Latest news with #EquineRabiesImmunoglobulin
Time of India
2 days ago
- Health
- Time of India
Lab-grown rabies antibodies show promise as cheaper, safer alternative
Mumbai: India's public hospitals and dispensaries may soon have a safer, more affordable option for preventing rabies after a suspected rabid dog bite: one already in use in private clinics since 2017 and by BMC since 2019. A post-marketing clinical trial involving more than 4,000 participants, conducted and funded by a pharmaceutical company and recently published in The Lancet, could now pave the way for its large-scale public use. For decades, the life-saving protocol has been the same across public or private health set ups: wash the wound, inject a dose of rabies immunoglobulin if the bite is severe, and follow with multiple doses of anti-rabies vaccine. The possible shift lies in the kind of immunoglobulin used. The relatively new lab-made candidate could replace the animal and human derived versions in use since the 1970s. An immunoglobulin is a concentrated solution of antibodies, injected directly into and around the bite, that offers immediate but short-term protection against the virus, effectively buying time until the vaccine takes full effect. The earliest ones in use have been derived either from rabies-vaccinated horses (Equine Rabies Immunoglobulin - ERIG) or human donated plasma (Human Rabies Immunoglobulin - HRIG). by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like No annual fees for life UnionBank Credit Card Apply Now Undo In 2016, Serum Institute of India (SII) received permission to make immunoglobulin which has monoclonal (lab-made,RmAb) antibodies. You Can Also Check: Mumbai AQI | Weather in Mumbai | Bank Holidays in Mumbai | Public Holidays in Mumbai | Gold Rates Today in Mumbai | Silver Rates Today in Mumbai "Most private facilities at least in Mumbai have phased out the use of the horse-derived one. While it has been proven safe at large, there are risks associated; it can cause mild allergic reactions or in rare cases a serious adverse event," said Dr Trupti Gilada, city-based infectious disease specialist. The private facilities have moved on to either the human derived or lab-made ones. "Both, human derived one and the lab-made one have high efficacy. The former has risk of infection transmission, though rare. The ones made in labs are safer and more easily available due to ease of largescale production," said Dr Mandar Kubal, another infectious disease specialist. A survey by ICMR published in July on the availability of anti-rabies vaccine and rabies immunoglobulin in health facilities found that, of the 534 facilities surveyed across 15 states and 60 districts -- 467 in the public sector -- 78% still used horse derived immunoglobulin. But even that was out of stock for most apart from a small 20.3% of those surveyed. While BMC uses the lab-made alternative, it is no stranger to shortages; at the moment it is short of rabies vaccine shots. A senior doctor from one of the four BMC-run medical college hospitals, said, "Mumbai has a heavy burden of dog bite cases and early on BMC decided to move on from animal derived ones due to risks associated. We either use generic human derived immunoglobulin or largely lab-made alternatives." But this lab-made alternative is still to make its way into the National Guidelines for Rabies Prophylaxis. The ICMR survey states, "RmAb presents as a promising alternative to both HRIG and ERIG. Compared to ERIG, RmAb offers the potential scope for large-scale production with standardised quality, elimination of animal use in the manufacturing, and reduced risk of adverse events. "It is cheaper compared to HRIG. Studies have shown that RmAbs are safe for human use, but... [there is] need for larger clinical trials and post-marketing surveillance to assess the safety and efficacy of RmAbs in the Indian setting." The Serum Institute–funded post marketing trial of its lab-made product compared with horse-derived immunoglobulin found to be equally effective in preventing rabies, with slightly higher average antibody levels on day 14. It was linked to fewer mild adverse events (11 vs. 17), and no serious reactions related to RmAb were reported, compared with one serious reaction related to ERIG. "Anti-rabies vaccines and immunoglobulins are severely in shortage across the country. Monoclonal antibodies is the answer [due to scalability] and it needs to be included in the national guidelines," said one of the authors of the ICMR survey. Stay updated with the latest local news from your city on Times of India (TOI). Check upcoming bank holidays , public holidays , and current gold rates and silver prices in your area.
