Vaccine Information: BOOSTRIX

BOOSTRIX- clostridium tetani toxoid antigen (formaldehyde inactivated), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) and bordetella pertussis pertactin antigen (formaldehyde inactivated) suspension
GlaxoSmithKline Biologicals SA

1 INDICATIONS AND USAGE

BOOSTRIX is indicated for active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Preparation for Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the vaccine if either of these conditions exist. Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 0.5-mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.

2.2 Administration, Dose, and Schedule

BOOSTRIX is administered as a 0.5-mL intramuscular injection into the deltoid muscle of the upper arm.

An initial dose of BOOSTRIX is administered 5 years or more after the last dose of the Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) series or 5 years or more after a dose of Tetanus and Diphtheria Toxoids Adsorbed (Td).

BOOSTRIX may be administered as an additional dose 9 years or more after the initial dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap).

BOOSTRIX may be administered for tetanus prophylaxis for wound management. For management of a tetanus-prone wound, a dose of BOOSTRIX may be administered if at least 5 years have elapsed since previous receipt of a tetanus toxoid-containing vaccine.

2.3 Additional Dosing Information

The use of BOOSTRIX as a primary series or to complete the primary series for diphtheria, tetanus, or pertussis has not been established.

3 DOSAGE FORMS AND STRENGTHS

BOOSTRIX is a suspension for injection available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

A severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or any component of this vaccine is a contraindication to administration of BOOSTRIX [see Description (11)]. Because of the uncertainty as to which component of the vaccine might be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered.

4.2 Encephalopathy

Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis antigen-containing vaccine, including BOOSTRIX.

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute hypersensitivity or anaphylactic reaction occur following the administration of BOOSTRIX.

5.2 Latex

The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

5.3 Guillain-Barré Syndrome and Brachial Neuritis

If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barré syndrome may be increased following a subsequent dose of tetanus toxoid-containing vaccine, including BOOSTRIX. A review by the Institute of Medicine (IOM) found evidence for a causal relationship between receipt of tetanus toxoid and both Guillain-Barré syndrome and brachial neuritis.1

5.4 Progressive or Unstable Neurologic Disorders

Progressive or unstable neurologic conditions (e.g., cerebrovascular events, acute encephalopathic conditions) are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. It is not known whether administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder might hasten manifestations of the disorder or affect the prognosis. Administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.

5.5 Arthus-Type Hypersensitivity

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have a high serum tetanus antitoxin level and should not receive BOOSTRIX or other tetanus toxoid-containing vaccines unless at least 10 years have elapsed since the last dose of tetanus toxoid-containing vaccine.

5.6 Altered Immunocompetence

As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.

5.7 Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including BOOSTRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Table 1 provides an overview of the studies that evaluated the safety of BOOSTRIX in various populations.

Table 1. Studies Conducted with BOOSTRIXa
a For details regarding study design and comparator vaccines, see Tables 2-7 and [see Clinical Studies (14.2, 14.3, 14.4, 14.5)].

Clinical Studies

Age

(Years)

Trial Arms (Number of Subjects Vaccinated)

Initial-Dose Studies

U.S. Adolescent Study (NCT00109330)

10 to 18

BOOSTRIX (3,080)

Td (1,034)

German Adolescent Study (NCT00263679)

10 to 12

BOOSTRIX (319)

U.S. Adult Study (NCT00346073)

19 to 64

BOOSTRIX (1,522)

Tdap (762)

U.S Elderly Study (NCT00835237)

≥65

BOOSTRIX (887)

Td (445)

Revaccination Studies (all subjects were vaccinated with BOOSTRIX and trial arms were defined based on initial-dose vaccination; subjects in the Control trial arm received a first dose of BOOSTRIX)

U.S. Revaccination Study – 10 Years after Initial Td or BOOSTRIX Dose (NCT01738477)

20 to 29

BOOSTRIX (128)

Td (37)

U.S. Revaccination Study – 9 Years after Initial BOOSTRIX or Tdap Dose (NCT00489970)

28 to 73

BOOSTRIX (309)

Tdap (138)

Control (362)

Concomitant Vaccine Studies

Concomitant Vaccination with Meningococcal Conjugate Vaccine (MCV4) (NCT00282295)

