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BioNTech & Pfizer COVID Connect SMS Text Messaging Program Terms & Conditions

  1. Joining the BioNTech & Pfizer COVID Connect SMS text messaging program is optional and is not required or a condition to make any purchase. By opting in to the BioNTech & Pfizer COVID Connect SMS text messaging program, you consent to receive up to 8 text messages per month from Pfizer Inc. Such messages may be marketing related and may include, for example, updates regarding Product Availability.
  2. To stop receiving text messages, text STOP to 833-658-1293. DOING SO WILL ONLY OPT YOU OUT OF THE BioNTech & Pfizer COVID Connect SMS text messaging program; you will remain opted in to any other Pfizer Inc. text message program(s) to which you separately opted in.
  3. To request more information or to obtain help, text HELP to 833-658-1293.
  4. You agree to Pfizer’s Privacy Policy, available at www.Pfizer.com/privacy, which is hereby incorporated as part of these terms.
  5. You represent that you are a US healthcare provider and the account holder for the mobile telephone number(s) that you provide to opt-in to the texting program. You are responsible for notifying Pfizer Inc. immediately if you change your mobile telephone number. You may notify Pfizer Inc. of a number change by calling 833-991-1933.
  6. Message and data rates may apply to each text message sent or received in connection with the texting program, as provided in your mobile telephone service rate plan (please contact your mobile telephone carrier for pricing plans), in addition to any applicable roaming charges. Charges are both billed and payable to your mobile service provider or deducted from your prepaid account. Pfizer Inc. does not impose a separate fee for sending text messages.
  7. Alerts sent via SMS may not be delivered if the mobile phone is not in range of a transmission site, or if sufficient network capacity is not available at a particular time. Even within a coverage area, factors beyond the control of the wireless carrier may interfere with message delivery, including the customer’s equipment, terrain, proximity to buildings, foliage, and weather. The wireless carrier does not guarantee that alerts will be delivered and will not be held liable for delayed or undelivered messages.
  8. For information on data collection and use, please read Pfizer Inc.’s full corporate Privacy Policy at www.Pfizer.com/privacy, which is incorporated by reference into these Terms.
  9. Pfizer Inc. will not be liable for any delays in the receipt of any SMS messages, as delivery is subject to effective transmission from your network operator.
  10. You agree to indemnify Pfizer Inc. and parties texting on its behalf in full for all claims, expenses, and damages related to or caused in whole or in part by your failure to notify Pfizer Inc. if you change your telephone number, including but not limited to all claims, expenses, and damages related to or arising under the Telephone Consumer Protection Act.
  11. The service may not be available through all mobile carriers.
  12. Pfizer Inc. may suspend or terminate your receipt of text messages if it believes you are in breach of these BioNTech & Pfizer COVID Connect SMS text messaging program Terms and Conditions. Your receipt of text messages is also subject to termination in the event that your mobile telephone service terminates or lapses. Pfizer Inc. reserves the right to modify or discontinue, temporarily or permanently, all or any part of the text messaging services you receive, with or without notice.
  13. Pfizer Inc. may revise, modify, or amend these BioNTech & Pfizer COVID Connect SMS text messaging program Terms and Conditions at any time. Any such revision, modification, or amendment shall take effect when it is posted to Pfizer Inc.’s website. You agree to review these BioNTech & Pfizer COVID Connect SMS text messaging program Terms and Conditions periodically to ensure that you are aware of any changes. Your continued consent to receive text messages will indicate your acceptance of those changes.

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Visit PfizerMedicalInformation.com
or call 1-800-438-1985

Shipment Support US Trade Customer Service Shipment Support US Trade Customer Service

Shipment Support
US Trade Customer Service

Call 1-800-666-7248

General Product Inquiries General Product Inquiries

General Product Inquiries

Call 1-877-829-2619

Pfizer Customer Service Pfizer Customer Service

Pfizer Customer Service

Call 1-800-879-3477

Medical Information Medical Information

Medical Information

Visit PfizerMedicalInformation.com
or call 1-800-438-1985

General Product Inquiries General Product Inquiries

General Product Inquiries

Call 1-877-829-2619

Shipment Support US Trade Customer Service Shipment Support US Trade Customer Service

Shipment Support
US Trade Customer Service

Call 1-800-666-7248

Pfizer Customer Service Pfizer Customer Service

Pfizer Customer Service

Call 1-800-879-3477

INDICATION AND AUTHORIZED USE

Indication & Authorized Use

Important Safety Information

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Important Safety Information

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INDICATION AND AUTHORIZED USE


COMIRNATY® (COVID-19 Vaccine, mRNA)


Indication & Authorized Use

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

Authorized Use

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent are authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Interchangeability of COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine (Primary Series for Individuals 12 Years of Age and Older)

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

Age-Specific Vaccine Presentation Information

Because of the potential for vaccine administration errors, including dosing errors, vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.



Important Safety Information

Do not administer Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY (COVID-19 Vaccine, mRNA), or Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccines.

Management of Acute Allergic Reactions

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, COMIRNATY, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Monitor vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Myocarditis and Pericarditis

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

Syncope

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.

Altered Immunocompetence

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

Limitation of Effectiveness

Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine recipients.

Adverse Reactions

The safety of a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (individuals 5 years of age and older) and for the third dose of the primary series in individuals 6 months through 4 years of age is based on:

  • safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1),
  • safety data from clinical trials which evaluated primary (6 months of age and older) and booster (5 years of age and older) vaccination with Pfizer-BioNTech COVID-19 Vaccine, and
  • postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent

The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

In a clinical study (3 mcg modRNA) of participants 6 through 23 months of age, adverse reactions following administration of any dose of Pfizer-BioNTech COVID-19 Vaccine included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).

In a clinical study (3 mcg modRNA) of participants 2 through 4 years of age, adverse reactions following administration of any dose of Pfizer-BioNTech COVID-19 Vaccine included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).

In a clinical study (10 mcg modRNA) of participants 5 through 11 years of age, adverse reactions following administration of any primary series dose of Pfizer-BioNTech COVID-19 Vaccine included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).

In a clinical study (10 mcg modRNA) of participants 5 through 11 years of age, adverse reactions following administration of a single booster dose of Pfizer-BioNTech COVID-19 Vaccine were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%), injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).

In clinical studies (30 mcg modRNA) of participants 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) following any dose of Pfizer-BioNTech COVID-19 Vaccine were 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%), and injection site redness (8.6%).

In clinical studies (30 mcg modRNA) of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) following any dose of Pfizer-BioNTech COVID-19 Vaccine were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).

In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose of Pfizer-BioNTech COVID-19 Vaccine were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%). Severe allergic reactions (including anaphylaxis), myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine.

In clinical studies (30 mcg modRNA) of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) following any dose of Pfizer-BioNTech COVID-19 Vaccine were pain at the injection site (78.2%), fatigue (56.9%), headache (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).

The clinical study (30 mcg modRNA) that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants greater than 55 years of age. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).

Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), syncope, and dizziness have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of Pfizer-BioNTech COVID-19 Vaccine and post authorization use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.


EUA Fact Sheet for Vaccination Providers


Full Prescribing Information


EUA Fact Sheet for Recipients and Caregivers




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