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<keyword id="242973" type="General" weightage="20" keywordseo="serum-institute" source="Orion">Serum Institute</keyword> of India (<keyword id="52604" type="General" weightage="20" keywordseo="sii" source="Orion">SII</keyword>) CEO <keyword id="201929" type="General" weightage="20" keywordseo="adar-poonawala" source="Orion">Adar Poonawala</keyword> on Friday said it has applied to Indian authorities for full market authorisation of <keyword id="9617748" type="General" weightage="100" keywordseo="covishield" source="Orion">Covishield</keyword>, stating supplies of the COVID-19 vaccine have exceeded 125 crore doses. SII had partnered with the developer of Covishield, AstraZeneca, for the supply of the vaccine to the Indian government, which had in January this year granted emergency use authorisation in the country. "Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (<keyword id="172241" type="General" weightage="20" keywordseo="dcgi" source="Orion">DCGI</keyword>) and @MoHFW_INDIA for this permission," Poonawala said in a tweet tagging the Central Drugs Standard Control Organisation (CDSCO) and <keyword id="191419" type="General" weightage="20" keywordseo="ministry-of-health-and-family-welfare" source="Orion">Ministry of Health and Family Welfare</keyword>. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/auto/news/tech-mahindra-buys-us-based-allyis-india-green-investments-for-125-million/articleshow/88611295.cms">Tech Mahindra buys US-based Allyis India, Green Investments for $125 million</a>

Serum Institute applies to Indian authorities for full market authorisation of Covishield

Vaccine maker Serum Institute of India's <keyword id="9625152" type="UNKNOWN" weightage="20" keywordseo="ceo-adar-poonawalla">CEO Adar Poonawalla</keyword> on Thursday said the Oxford COVID-19 vaccine should be available for <keyword id="893440" type="PERSON" weightage="20" keywordseo="healthcare-workers">healthcare workers</keyword> and <keyword id="56756" type="PERSON" weightage="20" keywordseo="Elderly-people">elderly people</keyword> by around February 2021 and by April for the general public, and will be priced at a maximum of Rs 1,000 for two necessary doses for the public, depending on the final trial results and regulatory approvals. Probably by 2024, every Indian will get vaccinated, he said at the Hindustan Times Leadership Summit (HTLS), 2020. "It will probably take two or three years for every Indian to get inoculated, not just because of the supply constraints but because you need the budget, the vaccine, logistics, infrastructure and then, people should be willing to take the vaccine. So these are the factors that lead up to being able to vaccinate 80-90 per cent of the population. "It will be 2024 for everybody, if willing to take a two-dose vaccine, to be vaccinated," Poonawalla said. Asked at what price the public will get it, he said it will be around USD 5-6 per dose with an MRP of around Rs 1,000 for the two necessary doses. "The government of India will be getting it at a far cheaper price at around USD 3-4, because it will be buying in a large volume and get access to the price that is similar to what COVAX has got. We are still pricing it far cheaper and more affordable than other vaccines we have in the market today," Poonawalla said. Asked about the efficacy of the vaccine, he said the Oxford-Astrazeneca vaccine is so far proving to work very well even in elderly people, which was a concern earlier. "It has induced a good T-cell response, which is an indicator for your long-term immunity and antibody response but then again, time will only tell if these vaccines are going to protect you in the long term. Nobody can answer that for any of the vaccines today," Poonawalla said. Responding to a question on the safety aspect, he said there has been no major complaints, reactions or adverse events, adding, "We would need to wait and see. The efficacy and immunogenicity results from the Indian trials will come out in about a month-and-a half." Asked when the SII will apply for an emergency authorisation, Poonawalla said as soon as the UK authorities and the European Medicines Evaluation Agency (EMEA) approve it for emergency use, it will apply to the drug controller for emergency use authorisation in India. "But that will be for a limited use for frontline workers, healthcare workers and elderly people," he added. Children would have to wait a little longer till the safety data is out, but the good news is that COVID-19 is not so bad and serious for them, Poonawalla said. "Unlike measles pneumonia, which is deadly, this disease is seeming to be less of a nuisance for children but then, they can be carriers and can give the infection to others. "We want to vaccinate the elderly people and others who are the most vulnerable first. Once we have enough safety data to go in on children, we can recommend it for children too," he said. Poonawalla said the Oxford vaccine is affordable, safe and stored at a temperature of two to eight degrees Celsius, which is an ideal temperature for it to be stored in the cold storages of India. He said the SII plans to make about 10 crore doses per month from February. As regards how many doses would be provided to India, Poonawalla said talks are still going on and no agreement has been arrived at in this regard. "India wants around 400 million doses by July. I do not know if it will take all from <keyword id="9265406" type="COMPANY" weightage="20" keywordseo="the-serum-institute">the Serum Institute</keyword>. We are gearing up to offer that kind of volume to India and still have a few 100 million to offer to COVAX by July and August. No agreement so far," he said. Poonawala said the SII is not entering into any agreement with other countries at this moment as India is its priority. "We have not signed and committed anything else beyond Bangladesh at the moment. We really do not want to partner right now with many countries because we will not have enough stocks to deliver. "We want to handle India as a priority first and manage Africa at the same time and then help out other countries," he said. Poonawalla said 30-40 crore doses of the Oxford vaccine will be available by the first quarter of 2021. In another session of the summit, AIIMS Director Dr Randeep Guleria said there is some talk going on between Pfizer and the Indian government but not much with Moderna. "It is going to be a huge challenge as far as the Pfizer vaccine is concerned, considering that it needs a cold chain of minus 70 degrees Celsius," he said and pinned hoped on the vaccines that are at various stages of trial in India. On the availability of a COVID-19 vaccine, Guleria said the percentage of population to be inoculated will depend on the number of vaccines getting the regulatory approvals and the number of shots they are producing. He further said the <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword> goes into the lungs without making a person symptomatic. "We have individuals who are asymptomatic and you can see patches in their lungs at CT scans directly. It really bypasses a person's defence mechanism, which means that you not only have the virus in your nose or throat, but it has gone right into your lungs. A virus which can do that is something we have to be wary of," Guleria said. PLB/UZM RC

