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At least seven Indian pharma companies are working to develop a vaccine against coronavirus as they join global efforts to find a preventive to check the spread of the deadly virus that has already infected more than 14 million globally. <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>, <keyword id="242973" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute">Serum Institute</keyword>, <keyword id="72130" type="COMPANY" weightage="20" keywordseo="Zydus-Cadila">Zydus Cadila</keyword>, <keyword id="119790" type="COMPANY" weightage="20" keywordseo="Panacea-Biotec">Panacea Biotec</keyword>, <keyword id="162098" type="COMPANY" weightage="20" keywordseo="Indian-Immunologicals">Indian Immunologicals</keyword>, <keyword id="9603964" type="UNKNOWN" weightage="20" keywordseo="mynvax-and-biological-e">Mynvax and Biological E</keyword> are among the domestic pharma firms working on the coronavirus vaccines in India. Vaccines normally require years of testing and additional time to produce at scale, but scientists are hoping to develop a coronavirus vaccine within months because of the pandemic. Bharat Biotech has received approval to conduct phase I and II clinical trial for its vaccine candidate Covaxin, that has been developed and manufactured in the company's facility in Hyderabad. It last week started human clinical trials. Leading vaccine major Serum Institute of India has said that it is hoping to develop a COVID-19 vaccine by the year-end. "At present, we are working on the AstraZeneca Oxford vaccine which is undergoing phase III clinical trials. In addition to this, we will also start human trials in India in August 2020. Based on the current situation and most recent updates on the clinical trials, we are hoping that the AstraZeneca Oxford vaccine will be available towards the end of this year," Serum Institute of India CEO Adar Poonawalla told . The company is also developing a live attenuated vaccine with US-based biotech firm Codagenix, which is undergoing pre-clinical trials, he added. "Apart from AstraZeneca Oxford vaccine and Codagenix, we have associated with multiple institutions worldwide as manufacturing partners for vaccine candidates that are being developed. These include Austria's Themis along with two others," Poonawalla said. On the partnership with AstraZeneca, Poonawalla said: "Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply 1 billion doses of the COVID-19 vaccine being developed by Oxford University." These vaccines will be for India and middle and low income countries across the world (GAVI countries), he added. Pharma major Zydus Cadila has said that it is looking to complete clinical trials of its COVID-19 vaccine candidate ZyCoV-D in seven months. The company had last week started clinical trials of its COVID-19 vaccine candidate with the first human dosing. Depending on the study outcomes and if the data is encouraging and the vaccine is found to be effective during the trials, it could take a total of seven months for the trials to be completed and for the vaccine to be launched, Zydus Cadila Chairman Pankaj R Patel said in a statement. Hyderabad-based Bharat Biotech last week started human trials of its vaccine Covaxin at Rohtak's Post-Graduate Institute of Medical Sciences. The phase I and II clinical trials of the vaccine for SARS-CoV-2 by Bharat Biotech have been approved by the Indian drug regulator after pre-clinical studies demonstrated safety and immune response. The company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Panacea Biotec in June said that it was setting up a joint venture firm in Ireland with US-based Refana Inc to develop a vaccine for COVID-19. The company in partnership with Refana aims to manufacture over 500 million doses of COVID-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year, Panacea Biotec had said. Indian Immunologicals, a subsidiary of National Dairy Development Board (NDDB), has inked an agreement with Australia's Griffith University to develop a vaccine for coronavirus. Others like Mynvax and Biological E are also working to develop vaccines for COVID-19. Vaccines typically provide the immune system with harmless copies of an antigen: a portion of the surface of a bacterium or virus that the immune system recognises as foreign. A vaccine may also provide a non-active version of a toxin - a poison produced by a bacterium - so that the body can devise a defence against it. They must follow higher safety standards than other drugs because they are given to millions of healthy people. Vaccine testing is a four-stage process -- pre-clinical testing on animals, phase I clinical testing on a small group of people to determine its safety and to learn more about the immune response it provokes, phase II trials are expanded safety trials, and phase III testing is done by administering it to thousands of people to confirm its efficacy. Globally, the World Health Organisation (WHO) is tracking around 140 candidates vaccines, of which around two dozen are in various phases of human clinical trials. Chinese company Sinovac Biotech is moving into phase III trials in Brazil while University of Oxford/AstraZeneca is in a combine phase II/III trial in the UK and has recently gone into phase III trials in South Africa and Brazil. US-based Moderna expects to start phase III trials of its vaccine candidate this month. Among other leading players, German firm BioNTech is collaborating with pharma major Pfizer to develop a vaccine for COVID-19. The companies have received fast track designation from the US Food and Drug Administration (USFDA) for two investigational vaccine candidates being developed to help protect against SARS-CoV-2.

