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Hepatitis B Vaccine for Newborns
To select a supplier for long-term cooperation and obtain highly protective Hepatitis B Vaccine for Newborns, you can contact AIM Honesty. The Hepatitis B birth dose vaccine is safe, affordable, and prevents a lifelong and potentially fatal infection, making it extremely important. We can provide a stable supply of reliable, high-quality vaccines.
AIM Honesty is a reliable manufacturer and supplier of Hepatitis B Vaccine for Newborns, possessing a complete R&D and production line. Their vaccines are of high quality, offer long-lasting efficacy, and provide reliable protection for newborns.
Why Is Hepatitis B Vaccination for Newborns So Important?
1. Prevention of chronic infection
If infected with the hepatitis B virus (HBV) at birth or during infancy, up to 90% of cases will develop into chronic infection; chronic infection can lead to cirrhosis or liver cancer decades later.
Vaccination at birth reduces the chronic infection rate in the immunized population to less than 1%.
2. Blocking mother-to-child transmission
Even without the use of hepatitis B immunoglobulin (HBIG), a single birth dose of vaccine is up to 75% effective against perinatal transmission; adding HBIG increases the effectiveness to 94%.
This protection is crucial because many mothers who are positive for the hepatitis B virus are unaware of their infection status.
3. Providing an early safety net of immunity
Infants may later be exposed to the virus through family contact, cuts, bites, or medical procedures; the birth dose vaccine activates the immune system before any exposure to the virus.
4. Providing long-lasting protection
More than 95% of healthy full-term newborns develop protective antibody levels after completing all three doses of the vaccine after birth. Follow-up studies show that immunity lasts for at least 20 years and may be lifelong.
AIM Honesty RECVAX® series hepatitis B vaccines are suitable for infants of all weights and gestational ages and can effectively reduce the incidence of chronic hepatitis B in children.
Product Specification
Compared to other technical routes, RECVAX® were produced with a more rigorous pharmacopeia standard, which improve the quality and safety of the product.
| Pharmacopoeia Item | Endotoxin content | Free formaldehyde | Thiocyanate | Residual amount of antibiotics | Residual amount of bovine serum albumin |
| Hansenula polymorpha | Less than 5 EU/ml | Less than 15 µg/ml | Not applicable | Not applicable | Not applicable |
| Saccharomyces cerevisiae | Less than 5 EU/ml | Less than 20 µg/ml | Should be less than 1 µg/ml | Not applicable | Not applicable |
| CHO cells | Less than 10 EU/ml | Less than 50 µg/ml | Not applicable | No more than 50 ng/dose | No more than 50 ng/dose |
| Process | Hansenula Yeast | Saccharomyces Yeast | CHO Cell |
| Process Description | Most advanced process | First generation yeast expression system | Most dated process |
| Tumorigenic Risk? | No | No | Yes |
| Antibiotic Added? | No | No | Yes |
| Bovine Serum Albumin Added? | No | No | Yes |
| Animal Pathogen Risk? | No | No | Yes |
| Thiocyanate Added? | No | Yes | No |
| Immunogenicity | High | Higher | Not much (general double dose vs. yeast shows poor response) |
| Vaccine Purity | Highest | Higher | More additives, lower purity |
| Potential Benefit | Strongest cellular immunity induction | Second strongest cellular immunity induction | Weakest cellular immunity induction |
| Representative Product Statement | 10 µg applicable to all populations | 10 µg applicable only to children | 10 µg immunogenicity poor, almost discontinued |
Storage and Packaging
Hepatitis B Vaccine for Newborns must be stored and transported in a dark environment at 2-8℃.
The vaccine's inner packaging materials include vials, ampoules, and pre-filled syringes, with the following specifications:
Vials: 0.5ml × 1 vial/box, 0.5ml × 3 vials/box, 0.5ml × 30 vials/box;
Ampoules: 0.5ml × 3 ampoules/box, 0.5ml × 9 ampoules/box;
Pre-filled syringes: 0.5ml × 1 syringe/box.
Please note the expiration dates:
Vials: 36 months, Ampoules: 24 months, Pre-filled syringes: 36 months.
Product Efficacy
RECVAX®'s patented adjuvant technology utilizes in-situ adsorption technology, allowing for sustained antigen release and prolonged antigen action time.
In terms of efficacy, a study led by Academician Li Lanjuan evaluated the booster immunization effect of four different hepatitis B vaccines in children aged 5 to 15 years. After receiving a booster dose of 10 μg RECVAX® (Hansenula polymorpha) vaccine using a 0-1-6 month schedule, the anti-HBs seropositivity rates at 1, 5, and 8 years post-booster immunization all reached 83.4%, the highest among all four vaccines.
Production Details
Professional and modern production workshops are the cornerstone of high-quality products!
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● 26F, T6, Dazu Square, NO.2 Ronghua South Road, ETDZ, Beijing, China
● 10F, Port Building, 1 Fenghe Road, Pudong, Shanghai, China -
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