Rabies Vaccine Vero Cell

AIM Honor is the supplier of Rabies Vaccine Vero Cell. This vaccine is suitable for pre- and post-exposure prophylaxis in all populations, strictly following the intramuscular injection immunization procedure. It is a preferred vaccine for rabies control worldwide. Please contact us for inquiries and collaboration!

COMPOSITION AND CHARACTER

The Rabies Vaccine Vero Cell is a freeze-dried preparation of rabies fixed virus (aGV strain) grown in Vero cells After cultivation and harvest, the virus suspension is inactivated, concentrated and purified, and lyophilized after the addition of human albumin, sucrose and gelatin as a stabilizer. It looks like a white crisp cake. After reconstitution, it turns into a clear liquid. This vaccine does not have any preservatives.

Active ingredient: Inactivated rabies fixed virus

Excipients: 1% human albumin, 1% gelatin, 5% sucrose, PBS Diluent: Sterile water for injection

SPECIFICATIONS

1.0ml of vaccine per vial after reconstitution. 1 vial accompanied with sterile water for injection 1.0ml per single human dose. The potency of the rabies vaccine shall not be less than 2.51U.

ELIGIBLE INDIVIDUALS

The preparation can induce immunity against rabies virus in recipients following immunization It is used to prevent rabies in human.

If a person is bitten or scratched by a rabid dog or any other rabid animal, regardless of age or sex, the wounds shall be cleaned immediately (flush the wounds repeatedly with clean water o「 soap water, followed by applying iodine tincture or ethanol for several times), and the exposed person shall be inoculated with the vaccine according to the post-exposure schedule as soon as possible.

The person at risk of contacting rabies virus (such as veterinarians, animal breeders, forestry workers, workers in slaughterhouse and staff in rabies laboratory) shall be immunized following the pre-exposure immunization schedule.

ADMINISTRATION AND DOSAGE

(1) Reconstitute the freeze-dried vaccine with the enclosed sterile water for injection as the stated value and shake the container thoroughly before use

(2) The Rabies Vaccine Vero Cell is for intramuscular (1.M) injection in the deltoid muscle of the upper arm. For young children, inoculate the vaccine in the muscle at Antero external aspect of the thigh.

(3) Postexposure immunization schedule: Normally one dose of the vaccine shall be administered to the exposed person on days 0 (the first day i.e. that very day), 3 (the fourth day, analogically henceforth), 7, 14 and 28, consecutively, five doses in total. Children shall be treated in the same way. It is recommended to double the first dose of vaccine in case of any one of the following conditions.

a. Individuals with chronic diseases were injected with rabies immunoglobulin or rabies antiserum one day or earlier before the day of receiving rabies vaccine

b. Those with congenital or acquired immunodeficiency

c. Those receiving immunosuppressive therapy (including antimalarial drugs)

d. The elderly

e. Rabies vaccine is administered to the exposed persons 48 hours or longer after exposure

Postexposure treatment shall be dependent on the following classification of wound severity:

Category I

Those petting an animal or licked by an animal on intact skin without any breaks-Neither wound treatment nor administration of the vaccine is necessary.

Category II

Those bitten or scratched by an animal on skin but without bleeding - The vaccine shall be administered following the postexposure immunization schedule

Category Ill

Those with single or multiple biting wounds on skin with bleeding or scratched with bleeding or mucous membrane contaminated by the saliva of suspected or confirmed rabid animal, the broken skin is licked-The exposed person shall be treated immediately with rabies vaccine and rabies antiserum(401UJkg) or rabies immunoglobulin (201U/kg). If anatomically feasible, infiltration injections of the serum or immunoglobulin shall be performed as much as possible around the wound(s); the rest, if any, shall be injected intramuscularly. The rabies antiserum or rabies immunoglobulin is only for single use

(4)Pre-exposure immunization schedule: A total of three doses shall be given on days 0, 7, and 21 or 28

(5)Recommendation of re-immunization for general patients immunized with rabies vaccine previously

a. Complete immunization schedule was conducted within the recent one year; If bitten by a suspected rabid animal, one dose given on days O and 3, separately

b. Complete immunization schedule was conducted more than one year ago; If bitten by a suspected rabid animal, carry out complete immunization schedule again

c. Complete immunization schedule was conducted within the last 3 years, and followed by booster doses: One dose of vaccine shall be given on days 0 and 3, separately, if bitten by a suspected rabid animal

d. Complete immunization schedule and booster dose(s) were given more than three years ago: A complete immunization schedule shall be executed if bitten by a suspected rabid animal

ADVERSE REACTIONS

Common adverse reactions

Redness, swelling, pain, itching may occur at the injection site within 24 hours after vaccination, which can be relieved spontaneously without treatment

Systemic reactions may include low fever, malaise, headache, dizziness, arthralgia, myalgia, vomiting and bellyache which can be relieved spontaneously and need no particular treatment

Rare adverse reactions

The recipients with transient moderate or severe fever shall receive physical therapy or symptomatic treatment to prevent febrile convulsions

Extremely rare adverse reactions

Allergic rash: Urticaria may occur generally within 72 hours after vaccination. The recipients with urticaria shall receive anti-anaphylactic treatment promptly

Anaphylac1ic shock: Anaphylactic shock may occur within one hour after vaccination. The recipients with anaphylactic shock shall receive emergency treatment immediately including prompt injection of adrenaline

Allergic purpura: The recipients with allergic purpura shall go to the clinic promptly and receive anti-anaphylactic treatment with corticosteroid in time. If the treatment is inappropriate or delayed, purpuric nephritis may be complicated

Those who suffer from angioneurotic edema or nervous system reactions after vaccination, shall receive the medical treatment in time

CONTRAINDICATIONS

Because rabies is a fatal disease, there are no contraindications for postexposure immunization

Pre-exposure immunization

Individuals with known allergic reactions to any component of the vaccine, including excipients and antibiotics

Patients with acute diseases, severe chronic diseases and chronic diseases at acute attack stage and fever

Individuals with uncontrolled epilepsy or other progressive diseases of nervous system

STORAGE

Store and ship the product between +2 °C and +8 °C, protected from light.

The validity period is 36 months.

Key Production Processes

The production of this Rabies Vaccine Vero Cell adheres to international GMP standards and is completed in AIM’s professional and modern workshop. Key production processes include:

1. Advanced purification technology: Adopts 20m² ultrafiltration system and 600mm chromatography system for multi-step purification, effectively removing foreign proteins, DNA, and other impurities, ensuring high antigen purity that meets global standards.

2. Strict quality control: Implements stricter internal control standards than national pharmacopoeia, including endotoxin ≤10EU/dose, sterile growth in sterility test, and strict pH value control, ensuring product quality stability and consistency.

3. Standardized freeze-drying technology: Uses 40m² freeze-drying system for formulation, reducing moisture content in the product to extend shelf life and maintain antigen activity; the entire preparation process is controlled in a B+A grade clean environment, ensuring product safety.

4. This section is the bacterial culture and passage process of vaccine production, completed in a closed sterile operation system under B+A grade clean environment throughout.

The operation team wears fully enclosed protective equipment, strictly follows sterile standards for strain passage and cell expansion to avoid external contamination.

Equipped with high-precision culture equipment, it precisely controls parameters such as temperature and pH to ensure strain activity and cell proliferation stability.

This process is one of the core links to ensure the purity and activity of vaccine antigens, laying a high-quality foundation for subsequent purification and formulation processes.