Haffkine Bio-Pharmaceutical Corporation Limited.
A GOVERNMENT OF MAHARASHTRA UNDERTAKING.

MONOVALENT TYPE I POLIOMYELITIS VACCINE (ORAL)

Monovalent type 1 oral poliomyelitis vaccine I.P.

Each bottle contains 2ml (20 doses)

Stabilised with 1m mgcl2

Each dose of 2 drops(0.1 ml) contains poliovirus(Sabin)

Type 1-106CCID50

MONOVALENT TYPE 1 ORAL POLIOMYELITIS VACCINE (mOPV1)

DESCRIPTION
How to read VVM?
  
 
The live, Monovalent Type 1 Oral Poliomyelitis vaccine (mOPV1), is a clear, transparent, yellowish orange or light pink coloured solution. It is a monovalent vaccine containing suspension of type 1 attenuated poliomyelitis virus (Sabin strain) propagated in primary monkey kidney cell cultures (P.M.K.C.C). Each dose of 2 drops (0.1 ml) contains at least Poliovirus (Sabin) Type 1 - 106 CCID50 [The potency of the vaccine is expressed in the quantity of the virus suspension, that will infect 50% of cell Cultures]. The poliovirus is suspended in Hanks- Balanced Salt Solution with one Molar Magnesium chloride as a stabilizer and phenol red as a pH indicator. mOPV1 may contain trace amounts of Erythromycin and Kanamycin. The vaccine fulfils WHO requirements for Monovalent Type 1 Oral Poliomyelitis Vaccine.
 
Monovalent Type1 Oral Poliomyelitis Vaccine is indicated for Poliomyelitis Supplementary Immunisation Activities (SIAs) in children from 0 to 5 years of age, to interrupt Type 1 poliovirus transmission in remaining polio endemic areas. The routine vaccination programme should continue to use trivalent vaccines according to national policy.
ADMINISTRATION
mOPV1 must only be administered orally. Two drops are delivered directly into the mouth from the multi dose vial by dropper. For older children it may be preferred to avoid the possible bitter taste by first placing the drops on a sugar lump or in syrup. Care should be taken not to contaminate a multi dose dropper with saliva of the vaccinee. Overdose, if any, will not result in ill-effect.

Once opened, multi-dose vials should be kept between +2°C and +8°C. Multi-dose vials of mOPV1 from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 4 weeks, provided that all of the following conditions are met (as described in the WHO policy statement: The use of opened multi dose vials in subsequent immunization sessions. WHO/V&B/00.09):

  • The expiry date has not passed;
  • The vaccines are stored under appropriate cold chain conditions;
  • The vaccine vial septum has not been submerged in water;
  • Aseptic technique has been used to withdraw all doses;
  • The vaccine vial monitor (VVM), if attached, has not reached the discard point (see figure).
    After first opening, immediate use is recommended.
ACTION & USES

Monovalent Type 1 Oral Poliomyelitis  vaccine (mOPV1)is administered  to stimulate the body mechanism to produce active immunity by simulating the natural infection without producing untoward symptoms of the disease. This is achieved by multiplication of the vaccine virus in the intestinal tract.

SIDE EFFECTS

In the vast majority of cases there are no side effects reported with the trivalent OPV, that includes the same OPV1 component.  Very rarely,  there may be vaccine-associated paralysis (less than one case per  one million doses administered). Persons in close contact with a  recently vaccinated child may very rarely be at risk of vaccine – associated paralytic poliomyelitis.

SPECIAL WARNINGS & PRECAUTIONS FOR USE
In case of diarrhoea or vomiting (including gastro-intestinal infection) the dose received will not be counted as part of the immunization schedule and it should be repeated after recovery.mOPV1 should not to be used for routine immunization.
CONTRAINDICATIONS

No adverse effects are produced by giving mOPV1 to a sick child.

IMMUNE DEFICIENCY

Individuals infected with human immunodeficiency virus (HIV), both asymptomatic and symptomatic, should be immunized with mOPV1 according to standard schedules. However,  the vaccine is contraindicated in those with primary  immune deficiency disease or suppressed immune response from medication, leukaemia, lymphoma or generalized malignancy.

STORAGE
Vaccine is potent if stored at or below -20°C until the expiry date indicated on the vial i.e. for a period of two years from the date of manufacture. It can be stored for up to six months between +2°C and +8°C. Exposure of the vaccine to sunlight must be avoided.