COVID-19 vaccine will be priced at ₹1,000 and would be available by February for healthcare workers and elderly people, says Serum CEO Adar Poonawalla

<ul><li>While Oxford’s vaccine candidate is in phase III trials, it will still take at least eight more months to make it available to the public, if successful. </li><li>Nonetheless, <keyword id="52604" type="ORGANIZATION" weightage="20" keywordseo="SII">SII</keyword> will soon start manufacturing about 300 million doses of the unproven <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword> vaccine, <a href="https://www.news18.com/news/india/ready-for-masses-by-march-2021-adar-poonawallas-plan-for-covid-19-vaccines-trials-in-mumbai-pune-2727337.html">CNN-News 18 reported citing Adar Poonawala.</a> </li><li>SII will also begin the actual trial of the coronavirus vaccine on hospital patients in <keyword id="6358070" type="DEFINITION" weightage="20" keywordseo="mumbai">Mumbai</keyword> and <keyword id="2094" type="COMPANY" weightage="20" keywordseo="Pune">Pune</keyword>. </li><li> The vaccine, if effective, is expected to hit the Indian market in the first quarter of 2021. </li></ul>After promising results from the phase I trial of Oxford’s coronavirus vaccine candidate, <keyword id="242973" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute">Serum Institute</keyword> of India(SII) is all set to conduct human trials in India. SII, the world’s largest vaccine manufacturer, earlier in April, partnered with the University of Oxford and AstraZeneca to mass-produce billions of doses of their potential coronavirus vaccine candidate. While Oxford’s vaccine candidate is in phase III trials, it will still take at least eight more months to make it available to the public, if successful. Nonetheless, SII will soon start manufacturing about 300 million doses of the unproven coronavirus vaccine, <a href="https://www.news18.com/news/india/ready-for-masses-by-march-2021-adar-poonawallas-plan-for-covid-19-vaccines-trials-in-mumbai-pune-2727337.html">CNN-News 18 reported citing Adar Poonawala.</a> Oxford vaccine trials in India: Indicative timeline Here’s what Adar Poonawala, the chief executive officer of SII has proposed — July 2020: SII to submit their DMCA seeking permission to conduct phase 2 trials. Poonawalla believes SII will be able to “conclude all the design, type, and all the other aspects of the trial” in the next few weeks. August 2020: On completion of all the aspects of the trials, SII will begin the actual trial of the coronavirus vaccine on hospital patients in Mumbai and Pune. November 2020: The trials will involve about 5,000 participants and are likely to be completed by November this year. December 2020: Once the trials are successful, the vaccine will go to Central Research Institute in Kasauli before making it publically available. However, a few million doses will be given to those immunocompromised, like health workers, by December. March 2021: The vaccine, if effective, is expected to hit the Indian market in the first quarter of 2021. SII, which can produce 800 million doses of vaccine annually, will be able to make 300 million doses in the next four months. Even if the vaccine is made publicly available by March next year, Poonawalla believes it will take another three to four years to vaccinate everybody in the world with two doses. Industry stalwarts have raised concerns about the accessibility and easy availability of vaccines. <a href="https://twitter.com/BiIndia/status/1257988686739673088">According to Kiran Mazumdar Shaw</a>, the Director, and Founder of Biocon, even after the vaccine is approved, India may not be able to produce more than 10-20 million doses in the first year, which is a negligible amount considering India’s population. “There are 26 million children born in India every year, but we still struggle to vaccinate even 70% of them. How can we think that we can overnight go and vaccinate 1.4 billion people?. I don’t think vaccines are a major option for India until 2022,” <a href="https://twitter.com/BiIndia/status/1257988686739673088">Dr Ramanan Laxminarayan, Director CDDEP earlier told Business Insider India</a>. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/coovid-vaccine-from-oxford-serum-institute-and-astrazeneca-shows-promising-immune-response/articleshow/77069321.cms">The COVID-19 vaccine from Oxford and AstraZeneca shows 'promising' results in early human trials</a> <a href="https://www.businessinsider.in/careers/news/from-intel-and-wipro-to-tcs-and-google-here-are-the-top-job-openings-in-the-multinational-companies/articleshow/77058769.cms">From Intel and Wipro to TCS and Google— Here are the top job openings in the multinational companies</a> <a href="https://www.businessinsider.in/tech/mobile/news/checkout-upcoming-affordable-smartphone-oneplus-nord-launch-price-specifications-features/articleshow/77061620.cms">OnePlus Nord launch price, specs and more – Everything we know about the upcoming affordable OnePlus smartphone</a>

