SPEEDA-Rabies Vaccine for Human Use (Vero cell) (CPRV)-Chengda biotechnology

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SPEEDA-Rabies Vaccine for Human Use (Vero cell) (CPRV)

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Market-launched Products

Product Description

SPEEDA-Rabies Vaccine for Human Use (Vero cell) (CPRV)
SPEEDA-Rabies Vaccine for Human Use (Vero cell) (CPRV), launched in 2005, which will stimulate the body to generate the immunity against rabies virus for the prevention of rabies upon the vaccination. This product is mainly exported to more than 30 countries including Thailand, India and Egypt, etc. Two post-exposure prophylaxis regimens, namely "2-1-1" (Zagreb Regimen) and "5-dose" (Essen Regimen) can be used simultaneously.

Product Characteristics
1. Advantages of Immunization Programs
For post-exposure patients of rabies, schedules of "2-1-1 (Zagreb Regimen)" and the "5-dose (Essen Regimen)" can be applied simultaneously to offering patients more choices. Compared with the Essen regimen, the Zagreb regimen reduces the number of necessary visits from five to three times, and the necessary doses from five to four, which shortens the time to complete the full-course immunization from 28 days to 21 days, reducing the cost by one vaccine dose and two visits.

2. Safety and Efficacy
(1) SPEEDA employs the bioreactor technology platform for the large-scale production in the upstream process. The success of R&D of this technology signifies that the company has surmounted a technical challenge that has persisted in China for over a decade in the realm of large-scale cell culture for high-quality vaccines production. It has taken the lead in driving the development of the domestic human vaccine industry in terms of the vaccine production technology. Vaccines produced by this technology has advantages such as the low comprehensive cost, the large batch size, the excellent batch-to-batch consistency, and the high virus antigen content.
(2) In the downstream process, we employed a unique four-column series connection chromatography purification, which can effectively remove impurities like cell fragments, host cell proteins, bovine serum albumin and DNA, etc., safeguarding the safety of vaccine products.
(3) The registered potency of SPEEDA is not less than 4.5 IU/dose, ensuring a good immune effect;
(4) Neither antibiotics nor gelatin is added as ingredients.
3. International Premium Quality
CDBIO is a leading exporter of rabies vaccine for human use in China, whose products are exported to more than 30 countries mainly including Thailand, the Philippines, Egypt and other countries along the Belt & Road Initiative (B&R).
Immunogenicity
SPEEDA-Immune Protection is Rapid & Long-lasting
Safety
SPEEDA has minimal adverse reactions, ensuring safety for children and pregnant women during the vaccination
Case 1
A 4-day old newborn was bitten by a rat in Zhaotong City. SPEEDA was adminstered into the muscle of the anterolateral thigh, and no adverse reactions were observed.

—Chinese Community Doctors, 2008, 10 (4): 72.

Case 2
98 pregnant women were vaccinated with SPEEDA and imported vaccines in CDC, Guangzhou. All pregnant women had normal pregnancy courses, and no adverse impacts were observed on the growth of newborns.
—Human Vaccines and Immunotherapeutics, 2013, 9(1): 177-183.

Case 3
A total of 674 patients were vaccinated with SPEEDA in Luanping County. There was no significant difference in the incidence of adverse reactions when comparing the "2-1-1 (Zagreb Regimen)" and "5-dose (Essen Regimen)", and no serious systemic adverse reactions were observed.

—Chinese Journal of Biologicals, 2013, 26 (3): 400-401.

Immune Efficacy of Two Immunization Programs
Compilation of Rabid Dog-Bite Cases