Best printers for Home

Best Mixer Grinder

Best wired Earphones

Best 43 Inch TV in India

Best Wi Fi Routers

Best Home Theatre in India

Smart Watch under 5000

Best Laptops for Education

Best Laptop for Students

The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation's (CDSCO) Subject Expert Committee and their next meeting will be held on January 1. The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII and Bharat Biotech Private Ltd. Further time was requested on behalf of Pfizer, while the additional data and information presented by the SII and Bharat Biotech was perused and analysed by the SEC. "The analysis of the additional data and information is going on. SEC will convene again on 1st January 2021 (Friday)," the Centre said in a statement. America's Pfizer was the first one to apply for the accelarated approval on December 4, followed by the SII and Bharat Biotech who applied on December 6 and 7, respectively. On December 9, the Subject Expert Committee had asked the SII and Bharat Biotech to submit more data and information to get approval. The expert panel had then recommended the SII to submit outcome of the assessment of UK regulatoe for grant of emergency use approval, the updated safety data of the Phase 2/3 clinical trial and immunogenicity data from the clinical trials in UK and India. Bharat Biotech was recommended to present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration. Their applications were reviewed again earlier on Wednesday, hours after the UK accepted the recommendation of the Medicines and Healthcare Regulatory Agency (MHRA) to authorise Oxford University-AstraZeneca's Covid-19 vaccine, named Covishield, for emergency use. The authorization was significant for India as the Pune-based SII had tied up with the company to conduct clinical trials and manufacture the vaccine. Besides, Bharat Biotech is developing country's indigenous coronavirus vaccine - Covaxin - in collaboration with the Indian Council of Medical Research. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities. Covishield uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the coronavirus if it later infects the body. The vaccine can be stored, transported and handled at normal refrigerated conditions at two to eight degrees Celsius for at least six months and administered within existing healthcare settings. Its interim analysis for efficacy showed that the vaccine was 70.4 per cent effective at preventing symptomatic COVID-19 occurring more than 14 days after receiving two doses of the vaccine. The SII has already made 40 to 50 million doses of the shot. "We have 40-50 million doses of Covishield stockpiled. We will be producing around 300 million doses by July 2021," its CEO Adar Poonawalla had recently said. Besides this, Bharat Biotech's Covaxin is India's indigenous vaccine and is being developed in collaboration with the ICMR's National Institute of Virology. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility SEE ALSO: <a href="https://www.businessinsider.in/personal-finance/income-tax/news/income-tax-returns-filing-deadline-extended-to-january-10/articleshow/80029154.cms">Relief for taxpayers: Deadline to file income tax returns extended further to January 10</a> <a href="https://www.businessinsider.in/science/health/news/uk-approves-oxford-astrazeneca-covid-19-vaccine-for-emergency-use/articleshow/80023778.cms">UK approves Oxford-AstraZeneca COVID-19 vaccine</a> <a href="https://www.businessinsider.in/tech/apps/news/google-is-testing-a-shortcut-feature-for-tiktok-and-instagram-videos/articleshow/80021865.cms">Google is testing a shortcut feature for TikTok and Instagram videos</a>.

India continues to mull over SII and Bharat Biotech's COVID-19 vaccine candidates

<ul><li>The Serum Institute of India (SII) has launched India’s first and only <keyword id="10507934" type="UNKNOWN" weightage="20" keywordseo="indigenous-pneumonia-vaccine">indigenous pneumonia vaccine</keyword> at $3 per dose, which is around ₹220, for the government. </li><li>For private purchase, the vaccine will cost about $10 — around ₹735 — which is still at least 50% cheaper than GSK and Pfizer’s pneumonia vaccines.</li><li>All four doses required to immunise a child against pneumonia from SII would cost less than ₹3,200, which is cheaper than a single dose of the Pfizer vaccine at ₹3,600. </li></ul>The Serum Institute of India (SII) has launched India’s <keyword id="10507932" type="UNKNOWN" weightage="20" keywordseo="first-homegrown-pneumonia">first homegrown pneumonia</keyword> vaccine called Pneumosil. CEO Adar Poonawalla Roughly stated that SII’s pneumococcal conjugate vaccine will cost the government around $3 dose, which is approximately ₹220. "It is the first vaccine made in India to protect children against the pneumonia disease in India. It is also the most affordable vaccine for pneumonia, in the whole world," he said. SII’s <keyword id="1240147" type="PERSON" weightage="20" keywordseo="Pneumonia-vaccine">pneumonia vaccine</keyword> versus GSK and Pfizer Each child has to be given four doses — at 6 weeks, 10 weeks and 14 weeks followed by a booster dose at nine months — of the vaccine for full protection. The cumulative four doses of SII’s pneumonia vaccine at ₹ 1,200 would cost less than a <a href="https://www.thehindu.com/sci-tech/science/serums-pneumococcal-vaccine-once-approved-could-be-cheaper-option-in-the-private-market/article30502005.ece">single dose</a> from its competitors. <table style="border-width: initial; border-style: none; width: 468pt; table-layout: fixed;"></colgroup><tbody><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Company </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Serotypes </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Price per dose </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">GSK </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">10 </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹1,600 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Pfizer </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">13 </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹3,600 </td></tr></tbody></table>Source: Reports Even in the private market, the vaccine will cost around $10 per dose, around ₹735. That’s still at least 50% cheaper than GSK and the whole process would still cost less than a single dose of Pfizer’s pneumonia vaccine. "We hope to achieve 70% to 80% coverage over the next two to three years," said Poonawalla. He explained that the company has multiple strategies planned for the private market and government avenues as well to help spread the vaccine across the country as far as possible. The vaccine is critical for a country like India, which saw the highest number of children under five years of age die due to pneumonia in 2019 — second only to Nigeria. According to the United Nations, the total death toll is pegged at 127,000. According to Union Health Minister Harsh Vardhan, the vaccine symbolises that India is well equipped to handle any health crisis, including the current COVID-19 pandemic. “This is symbolic that India can make any vaccine in an affordable way without compromising on safety and quality,” he said. SEE ALSO: <a href="https://www.businessinsider.in/science/space/news/indian-space-startup-skyroot-aerospace-successfully-test-fires-first-solid-rocket-propulsion-stage-demonstrator-called-kalam-5/articleshow/79988975.cms">India’s first-ever privately designed and developed rocket is a step closer to becoming a reality in 2021</a> <a href="https://www.businessinsider.in/business/corporates/news/jack-ma-ant-group-asked-to-overhaul-its-business-model-by-china-central-bank/articleshow/79987683.cms">China's central bank wants Jack Ma's Ant Group to overhaul its business model</a> <a href="https://www.businessinsider.in/science/environment/news/top-10-most-expensive-natural-disasters-of-2020-in-the-world/slidelist/79986294.cms">Cyclone Amphan was the most expensive cyclone of 2020 and the fourth most expensive natural disaster overall</a>

