Vaccine Information: TicoVac (Page 3 of 3)

14.2 Field Vaccine Effectiveness

In Austria, field effectiveness of TBE vaccines was assessed retrospectively for the period from 2000 to 2011. During this period, two TBE vaccines were available in Austria. The market coverage in Austria for TICOVAC was 95%, 90%, and 80%, in 2000, 2006, and 2011, respectively.1 The calculation of TBE vaccine effectiveness overall is based on (1) the annual numbers of serologically confirmed cases of TBE virus infections with neurological symptoms causing hospitalization (2) their vaccination history, and (3) the proportion of vaccinated and unvaccinated in the Austrian population. During the study period, the recommended vaccination schedule in Austria consisted of 2 vaccinations approximately 4 weeks apart followed by a third vaccination 5–12 months after the second dose, and a booster vaccination ≥3 years after the third dose. The TBE cases were categorized based on their vaccination status. Among the 883 TBE cases in Austria between 2000 and 2011, 45 patients did not have an accurate vaccination history. The best-case and worst-case estimates of vaccine effectiveness were calculated. For the best-case estimate, the 45 patients without an accurate vaccination history were excluded from the calculation. For the worst-case estimate, these 45 patients were assumed to have been vaccinated according to the recommended schedule. The proportions of vaccinated and unvaccinated individuals in the general population were estimated using annual postal surveys sent to 4,000 households (8,500–10,000 household members). Overall, worst-case and best-case TBE vaccine effectiveness for preventing hospitalized TBE was estimated to be 96.3% (95% CI: 95.5, 97.0) and 98.7% (95% CI: 98.2, 99.0), respectively, following at least 3 doses of TBE vaccine administered according to the recommended schedule in Austria.2

15 REFERENCES

  1. Heinz FX, Holzmann H, Essl A, et al. Field effectiveness of vaccination against tick-borne encephalitis. Vaccine 2007;25(43):7559–67.
  2. Heinz FX, Stiasny K, Holzmann H, et al. Vaccination and tick-borne encephalitis, central Europe. Emerg Infect Dis 2013;19(1):69–76.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

TICOVAC is supplied in the following strengths and package configurations:

Presentation Carton NDC Components
One dose (10 per package) NDC 0069-0411-10 0.5 mL pre-filled syringe
One dose (1 per package) NDC 0069-0411-02 0.5 mL pre-filled syringe
One dose (10 per package) NDC 0069-0297-10 0.25 mL pre-filled syringe
One dose (1 per package) NDC 0069-0297-02 0.25 mL pre-filled syringe

The tip cap and rubber plunger of the pre-filled syringe are not made with natural rubber latex.

16.2 Storage and Handling

Upon receipt, store refrigerated at 2ºC to 8ºC (36ºF to 46ºF).

Keep the syringe in the outer carton in order to protect from light. Do not freeze. Discard if the vaccine has been frozen.

17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine, inform the individual, parent, guardian, or other responsible adult of the following:

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Manufactured by: Pfizer Ireland Pharmaceuticals
Ringaskiddy,
Co. Cork,
Ireland

US License No. 2060

Logo

LAB-1467-1.0

PRINCIPAL DISPLAY PANEL — 0.25 mL Syringe Label

(01)10300690297016

NDC 0069-0297-01
Rx only

Tick-Borne Encephalitis Vaccine

TICOVAC™ 1 through 15 years

One Dose (0.25 mL)

FOR IM USE ONLY
REFRIGERATE
DO NOT FREEZE
SHAKE WELL

Pfizer Ireland PharmaceuticalsUS License No. 2060

PAA178117

LOT/EXP:

PRINCIPAL DISPLAY PANEL -- 0.25 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25 mL Syringe Carton — 0069-0297-02

NDC 0069-0297-02

Tick-Borne Encephalitis Vaccine

TICOVAC™

For use in individuals aged 1 to 15 yearsFOR INTRAMUSCULAR USE ONLY

1 One-Dose (0.25 mL) Disposable Syringe

Rx only

Pfizer

PRINCIPAL DISPLAY PANEL -- 0.25 mL Syringe Carton -- 0069-0297-02
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25 mL Syringe Carton — 0069-0297-10

