently no FDA approved vaccines for COVID-19.

FDA Expands Pfizer-BioNTech COVID-19 Vaccine EUA to Include Adolescents to include adolescents 12 to 15 years of age. Previously, the vaccine had only been authorized to prevent COVID-19 in patients 16 years of age and older.

The safety of the vaccine in this patient population was based on data from 2260 adolescent participants enrolled in an ongoing randomized, placebo-controlled study in the United States. Participants were randomly assigned to receive either the vaccine (n=1131) or placebo (n=1129) and more than half were followed for at least 2 months following the second dose.

The most common adverse reactions reported in the trial included injection site pain, tiredness, headache, chills, muscle pain, fever, and joint pain. These side effects typically lasted 1 to 3 days and occurred more frequently following the second dose.

As for effectiveness, analysis of immunogenicity data showed that immune responses to the vaccine in the adolescent group (n=190) were non-inferior to those observed in older participants (16 to 25 years; n=170). Additionally, a review of COVID-19 cases that occurred 7 days after the second dose among 12 to 15 year olds without evidence of prior SARS-CoV-2 infection demonstrated that the vaccine was 100% effective in preventing COVID-19. No cases occurred among the 1005 participants who received the vaccine, while 16 were reported among the 978 placebo recipients.

What is the mechanism of action? The Pfizer-BioNTech COVID-19 Vaccine works by using genetic material (messenger-RNA) to initiate the body to create a protein from the virus which then promotes an immune system response to recognize the virus and learn to attack the virus. There are no vaccines using this technology that have ever been approved by the FDA.

How is the Pfizer-BioNTech COVID-19 Vaccine typically given (administered)? Pfizer-BioNTech COVID-19 Vaccine is an intramuscular injection given in two doses, three weeks apart. Individuals who have received one dose of the Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of the Pfizer-BioNTech COVID-19 Vaccine. There is no data to support interchangeability of this vaccine with other COVID-19 vaccines.

How are patients typically monitored? Patients will be monitored for immediate allergic reactions after receiving the Pfizer-BioNTech COVID-19 Vaccine.

What side effects have been reported? Side effects that have been reported include the following:

  • Injection site pain
  • Fatigue
  • Headache
  • Muscle pain
  • Chills
  • Joint pain
  • Fever
  • Injection site swelling
  • Injection site redness
  • Nausea
  • Feeling unwell
  • Swollen lymph nodes

It is important to report side effects to your healthcare provider. Some patients may experience other side effects that are not listed here and additional side effects may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

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What can patients do to help alleviate or prevent discomfort and side effects?

  • If you have a history of severe allergic reaction to any component of the Pfizer-BioNTech COVID-19 Vaccine, tell your healthcare provider and do not receive the vaccine. Components of the Pfizer-BioNTech COVID-19 Vaccine include mRNA, lipids, potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate and sucrose.

Are there any special precautions patients should be aware of before receiving the Pfizer-BioNTech COVID-19 Vaccine?

  • Tell your vaccination provider if any of the following apply to you: Have any allergies Have a fever Have a bleeding disorder or are on a blood thinner Are immunocompromised Are on a medicine that affects your immune system Are pregnant or plan to become pregnant Are breastfeeding Have received another COVID-19 vaccine
  • Tell your healthcare provider if you have a history of a severe allergic reaction to any component of the Pfizer-BioNTech COVID-19 Vaccine.
  • Individuals who are immunocompromised, should be aware that they could have a diminished immune response to the vaccine.
  • The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients from contracting COVID-19.
  • At this time, the vaccine-associated risks are unknown in individuals who are pregnant or breastfeeding.
  • The EUA of the Pfizer-BioNTech COVID-19 Vaccine does not include use in individuals younger than 16.

When should patients notify their physician? Notify your physicians of any signs of severe allergic reaction that include difficulty breathing, swelling of your face and throat, rapid heartbeat, rash, dizziness and weakness. You should also notify your physician of any side effects that bother you or do not go away.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 12/20.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.