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Pfizer-BioNTech COVID-19 Vaccine Clinical Studies

Clinical Studies

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

18.1 Efficacy 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 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 7 presents the specific demographic characteristics in the studied population.

Table 7: Demographics (population for the primary efficacy endpoint)*
Pfizer-BioNTech COVID-19 Vaccine
(N=18,242)
n (%)
Placebo
(N=18,379)
n (%)
*
All eligible randomized participants who receive all vaccination(s) as randomized within the predefined window, have no other important protocol deviations as determined by the clinician, and have no evidence of SARS-CoV-2 infection prior to 7 days after Dose 2.
100 participants 12 through 15 years of age with limited follow-up in the randomized population received at least one dose (49 in the vaccine group and 51 in the placebo group). Some of these participants were included in the efficacy evaluation depending on the population analyzed. They contributed to exposure information but with no confirmed COVID-19 cases, and did not affect efficacy conclusions.
Includes multiracial and not reported.
§
Number of participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease
  • Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis, and cystic fibrosis) or moderate to severe asthma
  • Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension)
  • Obesity (body mass index ≥30 kg/m2)
  • Diabetes (Type 1, Type 2 or gestational)
  • Liver disease
  • Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation)
Sex
  Male9318 (51.1)9225 (50.2)
  Female8924 (48.9)9154 (49.8)
Age (years)
  Mean (SD)50.6 (15.70)50.4 (15.81)
  Median52.052.0
  Min, max(12, 89)(12, 91)
Age group
  ≥12 through 15 years46 (0.3)42 (0.2)
  ≥16 through 17 years66 (0.4)68 (0.4)
  ≥16 through 64 years14,216 (77.9)14,299 (77.8)
  ≥65 through 74 years3176 (17.4)3226 (17.6)
  ≥75 years804 (4.4)812 (4.4)
Race
  White15,110 (82.8)15,301 (83.3)
  Black or African American1617 (8.9)1617 (8.8)
  American Indian or Alaska Native118 (0.6)106 (0.6)
  Asian815 (4.5)810 (4.4)
  Native Hawaiian or other Pacific Islander48 (0.3)29 (0.2)
  Other534 (2.9)516 (2.8)
Ethnicity
  Hispanic or Latino4886 (26.8)4857 (26.4)
  Not Hispanic or Latino13,253 (72.7)13,412 (73.0)
  Not reported103 (0.6)110 (0.6)
Comorbidities§
  Yes8432 (46.2)8450 (46.0)
  No9810 (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 8.

Table 8: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup –Participants Without Evidence of Infection and Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population
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).
*
Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
N = Number of participants in the specified group.
n1 = Number of participants meeting the endpoint definition.
§
Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
n2 = Number of participants at risk for the endpoint.
#
No confirmed cases were identified in adolescents 12 through 15 years of age.
Þ
Credible interval for vaccine efficacy (VE) was calculated using a beta-binomial model with a beta (0.700102, 1) prior for θ=r(1-VE)/(1+r(1-VE)), where r is the ratio of surveillance time in the active vaccine group over that in the placebo group.
ß
Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the surveillance time.
First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*
Pfizer-BioNTech COVID-19 VaccinePlacebo
SubgroupN=18,198 Cases
n1
Surveillance Time§ (n2)
N=18,325 Cases
n1
Surveillance Time§ (n2)
Vaccine Efficacy %
(95% CI)
  All subjects#8
2.214 (17,411)
162
2.222 (17,511)
95.0 (90.3, 97.6)Þ
  16 through 64 years7
1.706 (13,549)
143
1.710 (13,618)
95.1 (89.6, 98.1)ß
  65 years and older1
0.508 (3848)
19
0.511 (3880)
94.7 (66.7, 99.9)ß
First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection
Pfizer-BioNTech COVID-19 VaccinePlacebo
SubgroupN=19,965 Cases
n1
Surveillance Time§ (n2)
N=20,172 Cases
n1
Surveillance Time§ (n2)
Vaccine Efficacy %
(95% CI)
  All subjects#9
2.332 (18,559)
169
2.345 (18,708)
94.6 (89.9, 97.3)Þ
  16 through 64 years8
1.802 (14,501)
150
1.814 (14,627)
94.6 (89.1, 97.7)ß
  65 years and older1
0.530 (4044)
19
0.532 (4067)
94.7 (66.8, 99.9)ß

18.2 Efficacy in Adolescents 12 Through 15 Years of Age

A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 adolescents 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021.

