&w=3840&q=100)
Bharat Biotech's oral cholera vaccine Hillchol clears phase 3 trials
Bharat Biotech, the makers of Covaxin, on Tuesday said that their oral cholera vaccine Hillchol has demonstrated against both the Ogawa and Inaba serotypes of Cholera in both adults and children in a phase 3 clinical study across 1800 individuals.
Cholera is an acute diarrhoeal infection caused by ingesting food or water contaminated with Vibrio cholerae bacteria. Studies have estimated that 2.86 million cases and 95,000 deaths occur annually. "Global demand for OCVs is close to 100 million doses a year, and given that only one manufacturer supplies them, there is a global shortage. Bharat Biotech's facilities in Hyderabad and Bhubaneswar have a capacity to produce up to 200 million doses of Hillchol," the company said. Sanofi India makes an oral cholera vaccine
The double-blind, randomised phase 3 clinical trial was evaluating safety, immunogenicity and non-inferiority as well as a lot-to-lot consistency of single component oral cholera vaccine Hillchol in comparison to a comparator vaccine in an 1800 participant study across 10 clinical sites in India. In this study, participants were divided into three age groups: adults over 18 years, children aged 5 to under 18 years, and infants aged 1 to under 5 years. They were randomized in a 3:1 ratio to receive either Hillchol or a comparator vaccine.The above study findings have been published in the ScienceDirect, Vaccine journal. The primary endpoint focused on the proportion of participants achieving over 4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses.
Bharat Biotech claimed that Hillchol demonstrated 4-fold rise in vibriocidal antibodies against both Ogawa (68.3 per cent) and Inaba (69.5 per cent) serotypes, proving non-inferiority to licensed vaccines. It also demonstrated a strong safety profile and was well-tolerated across all age groups including infants less than 1 year old.
"This publication reaffirms our commitment to advancing vaccines built on rigorous research, thorough clinical trials, and reliable clinical data. It highlights our continued commitment to providing affordable, effective, and accessible vaccines for the populations who need them the most,' said Krishna Ella, Executive Chairman of Bharat Biotech.
Dr. Ella added, 'Cholera is a vaccine-preventable disease that has faced a surge in outbreaks along with a huge shortage of vaccines. The new generation Oral Cholera Vaccine Hillchol, featuring a simplified single stable O1 Hikojima strain, inducing robust antibodies against both Ogawa and Inaba serotypes, aims to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.'
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Indian Express
a day ago
- Indian Express
UP govt's ‘fully state-funded pharma park' invites centres from Gujarat pharma industry
A delegation from the Uttar Pradesh government, visiting Ahmedabad on Friday to promote its upcoming Bulk Drug Pharma Park in UP's Lalitpur district, announced that five companies, including Bharat Biotech and Dr Reddy's Laboratories, have already been allocated land and begun to set up their units. In total, 26 companies have expressed interest, including NATCO Pharma, Vins Bioproducts Ltd, and Rockwell Industries Ltd. The outreach event was held in collaboration with the Confederation of Indian Industry (CII). Mayur Maheshwari, CEO of the Uttar Pradesh State Industrial Development Authority (UPSIDA) and an IAS officer, addressed industry stakeholders and highlighted the park's strategic importance in reducing India's dependence on China for bulk drug production. Appealing directly to the Gujarat pharma industry, he said, 'We've come to Ahmedabad, which has shown the way for India. We request you to set up a parallel centre (in UP). We are more than ready to welcome you with open arms and we hope to match and provide even better facilities…' 'We have had this vacuum of bulk drugs and formulation in India. About 60% of Active Pharmaceutical Ingredients (APIs) are imported from China. This dependence is not only strategic, but it is a challenge to our entrepreneurs. If China can do it, why not UP and the rest of India?' Maheshwari said. During an interaction with the press, Maheshwari said that Gujarat was an important link for the Bulk Drug Pharma Park for its connectivity to the ports. Invoking cultural and spiritual references, Maheshwari said, 'This is the land of Shri Ram, Shri Krishna and Shri Buddha. When these three powers are present in a state, in a country, there can only be prosperity.' He praised the Yogi Adityanath-led government's leadership, citing the 'successful' hosting of the Mahakumbh, where 67 crore people had the opportunity to take the holy dip and that it 'went very well'. 