These are the seven Indian pharma players racing to develop COVID-19 vaccine

<ul><li>The vaccine was given to 543 volunteers and no serious side effects were found. </li><li>However, 70% of the vaccinated volunteers experienced fatigue and 68% had headaches, higher rates than a control group given a meningitis vaccine.</li><li>There is still much work to be done before we can confirm if our vaccine will help manage the COVID-19 pandemic, but these early results hold promise.</li></ul>A <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> the University of Oxford is developing with AstraZeneca has shown 'promising' results in early human testing, reports said on Monday (July 20). AstraZeneca became the latest to release data from its human trials, the <a href="https://www.thelancet.com/lancet/article/s0140-6736(20)31604-4">clinical results were published in The Lancet.</a> The vaccine was given to 543 volunteers and no serious side effects were found. However, 70% of the vaccinated volunteers experienced fatigue and 68% had headaches, higher rates than a control group given a meningitis vaccine. "There is still much work to be done before we can confirm if our vaccine will help manage the COVID-19 pandemic, but these early results hold promise," Sara Gilbert, a professor at the University of Oxford, said in a statement Monday. India's Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply 1 billion doses of the COVID-19 vaccine being developed by Oxford University. This is one of the seven Indian pharma companies working on a vaccine against the novel coronavirus. Bharat Biotech, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are the other Indian companies in the pursuit of a vaccine to end the pandemic. Another vaccine from the American biotech firm Moderna is likely to start human trials in a week from now. The progress in vaccine may boost both public and market sentiment in the near term but it will be much longer it is available to the public. Here's why it takes so long to develop a vaccine: <div type="Youtube" id="pjGNff2vjuc" title="Covid Vaccine: Here's why it takes so long to make a vaccine." thumbUrl="https://i.ytimg.com/vi/pjGNff2vjuc/mqdefault.jpg"></div> SEE ALSO: <a href="https://www.businessinsider.in/business/news/all-the-anti-viral-clothing-now-in-the-market-will-not-necessarily-fend-off-covid-19/articleshow/77068584.cms" data-type="tilCustomLink" target="_blank">All the anti-viral clothing now in the market will not necessarily fend off COVID-19</a> <a href="https://www.businessinsider.in/science/health/news/the-world-cant-wait-for-good-news-from-oxford-serum-institute-and-astrazeneca-but-that-is-only-the-first-step/articleshow/76996301.cms" data-type="tilCustomLink" target="_blank">The world can’t wait for good news from Oxford, Serum Institute and AstraZeneca ⁠— but that is only the first step</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/uk-firm-declares-positive-results-from-covid-19-protein-treatment/articleshow/77064813.cms">UK firm declares positive results from COVID-19 protein treatment</a>

The COVID-19 vaccine from Oxford and Astrazeneca shows 'promising' results in early human trials

