Clinical Trials | CVDvaccine-US.com

AUTHORIZED FOR EMERGENCY USE²

The emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and 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. ²

*The licensed COMIRNATY^® vaccine has the same formulation as the authorized vaccine Pfizer-BioNTech COVID-19 Vaccine, and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct, with certain differences that do not impact safety or effectiveness.

Clinical Efficacy & Safety

In individuals 16 years of age and older¹

Please see the full Prescribing Information to see the clinical trial design and efficacy (Section 14 - pg. 15) and safety (Section 6 - pg. 6).¹

In individuals 12 through 15 years of age²

Please see the EUA Fact Sheet for Vaccination Providers to see the clinical trial design and efficacy (Section 18 - pg. 34) and safety (Section 6 - pg. 21).²

Important Safety Information

Indication & Authorized Use

Important Safety Information
- Known history of a severe allergic reaction (eg, anaphylaxis) to any component of COMIRNATY^® is a contraindication.
- Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.
  
  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).
- Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
- Syncope (fainting) may occur in association with administration of injectable vaccines, including this vaccine. 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 vaccine.
- The vaccine may not protect all vaccine recipients.
- In clinical studies of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) 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 clinical studies of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) 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%).
- In a clinical study evaluating administration of a booster dose in participants 18 through 55 years of age, the most commonly reported adverse reactions (≥10%) following the dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%).
- In a clinical study of adolescents 12 through 15 years of age, the most commonly reported adverse reactions 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%).
- Before administration of the vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers (12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age).
- Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://vaers.hhs.gov/reportevent.html or call 1-800-822-7967.
Indication & Authorized Use

The FDA-approved COMIRNATY^® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

Indication

COMIRNATY^® 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 16 years of age and older.

Authorized Use

COMIRNATY^® (COVID-19 Vaccine, mRNA) is also authorized for emergency use to provide:
- a two-dose primary series in individuals 12 through 15 years
- a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
- a single booster dose in individuals:
  
  65 years of age and older
  
  18 through 64 years of age at high risk of severe COVID-19
  
  18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19
The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 12 years of age and older to provide:
- a two-dose primary series in individuals 12 years of age and older
- a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
- a single booster dose in individuals:
  
  65 years of age and older
  
  18 through 64 years of age at high risk of severe COVID-19
  
  18 through 64 years of age at risk of serious complications of COVID-19 in the setting of frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19