Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell)
The first inactivated EV71 vaccine all over the world
Cultivated in human diploid cell substrate, without any preservative
Suitable to the EV71 susceptible people from 6 months to 5 years age
The efficacy of the EV71-caused HFMD reaches 97.3%
The First Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell) All Over the World
After 8 year’s efficient work, EntroVac® , the first vaccine against Hand, Foot and Mouth Disease (HFMD) caused by Enterovirus Type 71 (EV-71) was approved by CFDA in 3rd December, 2015.
In 2007, Laboratory research was started.
In 2008, a viral strain was isolated in Fuyang, Anhui province, China.
In 2010, the approval to conduct clinical trials was obtained.
In 2013, clinical trials were finished.
In 2015.12.3, approval certificate of EntroVac® was released by CFDA.
In 2016.3.18, EntroVac® was launched to market.
In 2016.3.22, the first dose was immunized.
The Innovative Vaccine from Theory to Practice
Utilizing domestic primate resources, IMBCAMS invented neonatal monkey model to extract pathological features of EV-71 infection and to evaluate protective effect of EntroVac®.
Immune response mechanism induced by EntroVac® was analyzed in clinical trials.
A multi-center phase III clinical trial involving 12000 subjects at 6 to 71 months age sufficiently proved the safety and efficacy of the product. Over two course of epidemic seasons, efficacy of the vaccine was 97.3%.
The Persistent Research Provides the World Powerful Weapons in Controlling HFMD
EntroVac® created by IMBCAMS is derived from the C4 subtype of EV-71, but the cross-neutralization test suggested that the vaccine could protect against most circulating EV-71 strains in different countries.
Main Active Composition:
Inactivated type 71 Enterovirus, the neutralizing antibody titer of EV71 is no less than 3.0EU (containing 100U EV71 antigen)
Adjuvants: Al(OH)3, Glycine
Description: Slightly milk-white suspension. Stratified precipitate may form, but it can disperse by shaking.
Storage: Stored and transported in 2-8℃, protected from light. Avoid freeze.
Period of Validity: 24 months.
Packaging: Pre-filled syringes or vials.
After administration, this vaccine can induce immune response to prevent hand, foot, and mouth disease (HFMD) caused by infection of EV71 virus. However, the vaccine cannot be used for the prevention of HFMD caused by other Enteroviruses (including Coxsackievirus A16 and etc).
The vaccine is suitable for EV71 virus susceptible children aged from 6 months to 5 years old.
Administration and Dosage:
Before use, the vaccine should be shaken well. Two doses of vaccines should be used in two months apart for primary immunization. Recommended intramuscular injection into the deltoid muscle of upper arm and 0.5ml per person per time.
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