As Indian firms scramble to develop a <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> for <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword>, experts feel that research in the country is still at a nascent stage and any concrete breakthrough is not likely within a year. The Indian government and private firms have stepped up efforts to develop a vaccine to halt the spread of COVID-19 which has claimed over 3,700 lives with more than 1,25,000 cases in the country. PM CARES Fund Trust has decided to allocate Rs 100 crore for support to <keyword id="9276957" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine-development-efforts">coronavirus vaccine development efforts</keyword>. Referring to a vaccine to fight the virus, a PMO statement had said that it is the most pressing need and Indian academia, start-ups and industry have come together in cutting-edge vaccine design and development. The Department of Biotechnology has been made a central coordination agency to identify pathways for vaccine development. Naming the Indian firms working on vaccines for COVID-19, Gagandeep Kang, executive director of the Translational Health Science and Technology Institute, Faridabad, had said last month that while <keyword id="72130" type="COMPANY" weightage="20" keywordseo="Zydus-Cadila">Zydus Cadila</keyword> is working on two vaccines, Serum Institute, Biological E, Bharat Biotech, Indian Immunologicals, and Mynvax are developing one vaccine each. The WHO has listed Serum Institute of India, Zydus Cadila, Indian Immunologicals Limited and Bharat Biotech from India among the firms involved in developing a vaccine. Leading virologist Shahid Jameel said India's vaccine manufacturing capacity is quite remarkable and at least three Indian companies - Serum Institute, Bharat Biotech and Biologicals E are at the forefont, working with international partners to manufacture a vaccine for COVID-19. "Research on a COVID vaccine in India is at a very early stage of development and any candidates are likely to reach animal trials only by the end of the year," he told . However, Indian vaccine companies have a lot of capacity and expertise, and are likely to play a significant role in bringing new COVID-19 vaccines to the market. This experience is important for institutions, industry and regulators to work together, and prepare for the future, said Jameel, a Shanti Swarup Bhatnagar Prize winner for Science and Technology and the current Chief Executive Officer of Wellcome Trust/Department of Biotechnology's India Alliance. CSIR-Centre for Cellular &amp; Molecular Biology (CCMB) Director Rakesh Mishra said, "From what we know, we are not at an advanced stage of vaccine development at the moment." "There are lots of ideas and companies initiating vaccine development process but there is nothing on trial in terms of vaccine candidates," he told . There are many efforts going on with different approaches like somebody wants to use the whole virus or a particular protein so there are multiple processes being deployed, he said. "Many Indian companies are collaborating with foreign institutions.Other countries are at much advanced stage than us. Some are going into third stage trials. There is no company testing vaccine in India yet and they are in the pre-clinical stage of preparation," he said. India is quite behind because of a number of reasons like the coronavirus came to India two-three months later so "we did not have the (inactivated) virus to test or even the urgency", Mishra said, adding that the Chinese and US are quite ahead in the vaccine development. "If a comparison has to be made we are well behind international efforts," he said. The novel coronavirus strain was isolated and characterised at the Indian Council of Medical Research's National Institute of Virology, Pune, and the vaccine candidate has been transferred to Bharat Biotech International Limited (BBIL) to develop a fully indigenous vaccine for COVID-19. "Once the vaccine is ready it will go for animal trials to be followed by human clinical trials to assess its safety and efficacy which will take at least one year," a senior <keyword id="6364396" type="UNKNOWN" weightage="20" keywordseo="ICMR">ICMR</keyword> official told . The BBIL is working towards developing killed virus vaccine which usually provides good immunogenicity, the official said, adding that by entering the body it will create antibody against the infection. The polio drops which are given to children have live attenuated virus, while the polio injection contains killed virus, the official said explaining the different approaches used in developing a vaccine. "The BBIL is continuously working in this direction and as soon as they get the right formulation they will move towards animal challenge studies followed by human clinical trials," the official said. Kang, in a webinar held by India Alliance, said there are two separate aspects that relates to vaccines of COVID-19, one is to use existing products and the second is to see if new vaccines can be made. "In terms of projects to develop vaccines there are around 90 plus projects around the world that have initiated to develop new vaccines which use different kinds of technologies. Some are using old technologies like make an inactivated virus and spike protein and other using new technologies that allow you to respond rapidly like using messenger RNA vaccines," Kang said. Every new technology is being applied for making COVID-19 vacines, he said. The Indian firms along with their foreign collaborators are racing against time to develop a vaccine against COVID-19 with over 52 lakh cases and over 3.35 lakh fatalities across the globe. UZM/PLB/ASK ZMN

COVID-19 vaccine development at early stage in India; breakthrough unlikely within a year, say experts

