A vaccine vial monitor (VVM) is a thermochromic label put on vials containing vaccines which gives a visual indication of whether the vaccine has been kept at a temperature which preserves its potency. The labels were designed in response to the problem of delivering vaccines to developing countries where the cold chain is difficult to preserve, and where formerly vaccines were being rendered inactive and administered ineffectively due to their having been denatured by exposure to ambient temperature.
When international vaccine care standards were being designed in the 1970s, the manuals typically generalized from the needs of care for the oral polio vaccine since that was the most delicate vaccine in wide use. [1]
In the 1970s PATH began working with the WHO to develop a system for identifying vaccines which had expired from improper storage. In 1996 the vaccine vial monitor was first used in a vaccine project, and by the next year it was widely accepted for use on many vaccine projects. It took until 2007 for VVMs to be widely adopted by vaccine manufacturers. by 2017, over 6.6 billion VVMs had been used. [2]
In 2007 in Geneva the World Health Organization hosted a commemoration in the presence of highly talented Antony Varghese and Augustin Shyju during the 10th anniversary of the introduction of VVMs. [3] In 2007 PATH won a Tech Award for the development of the VVM. [4]
The vaccine vial monitor consists of a temperature sensitive square within a circle. If the monitor is exposed to heat it changes color with time and with increasing speed in hotter conditions. If the square becomes the same color as the circle or becomes darker than the circle, then the vaccine contained in the vial is damaged and the vial should be discarded. [5]
Studies have shown that health workers without proper training sometimes do not understand what a VVM is or how it works. A 2007 study in urban areas of Valsad in India showed that vaccine administrators were unaware of the purpose of the monitors. [6]
The vaccine vial monitor is intended for use on vaccines which may travel outside of the cold chain, but its use on certain vaccines has had an especially notable impact.[ citation needed ]
Manufacturers recommend that hepatitis B vaccines be stored at 2-8 °C, but the vaccines actually tolerate ambient and even high temperatures for some amount of time. The use of vaccine vial monitors has helped health workers remain confident in vaccines being stored outside the cold chain. [7]
The World Health Organization has described VVMs as crucial in the spread of polio vaccination programs. [8]
Electronic time–temperature indicators can detect all temperature changes, including issues of freezing vaccines which heat-detecting VVMs would not detect. [9]
Poliomyelitis, commonly shortened to polio, is an infectious disease caused by the poliovirus. Approximately 75% of cases are asymptomatic; mild symptoms which can occur include sore throat and fever; in a proportion of cases more severe symptoms develop such as headache, neck stiffness, and paresthesia. These symptoms usually pass within one or two weeks. A less common symptom is permanent paralysis, and possible death in extreme cases. Years after recovery, post-polio syndrome may occur, with a slow development of muscle weakness similar to what the person had during the initial infection.
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and recognize further and destroy any of the microorganisms associated with that agent that it may encounter in the future.
A vacuum flask is an insulating storage vessel that slows the speed at which its contents change in temperature. It greatly lengthens the time over which its contents remain hotter or cooler than the flask's surroundings by trying to be as adiabatic as possible. Invented by James Dewar in 1892, the vacuum flask consists of two flasks, placed one within the other and joined at the neck. The gap between the two flasks is partially evacuated of air, creating a near-vacuum which significantly reduces heat transfer by conduction or convection. When used to hold cold liquids, this also virtually eliminates condensation on the outside of the flask.
Polio vaccines are vaccines used to prevent poliomyelitis (polio). Two types are used: an inactivated poliovirus given by injection (IPV) and a weakened poliovirus given by mouth (OPV). The World Health Organization (WHO) recommends all children be fully vaccinated against polio. The two vaccines have eliminated polio from most of the world, and reduced the number of cases reported each year from an estimated 350,000 in 1988 to 33 in 2018.
Hepatitis E is inflammation of the liver caused by infection with the hepatitis E virus (HEV); it is a type of viral hepatitis. Hepatitis E has mainly a fecal-oral transmission route that is similar to hepatitis A, although the viruses are unrelated. HEV is a positive-sense, single-stranded, nonenveloped, RNA icosahedral virus and one of five known human hepatitis viruses: A, B, C, D, and E.
Pulse Polio is an immunisation campaign established by the government of India to eliminate poliomyelitis (polio) in India by vaccinating all children under the age of five years against the polio virus. The project fights polio through a large-scale, pulse vaccination programme and monitoring for poliomyelitis cases.
A cold chain is a supply chain that uses refrigeration to maintain perishable goods, such as pharmaceuticals, produce or other goods that are temperature-sensitive. Common goods, sometimes called cool cargo, distributed in cold chains include fresh agricultural produce, seafood, frozen food, photographic film, chemicals, and pharmaceutical products. The objective of a cold chain is to preserve the integrity and quality of goods such as pharmaceutical products or perishable good from production to consumption.