NDC 0069-0297-10

Tick-Borne Encephalitis Vaccine

TICOVAC™

For use in individuals aged 1 to 15 yearsFOR INTRAMUSCULAR USE ONLY

10 One-Dose (0.25 mL) Disposable Syringes

Rx only

Pfizer

PRINCIPAL DISPLAY PANEL -- 0.25 mL Syringe Carton -- 0069-0297-10
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

(01)10300690411016

NDC 0069-0411-01
Rx only

Tick-Borne Encephalitis Vaccine

TICOVAC™
16 years and older

One Dose (0.5 mL)
FOR IM USE ONLY
REFRIGERATE
DO NOT FREEZE
SHAKE WELL

Pfizer Ireland PharmaceuticalsUS License No. 2060

PAA178116

LOT/EXP:

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton — 0069-0411-02

NDC 0069-0411-02

Tick-Borne Encephalitis Vaccine

TICOVAC™

For use in individuals 16 years of age and olderFOR INTRAMUSCULAR USE ONLY

1 One-Dose (0.5 mL) Disposable Syringe

Rx only

Pfizer

PPRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton -- 0069-0411-02
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton — 0069-0411-10

NDC 0069-0411-10

Tick-Borne Encephalitis Vaccine
TICOVAC™

For use in individuals 16 years of age and olderFOR INTRAMUSCULAR USE ONLY

10 One-Dose (0.5 mL) Disposable Syringes

Rx only

Pfizer

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton -- 0069-0411-10
(click image for full-size original)
TICOVAC tick-borne encephalitis vaccine injection
Product Information
Product Type VACCINE Item Code (Source) NDC:0069-0297
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED) (TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED)) TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED) 1.2 ug in 0.25 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 1.725 mg in 0.25 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.11 mg in 0.25 mL
MONOBASIC POTASSIUM PHOSPHATE 0.0225 mg in 0.25 mL
WATER
ALGELDRATE 0.175 mg in 0.25 mL
ALBUMIN HUMAN 0.25 mg in 0.25 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0297-02 1 SYRINGE in 1 CARTON contains a SYRINGE (0069-0297-01)
1 NDC:0069-0297-01 0.25 mL in 1 SYRINGE This package is contained within the CARTON (0069-0297-02)
2 NDC:0069-0297-10 10 SYRINGE in 1 CARTON contains a SYRINGE (0069-0297-01)
2 NDC:0069-0297-01 0.25 mL in 1 SYRINGE This package is contained within the CARTON (0069-0297-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125740 10/25/2021 10/25/2021
TICOVAC tick-borne encephalitis vaccine injection
Product Information
Product Type VACCINE Item Code (Source) NDC:0069-0411
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED) (TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED)) TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED) 2.4 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 3.45 mg in 0.5 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.22 mg in 0.5 mL
MONOBASIC POTASSIUM PHOSPHATE 0.045 mg in 0.5 mL
WATER
ALGELDRATE 0.35 mg in 0.5 mL
ALBUMIN HUMAN 0.5 mg in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0411-02 1 SYRINGE in 1 CARTON contains a SYRINGE (0069-0411-01)
1 NDC:0069-0411-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0069-0411-02)
2 NDC:0069-0411-10 10 SYRINGE in 1 CARTON contains a SYRINGE (0069-0411-01)
2 NDC:0069-0411-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0069-0411-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125740 10/25/2021
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Belgium NV 370156507 ANALYSIS (0069-0297), ANALYSIS (0069-0411), MANUFACTURE (0069-0297), MANUFACTURE (0069-0411), PACK (0069-0297), PACK (0069-0411), LABEL (0069-0297), LABEL (0069-0411)
Establishment
Name Address ID/FEI Operations
Pfizer Manufacturing Austria GmbH 300453240 ANALYSIS (0069-0297), ANALYSIS (0069-0411), API MANUFACTURE (0069-0297), API MANUFACTURE (0069-0411)

Revised: 10/2021 Pfizer Laboratories Div Pfizer Inc

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