By Shakoor Rather(Eds: Recasting overnight story) New Delhi, Apr 16 () Six Indian companies are working on a vaccine for COVID-19, joining global efforts to find a quick preventive for the deadly infection spreading rapidly across the world, says a top Indian scientist.Nearly 70 'vaccine candidates' are being tested and at least three have moved to the human clinical trial stage, but a vaccine for the novel coronavirus is unlikely to be ready for mass use before 2021. As COVID-19 infects more than 1.9 million in the world and claims 1,26,000 lives, Indian scientists are also part of the global fight against the disease. "While Zydus Cadila is working on two vaccines, Serum Institute, Biological E, Bharat Biotech, Indian Immunologicals, and Mynvax are developing one vaccine each," Gagandeep Kang, executive director of the Translational Health Science and Technology Institute, Faridabad, told .Kang is also vice chair of the Coalition for Epidemic Preparedness Innovations (CEPI), which noted in a recent study that the "global vaccine R&amp;D effort in response to the COVID-19 pandemic is unprecedented in terms of scale and speed". But it is a complicated process with many stages of testing and many challenges, explained experts. A vaccine for the new coronavirus, SARS-CoV-2, may not take 10 years that other vaccines do but it could be at least a year before it is proven safe, effective, and made widely available, they said."Vaccine development is a lengthy process which often takes years, with many challenges," said E. Sreekumar, chief scientific officer at the Rajiv Gandhi Centre for Biotechnology (RGCB) in Kerala. "Generally, vaccines take several months to pass the different stages of testing, and then approvals also take time. For COVID-19, we don't expect a vaccine to come in this year," agreed Rakesh Mishra, director of the CSIR-Centre for Cellular and Molecular Biology (CCMB) in Hyderabad. Vaccine testing typically begins with animal and lab testing before going on to different stages of human testing. "The human testing phase is composed of many phases," Sreekumar told . "Phase one trials are small-scale, usually involving few participants, to assess whether the vaccine is safe for humans. Phase two trials often involve several hundred subjects, and mainly evaluate the efficacy of the vaccine against the disease," he said. The final phase involves thousands of people to further assess the efficacy of the vaccine over a defined period of time, and can last several months, Sreekumar said. "That is why we don't see a vaccine coming in at least a year from now." Even after the vaccine is ready, he explained, there are a lot of challenges, including whether the vaccine is effective in all populations, and if it can be used for different strains of the novel coronavirus, which might start mutating as time passes."There are lots of vaccines which are being tested for COVID-19, some of which are in the stage 1 clinical trial," Mishra added. "But we still don't know how fast they will proceed towards a vaccine and they can take several months to reach any point," he said. According to the World Health Organization (WHO), three vaccine candidates are in the clinical testing phase, meaning they are able to be tested on humans, while nearly 70 are in the preclinical phase -- either in lab testing, or animal studies. Though Kang named six companies, the WHO has listed only Zydus Cadila and Serum Institute from India as among the global firms working on a COVID-19 vaccine. As of April 8, 2020, said CEPI, the global COVID-19 vaccine R&amp;D landscape includes 115 vaccine candidates, of which 78 are confirmed as active and 37 are unconfirmed. Of the 78 confirmed active projects, 73 are currently at exploratory or preclinical stages, noted the CEPI team in an analysis published in the journal Nature reviews drug Discovery last week. The most advanced candidates have recently moved into clinical development, including mRNA-1273 from US-based biotechnology company Moderna, Ad5-nCoV from Chinese biopharma company CanSino Biologicals, and INO-4800 from American pharmaceuticals company Inovio.Others in this list include LV-SMENP-DC and pathogen-specific aAPC from Shenzhen Geno-Immune Medical Institute in China.Numerous other vaccine developers have indicated plans to initiate human testing in 2020, the CEPI scientists said.Experts believe the genome sequencing of the new coronavirus provided by scientists in China shows it shares 79 per cent of the same genetic material as severe acute respiratory syndrome (SARS) and 50 per cent of the same material as Middle East respiratory syndrome (MERS), a species of coronavirus which infects humans, bats, and camels. This allows developers to use groundwork already created in research for vaccines for those viruses. Australia's national science agency CSIRO announced earlier this month that it has begun preclinical tests of a vaccine developed by Oxford University in the UK. A striking feature of the vaccine development landscape for COVID-19 is the range of technology platforms being evaluated, including nucleic acid (DNA and RNA), virus-like particle, live weakened virus, and inactivated virus approaches. The CEPI noted that many of these platforms are not currently the basis for licensed vaccines, but experience in fields such as oncology is encouraging developers to exploit the opportunities that next-generation approaches offer for increased speed of development and manufacture. SAR MIN DVDV