Here's an indicative timeline for the Oxford vaccine — from phase-3 trials to the final supply in the market

Pune, Oct 2 (IANS) Nationalist Congress Party President Sharad Pawar on Friday said that the Covid-19 vaccine being manufactured by the Serum Institute of India (SII) in Pune would be made available by the end of January 2021. The 79-year-old leader's brief comments came after a visit to the SII facility to get a dose of the BCG vaccine to increase immunity. This was Pawar's second visit since August to the SII which is currently under global spotlight for its plans to produce vaccines against coronavirus. SII Chairman Dr Cyrus S. Poonawalla and his son and CEO Adar Poonawala share a close rapport with the Pawar family. --IANS qn/vd

Covid vaccine to be available from January, says Sharad Pawar

<ul><li><keyword id="29334" type="General" weightage="20" keywordseo="cyrus-poonawalla" source="Orion">Cyrus Poonawalla</keyword>, who was recently awarded the Dean’s Medal by Johns Hopkins Bloomberg School of Public Health, has led a fascinating life.</li><li>He started with building sports cars and later went on to build a vaccine empire, which has made immunization accessible for all, against various diseases, including the coronavirus.</li></ul>The chairman of India’s top biotech company and the world’s largest vaccine manufacturer, Dr. Cyrus Poonawalla of Serum Institute of India (SII), is among the top 70 richest billionaires in the world today. At the age of 81, Poonawalla’s net worth is <a href="https://www.forbes.com/profile/cyrus-poonawalla/?list=rtb/&amp;sh=488fcc447d01">$21.5 billion</a>, as per Forbes, and has been recently awarded the Dean’s award by John Hopkins for his work in providing affordable vaccines. He is called the ‘vaccine king’ as his company SII produces over 1.5 billion vaccines annually for coronavirus, polio, diphtheria, tetanus, pertussis, Hib, BCG, r-hepatitis B, measles, mumps, rubella, among others. From horse breeding to building a vaccine empire Poonawala was born into a family of horse breeders, as his father Soli Poonawalla owned ‘Poonawalla Stud Farms.’ However, he was 20 when he decided to explore more options because he realized that horse racing had ‘<a href="https://www.forbesindia.com/article/leadership-awards-202021/fila-2021-lifestime-achievement-cyrus-poonawalla-the-vaccine-king/66877/1">no future</a> in a socialist country like India’. <div type="image" title="Horse racing" msid="91764331" hostid="261" caption="&amp;lt;p&amp;gt;Representative image of a horse race, which was attended by Poonawalla in 2013&amp;lt;/p&amp;gt;"></div> Vaccines from serum When he was 20, Poonawalla decided to leverage his passion for cars and turn it into a viable business. So, he built a $120 replica of the Jaguar D-type with his school friend. However, he abandoned the idea of commercial production due to a shortage of funds. After dropping his first business plan, he wanted to make a ‘product for the masses’. He discovered that horse serum can be used to make vaccines. He decided to use his stud farm for a better cause and make vaccines affordable. There was no going back since then. Back in the 1960s, when Poonawalla was just in the research phase of launching his serum business, which is now worth <a href="https://www.businesstoday.in/latest/corporate/story/serum-institute-founder-cyrus-poonawalla-adar-wealth-85pc-to-138-bn-271174-2020-08-26">$13.8 billion</a>, the vaccine market was still in its nascent stages. With only a few players in the game, there was a huge demand and very low supply. It was a safe option for