11 to 18

BOOSTRIX+MCV4 (446)

BOOSTRIX→MCV4 (446)

MCV4→BOOSTRIX (449)

Concomitant Vaccination with Inactivated Trivalent Influenza Vaccine (TIV) (NCT00385255)

19 to 64

BOOSTRIX+TIV (748)

TIV→BOOSTRIX (749)

In these studies, subjects were monitored for solicited adverse events using standardized diary cards during the 4 days (Days 0 to 3) or 15 days (Days 0 to 14) following vaccination. Unsolicited adverse events were monitored for the 31-day period following vaccination (Days 0 to 30).

Serious adverse events were monitored for 6 months post-vaccination in the initial-dose studies (NCT00109330, NCT00263679, NCT00346073, NCT00835237) and for the 31-day (Days 0 to 30) period post-vaccination in the revaccination (NCT01738477, NCT00489970) and the concomitant-vaccine administration studies (NCT00282295, NCT00385255).

Initial-Dose Studies

In clinical studies, 4,949 adolescents (aged 10 to 18 years) and 4,076 adults (aged 19 years and older) were vaccinated with a single dose of BOOSTRIX. Of these adolescents, 1,341 were vaccinated with BOOSTRIX in a coadministration study with meningococcal conjugate vaccine [see Drug Interactions (7.1), Clinical Studies (14.4)]. Of these adults, 1,104 were aged 65 years and older [see Clinical Studies (14.2)]. A total of 860 adults aged 19 years and older received concomitant vaccination with BOOSTRIX and influenza vaccines in a coadministration study [see Drug Interactions (7.1), Clinical Studies (14.5)].

Solicited Adverse Events in the U.S. Adolescent Study: Table 2 presents the solicited local adverse reactions and general adverse events within 15 days of vaccination with BOOSTRIX or Td vaccine for the total vaccinated cohort.

The primary safety endpoint was the incidence of Grade 3 pain (spontaneously painful and/or prevented normal activity) at the injection site within 15 days of vaccination. Grade 3 pain was reported in 4.6% of those who received BOOSTRIX compared with 4.0% of those who received the Td vaccine. The difference in rate of Grade 3 pain was within the pre-defined clinical limit for non-inferiority (upper limit of the 95% CI for the difference [BOOSTRIX minus Td] ≤4%).

Table 2. Rates of Solicited Local Adverse Reactions or General Adverse Events within the 15-Daya Post-Vaccination Period in Adolescents Aged 10 to 18 Years (Total Vaccinated Cohort)
Td = Tetanus and Diphtheria Toxoids Adsorbed manufactured by MassBiologics.n = Number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.Grade 2 = Local: painful when limb moved; General: interfered with normal activity.Grade 3 = Local: spontaneously painful and/or prevented normal activity; General: prevented normal activity.a Day of vaccination and the next 14 days.b Statistically significantly higher (P <0.05) following BOOSTRIX as compared with Td vaccine.c Grade 3 injection site pain following BOOSTRIX was not inferior to Td vaccine (upper limit of 2-sided 95% CI for the difference [BOOSTRIX minus Td] in the percentage of subjects ≤4%).d Mid-upper region of the vaccinated arm.e Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.f Oral temperatures or axillary temperatures.

Adverse Reactions/Adverse Events

BOOSTRIX

(n = 3,032)

%

Td

(n = 1,013)

%

Local

Pain, anyb

75

72

Pain, Grade 2 or 3b

51

43

Pain, Grade 3c

5

4

Redness, any

23

20

Redness, >20 mm

4

4

Redness, ≥50 mm

2

2

Swelling, any

21

20

Swelling, >20 mm

5

5

Swelling, ≥50 mm

3

3

Arm circumference increase, >5 mmd

28

30

Arm circumference increase, >20 mmd

2

2

Arm circumference increase, >40 mmd

1

0.3

General

Headache, any

43

42

Headache, Grade 2 or 3b

16

13

Headache, Grade 3

4

3

Fatigue, any

37

37

Fatigue, Grade 2 or 3

14

13

Fatigue, Grade 3

4

3

Gastrointestinal symptoms, anye

26

26

Gastrointestinal symptoms, Grade 2 or 3e

10

10

Gastrointestinal symptoms, Grade 3e

3

3

Fever, ≥99.5°F (37.5°C)f

14

13

Fever, >100.4°F (38.0°C)f

5

5

Fever, >102.2°F (39.0°C)f

1

1

Unsolicited Adverse Events in the U.S. Adolescent Study: The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (25.4% and 24.5% for BOOSTRIX and Td vaccine, respectively).

