China Inactivated Hepatitis A Vaccine For Preventing HAV Infection Manufacturer, Supplier, Factory

AIM Honesty Biopharmaceutical Co., Ltd. is a China manufacturer specialized in Inactivated Hepatitis A Vaccine For Preventing HAV Infection. This product is developed with human diploid cell culture platform, formaldehyde inactivation and multi-step purification process, to trigger specific immune response and protect susceptible populations from HAV infection. Backed by GMP compliant manufacturing lines and NMPA marketing authorization, the vaccine serves global public health buyers, government immunization programs, medical distributors and international healthcare organizations seeking reliable, stable inactivated hepatitis A vaccine supply.

Product Profile

Inactivated Hepatitis A Vaccine For Preventing HAV Infection is an inactivated whole-virus vaccine, prepared by culturing HAV LV‑8 strain on KMB17 human diploid cell substrate. After virus harvesting, ultrafiltration, chromatographic purification and formaldehyde inactivation, aluminum hydroxide adjuvant is added to form a milky white injectable suspension. Slight sediment may form after storage, which can be homogenized by gentle shaking before administration.

The core function is active immunization: once injected, the vaccine stimulates the human immune system to produce anti-HAV antibodies. These circulating antibodies can recognize and neutralize live hepatitis A virus upon exposure, reducing the chance of symptomatic hepatitis A infection and preventing virus transmission within groups.

As an inactivated vaccine, it contains no live virus. The inactivation procedure fully abolishes viral replication capacity while retaining critical antigenic epitopes required to induce protective immunity. This safety feature makes it suitable for wider immunization planning compared with live attenuated alternatives.

Raw Material & Cell Substrate Background

1. LV‑8 strain: This HAV strain was isolated and patented in China during the 1988 hepatitis A outbreak. It features stable genetic traits, high virus yield during cell culture and consistent immunogenicity batch to batch.

2. KMB17 human diploid cell line: Established in 1974 and fully validated for vaccine production, the cell substrate does not carry exogenous infectious agents and has long-term safety records for human vaccine manufacturing.

3. Aluminum adjuvant: Physiologically compatible adjuvant to boost antigen presentation and enhance antibody production after intramuscular injection.

Technical Parameters

The finished vaccine is supplied in vial or pre-filled syringe formats, split into pediatric and adult strengths for flexible dosing in different age cohorts.

Storage requirements: Keep refrigerated at 2–8°C, avoid freezing. Freezing will damage the antigen structure and destroy vaccine potency. Protect the product from direct sunlight and high temperature during transportation and warehousing.

Shake thoroughly before each administration. Visually inspect each unit for foreign particles or abnormal discoloration. Discard the product if container leakage, cracking or unexpected texture changes are observed.

The parameter set is standardized across production batches, which simplifies batch testing, inventory management and documentation for international buyers of Inactivated Hepatitis A Vaccine For Preventing HAV Infection.

Application Scenarios

This vaccine is widely deployed in multiple public health and commercial healthcare settings. Each scenario has distinct procurement requirements, packaging needs and documentation expectations.

1. National or regional routine immunization campaigns: Health authorities purchase bulk vaccine stock to cover children and adolescents in endemic regions, to reduce community transmission of HAV.

2. Pre-travel vaccination for high-risk travellers: People travelling to regions with high hepatitis A prevalence can complete two-dose immunization before departure to avoid infection via contaminated food and water.

3. Institutional immunization: Schools, childcare centres, food industry workers, laboratory staff and healthcare workers can receive vaccination to lower workplace outbreak risks.

4. Post-exposure prophylaxis planning: While pre-exposure vaccination is the primary use, public health teams can integrate the vaccine into rapid response protocols during local hepatitis A outbreaks for susceptible populations.

Buyers can select packaging type and batch size according to their local immunization calendar, cold chain infrastructure and distribution network.

Quality Assurance

Manufacturing of Inactivated Hepatitis A Vaccine For Preventing HAV Infection follows NMPA GMP standards. The production facility has passed official GMP inspection, with full process traceability from cell bank seed, virus culture, purification, inactivation, filling, packaging and final release testing.