Poonwalla to enter a less competitive market and India with an acute shortage, which were imported at high prices. He decided to look no further and launched his vaccine business under the name SII in 1966, with a capital of <a href="https://www.forbesindia.com/article/leadership-awards-202021/fila-2021-lifestime-achievement-cyrus-poonawalla-the-vaccine-king/66877/1">Rs 9 lakh</a>, which would later go on to help millions of people during a global pandemic, thanks to its domestically manufactured Covishield. Since he had no medical background, he employed doctors and scientists from the government-owned Haffkine Institute at SII. Within two years, the company produced its first therapeutic anti-tetanus serum. By 1989, his company had a diverse portfolio of DTP vaccine, which protects children from diphtheria, tetanus and pertussis, anti-snake-venom serum for snakebites and measles vaccine. A year later, SII became the country’s largest vaccine manufacturer. Supplying to every second vaccinated child in the world It was time to expand their business offshores. In 1994, Serum Institute got accredited by the World Health Organization (WHO) for supplying vaccines to U.N. Agencies such as UNICEF (United Nations Children’s Fund) and PAHO (Pan American Health Organization). By 1998, Serum Institute was exporting vaccines to over 100 countries and by the year 2000, one out of every two children in the world was vaccinated with an SII dose. The vaccine king’s wealth grew the <a href="https://economictimes.indiatimes.com/magazines/panache/cyrus-poonawalla-enters-top-100-rich-list-his-wealth-grows-fifth-fastest-in-the-world-during-coronavirus-pandemic/articleshow/76543094.cms?from=mdr">fastest </a>among India’s billionaires during the COVID-19 pandemic and SII became a household name. His home-grown business gained international recognition after they struck a deal with Oxford University’s Jenner Institute. SII then went on to strike at least four more global partnerships with biotech companies. <div type="image" title="serumII" msid="91766062" hostid="261" caption="&amp;lt;p&amp;gt;Serum Institute of India&amp;#39;s financials &amp;lt;/p&amp;gt;"></div> His son, Adar Poonawalla is at the helm of the company now. Junior Poonawalla joined his family business in 2001 and today, he runs the day-to-day operations as company ceo and is the <a href="https://www.forbesindia.com/article/take-one-big-story-of-the-day/his-father-built-a-vaccine-empire-adar-poonawalla-is-now-busy-diversifying-it/73375/1">fifth </a>richest person in India. <div type="image" title="Vaccine giant Serum Institute of India plans African plant in global expansion" msid="91764213" hostid="261" caption="&amp;lt;p&amp;gt; Junior Poonawalla joined his family business in 2001&amp;lt;br /&amp;gt;&amp;lt;/p&amp;gt;"></div> Expansion to renewable energy, real estate and more Along the way, Senior Poonwalla also expanded his business portfolio into newer areas such as real estate, finance, renewable energy solutions, hospitality, and aviation. But, Serum Institute continues to bring in the lion’s share of his income. While he built his business empire, his passion for sports and luxurious cars has not waned. <div type="image" title="Cryus and his car" msid="91764182" hostid="261" caption="&amp;lt;p&amp;gt;Padmashree Cyrus Poonawalla with his new Ferreri car outside his palace in Pune in 2013&amp;lt;/p&amp;gt;"></div> Today, his collection includes Rolls-Royce cars, Bentleys and Ferrari F430. It is his love for affordable vaccines, sports cars and horse racing - that make Poonawalla a man of diverse interests.