'This is the first completely state-funded pharma park. All the money is from the UP government. We don't need to approach the Centre. Himachal Pradesh got a bulk drug pharma park in 2020-21 which is a non starter. In Andhra Pradesh, it has been four years and it is still just starting out… For allocation of resources and funding, we will do this on our own, which has not been possible even in Andhra and Gujarat,' said Maheshwari. When asked about skilled manpower by a stakeholder, Maheshwari said, 'We have developed a Promote Pharma initiative, which is a Section 8 company to strengthen and develop capacity building. It will invite the best professionals and will have industry, academia and govt linkage. Need-based professionals will come from there. We are also trying to get a National Institute of Pharmaceutical Education and Research (NIPER) in UP, to add to this ecosystem.' The Bulk Drug Pharma Park is coming up in Lalitpur district, located near the geographic centre of India. Delegation members highlighted that Uttar Pradesh has 14 airports, six of them international, and a dedicated helipad is also planned within the park. Additionally, both the Eastern and Western dedicated Railway Freight Corridors pass through the state, further strengthening connectivity. In the first phase, the UP government is developing 352 acres of the park. Officials said that 1,500 acre were already available for future expansion and that the park can be scaled up to 5,000 acres if needed. Maheshwari said, 'Lalitpur was also chosen because it is important to avail environmental clearance (EC) for the bulk drug and API industries. This place has less habitation. We have already got the EC. Masterplan is also approved and facility building work is already underway.' Of the park's total area, 67% is reserved for industry, 13% for green spaces, and the rest for support infrastructure and common facilities. Comparing it to other pharma parks in other states, Maheshwari said, 'We have lab testing, R&D incubation facilities, common climate controlled warehouses and technical regulatory support. We have these facilities which are missing in other places like Genome Park in Telangana and Jawaharlal Nehru Pharma City in Vizag of Andhra Pradesh.' On land pricing, he explained, 'We are giving land on a 90 year lease at Rs 75-77 lakh per acre but those setting up anchor units on 35-50 acre land will get 10% more discount. Basically, it is at Rs 1,700 per square metre of land for anchor units and Rs 1,914 per square metre for normal units. There is a 2% additional waiver if you make a full one-time payment.' Maheshwari said the park's incentives fall under the UP Pharma and Medical Devices Policy 2023 and include capital and interest subsidies, stamp duty exemption, patent and clinical trial support, a 10-year electricity duty waiver, and subsidies for quality certifications. Asked when companies can start operations, Maheshwari said, 'Right now.'
The Hindu
2 days ago
- The Hindu
As COVID-19 cases register an uptick in India, a look at the vaccine stock position
Over the past few weeks, headlines around India and Southeast Asia have centered around a virus that the world has wanted to forget: Covid-19. At first, an uptick in cases in Hong Kong, Singapore and other parts of the region caused concern. Gradually though, India too, witnessed a surge in cases, with numbers as of Thursday, June 5, standing at 4,866, and fatalities at 51. Doctors and experts have said time and again that there is no reason to panic – spikes and dips in Covid-19 cases are expected; the virus they say, is co-circulating with other seasonal infections and no major waves are expected. Misinformation in fact, is harder to battle, they point out. Residents however, are raising questions about the Covid-19 vaccines: it may be recalled that India launched the world's largest Covid-19 immunisation drive in January 2021. To date over 220 crore doses of Covid-19 vaccines have been administered in the country as per the Co-WIN dashboard. These were primarily of the two vaccines available then, AstraZeneca's Covishield and Bharat Biotech's Covaxin. Also Read: Readiness, not panic: On India and COVID-19 What is the vaccine situation now? Rajiv Bahl, Director General of the Indian Council of Medical Research (ICMR), the country's nodal scientific body, has said there is absolutely no need to initiate mass booster doses for Covid-19 vaccination at present, and neither is there a direction from the Central government for this. Speaking about the rising number of Covid-19 cases in India, Dr. Bahl however noted that individual doctors could recommend booster doses to patients on a case-to-case basis, depending on the needs of individuals. He further explained that the need for mass vaccination, while not felt at present, could arise, with perhaps a mutation in the virus or its spread. 'For that, India already has the capacity to scale up production and provide for the general public. We have done this before and there is no need to panic,' he said, reiterating that as of now there was no need for individuals to rush in to get a booster vaccine. Since vaccines used in 2021 and 2022 have now fallen into disuse and expired, there are no stocks at present, a government official said, adding however that the government could direct manufacturers to produce more stocks as and when necessary. Most States, including Kerala, Tamil Nadu, Karnataka and West Bengal have no stocks or supplies of the vaccine at present either in the government or private sector. Understanding the variants driving the spike As of now, the variants of Covid-19 doing the rounds in India are descendants of the Omicron variant, first reported in November 2021. The emerging sub-variants - NB.1.8.1 and LF.7 - that are driving the current COVID surge are descendants of JN.1, a sub-lineage of the Omicron BA.2.86 variant. In Kerala for instance, a senior Health Department official said: 'Almost all of the samples sent for whole genome sequencing from the State have shown that the circulating virus variant is LF.1, one of the descendants of Omicron, the immune evasiveness of which is quite well known.' These sub-variants, doctors say, are, so far, causing mild illnesses. P. Senthur Nambi, senior consultant, Infectious Diseases, Apollo Hospitals, Chennai, said that most of the Covid-19 patients he had seen so far have done well. 