Open Vial Policy has been developed to minimise and prevent vaccine wastage under the UIP.
It permits the reuse of partially used multi dose vials of relevant vaccines under UIP in succeeding sessions up to 28 days PROVIDED certain conditions are fulfilled. It is essential that the policy is followed correctly, so as to minimize wastage, adverse effects following immunization and ensuring that the vaccination is effective.
Open Vial Policy is valid for the following vaccines:
• DPT, Td & TT,
• Hepatitis B,
• Oral Polio Vaccine (OPV)
• Haemophilus influenzae type B (Hib) containing Pentavalent vaccine and
• injectable Inactivated Poliovirus Vaccine (IPV).
Open Vial Policy does NOT apply to:
• BCG and
• Japanese Encephalitis (JE) vaccines.
Provided that certain conditions are upheld, a vial of the vaccine that has been opened during a session can be utilized for multiple immunization sessions WITHIN a period of 28 DAYS.
• The expiry date has not passed.
• The vaccines are stored under appropriate cold chain conditions both during transportation and storage in cold chain storage point.
• The vaccine vial septum has not been submerged in water or contaminated in any way.
• Aseptic technique has been used to withdraw vaccine doses. (That is needle/septum has not been contaminated in anyway)
• The vaccine vial monitor (VVM), has not reached/crossed the discard point.
A vaccine vial should be DISCADED if any of the following conditions are met and the Medical Officer or Supervisor should be informed:
• VVM reached/crossed discard point (for freeze dried vaccine, before reconstitution only) or vaccine vials without VVM or disfigured VVM.
• No label/partially torn label and/or writing on label not legible.
• Any vial thought to be exposed to non-sterile procedure for withdrawal.
• Open vials that have been under water or vials removed from a vaccine carrier that has water.
• If vaccine vial is frozen or contains floccules or any foreign body.
• If there is breakage in the continuity of the vials (crack/leaks).
• If there is any reported AEFI following use of any of the vaccine vial, do not use it, and retain it safely.
WHO Policy Statement, 2014. Multi-dose Vial Policy (MDVP), HANDLING OF MULTI-DOSE VACCINE VIALS AFTER OPENINGWHO. WHO Document Production Services, Geneva, Switzerland
GOI, 2015. Guidelines on Open Vial Policy for using multi-dose vials in Universal Immunization Program. MoHFW, Immunization Division, New Delhi, India.