The success story of Cyrus Poonawalla: The vaccine king who is one of the world’s richest billionaires

<ul><li>The <keyword id="242973" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute">Serum Institute</keyword> of India (SII) claims that it has a clean chit from the concerned authorities for its COVID-19 vaccine, Covishield. </li><li>The company’s comments come after a 40-year old volunteer from Chennai issued a legal notice suing SII for neurological and psychological side effects from its COVID-19 vaccine.</li><li>SII added that the vaccine is ‘safe and immunogenic’ to roll out to the masses. </li></ul>The Serum Institute of India (SII) claims it has a clean chit from the authorities and that its COVID-19 vaccine is perfectly safe to roll out to the masses. Dubbed Covishield, the vaccine being developed by UK's Oxford University and the US pharma giant AstraZeneca recently came under scrutiny after a 40-year old volunteer from Chennai claimed to suffer from neurological and psychological side effects as a result of the trials. <div type="Article" hostid="261" msid="79490838" title="Serum Covishield legal row: Chennai volunteer seeks investigation, lawyer says company is intimidating him with ₹100 crore suit" mstype="2" mssubtype="0"></div> “The concerned authorities were informed and the Principal Investigator, DSMB and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial,” SII said in a statement on Facebook. The company added that the vaccine is ‘safe and immunogenic’ to roll out to the masses. “The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition,” it said. Concerns over SII’s trials in India The phase-III volunteer who accused SII of extreme side effects due to the vaccine sent the company a legal notice and is seeking ₹5 crore as compensation. He claims that the side effects of the vaccine were so extreme that he now finds himself unable to get back to his life as it was before the vaccine trials. In the legal notice to the SII, AstraZeneca and the Oxford Vaccine Group, he also demands that the vaccine trial with 1,600 volunteers in India should be halted immediately. SII hit back, saying that it would fight these claims tooth-and-nail and seek at least ₹100 crore in damages, which the volunteer’s advocates saw as an ‘<a href="https://www.businessinsider.in/india/news/serum-covishield-legal-row-chennai-volunteer-seeks-investigation-lawyer-says-company-is-intimidating-him-with-100-crore-suit/articleshow/79490838.cms">intimidation</a>’ tactic. The <keyword id="9626040" type="UNKNOWN" weightage="20" keywordseo="Covishield-vaccine">Covishield vaccine</keyword> being manufactured by SII is among the leading candidates for a COVID-19 vaccine around the world, locked in a race against the likes of Pfizer, Moderna and Sputnik-V. After meeting with Prime Minister Narendra Modi on November 28, SII CEO Adar Poonawala revealed that the company is in the process of applying for an emergency use license for Covishield in the next two weeks. SEE ALSO: <a href="https://www.businessinsider.in/tech/apps/news/pubg-mobile-india-is-still-fighting-its-ban-as-indigenous-clone-fau-g-makes-its-debut/articleshow/79503526.cms">PUBG Mobile India is still fighting its ban as indigenous clone FAU-G makes its debut</a> <a href="https://www.businessinsider.in/science/space/news/new-technology-to-create-fuel-and-oxygen-on-mars-could-help-humans-explore-the-deep-sea-here-on-earth/articleshow/79504876.cms">New technology to create fuel and oxygen on Mars could help humans explore the deep sea here on Earth</a> <a href="https://www.businessinsider.in/stock-market/news/tech-mahindras-share-price-hits-a-new-high-as-the-company-targets-the-100-billion-cloud-opportunity-and-guns-for-5g/articleshow/79506939.cms">Tech Mahindra's share price hits a new high as the company targets the $100 billion cloud opportunity and guns for 5G</a>

Serum Institute claims that its COVID vaccine is safe and that it has a clean chit from the authorities for Covishield

