Despite millions at risk, pharmaceutical companies have deprioritised production due to low profitability, and the shift to multi-dose vials has worsened the shortage. Doctors warn this could lead to a broader public health crisis.
Published Nov 06, 2024 | 7:00 AM ⚊ Updated Nov 06, 2024 | 7:00 AM
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Several Indian states, including Karnataka and Kerala, are grappling with an acute shortage of the Hepatitis B vaccine.
Hospitals, both government and private, are urging the respective state health departments for immediate intervention to counter a scarcity that has left health officials and the public concerned.
Yet, while millions are at risk, pharmaceutical companies have deprioritised production, citing low profitability, and shifting to multi-dose vials, exacerbating the issue. Doctors warn that the impact of the shortage could have far-reaching consequences, potentially creating a public health crisis that leaves the most vulnerable populations exposed.
Speaking to South First, Dr Naveen Ganjoo, senior consultant hepatology and integrated liver care at Aster RV in Bengaluru, said the Hepatitis B vaccine — the key preventive strategy against Hepatitis B as there is no other way to prevent this disease — is seeing a worrying shortage across the country.
India bears a significant Hepatitis B burden, with over 40 million people chronically infected and thousands succumbing annually to severe outcomes, such as liver cirrhosis and cancer.
Even states like Kerala, a state with a robust public health commitment, are now left vulnerable as this shortage threatens to undo progress in reducing Hepatitis B transmission.
For infants born to infected mothers, delays in vaccination heighten the risk of lifelong infection. Rural communities, healthcare workers, and economically disadvantaged populations remain disproportionately affected as vaccine scarcity continues in states.
Hepatitis B is a viral infection that affects the liver and can lead to both acute and chronic disease.
It is caused by the Hepatitis B virus (HBV) and is primarily spread through contact with infectious bodily fluids, such as blood, semen, and vaginal secretions. This can happen through activities like unprotected sex, sharing needles, or from mother to child at birth.
Doctors told South First that some people with Hepatitis B experience symptoms such as jaundice (yellowing of the skin and eyes), fatigue, abdominal pain, loss of appetite, nausea, and dark urine.
However, many people, especially children, may have no symptoms, making it easy for the disease to spread undetected.
Dr Arvind Canchi, consultant nephrologist and transplant physician at Trustwell Hospitals in Bengaluru said, there are more than two billion individuals with serologic evidence of Hepatitis B virus (HBV) infection worldwide.
“In 2015, the World Health Organisation (WHO) estimated that there were 257 million individuals with chronic Hepatitis B infection globally, of whom 887,000 died within that year due to chronic hepatitis B-associated cirrhosis and hepatocellular carcinoma,” he said.
He added that despite advances in antiviral therapy, it was estimated that only 10.5 percent of patients with chronic Hepatitis B were aware of their infection, and less than two percent underwent treatment. Thus, primary prevention by vaccination to increase herd immunity remains the main focus of controlling HBV infection.
Narayana Subramaniam, Senior Consultant and Director of Head and Neck Surgery and Oncology and Director of Clinical Innovation at Sparsh Hospitals in Bengaluru said the Hepatitis B vaccine is effective against developing the highly infective and potentially deadly disease.
He said it is “also one of the few vaccines that prevent cancer, chronic Hepatitis B infection causes liver cancer. Shortage of this vaccine is highly concerning and needs to be addressed on priority.”
Meanwhile, Dr Sundar Sankaran, Consultant Nephrologist and Program Director at Aster Institute and Program Director at Aster Institute of Renal Transplantation in Bengaluru said, “As a nephrologist, I believe that Hepatitis B vaccination is an essential tool in preventing Hepatitis B infection, particularly in dialysis patients.
“Dialysis patients are at an elevated risk of contracting Hepatitis B due to frequent exposure to blood products, shared equipment, and the potential for cross-contamination within dialysis settings. Vaccination is therefore a critical strategy in reducing this risk,” he added.