'Most of them had only an upper respiratory infection. Gone are the days when Covid-19 affected the lungs causing pneumonia and breathing difficulties. These patients were managed based on their symptoms and most of them did not require any Covid-specific antiviral medications. Prior exposure to the infection, the effects of the vaccines taken or a combination of both factors with vaccine-induced antibodies could be playing a protective role,' he explained. Cases this time around have mostly been mild, the ICMR has maintained, with reported symptoms akin to those of the common cold or seasonal flu, including fever, cough, sore throat, runny nose, headache, fatigue, body aches, and loss of appetite. 'The key difference with these new strains,' said Sujan Bardhan, consultant (tuberculosis & chest diseases), Narayana Hospital, RN Tagore Hospital, Kolkata, 'is their speed, not their severity. Hospitals are well-prepared and the healthcare system remains under no immediate strain. Nonetheless, the importance of basic preventive measures cannot be overstated.' Are vaccines needed at present? Doctors across the board say that at present, they see no need for a mass vaccination drive. 'By the time Omicron ran its course, almost all of our population had been exposed to the virus. Even when this antibody protection wanes, the long-term immune memory remains. This innate immunity plus the vaccine-derived immunity through good coverage of the initial two doses means that most people have strong hybrid immunity against Covid-19,' the Kerala health department official said, adding that the previous vaccines may not even be very effective against the Omicron variants – they would however, offer protection against serious forms of the disease. Though two indigenously developed nasal vaccines specifically targeting Omicron variant from Bharat Biotech and Indian Immunologicals as well as another indigenous mRNA vaccine for the Omicron variant were made available in the Indian market, the uptake was low, doctors said. Kiran Madala, a Hyderabad-based doctor, part of an international group of genetic epidemiologists under the COVID Treatment Exchange Organisation, said the current World Health Organization guidelines recommend vaccines primarily for individuals above 70 to 80 years of age, those who are immunocompromised, and patients with multiple comorbidities. Children, especially those aged two to six years, do not need vaccination unless they have underlying health issues or are immunosuppressed. Dr. Nambi in Chennai said some patients, those who have travel obligations, have requested the vaccines, but none are available at present. 'But I wish that there was an option of vaccination, not for the general population in large but for two subsets of patient groups in whom the infection could cause problems,' he said. The first group of patients are those who have not received any Covid-19 vaccine due to various factors and had no Covid-19 infection in the past. So, they will neither have natural immunity or vaccine-induced immunity. Though a weakened virus, it could cause complications such as pneumonia leading to hospitalisation especially if they are over 65 years of age,' he said. The second subset of patients are those with underlying comorbidities such as heart ailments, Chronic Obstructive Pulmonary Disease with poor lung function and immune-compromised persons including those who have undergone organ transplants. 'Other coronaviruses such as the Middle East Respiratory Syndrome did not last long, but we are still talking about Covid since the end of 2019. So, a vaccine will be beneficial for these two groups of persons in the long run from the public health perspective. But this being a mutating virus, we will need to modify the vaccines on a regular basis,' Dr. Nambi observed. T. Jacob John, retired professor of clinical virology at Christian Medical College, Vellore also said that the elderly and immunocompromised people needed to be vaccinated again, irrespective of whether they were fully vaccinated (two doses and a booster) or had been exposed to the virus earlier. 'These people are vulnerable even with mild variants as their immune systems are weak, and they are at greater risk of complications.' State governments however have taken a more cautious stance: 'Whether vaccination is required or not depends on many factors, said T. S. Selvavinayagam, T.N. Director of Public Health and Preventive Medicine. 