Mumbai, Jul 16 () Despite the massive disruptions due to the pandemic, deal street was vibrant in the first half of 2020 with M&amp;A value rising 14.5 per cent to USD 43.54 billion, thanks to Reliance contributing nearly half of the deal value, according to a report. However, as per the data collated by Mergermarket, the deal count dipped 24.7 per cent to 183 transactions during the period under review. Between late April and June, Reliance Industries sold nearly 25 per cent in its telecom arm Jio Platforms to 10 investors, including Facebook, which snapped up 9.99 per cent for over Rs 43,000 crore. Together, Reliance raised around Rs 1.2 lakh crore, including through the largest QIP sale for over Rs 53,100 crore. Beginning April 22, Reliance sold 24.71 per cent stake in Jio to Facebook, Silver Lake Partners, General Atlantic, KKR and other investors scooping up USD 15.27 billion. The selling spree continued into July with the latest being Google picking up 7.7 per cent for over Rs 33,700 crore on Wednesday. "H1 M&amp;As increased 14.55 per cent to USD 43.54 billion in value despite the pandemic, largely thanks to a series of stake sale by Jio Platforms to 10 investors since April, despite a 24.69 per cent year-on-year drop in volume to 183 transactions from 243 deals in H1 of 2019 generating USD 38 billion," Mergermarket said. Though the in-bound deals came down 28.8 per cent to 89, the deal value increased to USD 26.9 billion compared to USD 21.38 billion from 125 deals in H1 of 2019. This was in spite of the deal value plunging from USD 20.22 billion to USD 6.68 billion, while in volume the same dipped to 42 from 47 deals. According to the data, the first half deal value of USD 26.9 billion through 89 transactions represents 71.66 per cent of the USD 37.53 billion from 242 deals reported in FY19. The out-bound deals dipped 37.6 per cent to USD 881 million across 21 deals from USD 1.42 billion from 34 transactions in H1 of 2019. This makes the first half to be the worst in terms of outbound deal value and deal count since the first half of 2014 at USD 650 million from 33 deals. Domestic M&amp;As generated USD 16.64 billion, on par with the last year levels, but the deal count shrank 20.3 per cent to 94. The largest domestic deals were the acquisition of Aircel by a group of investors including UVARC for USD 2.6 billion and the 75 per cent stake sale in Krishnapatnam Port Company to Adani Ports &amp; Special Economic Zone for USD 1.63 billion. Other high-profile deals included divestment of NTPC's hydroelectric power unit THDC for USD 1.5 billion and power utility Neepco for USD 1.44 billion. Private equity buyouts jumped by 48 per cent to USD 9.07 billion across 53 deals from USD 6.1 billion across 66 deals. The telecom sector accounted for almost 67 per cent of total such deals in value worth USD 6.1 billion across seven deals. Mergermarkets expects deal-making volume to further fall as the economy remains crippled and the uncertainties over the potential re-emergence of the pandemic. Infrastructure, renewables and pharma and healthcare may attract investments in the second half as deals that are at advance stage could get closed. JB Chemicals sold its majority stake to KKR for USD 617 million earlier this month and a few other deals in the pharma segment include Adar Poonawala's Serum Institute looking to raise up to USD 1 billion for its pandemic division to develop vaccines. In the renewables sector, Sembcorp Energy, IL&amp;FS and Mytrah Energy are in active discussions planning to sell stakes to PEs. BEN BAL BAL