Time of India
2 days ago
- Health
- Time of India
Lab-grown rabies antibodies show promise as safe alternative
MUMBAI: India's public hospitals and dispensaries may soon have a safer, more affordable option for preventing rabies after a suspected rabid dog bite: one already in use in private clinics since 2017 and by BMC since 2019. Tired of too many ads? go ad free now A post-marketing clinical trial involving more than 4,000 participants, conducted and funded by a pharmaceutical company and recently published in The Lancet, could now pave the way for its large-scale public use. For decades, the life-saving protocol has been the same across public or private health set ups: wash the wound, inject a dose of rabies immunoglobulin if the bite is severe, and follow with multiple doses of anti-rabies vaccine. The possible shift lies in the kind of immunoglobulin used. The relatively new lab-made candidate could replace the animal and human derived versions in use since the 1970s. An immunoglobulin is a concentrated solution of antibodies, injected directly into and around the bite, that offers immediate but short-term protection against the virus, effectively buying time until the vaccine takes full effect. The earliest ones in use were derived either from rabies-vaccinated horses (Equine Rabies Immunoglobulin - ERIG) or human donated plasma (Human Rabies Immunoglobulin - HRIG). In 2016, (SII) received permission to make immunoglobulin which has monoclonal (lab-made,RmAb) antibodies. "Most private facilities at least in Mumbai have phased out the use of the horse-derived one. While it has been proven safe at large, there are risks associated; it can cause mild allergic reactions or in rare cases a serious adverse event," said Dr Trupti Gilada, city-based infectious disease specialist. The private facilities have moved on to either the human derived or lab-made ones. "Both, human derived one and the lab-made one have high efficacy. Tired of too many ads? go ad free now The former has risk of infection transmission, though rare. The ones made in labs are safer and more easily available due to ease of largescale production," said Dr Mandar Kubal, another infectious disease specialist. A survey by ICMR published in July on the availability of anti-rabies vaccine and rabies immunoglobulin in health facilities found that, of the 534 facilities surveyed across 15 states and 60 districts -- 467 in the public sector -- 78% still used horse derived immunoglobulin. But even that was out of stock for most apart from a small 20.3% of those surveyed. While BMC uses the lab-made alternative, it is no stranger to shortages; at the moment it is short of rabies vaccine shots. A doctor from one of the four BMC-run medical college hospitals, said, "Mumbai has a heavy burden of dog bite cases and early on BMC decided to move on from animal derived ones due to risks associated. We either use generic human derived immunoglobulin or largely lab-made alternatives." But this lab-made alternative is still to make its way into National Guidelines for Rabies Prophylaxis. The ICMR survey states, "RmAb presents as a promising alternative to both HRIG and ERIG. Compared to ERIG, RmAb offers the potential scope for large-scale production with standardised quality, elimination of animal use in the manufacturing, & reduced risk of adverse events. "It is cheaper compared to HRIG. Studies have shown that RmAbs are safe for human use, but... [there is] a need for larger clinical trials and post-marketing surveillance to assess the safety and efficacy of RmAbs in the Indian setting." The Serum Institute-funded post marketing trial of its lab-made product compared with horse-derived immunoglobulin found to be equally effective in preventing rabies, with slightly higher average antibody levels on day 14.
