What is the Pfizer-BioNTech COVID-19 vaccine?

The Pfizer-BioNTech COVID-19 vaccine is the first of its kind; an mRNA vaccine that uses modified genetic material to induce the body to manufacture virus proteins. These proteins make the body develop antibodies to coronavirus, protecting from COVID-19
The Pfizer-BioNTech COVID-19 vaccine is the first of its kind; an mRNA vaccine that uses modified genetic material to induce the body to manufacture virus proteins. These proteins make the body develop antibodies to coronavirus, protecting from COVID-19

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 16 years of age and older.

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.

What are the side effects of the Pfizer-BioNTech COVID 19 Vaccine?

WARNING

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, and lymphadenopathy.

Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine.

What is the dosage for the Pfizer-BioNTech COVID-19 Vaccine?

The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart.

Storage and Handling

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

Do not refreeze thawed vials.

Frozen Vials Prior to Use

Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and store in an ultra-low temperature freezer between -80°C to -60°C (-112°F to -76°F). Vials must be kept frozen between -80°C to -60°C (-112°F to -76°F) and protected from light until ready to use. If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled 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 -90°C to -60°C (-130°F to -76°F). 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 the refrigerator [2°C to 8°C (35°F to 46°F)] for up to 5 days (120 hours). A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time.

Thawed at Room Temperature

For immediate use, thaw undiluted vials at room temperature [up to 25°C (77°F)] 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 hours. After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution.

  • During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
  • Any vaccine remaining in vials must be discarded after 6 hours.
  • Do not refreeze.

Dosing and Schedule

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL each) 3 weeks apart.

There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series.

What drugs interact with the Pfizer-BioNTech COVID-19 Vaccine?

There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

Is the Pfizer-BioNTech COVID-19 Vaccine safe to use while pregnant or breastfeeding?

Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20% , respectively.

Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

Summary

The Pfizer-BioNTech COVID 19 vaccine uses RNA -- a type of genetic coding molecule -- to get the body to produce its own copies of a certain coronavirus protein. Harmless by themselves, the protein molecules spur the immune system to develop antibodies. These antibodies protect you against COVID-19 (or at least, the most severe symptoms). The vaccine is not approved, but authorized for emergency use to combat the coronavirus pandemic.

Treatment & Diagnosis

Medications & Supplements

Prevention & Wellness

Health Solutions From Our Sponsors

FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Medically Reviewed on 1/6/2021
References
All sections courtesy of the U.S. Food and Drug Administration