It was also NIV’s scientists who came up with an early working hypothesis of where in the forest the virus was coming from - their research suggested that the virus survived in rodents. They named the virus after the Kyasanur Forest, where it was first found. This fever, that had hitherto been restricted to South America and Africa, was also a haemorrhagic fever that affected both humans and monkeys.īut when NIV’s scientists isolated the virus from a Hanuman langur, they found it to be a pathogen distinct from the Yellow Fever virus. This had raised questions about whether the outbreak was Yellow Fever. They were investigating a mysterious outbreak of haemorrhagic fever among locals, which coincided with the deaths of monkeys in the region. In 1957, NIV scientists were the first to isolate the virus from the Kyasanur Forest-a hilly tropical forest, interspersed with rice farms. Mint learnt that even though the CDSCO was repeatedly made aware-since atleast 2020- about the KFD vaccine being used in Karnataka without its permission, the national regulator didn’t do anything to tackle the issue.ĭespite NIV’s troubling role in the KFD vaccine story, the institute’s historical contributions to studying the disease and developing the vaccine are recognised as pioneering. The entire saga also raises questions about CDSCO’s performance as India’s national regulator, already in question after the deaths of 69 children in The Gambia, following the consumption of adulterated Indian cough syrup. “I don’t think it works," Krishna (who goes by one name), a community health officer in the Kannangi village of Karnataka’s Shivamogga district, told Mint in a July 2022 interview. The apparent loss of vaccine efficacy didn’t go unnoticed by healthcare workers in KFD-affected regions, many of whom lost confidence in the vaccine. Between 5 and 10% is not an insignificant case fatality rate dengue, in comparison, kills around 2.6% of confirmed cases, as per one estimate. In severe disease, the virus impacts multiple organs, or causes haemorrhagic symptoms-like bleeding from the eyes, nose and intestines. But in 5-10% of patients, the virus can take a severe course, resulting in death. The disease, which sickens some 500 people annually in the Western Ghats regions of the affected states, is mild in most cases, characterised by fever and chills. This meant that most recipients of a single dose were unprotected against the potentially deadly KFD. Meanwhile, the effectiveness of two doses was a mere 62%, compared to 93.5% in 1994. Using 2005-2010 KFD data, the National Institute of Epidemiology, a sister agency of NIV under the Indian Council of Medical Research, found that the effectiveness of one vaccine dose was zero during this period, compared to 79.3% in a 1994 study. Studies conducted by the Chennai-based National Institute of Epidemiology show that the vaccine’s effectiveness had dropped dramatically by the mid-2000s. But these states were spending money on a shot that worked poorly, and whose quality and safety were questionable. Historically, atleast five Indian states, namely Karnataka, Goa, Maharashtra, Tamil Nadu and Kerala, have purchased the KFD vaccine from IAHVB. Ultimately, people paid the price of this multi-level institutional failure. In doing so, the NIV, which falls under India’s apex government medical-research organisation, the Indian Council of Medical Research, had helped the manufacturer release an ineffective vaccine to people. Mint learnt that NIV repeatedly suggested cosmetic-fixes to the problem of falling potency, instead of asking IAHVB to stop manufacturing altogether. Their decisions were enabled by one of the country’s top public health agencies, the National Institute of Virology (NIV).
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Nor had the IAHVB, VDL and the health department acted in isolation, Mint’s investigation found. And the Karnataka health department had okayed these troubling decisions.
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KKR, Temasek eye stakes in Manipal HealthĬentre wants Voda Idea promoters to pump in more equityĭamningly, Mint uncovered atleast two instances in which the KFD vaccine’s manufacturer, IAHVB, and quality-testing laboratory, the Shivamogga-based Government Virus Diagnostic Laboratory (VDL), had released the vaccine to the public despite the vaccine failing potency tests. Why Nykaa's fashion biz is a blemish for growth The test for India’s sovereign green bonds So, if a vaccine fails a potency test, it means the vaccine may not be able to protect people well against KFD anymore. In other words, potency is closely linked to the ‘effectiveness’ of the vaccine. The potency of a vaccine, which is measured in animals, is an indicator of how well the vaccine can prevent KFD in humans.
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Specifically, the vaccine had been failing ‘potency’ tests repeatedly. With the CDSCO missing from the picture, the vaccine’s quality had deteriorated measurably in the previous two decades.