The Hindu
01-07-2025
- Health
- The Hindu
Uneven access to Rabies care: survey flags gaps in vaccine and Immunoglobulin availability
A nationwide health facility survey has found significant gaps in the availability of anti-rabies vaccine (ARV) and rabies immunoglobulin (RIG) across India, especially in primary care centres and underserved regions such as the North-East. While secondary and tertiary care institutions have shown relatively better preparedness, the low availability in primary settings could undermine India's goal of eliminating dog-mediated human rabies deaths by 2030. Conducted across 60 districts in 15 states, the study assessed 467 public health facilities -- including primary health centres (PHCs), community health centres (CHCs), district hospitals, and medical college hospitals. It found that while ARV was available in nearly 80% of public facilities, only about 20% stocked RIG -- an essential component in treating category III animal bites. 'The availability of ARV in over 90% of secondary and tertiary care centres is an important milestone for India,' said a member of the study panel. 'However, the persistent shortfall at the primary level and in specific geographies like the eastern and north-eastern states needs urgent intervention.' The study noted that 93.8% of facilities with ARV had sufficient stock for the next 15 days. Yet, around a quarter of facilities reported stockouts in the past year. The availability of ARV was highest in the southern zone (93.2%) and lowest in the North-East (60%). The survey also highlighted a shift toward cost-effective vaccine regimens. About 60% of public facilities have adopted the intradermal (ID) Thai Red Cross regimen -- recommended for its dose-saving benefits. However, uptake of the ID regimen remains poor in the East and North-East. Production bottlenecks and cost barriers The availability of RIG, which is critical for treating severe bites, was markedly low -- only 5.9% of primary facilities stocked it. In contrast, over half the tertiary institutions surveyed had RIG in stock. Experts attributed the low penetration to production and pricing issues. 'Equine Rabies Immunoglobulin (ERIG) has limited manufacturers, and supply disruptions are common. Meanwhile, Human RIG (HRIG) and monoclonal antibodies, though safer and effective, remain unaffordable for most public health facilities,' explained Dr. Raman Swathy Vaman, infectious disease epidemiologist and member of the research team. Dr. Vaman added that procurement delays are often tied to slow disbursal of National Health Mission (NHM) funds. 'Centralised procurement agencies like KMSCL and TNMSCL are effective, but vendor payments are delayed, disrupting the supply chain.' He pointed to a promising model from Kerala's Kasaragod district, where the District Hospital in Kanhangad uses ₹20 lakh annually -- allocated by the District Panchayat -- to procure monoclonal antibodies such as Rabishield, ensuring uninterrupted access to RIG for surrounding areas. Training and infrastructure The study found that while cold-chain infrastructure for storing rabies biologicals is largely adequate, training and supervision gaps persist. Only 45% of facilities had staff recently trained in administering rabies prophylaxis. 'Administering ID vaccines requires skill and RIG infiltration is even more technically demanding,' said Dr. Vaman. 'Many cases are handled in busy outpatient or emergency departments, which increases the risk of improper administration.' He suggested introducing structured training, regular audits, and use of visual aids like QR-code-accessible video guides. 'Dedicated anti-rabies clinics, particularly in district hospitals, can improve service delivery and reduce errors.' Need for context-driven policies The survey team recommended initiating state-level operational research to identify bottlenecks in procurement, stock indenting, and fund flow. 'We need to understand why the availability of rabies biologicals varies so sharply by region. Without this, we cannot design effective interventions,' a panel member said. Dr. Vaman underscored the urgency of integrating rabies care into routine primary healthcare delivery. 'We are dealing with an estimated 9.1 million animal bite cases annually. This is not a marginal problem. Most rabies deaths occur in young people and in rural areas. Yet the disease doesn't get the attention it deserves in policy and budgeting.' According to estimates from a parallel community survey, India records around 6,000 dog-mediated human rabies deaths annually. Experts stress that such figures should influence planning and forecasting of vaccine and immunoglobulin supply. Towards zero deaths by 2030 The study aligns with the broader objectives of the National Rabies Control Programme (NRCP) and the WHO-backed 'Zero by 30' initiative, which aims to eliminate dog-mediated human rabies deaths by 2030. However, experts caution that progress will depend on equitable access, context-specific policy and consistent financing. The inclusion of Rabies Monoclonal Antibodies (RmAbs) in national guidelines is also being recommended for their scalability and cost-effectiveness. 'Timely and complete post-exposure prophylaxis (PEP) -- including immediate wound washing, ARV, and RIG -- is the only way to prevent rabies,' said Dr. Vaman. 'Strengthening primary care and plugging regional gaps will be essential if we are serious about achieving elimination goals,'he said.
