The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Cardiac Disorders: myocarditis, pericarditis
Gastrointestinal Disorders: diarrhea, vomiting
Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)
Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm) Nervous System Disorders: syncope
See Overall Safety Summary (Section 6) for additional information.
The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following administration of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to the Vaccine Adverse Event Reporting System (VAERS):
- Vaccine administration errors whether or not associated with an adverse event
- Serious adverse events* (irrespective of attribution to vaccination)
- Cases of myocarditis
- Cases of pericarditis
- Cases of Multisystem Inflammatory Syndrome (MIS) in children and adults
- Cases of COVID-19 that result in hospitalization or death
* Serious adverse events are defined as:
- A life-threatening adverse event
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect
- An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent 1 of the outcomes listed above
Instructions for Reporting to VAERS
The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using 1 of the following methods:
- Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
- If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to email@example.com.
IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include:
- Patient demographics (e.g., patient name, date of birth)
- Pertinent medical history
- Pertinent details regarding admission and course of illness
- Concomitant medications
- Timing of adverse event(s) in relationship to administration of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent
- Pertinent laboratory and virology information
- Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.
The following steps are highlighted to provide the necessary information for safety tracking:
- In Box 17, provide information on Pfizer-BioNTech COVID-19 Vaccine, Bivalent and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within 1 month prior.
- In Box 18, description of the event:
- Write “Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA” as the first line.
- Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above.
- Contact information:
- In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report.
- In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event.
- In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider’s office address).
Other Reporting Instructions
Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.
To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc.
|Website||Fax number||Telephone number|
There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines.
No data are available regarding the use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent during 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. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (modRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study.
Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent on the breastfed infant or on milk production/excretion.
Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in adolescents 12 through 17 years of age is based on the safety and effectiveness of Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months of age and older and safety and immunogenicity data with the bivalent vaccine (Original and Omicron BA.1) in adults 55 years of age and older.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent is not authorized for use in individuals younger than 12 years of age.
Clinical studies of Pfizer-BioNTech COVID-19 Vaccine include participants 65 years of age and older who received the primary series and their data contributes to the overall assessment of safety and effectiveness of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent [see Overall Safety Summary (6.1) and Clinical Trial Results and Supporting Data for EUA (18.1)]. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older.
A clinical study with the bivalent vaccine (Original and Omicron BA.1) included 197 individuals 65 years of age and older and their data contribute to the overall assessment of safety and effectiveness of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is supplied as a sterile, frozen suspension in single dose and multiple dose vials with gray caps and labels with gray borders.
Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent is formulated to contain 15 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 15 mcg of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). The S-proteins of the SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 are identical. Each dose contains 30 mcg modRNA.
Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in single dose and multiple dose vials also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.19 mg cholesterol), 0.06 mg tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose.
The Pfizer-BioNTech COVID-19 Vaccine, Bivalent does not contain preservative. The vial stoppers are not made with natural rubber latex.
The modRNA in the Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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.
The effectiveness of a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is based on effectiveness of primary and booster vaccination with Pfizer-BioNTech COVID-19 Vaccine and immunogenicity of a second booster dose with the bivalent vaccine (Original and Omicron BA.1).
18.1 Efficacy of Primary Series of Pfizer-BioNTech COVID-19 Vaccine in Participants 16 Years of Age and Older
Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older. Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) or placebo separated by 21 days. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19.
The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Table 5 presents the specific demographic characteristics in the studied population.
|Pfizer-BioNTech COVID-19 Vaccine †(N=18,242)n (%)||Placebo(N=18,379)n (%)|
|Male||9318 (51.1)||9225 (50.2)|
|Female||8924 (48.9)||9154 (49.8)|
|Mean (SD)||50.6 (15.70)||50.4 (15.81)|
|Min, max||(12, 89)||(12, 91)|
|≥12 through 15 years ‡||46 (0.3)||42 (0.2)|
|≥16 through 17 years||66 (0.4)||68 (0.4)|
|≥16 through 64 years||14,216 (77.9)||14,299 (77.8)|
|≥65 through 74 years||3176 (17.4)||3226 (17.6)|
|≥75 years||804 (4.4)||812 (4.4)|
|White||15,110 (82.8)||15,301 (83.3)|
|Black or African American||1617 (8.9)||1617 (8.8)|
|American Indian or Alaska Native||118 (0.6)||106 (0.6)|
|Asian||815 (4.5)||810 (4.4)|
|Native Hawaiian or other Pacific Islander||48 (0.3)||29 (0.2)|
|Other §||534 (2.9)||516 (2.8)|
|Hispanic or Latino||4886 (26.8)||4857 (26.4)|
|Not Hispanic or Latino||13,253 (72.7)||13,412 (73.0)|
|Not reported||103 (0.6)||110 (0.6)|
|Yes||8432 (46.2)||8450 (46.0)|
|No||9810 (53.8)||9929 (54.0)|
The population in the primary efficacy analysis included all participants 12 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020, 16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began enrollment from October 15, 2020.
The vaccine efficacy information is presented in Table 6.
|Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).|
|First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection *|
|Subgroup||Pfizer-BioNTech COVID-19 Vaccine †N ‡=18,198Casesn1§Surveillance Time ¶ (n2#)||PlaceboN ‡=18,325Casesn1§Surveillance Time ¶ (n2#)||Vaccine Efficacy %(95% CI)|
|All subjects Þ||82.214 (17,411)||1622.222 (17,511)||95.0(90.3, 97.6)ß|
|16 through 64 years||71.706 (13,549)||1431.710 (13,618)||95.1(89.6, 98.1)à|
|65 years and older||10.508 (3848)||190.511 (3880)||94.7(66.7, 99.9)à|
|First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection|
|Subgroup||Pfizer-BioNTech COVID-19 Vaccine †N ‡=19,965Casesn1§Surveillance Time ¶ (n2#)||PlaceboN ‡=20,172Casesn1§Surveillance Time ¶ (n2#)||Vaccine Efficacy %(95% CI)|
|All subjects Þ||92.332 (18,559)||1692.345 (18,708)||94.6(89.9, 97.3)ß|
|16 through 64 years||81.802 (14,501)||1501.814 (14,627)||94.6(89.1, 97.7)à|
|65 years and older||10.530 (4044)||190.532 (4067)||94.7(66.8, 99.9)à|
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