The efficacy information in adolescents 12 through 15 years of age is presented in Table 9.

Table 9: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Blinded Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable Efficacy (7 Days) Population
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).
*
Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis.
N = Number of participants in the specified group.
n1 = Number of participants meeting the endpoint definition.
§
Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
n2 = Number of participants at risk for the endpoint.
#
Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted for surveillance time.
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without evidence of prior SARS-CoV-2 infection*
Pfizer-BioNTech COVID-19 Vaccine
N=1005
Cases
n1
Surveillance Time§ (n2)
Placebo
N=978
Cases
n1
Surveillance Time§ (n2)
Vaccine Efficacy %
(95% CI#)
Adolescents
12 through 15 years of age
0
0.154 (1001)
16
0.147 (972)

100.0 (75.3, 100.0)
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age with or without evidence of prior SARS-CoV-2 infection
Pfizer-BioNTech COVID-19 Vaccine
N=1119
Cases
n1
Surveillance Time§ (n2)
Placebo

N=1110
Cases
n1
Surveillance Time§ (n2)
Vaccine Efficacy %
(95% CI#)
Adolescents
12 through 15 years of age
0
0.170 (1109)
18
0.163 (1094)

100.0 (78.1, 100.0)

18.3 Immunogenicity in Adolescents 12 Through 15 Years of Age

In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers 1 month after Dose 2 in a randomly selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 10).

Table 10: Summary of Geometric Mean Ratio for 50% Neutralizing Titer – Comparison of Adolescents 12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity Subset) –Participants Without Evidence of Infection up to 1 Month After Dose 2 – Dose 2 Evaluable Immunogenicity Population
Pfizer-BioNTech COVID-19 Vaccine
12 Through 15 Years
n*=190
16 Through 25 Years
n*=170
12 Through 15 Years/16 Through 25 Years
AssayTime PointGMT
(95% CI)
GMT
(95% CI)
GMR§
(95% CI§)
Met Noninferiority Objective
(Y/N)
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; NAAT = nucleic-acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
Note: Participants who had no serological or virological evidence (up to 1 month after receipt of the last dose) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 were included in the analysis.
*
n = Number of participants with valid and determinate assay results for the specified assay at the given dose/sampling time point.
Protocol-specified timing for blood sample collection.
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
§
GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1 [12 through 15 years of age] – Group 2 [16 through 25 years of age]) and the corresponding CI (based on the Student t distribution).
Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.
#
SARS-CoV-2 50% neutralization titers (NT50) were determined using the SARS-CoV-2 mNeonGreen Virus Microneutralization Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus neutralization is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of the virus is neutralized.
SARS-CoV-2 neutralization assay - NT50 (titer)#1 month after Dose 21239.5
(1095.5, 1402.5)
705.1
(621.4, 800.2)
1.76
(1.47, 2.10)
Y

Indications and Usage

1 AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused...

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

...
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Dosage Forms and Strengths

3 DOSAGE FORMS AND STRENGTHS

Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. After preparation, a single dose is 0.3 mL.

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Contraindications

4 CONTRAINDICATIONS

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...

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Warnings and Precautions

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic...

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Adverse Reactions

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious...

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Drug Interactions

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.

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Use in Specific Populations

11 USE IN SPECIFIC POPULATIONS

11.1 Pregnancy

Risk...

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Description

13 DESCRIPTION

The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to...

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Clinical Pharmacology

14 CLINICAL PHARMACOLOGY

14.1 Mechanism of Action

The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles,...

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Clinical Studies

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

18.1 Efficacy in Participants 16 Years of Age and Older

Study 2 is a multicenter,...

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How Supplied/Storage and Handling

19 HOW SUPPLIED/STORAGE AND HANDLING

Pfizer-BioNTech COVID-19 Vaccine Suspension for Intramuscular Injection, Multiple Dose Vials are supplied in a carton containing 25 multiple...

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Patient Counseling Information

20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.

The vaccination provider must include vaccination...

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Emergency Use Authorization Fact Sheet for Recipients and Caregivers

FACT SHEET FOR RECIPIENTS AND CAREGIVERS

EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT...

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Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers)

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)

EMERGENCY...

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Contact Information

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

21 CONTACT INFORMATION

For...

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