Deal street jumps 14.5% in H1 to $43.5 bn on Jio stake sales

By Shakoor Rather New Delhi, Jun 16 () Vaccine design is still an empirical, trial and error process and a preventive against COVID-19 could be at least a year away, say scientists as information on developments in therapeutics to combat the infection flows in a steady trickle from across the world. While quelling the buzz of a quick breakthrough, the scientists also hold out hope that the process might be cut short by a few months if testing approvals and scale-ups in manufacturing happen simultaneously. According to the World Health Organisation, 10 candidate vaccines for COVID-19 are in the clinical evaluation and 126 are in the preclinical stage. Preclinical development is a stage of research during which important feasibility, iterative testing and drug safety data are collected, while clinical trials are research studies performed on people. There are different broad strategies by which SARS-CoV-2 vaccines are being developed the world over, explained immunologist Satyajit Rath. While all are well-known strategies -- some almost two centuries old and some almost two decades old -- none are 'guaranteed' to yield a usable vaccine, the scientist from the National Institute of Immunology (NII) in New Delhi told . "Vaccine design still remains mostly an empirical, trial and error process, rather than an innovative knowledge-driven one. This is why, while any of these approaches is being put through trial and error, it remains a 'vaccine candidate' rather than a 'vaccine'," he added. According to Robert Gallo, director of the Institute of Human Virology at the University of Maryland in the US, "What's being confused -- and scientists and politicians are contributing to the confusion -- is the difference between a candidate and a vaccine." He was speaking at a virtual meeting earlier this month when scientists at the University of California (UC) Davis and from other institutes in the US gathered to lay out a full picture of the complexities of developing and distributing a COVID-19 vaccine -- which they generally agreed won't happen until some time in 2021. "We are not expected to return to a fully normal life until a vaccine is developed. But how long will that take?" UC Davis Chancellor Gary S. May asked in the meeting. About a year, maybe more, was the consensus. In India, where the number of COVID-19 cases on Tuesday rose to 3,43,091 and the death toll to 9,900, scientists agreed with their counterparts abroad With at least six Indian companies working on a vaccine for COVID-19 and the Serum Institute of India last week announcing a deal with the company Astra Zeneca to supply one billion doses of vaccine for low and middle-income countries to combat the coronavirus, the buzz has been growing louder. "We finally have a deal signed with @AstraZeneca, to exclusively manufacture their product for India and @gavi countries, up to a billion doses annually. This will ensure supply and access to all Indians," Adar Poonawala, the CEO of the Serum Institute, tweeted on June 13. Earlier this month, Prime Minister Narendra Modi pledged USD 15 million as India's contribution to the vaccines alliance GAVI at the Global Vaccine Summit hosted by the UK. But that does not translate into a vaccine anytime soon, scientists said. "My guess for that is, not before the middle of the next year," Rath said. However, he noted that the time estimates might be pruned by a couple of months with simultaneous movements on testing-approval and manufacturing scale-up, and also by exception-shortcuts from regulatory authorities. He explained that there are several challenges that will arise once such vaccines are ready to go into the market, since 'going into the market' and going into the 'public health system' are not the same thing. Questions will remain on the 'availability' at a large scale, especially to the poor. "One limitation, of course, is the scale of manufacturing. Huge numbers of doses will have to be manufactured in very short times to reach everyone. A number of governmental and non-governmental organisations are trying to set up industrial partnerships to address this issue," he said. A second issue, the scientist said, will be the cost of vaccines, with the linked issue of intellectual property rights. A final issue, he noted, is of actual implementation and delivery of vaccination. "The resources and the technical-administrative structures needed for such a vaccination campaign are massive. It is not clear if any national governments have the understanding and the practical commitment to them. That might end up being the biggest roadblock of all," Rath said. Umashankar Singh, assistant professor, Biological Engineering, IIT-Gandhinagar, said he is hoping a candidate vaccine may be available by the end of 2020, even if it is for a limited set of the population. Two facets of vaccine production, in his view, need to be considered – mass production of the lab product and also ensuring that the product is actually effective enough to justify mass production. There are other challenges too, he said, adding that there is evidence for a range of virulence, variable infection rates and asymptomatic infections and emergence of multiple strains. "The uncertainty posed by these issues is likely to throw spanner in the works towards mass production of vaccines. This vaccine development is like chasing a moving target, a target we don't know well enough. The question we should be asking is, even if a vaccine were to be available, how long would its effectiveness last?" he told . Singh noted that the emergence of a vaccine may or may not allow real protection against a rapidly evolving pathogen, but it would certainly allow us a psychological relief of being immune to the virus. "That would allow us to move on to the issues of economy, social interactions and ease of governance," he said. "Even if by end of the year 2020 a candidate vaccine gets regulatory approval, mass production and supply chain is going to be a challenge," added an Indian virologist who didn't wish to be named. If it is a single dose vaccine, the world will need at least eight billion doses, a task that might several months and maybe years. If it is a two dose vaccine, the challenge becomes bigger. SAR MIN MIN MIN