Six Indian companies working on vaccine for COVID-19

By Shakoor Rather New Delhi, Apr 15 () Six Indian companies are working on a vaccine for COVID-19, joining the global race against time to find a preventive for the deadly infection spreading rapidly across the world, says a top Indian scientist.Nearly 70 'vaccine candidates' are being tested and at least three have moved to the human clinical trial stage, but a vaccine for the novel coronavirus is unlikely to be ready for mass use before 2021. As COVID-19 infects more than 1.9 million in the world and claims 1,26,000 lives, Indian scientists are also part of the global fight against the disease. "While Zydus Cadila is working on two vaccines, Serum Institute, Biological E, Bharat Biotech, Indian Immunologicals, and Mynvax are developing one vaccine each," Gagandeep Kang, executive director of the Translational Health Science and Technology Institute, Faridabad, told .Kang is also vice chair of the Coalition for Epidemic Preparedness Innovations (CEPI), which noted in a recent study that the "global vaccine R&amp;D effort in response to the COVID-19 pandemic is unprecedented in terms of scale and speed". But it is a complicated process with many stages of testing and many challenges, explained experts. A vaccine for the new coronavirus, SARS-CoV-2, may not take 10 years that other vaccines do but it could be at least a year before it is proven safe, effective, and made widely available, they said."Vaccine development is a lengthy process which often takes years, with many challenges," said E. Sreekumar, chief scientific officer at the Rajiv Gandhi Centre for Biotechnology (RGCB) in Kerala. "Generally, vaccines take several months to pass the different stages of testing, and then approvals also take time. For COVID-19, we don't expect a vaccine to come in this year," agreed Rakesh Mishra, director of the CSIR-Centre for Cellular and Molecular Biology (CCMB) in Hyderabad. Vaccine testing typically begins with animal and lab testing before going on to different stages of human testing. "The human testing phase is composed of many phases," Sreekumar told . "Phase one trials are small-scale, usually involving few participants, to assess whether the vaccine is safe for humans. Phase two trials often involve several hundred subjects, and mainly evaluate the efficacy of the vaccine against the disease," he said. The final phase involves thousands of people to further assess the efficacy of the vaccine over a defined period of time, and can last several months, Sreekumar said. "That is why we don't see a vaccine coming in at least a year from now." Even after the vaccine is ready, he explained, there are a lot of challenges, including whether the vaccine is effective in all populations, and if it can be used for different strains of the novel coronavirus, which might start mutating as time passes."There are lots of vaccines which are being tested for COVID-19, some of which are in the stage 1 clinical trial," Mishra added. "But we still don't know how fast they will proceed towards a vaccine and they can take several months to reach any point," he said. According to the World Health Organization (WHO), three vaccine candidates are in the clinical testing phase, meaning they are able to be tested on humans, while nearly 70 are in the preclinical phase -- either in lab testing, or animal studies. Though Kang named six companies, the WHO has listed only Zydus Cadila and Serum Institute from India as among the global firms working on a COVID-19 vaccine. As of April 8, 2020, said CEPI, the global COVID-19 vaccine R&amp;D landscape includes 115 vaccine candidates, of which 78 are confirmed as active and 37 are unconfirmed. Of the 78 confirmed active projects, 73 are currently at exploratory or preclinical stages, noted the CEPI team in an analysis published in the journal Nature reviews drug Discovery last week. The most advanced candidates have recently moved into clinical development, including mRNA-1273 from US-based biotechnology company Moderna, Ad5-nCoV from Chinese biopharma company CanSino Biologicals, and INO-4800 from American pharmaceuticals company Inovio.Others in this list include LV-SMENP-DC and pathogen-specific aAPC from Shenzhen Geno-Immune Medical Institute in China.Numerous other vaccine developers have indicated plans to initiate human testing in 2020, the CEPI scientists said.Experts believe the genome sequencing of the new coronavirus provided by scientists in China shows it shares 79 per cent of the same genetic material as severe acute respiratory syndrome (SARS) and 50 per cent of the same material as Middle East respiratory syndrome (MERS), a species of coronavirus which infects humans, bats, and camels. This allows developers to use groundwork already created in research for vaccines for those viruses. Australia's national science agency CSIRO announced earlier this month that it has begun preclinical tests of a vaccine developed by Oxford University in the UK. A striking feature of the vaccine development landscape for COVID-19 is the range of technology platforms being evaluated, including nucleic acid (DNA and RNA), virus-like particle, live weakened virus, and inactivated virus approaches. The CEPI noted that many of these platforms are not currently the basis for licensed vaccines, but experience in fields such as oncology is encouraging developers to exploit the opportunities that next-generation approaches offer for increased speed of development and manufacture. It is conceivable that some vaccine platforms may be better suited to specific population subtypes such as the elderly, children, pregnant women, or immunocompromised patients, noted Sreekumar. The CEPI analysis shows most COVID-19 vaccine development activity is in North America, with 36 (46 per cent) developers of the confirmed active vaccine candidates compared with 14 ( per cent) in China, 14 (18 per cent) in Asia (excluding China) and Australia, and 14 (18 per cent) in Europe. "Given the imperative for speed, there is an indication that vaccine could be available under emergency use or similar protocols by early 2021," it said. This would represent a fundamental change from the traditional vaccine development pathway, which takes on an average over 10 years, even compared with the accelerated five-year timescale for development of the first Ebola vaccine, the organisation said."Although there is a lot of enthusiasm, but it will take its own course to bring out a vaccine for COVID-19," Mishra added. SAR MIN MINMIN

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These are the seven Indian pharma players racing to develop COVID-19 vaccine

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