Every finished batch undergoes a full panel of quality tests. Key test items include antigen content verification, sterility test, bacterial endotoxin test, inactivation validation, pH test and visual inspection. Batch release reports are available for qualified purchasers.

AIM Honesty Biopharmaceutical Co., Ltd. maintains a dedicated quality control laboratory and quality assurance team. All production operators receive regular training on bioprocess control and regulatory compliance. The company also participates in international pharmaceutical exhibitions such as CPHI to communicate with global regulators and vaccine distributors.

Cold chain management guidelines are provided together with shipment documents, helping customers maintain stable storage conditions and preserve vaccine potency after delivery.

Immunization Outcomes

Clinical comparison data shows that the seroconversion rate of this inactivated hepatitis A vaccine is comparable to imported reference vaccines, and the geometric mean titer of protective antibodies can reach favourable levels after two-dose schedule. The antibody level builds progressively after primary injection and rises significantly after the booster dose administered at 6 months.

Immune response varies mildly among individuals, which is normal for biological products. Factors such as age, baseline health status and immune function may affect antibody production. Immunization should be completed according to the full two-dose regimen to achieve optimal protection against HAV infection.

Local mild adverse reactions may occur after injection, including temporary injection site tenderness, redness or slight swelling. Most symptoms resolve spontaneously within a short period without special intervention. Severe adverse events are rare. Healthcare providers should monitor vaccine recipients for immediate hypersensitivity reactions after injection.

For large-scale immunization programs, the consistent immune performance of Inactivated Hepatitis A Vaccine For Preventing HAV Infection simplifies outcome forecasting for public health planners.

Packaging & Logistics

The product can be supplied in vial packaging or pre-filled syringe packaging. Each unit is individually labelled with batch number, expiry date, storage instruction, antigen content and product name. Outer cartons are designed for stackable cold chain transport and marked with temperature control warning signs.

All shipments require cold chain transport maintaining 2–8°C. The logistics team can cooperate with specialized pharmaceutical cold chain carriers for international delivery. Temperature monitoring logs can be provided upon request for cross-border customs clearance and local regulatory filing.

Packaging specifications can be adjusted for bulk orders. The sales team will confirm lead time, documentation list and shipping terms after order details are finalized. Minimum order quantity is negotiable, buyers can contact the sales team for formal quotation.

FAQ

Q: What is the core mechanism of this vaccine against hepatitis A?

A: It is an inactivated vaccine. HAV virus is cultured, purified and fully inactivated by formaldehyde. The virus loses replication ability but retains antigen structure. After intramuscular injection, the human immune system generates specific anti-HAV antibodies. When the person contacts live hepatitis A virus later, these antibodies neutralize the pathogen to prevent HAV infection.

Q: Can this vaccine be used for both children and adults?

A: Yes, separate dosage formulations are designed. The 0.5 mL pediatric dose applies to people aged 1 to 15 years old. Individuals older than 15 years use the 1.0 mL adult formulation. Two doses are required for both groups, with a 6-month interval between primary and booster injection.

Q: What cold chain conditions are mandatory during storage and transit?

A: Store and transport at 2°C to 8°C. Freezing must be avoided. Frozen vaccine cannot be used because freezing destroys antigen activity. Direct sunlight and high ambient temperature should also be prevented.

Q: What documents can be provided for import registration?

A: Qualified buyers can obtain batch release certificates, GMP documentation, product specification sheets, COA for each batch and supporting manufacturing documents. The company’s international team supports customers for local import filing, and additional documents can be discussed during business communication.

Q: What is the difference between inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine?

A: Inactivated vaccine contains no live virus, so there is no risk of virus revert to virulence. It relies on purified, killed viral antigen to induce immunity. Live attenuated vaccine uses weakened live virus strain. Inactivated vaccine usually requires two doses and has a broader suitable population, which makes it widely selected for organized immunization projects.

Q: Is sample available for testing before bulk purchase?

A: Sample application is available. Please contact our international sales team to submit your institution information, intended use and target quantity. Sample supply is subject to stock availability and compliance requirements.

Structure of hepatitis A virus