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Each 10-dose vial of vaccine must be used within 4 hours of opening. India News

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BENGALURU: Initial batches of Covid-19 vaccines, likely to be used starting January 16, will need to be used or discarded within four hours of opening the vials, each of which is estimated to contain 10 doses . The reason: the lack of availability of Vaccine Vial Monitors (VVM) because the situation of the pandemic has led the government to eliminate the open vial policy that allows the storage and use of vaccines for much longer even after they are have opened the vial.
For example, some vaccines under the Universal Immunization Program (UIP) can be used for about four weeks after the vial is opened (for the first time). This cannot be done without VVMs as they display key indicators, especially storage temperature, which helps to properly store and transport vials.
“As there will be no VVM and expiration date on the vaccine vial to be supplied, maintaining the cold chain will be of paramount importance … The open vial policy will not be applicable and, therefore, the vaccination must mark the date and time of opening the vial, all opened vials must be discarded after four hours of having been opened or at the end of the session, “said the Union Ministry of Health in its guidelines shared with the states. The guidelines added that at each site a supervisor must ensure that the temperature of vaccine carriers is properly maintained and recorded.
Veteran virologist T Jacob John explained that, unlike inactivated vaccines that may contain agents that keep them sterile, live vaccines like the one that produces IBS (Serum Institute of India) do not. This means that whether or not a vaccine becomes contaminated depends on its cold storage.
“Any inactivated vaccine can resist breaking the cold chain, but live virus vaccines must be kept at a certain temperature. If it breaks and the temperature rises above 8 ° C, its power may drop. Usually once you are out of the cold chain these vaccines can be used for 4-6 hours, beyond that if you do not have a VVM you are not sure if the temperature is maintained so it’s better not to have an open road policy, ”John said.
However, this also means that there are high chances of waste given that the vials must be used / disposed of within four hours and under current guidelines only 100 people can receive vaccine injections per site / per day. By the way, this has been fixed since, unlike regular immunization programs, in which people enter how and when on a given day, vaccination against Covid is done by appointment, allowing officials to know how many people will be in one place on any given day. . Unlike the SII vaccine, the one being developed by Bharath Biotech is an inactivated vaccine, and an open vial policy can be applied there. The ministry’s guidelines say that appropriate instructions will be given for different types of vaccines.

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