The Pfizer-BioNTechCOVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
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Important Safety Information
Do not administer Pfizer-BioNTechCOVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTechCOVID-19 Vaccine
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-BioNTechCOVID-19 Vaccine
Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTechCOVID-19 Vaccine
The Pfizer-BioNTechCOVID-19 Vaccine may not protect all vaccine recipients
In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)
Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTechCOVID-19 Vaccine outside of clinical trials
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTechCOVID-19 Vaccine
Available data on Pfizer-BioNTechCOVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
Data are not available to assess the effects of Pfizer-BioNTechCOVID-19 Vaccine on the breastfed infant or on milk production/excretion
There are no data available on the interchangeability of the Pfizer-BioNTechCOVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTechCOVID-19 Vaccine should receive a second dose of Pfizer-BioNTechCOVID-19 Vaccine to complete the vaccination series
Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTechCOVID-19 Vaccine EUA” in the description section of the report
Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTechCOVID-19 Vaccine Administration Under Emergency Use Authorization
Before administration of Pfizer-BioNTechCOVID-19 Vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com
Ensuring the Authenticity of Pfizer-BioNTechCOVID-19 Vaccine
Pfizer is committed to patient safety and ensuring that people have accurate information about the
investigational Pfizer-BioNTechCOVID-19 Vaccine, including how it is accessed and administered. We
are actively monitoring for fraudulent offers of illegitimate Pfizer-BioNTechCOVID-19 Vaccines to
protect patients from products that might be dangerous and lead to serious and life-threatening harm
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 12 years of age and older.
The Pfizer-BioNTechCOVID-19 Vaccine is only administered intramuscularly by a healthcare professional
The Pfizer-BioNTechCOVID-19 Vaccine is not taken orally and is not available in a capsule or tablet
Authentic Pfizer-BioNTechCOVID-19 Vaccines, manufactured by Pfizer Inc., will include the Pfizer and BioNTech names on
the label and are dispensed in a vial with a purple cap
Ensure the safety of the vaccine vials by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use. To prevent counterfeits, discard vaccine vials in sharps containers and empty vial trays as medical waste or deface or safely crush all materials so they cannot be reused. Remember, Pfizer-BioNTechCOVID-19 Vaccines are only available through government-authorized vaccination centers – such as hospitals, outpatient clinics, pharmacies, and community vaccination locations. The Pfizer-BioNTechCOVID-19 Vaccine can only be administered by licensed healthcare professionals, or other individuals that are approved vaccinators, at government-authorized vaccination sites. Individual doses are not for sale
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
Emergency Use Authorization Holder
The Pfizer-BioNTechCOVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.
This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.