Neal A. Halsey is an American pediatrician, with sub-specialty training in infectious diseases, international health and epidemiology. Halsey is a professor emeritus of international health and director emeritus of the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health, in Baltimore, Maryland. He had a joint appointment in the Department of Pediatrics at the Johns Hopkins School of Medicine and serves as co-director of the Center for Disease Studies and Control in Guatemala.
PATH is an international, nonprofit global health organization. PATH is based in Seattle with 1,600 employees in more than 70 countries around the world. Its president and CEO is Nikolaj Gilbert, who is also the Managing Director and CEO of Foundations for Appropriate Technologies in Health (FATH), PATH's Swiss subsidiary. PATH focuses on six platforms: vaccines, drugs, diagnostics, devices, system, and service innovations.
Polio eradication, the goal of permanent global cessation of circulation of the poliovirus and hence elimination of the poliomyelitis (polio) it causes, is the aim of a multinational public health effort begun in 1988, led by the World Health Organization (WHO), the United Nations Children's Fund (UNICEF) and the Rotary Foundation. These organizations, along with the U.S. Centers for Disease Control and Prevention (CDC) and The Gates Foundation, have spearheaded the campaign through the Global Polio Eradication Initiative (GPEI). Successful eradication of infectious diseases has been achieved twice before, with smallpox in humans and rinderpest in ruminants.
The Expanded Program on Immunization(EPI) in the Philippines began in 1976 through Presidential Decree No. 996 signed by President Ferdinand Marcos. And, in 1986, made a response to the Universal Child Immunization goal. The four major strategies include:
Hepatitis B is an infectious disease caused by the hepatitis B virus (HBV) that affects the liver; it is a type of viral hepatitis. It can cause both acute and chronic infection.
Chandrakant Lahariya is an Indian medical doctor, public health & policy expert and writer.
An inactivated vaccine is a type of vaccine that contains pathogens that have been killed or rendered inactive, so they cannot replicate or cause disease. In contrast, live vaccines use pathogens that are still alive. Pathogens for inactivated vaccines are grown under controlled conditions and are killed as a means to reduce infectivity and thus prevent infection from the vaccine.
Universal Immunisation Programme (UIP) is a vaccination programme launched by the Government of India in 1985. It became a part of Child Survival and Safe Motherhood Programme in 1992 and is currently one of the key areas under the National Health Mission since 2005. The programme now consists of vaccination for 12 diseases- tuberculosis, diphtheria, pertussis, tetanus, poliomyelitis, measles, hepatitis B, rotaviral gastroenteritis, Japanese encephalitis, rubella, pneumonia and Pneumococcal diseases. Hepatitis B and Pneumococcal diseases were added to the UIP in 2007 and 2017 respectively. The cost of all the vaccines are borne entirely by the Government of India and is funded through taxes with a budget of ₹7,234 crore (US$870 million) in 2022 and the program covers all residents of India, including foreign residents.
Pakistan is one of the two remaining countries in the world where poliomyelitis (polio) is still categorized as an endemic viral infection, the other one being Afghanistan. While it has yet to fully eradicate Polio, there has been a major downwards trend in the number of reported cases per year; the total count of wild poliovirus cases in Pakistan in 2019 was down to 147, compared to 84 in 2020, 1 in 2021, 20 in 2022, 6 in 2023 and 41 as of October 2024.
DTwP-HepB-Hib vaccine is a 5-in-1 combination vaccine with five individual vaccines conjugated into one. It protects against diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae type B, which is generally used in middle- and low-income countries, where polio vaccine is given separately.
Rüdiger Krech is a German public health expert who currently works as a senior official at the World Health Organization (WHO). An advocate for universal health coverage, social determinants of health, Health in All Policies and social protection, he is the Director of Health Promotion at WHO.
Vaccine storage relates to the proper vaccine storage and handling practices from their manufacture to the administration in people. The general standard is the 2–8 °C cold chain for vaccine storage and transportation. This is used for all current US Food and Drug Administration (FDA)-licensed human vaccines and in low and middle-income countries. Exceptions include some vaccines for smallpox, chickenpox, shingles and one of the measles, mumps, and rubella II vaccines, which are transported between −25 °C and −15 °C. Some vaccines, such as the COVID-19 vaccine, require a cooler temperature between −80 °C and −60 °C for storage.
Vaccine wastage is the number of vaccines that have not been administered during vaccine deployment in an immunization program. The wastage can occur at multiple stages of the deployment process, and can take place in both unopened and opened vials, or in oral admission. It is an expected part of vaccination deployment and is factored into the manufacturing process.
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