M-Vac

M-Vac (Live Attenuated Measles Vaccine (Freeze-dried) Powder for Injection, S.C.) is prepared from the Edmonston strain measles virus which has been further attenuated by twenty two passages on human diploid cells (HDC) and is known as the Edmonston-Zagreb strain. The virus in the final vaccine is also propagated on HDC and is from the second cell culture passage from the seed virus. The vaccine is lyophilized and is provided with diluent. The product has the appearance of a yellowish-white dry cake. The vaccine meets the requirements of W.H.O. when tested by the methods outlined in W.H.O., TRS 840 (1994).
Potency: Each single human dose when reconstituted in a volume of 0.5 mL contains not less than 1000 CCID₅₀ of live virus particles. Stability data has shown that the freeze-dried vaccine retains the potency of 1000 CCID₅₀ per dose after 1 week at 37°C.

For active immunization against measles. A single dose of measles vaccine is sufficient to provide prolonged immunity to infection. In countries where the incidence and mortality from measles is high in the first year of life, the recommended age for immunization against measles is as soon as possible at 9 months of age (270 days). In countries where infection occurs later in life (due to sustained high vaccine coverage), the age of immunisation can be moved to 12-15 months. Countries where measles is less of a problem may decide on a later date for immunization. The vaccine is also recommended for use in children and adolescents with no evidence of vaccination or measles infection. The vaccine can also be administered to children and adolescents who have been vaccinated before or have had measles infection earlier. Measles vaccine can be safely and effectively given simultaneously with DTP, DT, TT, Td, BCG, Polio vaccine (OPV and IPV), Haemophilus influenzae type b, Hepatitis B, Yellow fever vaccine and vitamin A supplementation.

The vaccine should be reconstituted only with the entire diluent supplied (Sterile water for injections) using a sterile syringe and needle. With gentle shaking the dried cake is easily dissolved. After reconstitution the vaccine should be used immediately. A single dose of 0.5 mL should be administered by deep subcutaneous injection into the anterolateral aspect of upper thigh in infants and upper arm in older children. If the vaccine is not used immediately then it should be stored in the dark at 2-8°C for no longer than 6 hours. Any opened container remaining at the end of a session (within six hours of reconstitution) should be discarded. The vaccine vial monitor (see Cautions for Usage), for this type of vaccine is attached to the vial cap and should be discarded when the vaccine is being reconstituted.
The diluent supplied is specially designed for use with the vaccine. Only this diluent must be used to reconstitute the vaccine. Do not use diluents from other types of vaccine or for Measles vaccine from other manufacturers. Water for injections must NOT be used for this purpose. Using an incorrect diluent may result in damage to the vaccine and/or serious reactions to those receiving the vaccine. Diluent must not be frozen, but should be kept cool.
The diluent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. In the event of either being observed, discard the diluent or reconstituted vaccine.

There are few contraindications to the administration of measles vaccine. Individuals receiving corticosteroids, other immuno-suppressive drugs or undergoing radio-therapy may not develop an optimal immune response. The vaccine should not be given in acute infectious diseases, leukaemia, severe anaemia and other severe diseases of the blood system, severe impairment of the renal function, decompensated heart disease, following administration of gammaglobulin or blood transfusions. Persons with a history of an anaphylactic reaction to any component of the vaccine should not be vaccinated. There are extremely rare reports of hypersensitivity reactions with MMR vaccines in individuals who are allergic to cow's milk. Such individuals should not receive the vaccine.
Low-grade fever, mild respiratory infections or diarrhoea, and other minor illness should not be considered as contraindications. It is particularly important to immunize children with malnutrition. Since the effect of the live measles vaccine on the fetus is not known, it is also contraindicated in pregnancy.
Immune Deficiency: Children with known or suspected HIV infection are at increased risk of severe measles and should be offered measles vaccine as early as possible. Measles vaccine is contraindicated in persons who are severely immunocompromised as a result of a congenital immune disorder, HIV infection, advanced leukaemia or lymphoma, serious malignant disease, or treatment with high-dose steroids, alkylating agents or anti-metabolites, or in persons who are receiving immunosuppressive therapeutic radiation.

Ensure that the vaccine is administered by subcutaneous route only. In rare cases anaphylactic shock may occur in susceptible individual and for such emergency keep handy 1:1000 adrenaline injection ready to be injected intramuscularly or subcutaneously. For treatment of severe anaphylaxis the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5 mL of 1:1000 injection) given s/c or i/m. Single dose should not exceed 1 mg (1 mL). For infants and children the recommended dose of adrenaline is 0.01 mg/kg (0.01 mL/kg of 1:1000 injection). Single paediatric dose should not exceed 0.5 mg (0.5 mL). This will help in tackling the anaphylactic shock/reaction effectively.
The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be lifesaving. It should be used at the first suspicion of anaphylaxis. As with the use of all vaccines the vaccinee should remain under observation for not less than 30 minutes for possibility of occurrence of rapid allergic reactions. Hydrocortisone and antihistaminics should also be available in addition to supportive measures such as oxygen inhalation.

The measles vaccine may cause within 24 hours of vaccination mild pain and tenderness at the injection site. In most cases, they spontaneously resolve within two to three days without further medical attention. A mild fever can occur in 5-15% of vaccinees 7 to 12 days after vaccination and last for 1-2 days. Rash occurs in approximately 2% of recipients, usually starting 7-10 days after vaccination and lasting 2 days. The mild side effects occur less frequently after the second dose of a measles-containing vaccine and tend to occur only in person not protected by the first dose. Encephalitis has been reported following measles vaccination at a frequency of approximately one case per million doses administered although a causal link is not proven. In susceptible individuals the vaccine may very rarely cause allergic reactions like urticaria, pruritis and allergic rash within 24 hours of vaccination.

Due to the risk of inactivation, the measles vaccine should not be given within the 6 weeks, and if it is possible the 3 months, after an injection of immunoglobulins or blood product containing immunoglobulins (blood, plasma).
For the same reason, immunoglobulins should not be administered within the two weeks after the vaccination.
Tuberculin positive individuals may transitionally become tuberculin negative after vaccination.

The Vaccine Vial Monitor (VVM) (Optional): Vaccine Vial Monitors (VVM): Use: Square is lighter than outer circle.
Discard Point: The colour of the inner square of the VVM starts with a shade that is lighter than the outer circle and continues to darken with time and/or exposure to heat.
Do not use: Square matches outer circle; Square is darker than outer circle.
Discard Point: Once a vaccine has reached or exceeded the discard point, the colour of the inner square will be the same colour or darker than the outer circle.
Inform the supervisor.
Cumulative heat exposure over time.
Vaccine Vial Monitors (VVMs) are on the cap of M-Vac (Live Attenuated Measles Vaccine (Freeze-dried) Powder for Injection, S.C.) supplied through Serum Institute of India Pvt. Ltd. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the outer circle, then the vaccine can be used. As soon as the colour of the central square is the same colour as the outer circle or of a darker colour than the outer circle, then the vial should be discarded.

It is important to protect both the lyophilized and reconstituted vaccine from the light. The vaccine should be stored in the dark at 2-8°C. For long term storage a temperature of -20°C is recommended for the lyophilised vaccine. Protect from light. The diluent should not be frozen, but should be kept cool.
Shelf Life: 30 months from the date of last satisfactory potency test, if stored in a dark place at a temperature between 2-8°C.

Vaccines, Antisera & Immunologicals

J07BD01 - measles, live attenuated ; Belongs to the class of morbilli viral vaccines.

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