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Menwayc

Specification for Group A /C/Y/W135 Meningococcal Polysaccharide Vaccines

【Drug name】
Common name: Meningococcal Polysaccharide Vaccine(Group A/C/Y/W135)
Business Name: Menwayc
Chinese spelling: A、C、Y、W135  Qun  Naomoyanqiujun  Duotang  Yimiao
【Description】
Menwayc was is a freeze-dried preparation of purified capsular polysaccharides obtained from suitable strains of Neisseria meningitidis group A, group C, group Y and group W135, which is a white or cream-coloured powder or pellet, freely soluble in water.
Every dosage containing 200 g purified capsular polysaccharides (active ingredients). 50 g purified capsular polysaccharides for each strain of Neisseria meningitides group A, group C, group Y and group W135. Menwayc contains inactive ingredient of 3.5 mg lactose.
【Object of inoculation】
Currently, we recommended the usage of this product within the high-risk groups who were more than 2 years old as follow:
1. People who travel to or live in the high-risk infected areas, such as sub-Saharan Africa, where the A, C, Y, W135 Neisseria meningococcal infection were prevalence.
2. People who engaged in laboratory work, medical work or vaccine production could contact with the A, C, Y, W135 Neisseria meningitidis through the air.
3. High-risk groups of people who live in the Neisseria meningitides outbreak areas which were forecasted by the National Ministry of Health and Disease Control Center by epidemiological investigation.
【Action and Uses】
Menwayc can be used to prevent epidemic cerebrospinal meningitis caused by meningococcus group A, C, Y, and W135 infection.
【Strength】
Each bottle containing 200 g purified capsular polysaccharides. 50 g purified capsular polysaccharides for each strain of Neisseria meningitides group A, group C, group Y and group W135. Each bottle contains a dosage for a single people.
【Immunization procedures and doses】
1. Open the aluminum-plastic composite cap of vials, add 0.6 mL steriled and pyrogen-free injection water. Use Menwayc immediately after shaking the solution.
2. Subcutaneous inject Menwayc to lateral deltoid attachment of the upper arm after skin degerming.
3. Dosage: 0.5 mL for each every time.
4. The primary vaccination and frequency: vaccinated once before the epidemic season of meningococcal meningitis.
5. Re-vaccination (international recommendation): People who are high-risk individual in infected area, especially the child who got his primary vaccination before 4 years old, should be re-vaccinated 2-3 years later after the primary vaccination. It has not determined the necessity of re-vaccination of elder children and adults, but if the meningococcl antibody decline quickly in 2-3 years after the last vaccination, re-vaccination should be carried out in 3-5 years after the last vaccination.
There are no research data of immune persistence and strengthening of immunization currently.
【Adverse reaction】

Adverse reactions of Menwayc are mild. The main ADR were swelling and pain in the injection area, and it would recover without any treatment. Short-lived low-heat occurred occasionally (less than 2%).
Report of the ADRs in 4 weeks after vaccination was showed in Table 1. Local and systemic ADRs disappeared within 72 h mainly. 

【Contraindication】
1. People who are allergic to the vaccine components.
2. People who have epilepsy, brain disorders or a history of allergy.
3. People who have Kidney disease, heart disease, HIV infection, and active tuberculosis.
4. Do not administer to anyone with acute infectious disease or fever.
5. This vaccine has not do reproductive toxicity tests in pregnant women and experimental animals. It has not decided that will influence the fetus. This vaccine could not be used in pregnant women, especially women in their first 3 months of pregnant.
【Precaution】
 1. Check the vials before use. If any of vials crack, stopper loosened, foreign body or color change of vaccine happened, the vaccine should not be used.  
2. Menwayc should only be used once according to the instruction within 30 minutes.
3. Intradermal, intramuscular or intravenous injection should be avoided, because intradermal, intramuscular or intravenous injection has not indicated to be safe and efficient.
4. Menwayc should not be vaccinated together with pertussis vaccine or typhoid vaccine, because of the superposition of the amount of endotoxin. 
5. It has not been determined whether the product excreted in human milk. Please be careful to use Menwayc to suckling period woman, because many drugs could be excreted in human milk.
6. People who are immunosuppressed, including persons receiving immunosuppressive therapy, may have no or diminished immune response to Menwayc.
7. Menwayc may not protect all recipients like other vaccines, such as meningitis caused by Neisseria meningitidis group B. It could not protect infants and children less than 2 years old from Neisseria meningitidis infection except a shot protection of group A infection in infants elder than 3 months.
8. There is no preservative in this vaccine, so the product may be used within 4 h after reconstitution if stored at 2 to 8℃.
9. Adrenalin injection (1:1000) treatment must be available to manage possible anaphylactic reactions following administration of the vaccine.
【Storage】
Dark storage and transport at 2 to 8℃.
【Packing】
200g/bottle
【Validity】
24 months.
【Performed standard】
A, C, Y, W135 meningococcal polysaccharide vaccine manufacturing and testing procedures (try out)
【Approval document No.】
GYZZ S20070025
【Manufacturer】
Enterprise name: Beijing Luzhu biopharmaceutical Co., Ltd.
Add: No. 22 Tongji Beilu, Beijing Economic-technological Development Area, China.
Post code: 100176
Tel: 010-67870189
Fax: 010-67870318
Web: www.vaccine.com.cn

 

Table 1. ADR rate after Menwayc vaccination(%)

Event(%)
2-6 years old(n=267)
7-16 years old(n=286)
> 16 years old(n=287)
Any
Moderate
Severe
Any
Moderate
Severe
Any
Moderate
Severe
Injection Site reaction*
 
 
 
 
 
 
 
 
 
Pain
2.62
1.49
0.74
5.59
0.00
2.24
17.07
1.04
0.69
Redness
2.24
1.87
0.00
3.14
3.84
0.00
1.39
1.74
0.00
Induration
0.00
0.00
0.00
0.34
0.34
0.00
0.00
0.00
0.00
Itching
0.37
0.00
0.00
0.34
0.00
0.00
0.70
0.00
0.00
Fever#
10.48
9.74
2.99
9.93
3.14
0.69
5.92
0.69
0.69
General Disorders and other reactions
 
 
 
 
 
 
 
 
 
Headache
 
1.12
 
 
0.69
 
 
7.32
 
Anorexia
 
0.75
 
 
1.04
 
 
0.69
 
Vomiting
 
1.12
 
 
0.00
 
 
0.34
 
Irritability
 
1.87
 
 
0.00
 
 
2.78
 
Drowsiness
 
1.49
 
 
0.69
 
 
5.22
 
Bellyache
 
0.74
 
 
1.39
 
 
1.04
 
diarrhea and rash
 
0.00
 
 
0.00
 
 
0.00
 

*Injection Site reaction(diameter):Any <2.5 cm,Moderate 2.5~4.9 cm,Severe ≥5.0 cm;
#Fever:Any 37.1~37.5℃,Moderate 37.6~38.5℃,Severe>38.6℃。