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:
- •
- The potential benefits and risks of immunization with TICOVAC [see Warnings and Precautions (5), Adverse Reactions (6) and Clinical Studies (14)].
- •
- The importance of completing the approved three dose primary immunization series before potential exposure to TBEV [see Dosage and Administration (2.1)].
- •
- Report any suspected adverse reactions to a healthcare professional.
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
LAB-1467-2.0
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
PAA180290
LOT/EXP:
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 — 0069-0297-10
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 — 0.5 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
PAA180461
LOT/EXP:
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
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
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| TICOVAC tick-borne encephalitis vaccine injection | |||||||||||||||||||||||||
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| 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: 07/2023 Pfizer Laboratories Div Pfizer Inc
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