Inactivated Rabies Vaccine Produced With Vero Cell Technology

Inactivated Rabies Vaccine Produced With Vero Cell Technology, supplied by AIM Honor (Ningbo) Biopharmaceutical Co., Ltd., is a highly purified freeze-dried biological developed for active immunization against rabies virus. As a professional vaccine manufacturer in China, we employ the aG fixed virus strain cultivated on Vero cell substrates, combined with advanced inactivation and multi-stage purification processes. Clinical data demonstrate that this vaccine achieves a 100% seroconversion rate within 14 days following the complete immunization schedule. Free from preservatives and antibiotics, with a potency of no less than 2.5 IU per dose, it ensures excellent immunogenicity and a favorable safety profile for global rabies prevention programs.

PRODUCT OVERVIEW

The Inactivated Rabies Vaccine Produced With Vero Cell Technology is a lyophilized formulation containing rabies fixed virus (aGV strain) that has been propagated in Vero cell cultures, then inactivated, concentrated, and purified through sophisticated downstream processing. The final product is a white, porous cake that readily dissolves in the supplied sterile water for injection to form a clear solution. This vaccine contains no preservatives or antibiotics, aligning with current WHO recommendations for reduced-reactogenicity rabies vaccines.

Active ingredient: Inactivated rabies fixed virus (aGV strain)

Excipients: 1% human albumin, 1% gelatin, 5% sucrose, phosphate-buffered saline (PBS)

Diluent: Sterile water for injection

TECHNICAL SPECIFICATIONS

Each carton contains one single human dose of lyophilized vaccine and one prefilled syringe of sterile water for injection (1.0 mL) for reconstitution. The final injectable volume is 1.0 mL per dose. The vaccine potency is stringently controlled and shall not be less than 2.5 International Units per dose, meeting the rigorous requirements of both the Chinese Pharmacopoeia and the World Health Organization.

TARGET POPULATION

The Inactivated Rabies Vaccine Produced With Vero Cell Technology elicits robust neutralizing antibody responses against rabies virus in vaccinated individuals. It is licensed for use in all age groups for the prevention of human rabies.

Post-exposure settings: Following a bite, scratch, or mucosal contamination by a suspected rabid animal, immediate wound cleansing with soap and water or iodine-based disinfectants is essential. The vaccine should be administered according to the established post-exposure schedule as rapidly as possible. Age and sex are not limiting factors for post-exposure vaccination.

Pre-exposure settings: Occupational groups with routine rabies virus exposure risk—including veterinarians, animal handlers, wildlife researchers, slaughterhouse personnel, and diagnostic laboratory staff—are recommended to receive pre-exposure immunization according to the three-dose primary series.

DOSAGE AND ADMINISTRATION

(1) Reconstitute the lyophilized vaccine using the accompanying sterile water for injection. Gently swirl until the cake is completely dissolved and a clear solution is obtained. Do not shake vigorously to avoid foaming.

(2) The Inactivated Rabies Vaccine Produced With Vero Cell Technology is intended for intramuscular injection. For adults and older children, the preferred site is the deltoid muscle of the upper arm. For infants and young children, the anterolateral aspect of the thigh is recommended.

(3) Standard post-exposure regimen (Essen regimen): A total of five doses are administered on days 0, 3, 7, 14, and 28 (day 0 being the day of the first vaccination). Children receive the same dosage as adults. A double dose on day 0 is recommended for the following high-risk scenarios:

a. Individuals with chronic diseases who have received rabies immunoglobulin or antiserum within 24 hours prior to the first vaccine dose

b. Patients with congenital or acquired immunodeficiency states

c. Persons receiving immunosuppressive therapy, including antimalarial agents

d. Elderly recipients aged 60 years and above

e. Cases where vaccine administration is initiated 48 hours or more after the rabies exposure incident

Wound severity classification for post-exposure management:

Category I: Touching or feeding animals, or licks on intact skin—no wound treatment or vaccination required.

Category II: Nibbling on uncovered skin, minor scratches without bleeding—vaccination according to the post-exposure schedule is indicated.

Category III: Single or multiple transdermal bites or scratches with bleeding, licks on broken skin, or contamination of mucous membranes with saliva from a rabid or suspected rabid animal—immediate vaccination combined with rabies immunoglobulin (20 IU/kg) or antiserum (40 IU/kg) is mandatory. Local infiltration around the wound site is recommended where anatomically feasible.

(4) Pre-exposure immunization schedule: Three doses administered on days 0, 7, and 21 or 28.

(5) Booster recommendations for previously immunized individuals:

a. Complete primary series within the last 12 months: two doses (days 0 and 3) following a suspected exposure.

b. Complete primary series more than 12 months ago: full five-dose post-exposure series is required.

c. Complete primary series plus booster(s) within the last 3 years: two doses (days 0 and 3) following exposure.

d. Complete primary series and boosters more than 3 years ago: full five-dose series is indicated.