While Karnataka health department officials are tightlipped on the shortage of the vaccine, private hospitals agreed that the shortage has been seen for the past six months and is causing major distress mainly to dialysis patients.
Dr Ganesh Prasad, nephrologist and transplant physician at Narayana Health City in Bengaluru is concerned over the shortage of the vaccine. He took to X to request the state governments to initiate action and address the issue of vaccine shortage.
Speaking to South First he said, “The transmission risk of Hepatitis B patients is so high that it is mandatory as per international and national guidelines as well that for Hepatitis B patients to have separate dialysis machines, The transmission risk is higher than in HIV or HCV infections,”
For the past few months, we have been facing a serious shortage of Hepatitis B vaccines in India.
CKD patients who are undergoing hemodialysis need mandatory Hepatitis B vaccine and many newborn need hepatitis B vaccine
There is an urgent need to address this issue…— Dr Ganesh Srinivasa Prasad (@thisis_drgsp) September 4, 2024
This being the scenario, Dr Ganesh said there has been a severe shortage of Hepatitis B vaccine in hospitals for the past six months and many children and neonates are not getting the vaccination properly.
“Even dialysis patients are not getting the vaccines and most of the time when we do dialysis of unvaccinated patients, in government hospitals or remote areas where there is no monitoring of dialysis, there could be a possible risk of contamination,”
Dr Sundar added that before the widespread use of the Hepatitis B vaccine, there was a significant number of dialysis patients contracting Hepatitis B. However, with the introduction of mandatory Hepatitis B vaccination, the incidence of infection has dramatically decreased, making it an effective public health intervention in dialysis care.
“As part of my practice, I ensure that all dialysis patients receive the full course of the hepatitis B vaccine. For patients who have previously been vaccinated, I routinely check their anti-HB titers to assess the effectiveness of the vaccine. If these titers are low, I advise a booster dose to ensure continued immunity,” he explained.
Doctors said that Hepatitis B vaccination is crucial for dialysis patients not only to prevent the transmission of the virus but also to safeguard against the severe liver complications associated with chronic Hepatitis B infection.
Given the potential for suboptimal immune responses in dialysis patients, regular monitoring of anti-HB titers is essential. If titers fall below protective levels, booster doses should be administered to maintain adequate immunity.
Speaking to South First, a health official from Kerala, on condition of anonymity, said, “Only a handful of companies manufacture the vaccine, so the supply could be affected by limited production or supply chain disruption.”
He also added that there’s a suspicion that manufacturers may be manipulating availability to drive up the prices. Meanwhile, adding to this challenge, health officials suggest that the supply shift from single-dose to multi-dose vials has exacerbated the situation.
Previously, hospitals could administer a single-dose vial to an individual as needed. However, manufacturers have now shifted to 10-dose vials, creating practical difficulties for healthcare providers.
Another official from Kerala said, “If a single person requests a Hepatitis B vaccine, hospitals often hesitate to open a 10-dose vial, as the remaining doses might go unused,”
However, Dr Ganjoo explained that pharmaceutical companies are less inclined to produce the Hepatitis B vaccine domestically, as the government of India has lowered its price, making exports more profitable.
Doctors opined that since the vaccine is part of the Universal Immunisation Programme (UIP), the government often negotiates lower prices to make it affordable for widespread distribution. This can reduce the profit margins for manufacturers, making it less attractive for them to produce the vaccine for the domestic market.
With reduced profit margins domestically, manufacturers may prefer to export the vaccine to international markets where they can command higher prices.
The shift in demand to multi-dose vials rather than single-dose ones (as mentioned in Kerala’s case) can add logistical challenges, potentially discouraging manufacturers from scaling up production due to wastage concerns and additional handling requirements.
“Sadly, Indian patients are missing out on the benefits of this vaccine. Our Hepatitis B prevention programmes, which focus on vaccinating people to protect them from infection, are also now severely impacted. If this is not addressed, the situation is going to get very critical soon,” Dr Ganjoo added.
(Edited by Ananya Rao)