COVID-19 vaccine at least a year away, say scientists

By Shakoor Rather New Delhi, Jul 4 () India's COVID-19 vaccine programme has gained sudden traction but it is imperative to strike a balance between giving it high priority and rushing into a process that takes months, even years, several scientists said on Saturday, a day after the ICMR announced it envisaged a preventive by next month. There was hope but caution too as the Indian Council of Medical Research on Friday said it aims to launch the world's first COVID-19 vaccine by August 15. The same day, Ahmedabad-based Zydus Cadila announced it has got the Drugs Controller General of India's (DCGI) nod for human clinical trials for a potential vaccine. "Fast tracking a vaccine trial in four weeks for safety, immunogenicity and efficacy is just not possible if things are to be done correctly," Shahid Jameel, virologist and CEO of the Wellcome Trust/DBT India Alliance, a public charity that invests in building biomedical sciences and health research framework, told . Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal, he explained. Virologist Upasana Ray added that an accelerated launch or promise for launch of a vaccine against the novel coronavirus deserves applause but it is important to ask whether "we are rushing too much". "We must rush albeit carefully. Giving this project high priority is absolutely important. However, excess pressure might not necessarily lead to a positive product for public use," the senior scientist at CSIR-IICB, Kolkata, told . India's premier medical body ICMR has said 12 clinical trial sites for the indigenous Covaxin, being developed in collaboration with the Hyderabad-based Bharat Biotech and the National Institute of Virology (NIV), have been identified. It asked medical institutions and principal investigators to ensure that the subject enrolment is initiated no later than July 7. "It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials," ICMR Director General Balram Bhargava said in his letter to the principal investigators of the 12 sites. The tone of the letter and the haste it indicated had some scientists worried. They questioned the timeline of the announcement mentioned in the letter, and advised against subverting the due vaccine development process. "The ICMR 'letter' is, to say the least, a deeply inappropriate letter, in tone and content, both in terms of the integrity of due processes of product development, and in terms of technically realistic estimates," immunologist Satyajit Rath told . Vaccine development is a multi-phase process. Phase 1 trials are small-scale, usually involving few participants, to assess whether the vaccine is safe for humans. Phase 2 trials often involve several hundred subjects, and mainly evaluate the efficacy. 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. Ray added that a vaccine normally takes at least 12-18 months to pass all necessary clinical trial phases. "From now till August 15, the company has just over a months' time to wrap up everything that normally a vaccine development process requires for releasing a vaccine for clinical use," she said. "How can such a sharp timeline be even decided? Where does the evidence come from that by such a short time all the essential steps will be completed? What about the safety and efficacy, the fundamental steps of any drug development? Have even the pre-clinical studies been completed? Too much rush comes with possible risks," she said. Ray noted that there are some broad mandatory steps for developing a vaccine. Preclinical tests in small animals and mammals, she stressed, are essential to assess neutralising antibody titers and that itself can take at least a month or two. A titer is a laboratory test that measures the presence and amount of antibodies in blood. "Next, we check for safety. Then is the human trial. Even if we are in a deep rush we have to wait for some time for immunised individuals to start generating antibodies. After that a population needs to be monitored over time to investigate if people are still being infected," she explained. Skipping steps could either be dangerous or lead to poor product, Ray said. "We must not compromise with the standard, the quality. We don't need to be the first to launch a drug but what we need is a Made in India vaccine that the entire world can rely on," she added. The vaccine landscape in India has been also bolstered after the approval for Zydus Cadila's vaccine candidate. It was fast-tracked following a recommendation by the subject expert committee on COVID-19, considering the emergency and unmet medical need during the pandemic. "DCGI Dr V G Somani has given approval for the phase I and II clinical trials (on humans) of the potential novel coronavirus vaccine developed by Zydus Cadila Healthcare Ltd on Thursday after its animal studies were found to be successful," an official source said. Jameel, winner of the 2000 Shanti Swarup Bhatnagar Prize for Science and Technology, one of the highest Indian science awards, noted that it is a vaccine funded by Biotechnology Industry Research Assistance Council (BIRAC) and the Department of Biotechnology. "Congratulations to Cadilla, BIRAC and DBT. We would look forward to properly conducted trials and good news in due course," he told . "I am glad that a locally made vaccine candidate is making the same progress that others elsewhere in the world are making, not just with SARS-CoV-2 vaccine candidates but with DNA-based SARS-CoV-2 vaccine candidates, and I will look forward to the results," added Rath from Delhi's National Institute of Immunology (NII). Gautam I. Menon, professor from the Departments of Physics and Biology at Ashoka University, said Zydus Cadila's vaccine appears to have shown safety and efficacy in animal trials and so they have been allowed to go to the next step, to human trials. "This is the standard procedure. It is the human trials that are time-consuming and it is important to get this right," Menon told . In another development, Serum Institute of India (SII) CEO Adar Poonawalla told The Tribune newspaper that the Covid-19 vaccine being developed at the University of Oxford will hit the market by the year-end. ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, and has been genetically changed so that it is impossible for it to reproduce in humans. "I think it is likely that the ChAdOx1-S vaccine candidate which has entered a phase 3 clinical trial in Brazil, will give at least somewhat promising results by late this calendar year," Rath said. "Whether this will lead to the 'vaccine' becoming available in the market, and in the public health system, more importantly, by the end of this calendar year in India is much more uncertain, Mr Poonawala's welcome optimism notwithstanding," he added. SAR MIN MIN MIN

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