SAFETY PROFILE

Common adverse events: Local reactions including erythema, edema, pain, and pruritus at the injection site may develop within 24 hours post-vaccination and typically resolve spontaneously without intervention. Systemic reactions such as low-grade fever, fatigue, headache, dizziness, arthralgia, myalgia, nausea, and abdominal discomfort have been reported; these are generally mild and self-limiting.

Uncommon adverse events: Moderate to severe febrile responses may occur, particularly in pediatric recipients. Physical cooling measures and symptomatic treatment are recommended to prevent febrile convulsions.

Rare adverse events:

Allergic urticaria: May appear within 72 hours post-vaccination and requires prompt antihistamine therapy.

Anaphylactic shock: A medical emergency that can occur within one hour of vaccination; immediate administration of epinephrine and emergency supportive care are critical.

Allergic purpura: Requires timely clinical evaluation and corticosteroid therapy; delayed treatment may lead to purpuric nephritis.

Angioneurotic edema or neurological manifestations demand urgent specialist consultation and management.

CONTRAINDICATIONS

For post-exposure prophylaxis: Rabies is a uniformly fatal encephalitis once clinical symptoms appear. Therefore, there are absolutely no contraindications to vaccine administration following a confirmed or suspected rabies exposure. The benefit of vaccination overwhelmingly outweighs any potential risk.

For pre-exposure prophylaxis:

• Individuals with known hypersensitivity to any vaccine component, including excipients (human albumin, gelatin, sucrose) or residual trace proteins

• Patients suffering from acute febrile illness, severe chronic conditions, or acute exacerbations of chronic diseases

• Persons with uncontrolled epilepsy or progressive neurological disorders

COLD CHAIN MANAGEMENT

Store and transport the Inactivated Rabies Vaccine Produced With Vero Cell Technology strictly between +2°C and +8°C. Protect from freezing and direct sunlight. The product retains full potency for 36 months when stored under recommended conditions. Reliable cold-chain integrity is essential to preserve antigen conformation and ensure consistent immunogenicity across all distributed batches.

CORE DIFFERENTIATORS

The Inactivated Rabies Vaccine Produced With Vero Cell Technology distinguishes itself through multiple technical and quality advantages. Manufactured under strict GMP oversight by a leading Chinese vaccine producer, this product combines robust immunogenicity with exceptional purity and stability.

1. Proprietary aG virus strain: The use of a domestically developed, highly immunogenic fixed virus strain ensures consistent antigen yield and potency across production batches.

2. Advanced purification train: Integration of 20m² ultrafiltration and 600mm chromatography systems enables efficient removal of host cell DNA, residual proteins, and other process-related impurities, resulting in a vaccine of superior purity.

3. Rigorous in-process controls: Internal specifications exceed national pharmacopoeia requirements, with endotoxin levels maintained at ≤10 EU per dose, sterility confirmed through culture-based assays, and pH tightly monitored throughout formulation.

4. State-of-the-art lyophilization: A 40m² freeze-drying system precisely controls sublimation parameters, achieving low residual moisture content that extends shelf life while preserving antigenic structure. All aseptic operations are conducted in B+A grade cleanroom environments.

5. Cell culture and viral propagation: Performed in closed, sterile systems under continuous B+A grade environmental monitoring. Operators wear full containment suits and follow stringent aseptic techniques to maintain culture purity and viral titers.

QUALITY AND REGULATORY COMPLIANCE

Every batch of Inactivated Rabies Vaccine Produced With Vero Cell Technology undergoes comprehensive quality release testing in accordance with GMP guidelines and pharmacopoeial standards. AIM Honor's manufacturing site is equipped with modern analytical laboratories and validated test methods to ensure batch-to-batch consistency.

The product is manufactured under a quality management system that aligns with international regulatory expectations, supporting registration and supply in multiple global markets. Comprehensive documentation, including batch release certificates and stability data, is available for regulatory submissions.

Frequently Asked Questions

Q: What is the recommended storage temperature for this vaccine?

A: The Inactivated Rabies Vaccine Produced With Vero Cell Technology must be stored and transported at +2°C to +8°C, protected from light and freezing. Under these conditions, the vaccine maintains full potency for 36 months from the manufacturing date.

Q: How is the vaccine administered?

A: This vaccine is given via intramuscular injection. The deltoid muscle of the upper arm is the preferred site for adults and older children. For infants and young children, the anterolateral thigh muscle is recommended.

Q: Is the vaccine suitable for pregnant women?

A: For post-exposure prophylaxis, rabies vaccination is indicated regardless of pregnancy status because rabies is a lethal disease. For pre-exposure prophylaxis, the decision should be made on an individual risk-benefit basis.

Q: What is the minimum order quantity for international procurement?

A: We support flexible order quantities for global clients. For specific MOQ, pricing, and shipping terms, please contact our export sales department directly.

Q: Does this vaccine contain thiomersal or other preservatives?

A: No. This vaccine is formulated without any preservatives or antibiotics, making it suitable for populations where reducing unnecessary excipient exposure is desired.