'We need to study the epidemiology of the current cases before commenting on the requirement for vaccination now.' Kerala has said it was 'not advocating for or against Covid booster shots' because of the lack of epidemiological data that booster doses offered enhanced protection against emerging immune-evasive variants. Overall, doctors say, there were not many takers for the booster dose offered even during the height of the pandemic: according to the Co-WIN dashboard, 22.74 crore doses of the precaution dose have been administered, far fewer than the first two doses. 'We are doubtful if people would want to get vaccinated now when the situation is not alarming,' said R. Ravindra, managing director of Suguna Hospital, Bengaluru. What next? The Delhi High Court, earlier this week, directed the Central government to submit a thorough status report detailing its actions regarding the policy for sample collection, collection centres, and transportation of samples. The Court also stressed urgency to finalise and implement Standard Operating Procedures. While preparedness of health systems remains crucial, doctors said that at present all individuals should focus on personal protection, with special care being given to vulnerable sections of the population including elderly citizens, young children, pregnant women and those with immune-compromised systems or chronic illnesses. Dr. Bardhan said that these groups should take extra precautions. 'Covid has become just one of many in our spectrum of seasonal infectious diseases, a 'new normal'. We will definitely need to protect our vulnerable population against serious disease, but right now, we are advising only standard precautions to prevent people from contracting Covid/ or transmitting it. Those with symptoms will be tested and treated as per our patient categorisation guidelines. We do however advise the elderly that they take the yearly influenza vaccine to prevent secondary bacterial infections,' said R. Aravind, head of infectious diseases, Government Medical College, Thiruvananthapuram. As the virus continues to adapt, so must we, as Dr. Bardhan pointed out. Staying informed and following trusted health sources, personal protection and hygiene measures such as hand washing, avoiding crowded places when possible or masking up, refraining from going outdoors when ill and maintaining a healthy, well-balanced lifestyle could all help navigate this phase and any more to come. (With inputs from C. Maya in Kerala, Serena Josephine M. in Chennai, Bindu Shajan Perappadan in Delhi, Afshan Yasmeen in Bengaluru, Shrabana Chatterjee in Kolkata and Siddharth Kumar Singh in Hyderabad.)
Time of India
6 days ago
- Time of India
Musi river water unfit for drinking except at Osman Sagar: Study
Hyderabad: A scientific study published in the June edition of the Cleaner Water journal by ScienceDirect has found that water from the Musi River is unfit for drinking at all locations except at its upstream source, Osman Sagar. Tired of too many ads? go ad free now The research, titled 'Spatial and Seasonal Assessment of Water Quality of Musi River, India,' was led by Ajmal Koya Pulikkal of the Department of Chemistry, National Institute of Technology Mizoram, and co-authored by Mohammad Zakwan from Maulana Azad National Urdu University, Hyderabad. Water samples were collected from four stations — Osman Sagar (upstream), Bapughat and Musarambagh (midstream), and Nagole (downstream) — during the pre-monsoon, monsoon, and post-monsoon seasons. The study analysed 27 water quality parameters using standard methods and indices such as the Weighted Arithmetic Water Quality Index (WAWQI), Nemerow's Pollution Index, and various irrigation indices. The WAWQI values across the sites showed a sharp deterioration in water quality downstream: 38 at Osman Sagar, 175 at Bapughat, 197 at Musarambagh, and 179 at Nagole. Only Osman Sagar met the Bureau of Indian Standards for potable water. The deterioration became significant at Bapughat, attributed to urban encroachments, waste dumping, and sewage discharge. The study noted a slight improvement in water quality at Nagole, likely due to the Amberpet sewage treatment plant near Musarambagh. Seasonal and irrigation assessment reflect pollution load Seasonal analysis revealed further insights. While water from Osman Sagar remained suitable for both drinking and irrigation in all seasons (S-1 category), the other stations fell into S-3 (unsuitable for irrigation) during the pre and post-monsoon periods, and into S-2 (moderately suitable) during the monsoon, due to dilution effects. Tired of too many ads? go ad free now Kelley's index also indicated that only Osman Sagar's water was suitable for irrigation throughout the year. The study flagged declining dissolved oxygen levels and rising biochemical oxygen demand downstream. Hydrochemical facies analysis (a method used to interpret the chemical composition of water) using Piper diagrams further revealed a shift in water composition from upstream to downstream. The authors call for urgent and consistent monitoring, improved wastewater treatment, effective stormwater management, and stronger environmental regulation to reverse the degradation.