Solicited Adverse Events in the German Adolescent Study: BOOSTRIX was administered to 319 children aged 10 to 12 years previously vaccinated with 5 doses of acellular pertussis antigen-containing vaccines; 193 of these subjects received 5 doses of INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). Table 3 presents the rates of solicited local adverse reactions and fever within 15 days of vaccination for those subjects who had previously been vaccinated with 5 doses of INFANRIX. No cases of whole arm swelling were reported. Two individuals (2/193) reported large injection site swelling (range: 110 to 200 mm diameter), in 1 case associated with Grade 3 pain. Neither individual sought medical attention. These episodes were reported to resolve without sequelae within 5 days.

Table 3. Rates of Solicited Local Adverse Reactions and Fever Reported within the 15-Daya Post-Vaccination Period following Administration of BOOSTRIX in Adolescents Aged 10 to 12 Years Who Had Previously Received 5 Doses of INFANRIX
INFANRIX = Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed manufactured by GlaxoSmithKline Biologics.n = Number of subjects with local/general symptoms sheets completed.Grade 2 = Painful when limb moved.Grade 3 = Spontaneously painful and/or prevented normal activity.a Day of vaccination and the next 14 days.b Oral temperatures or axillary temperatures.

Adverse Reactions and Fever

BOOSTRIX

(n = 193)

%

Pain, any

62

Pain, Grade 2 or 3

33

Pain, Grade 3

6

Redness, any

48

Redness, >20 mm

15

Redness, ≥50 mm

11

Swelling, any

39

Swelling, >20 mm

18

Swelling, ≥50 mm

14

Fever, ≥99.5°F (37.5°C)b

9

Fever, >100.4°F (38.0°C)b

4

Fever, >102.2°F (39.0°C)b

1

Solicited Adverse Events in the U.S. Adult (Aged 19 to 64 Years) Study: Table 4 presents solicited local adverse reactions and general adverse events within 15 days of vaccination with BOOSTRIX or the comparator Tdap vaccine for the total vaccinated cohort.

Table 4. Rates of Solicited Local Adverse Reactions or General Adverse Events within the 15-Daya Post-Vaccination Period in Adults Aged 19 to 64 Years (Total Vaccinated Cohort)
Tdap = ADACEL (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, a Tdap vaccine manufactured by Sanofi Pasteur).n = Number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.Grade 2 = Local: painful when limb moved; General: interfered with normal activity.Grade 3 = Local/General: prevented normal activity.a Day of vaccination and the next 14 days.b Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.c Oral temperatures.

Adverse Reactions/Adverse Events

BOOSTRIX

(n = 1,480)

%

Tdap

(n = 741)

%

Local

Pain, any

61

69

Pain, Grade 2 or 3

35

44

Pain, Grade 3

2

2

Redness, any

21

27

Redness, >20 mm

4

6

Redness, ≥50 mm

2

2

Swelling, any

18

26

Swelling, >20 mm

4

6

Swelling, ≥50 mm

1

3

General

Headache, any

30

31

Headache, Grade 2 or 3

11

11

Headache, Grade 3

2

2

Fatigue, any

28

29

Fatigue, Grade 2 or 3

9

9

Fatigue, Grade 3

3

1

Gastrointestinal symptoms, anyb

16

18

Gastrointestinal symptoms, Grade 2 or 3b

4

6

Gastrointestinal symptoms, Grade 3b

1

1

Fever, ≥99.5°F (37.5°C)c

6

8

Fever, >100.4°F (38.0°C)c

1

2

Fever, >102.2°F (39.0°C)c

0

0

Unsolicited Adverse Events in the U.S. Adult (Aged 19 to 64 Years) Study: The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (17.8% and 22.2% for BOOSTRIX and Tdap vaccine, respectively).

