Studies at various ambient temperatures and duration are required to finalize when the vaccine reaches endpoint beyond which it cannot be used to decide the type of Vaccine Vial Monitoring (VVM) to be used. VVM is manufactured by a single offshore manufacturer and in view of the global urgency to use COVID-19 vaccine upon development, the requirement of very high volumes of VVM and limited production capacity, COVID-19 vaccines are used without VVM across the world.
The National Regulator i.e. Central Drugs Standard Control Organization, has approved the shelf life of 9 months for the Covishield vaccine and 12 months for the Covaxin & Sputnik vaccine from the date of manufacture. The government of India has issued suitable guidelines and training material highlighting appropriate storage, handling and administration of Covid-19 vaccines.
The storage and transportation of COVID-19 vaccines from the manufacturer up to the Covid-19 Vaccination Center (CVC) is ensured in a temperature-controlled environment at 2-8 degrees Celsius. A robust Cold Chain Network of around 29,000 cold chain points along with insulated/refrigerated vaccine vans, Cold Boxes and Vaccine carriers is used to ensure storage and transport of COVID-19 vaccines in a temperature-controlled environment. Monitoring of storage temperature is also done on real-time basis so as to ensure maintenance of recommended storage temperature.
The Union Minister of State for Health and Family Welfare, Dr. Bharati Pravin Pawar stated this in a written reply in the Rajya Sabha today.