Solicited Adverse Events in the U.S. Elderly (Aged 65 Years and Older) Study: Table 5 presents solicited local adverse reactions and general adverse events within 4 days of vaccination with BOOSTRIX or the comparator Td vaccine for the total vaccinated cohort.

Table 5. Rates of Solicited Local Adverse Reactions or General Adverse Events within 4 Daysa of Vaccination in the Elderly Aged 65 Years and Older (Total Vaccinated Cohort)
Td = DECAVAC (Tetanus and Diphtheria Toxoids Adsorbed, a U.S.-licensed Td vaccine, manufactured by Sanofi Pasteur).n = Number of subjects with a documented dose.Grade 2 = Local: painful when limb moved; General: interfered with normal activity.Grade 3 = Local/General: prevented normal activity.a Day of vaccination and the next 3 days.b Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.c Oral temperatures.

Adverse Reactions/Adverse Events

BOOSTRIX

%

Td

%

Local

(n = 882)

(n = 444)

Pain, any

22

28

Pain, Grade 2 or 3

8

10

Pain, Grade 3

0.2

1

Redness, any

11

13

Redness, >20 mm

1

3

Redness, ≥50 mm

1

1

Swelling, any

8

12

Swelling, >20 mm

2

3

Swelling, ≥50 mm

1

1

General

(n = 882)

(n = 445)

Fatigue, any

13

15

Fatigue, Grade 2 or 3

3

3

Fatigue, Grade 3

1

1

Headache, any

12

12

Headache, Grade 2 or 3

2

2

Headache, Grade 3

1

0

Gastrointestinal symptoms, anyb

8

9

Gastrointestinal symptoms, Grade 2 or 3b

2

2

Gastrointestinal symptoms, Grade 3b

0.3

0.4

Fever, ≥99.5°F (37.5°C)c

2

3

Fever, >100.4°F (38.0°C)c

0.2

0.2

Fever, >102.2°F (39.0°C)c

0

0

Unsolicited Adverse Events in the U.S. Elderly (Aged 65 Years and Older) Study: The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (17.1% and 14.4% for BOOSTRIX and Td vaccine, respectively).

Serious Adverse Events (SAEs): In the U.S. and German adolescent safety studies, no serious adverse events were reported to occur within 31 days of vaccination. During the 6-month extended safety evaluation period, no serious adverse events that were of potential autoimmune origin or new onset and chronic in nature were reported to occur. In non-U.S. adolescent studies in which serious adverse events were monitored for up to 37 days, 1 subject was diagnosed with insulin-dependent diabetes 20 days following administration of BOOSTRIX. No other serious adverse events of potential autoimmune origin or that were new onset and chronic in nature were reported to occur in these studies. In the U.S. adult (aged 19 to 64 years) study, serious adverse events were reported to occur during the entire study period (0-6 months) by 1.4% and 1.7% of subjects who received BOOSTRIX and the comparator Tdap vaccine, respectively. During the 6-month extended safety evaluation period, no serious adverse events of a neuroinflammatory nature or with information suggesting an autoimmune etiology were reported in subjects who received BOOSTRIX. In the U.S. elderly (aged 65 years and older) study, serious adverse events were reported to occur by 0.7% and 0.9% of subjects who received BOOSTRIX and the comparator Td vaccine, respectively, during the 31-day period after vaccination. Serious adverse events were reported to occur by 4.2% and 2.2% of subjects who received BOOSTRIX and the comparator Td vaccine, respectively, during the 6-month period after vaccination.

Revaccination Studies

U.S. Revaccination Studies in Adults: In 2 clinical studies, 974 adults (aged 20 years and older) were vaccinated with a dose of BOOSTRIX [see Clinical Studies (14.3)].

Solicited Adverse Events in the U.S. Revaccination Studies: Table 6 presents solicited local adverse reactions and general adverse events within 4 days of vaccination with BOOSTRIX for the total vaccinated cohort in both studies.

Table 6. Rates of Solicited Local Adverse Reactions or General Adverse Events within 4 Daysa of Vaccination in Adults Aged 20 to 73 Years (Total Vaccinated Cohort)
Td = Tetanus and Diphtheria Toxoids Adsorbed for Adult Use manufactured by MassBiologics.Tdap = ADACEL (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, a Tdap vaccine manufactured by Sanofi Pasteur).n = Number of subjects with a documented dose.Grade 2 = Local: painful when limb moved and interfered with normal activities; General: interfered with normal activity.Grade 3 = Local: significant pain at rest and/or prevented normal activity; General: prevented normal activity.a Day of vaccination and the next 3 days.b Subjects who were revaccinated with BOOSTRIX 10 years after initial vaccination with BOOSTRIX.c Subjects who received a dose of BOOSTRIX 10 years after initial vaccination with Td vaccine.d Subjects who were revaccinated with BOOSTRIX 9 years after initial vaccination with BOOSTRIX.e Subjects who received a dose of BOOSTRIX 9 years after initial vaccination with Tdap vaccine.f Control Group = Newly enrolled subjects who received an initial dose of BOOSTRIX.g In the study of adults aged 20 to 29 years, redness >50 mm was recorded.h In the study of adults aged 20 to 29 years, swelling >50 mm was recorded.i Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.j Oral temperatures.

Adverse Reactions/ Adverse Events

Adults Aged 20 to 29 Years

Adults Aged 28 to 73 Years

BOOSTRIXb

(n = 125)

%

Tdc

(n = 36)

%

BOOSTRIXd

(n = 306)

%

Tdape

(n = 137)

%

Controlf

(n = 358)

%

Local

Pain, any

78

58

59

61

37

Pain, Grade 2 or 3

33

19

17

15

9

Pain, Grade 3

5

6

1

1

1

Redness, any

38

42

24

23

15

Redness, >20 mm

4

0

6

4

1

Redness, ≥50 mm g

1

0

2

2

0

Swelling, any

24

19

19

19

12

Swelling, >20 mm

2

3

3

3

3

Swelling, ≥50 mm h

0

0

1

2

1

General

Headache, any

32

22

17

18

15

Headache, Grade 2 or 3

10

3

4

4

2

Headache, Grade 3

2

0

0

1

0.3

Fatigue, any

30

22

23

17

14

Fatigue, Grade 2 or 3

14

3

8

7

3

Fatigue, Grade 3

2

0

1

1

0

Gastrointestinal symptoms, anyi

9

3

9

3

8

Gastrointestinal symptoms, Grade 2 or 3i

2

0

2

0

3

Gastrointestinal symptoms, Grade 3i

2

0

0

0

0

Fever, ≥100.4°F (38.0°C)j

1

0

1

0

1

Fever, >102.2°F (39.0°C)j

0

0

0.3

0

0

Concomitant Vaccination with Meningococcal Conjugate Vaccine in Adolescents

Table 7 presents the percentages of subjects experiencing local reactions at the injection site for BOOSTRIX and solicited general events following BOOSTRIX. The incidence of unsolicited adverse events reported in the 31 days after any vaccination was similar following each dose of BOOSTRIX in all cohorts.

Table 7. Rates of Solicited Local Adverse Reactions or General Adverse Events Reported within the 4-Day Post-Vaccination Period following Administration of BOOSTRIX in Individuals Aged 11 to 18 Years (Total Vaccinated Cohort)
MCV4 = MENACTRA (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), Sanofi Pasteur.n = number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.a BOOSTRIX+MCV4 = Concomitant vaccination with BOOSTRIX and MENACTRA.b BOOSTRIX→MCV4 = BOOSTRIX followed by MCV4 1 month later.c MCV4→BOOSTRIX = MCV4 followed by BOOSTRIX 1 month later.d Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.e Oral temperatures.

Adverse Reactions/Adverse Events

BOOSTRIX+MCV4a

(n = 441)

%

BOOSTRIXMCV4b

(n = 432-433)

%

MCV4BOOSTRIXc

(n = 441)

%

Local (at injection site for BOOSTRIX)

Pain, any

70

70

48

Redness, any

23

26

18

Swelling, any

18

18

12

General (following administration of BOOSTRIX)

Fatigue

34

32

20

Headache

34

31

17

Gastrointestinal symptomsd

15

15

8

Fever, ≥99.5°F (37.5°C)e

5

4

2

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.