SII launches India's first indigenous pneumonia vaccine at $3 per dose

<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

<ul><li>The <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> has paused the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations. </li><li>The Drug Control General of India (DCGI) issued a show-cause notice, seeking an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear. </li><li>The notice was issued after <keyword id="6409874" type="COMPANY" weightage="20" keywordseo="astrazeneca">AstraZeneca</keyword> halted the late-trials of its coronavirus vaccine over safety concerns. </li></ul>The Serum Institute of India has paused the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations as a precaution, following a show-cause notice. SII<a href="https://twitter.com/CNBCTV18Live/status/1303981172200882176"> says</a> there have been no issues in India. It is a precautionary measure, and it will restart the trial as soon as AstraZeneca does. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front," SII said. The Drug Control General of India (DCGI), VG Somani, issued a show-cause notice to it asking for an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear. "The Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns," <a href="https://www.deccanchronicle.com/nation/in-other-news/100920/dcgi-issues-notice-to-serum-institute-over-astrazenecas-trial-suspens.html">the notice by DGCI read.</a> The DGCI further asked the institute as to why the authority did not suspend the permission given to SII for the clinical trials of Covishield. The notice was issued after AstraZeneca halted the late-trials of its coronavirus vaccine over safety concerns. According to<a href="https://www.businessinsider.com/astrazeneca-covid-19-vaccine-trial-paused-after-potential-adverse-reaction-2020-9?IR=T"> reports</a>, one of the participants in the United Kingdom reported a severe adverse reaction after being administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and the University of Oxford, on Tuesday. AstraZeneca was conducting human trials at over 60 locations including the US, Brazil and South Africa. SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Last month, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India. SEE ALSO: <a href="https://www.businessinsider.com/astrazeneca-covid-19-vaccine-trial-paused-after-potential-adverse-reaction-2020-9?IR=T">AstraZeneca's phase 3 coronavirus vaccine trial was just put on pause because a participant may have had an adverse reaction</a>

Oxford COVID-19 vaccine: SII pauses trials in India following show-cause notice

<ul><li><keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII) to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for India and low- and middle-income countries (LMICs).</li><li>The collaboration will provide upfront capital to SII to help them increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO prequalification, doses can be produced at scale for distribution to India and LMIC as part of the Gavi COVAX AMC mechanism as early as the first half of 2021.</li><li>The funding will support at-risk manufacturing by SII for candidate vaccines from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and WHO Prequalification.</li></ul> Serum Institute of India (SII), the worlds largest vaccine manufacturer by volume, has entered into a new landmark partnership with Gavi, The Vaccine Alliance and the Bill &amp; Melinda Gates Foundation, to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for India and low- and middle-income countries (LMICs). The collaboration will provide upfront capital to SII to help them increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO prequalification, doses can be produced at scale for distribution to India and LMIC as part of the Gavi COVAX AMC mechanism as early as the first half of 2021. The funding will support at-risk manufacturing by SII for candidate vaccines from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and WHO Prequalification. SII has set an affordable ceiling price of $3 per dose. The arrangement also provides an option to secure additional doses if the vaccines pillar of the ACT Accelerator sees a need for it. "In an attempt to make our fight against COVID-19 stronger and all-embracing; SII has partnered with Gavi and the Bill &amp; Melinda Gates Foundation to advance the manufacturing and delivery of up to 100 million doses of future COVID vaccines for India and low and middle income countries in 2021," said Adar Poonawalla, CEO of Serum Institute of India. "The rampant spread of the virus has rendered the entire world in an unimaginable halt of uncertainty. And to ensure maximum immunization coverage and contain the pandemic, it is important to make sure that the most remote and poorest countries of the world have access to affordable cure and preventive measures. Through this association, we seek to ramp up our constant efforts to save the lives of millions of people from this dreadful disease." SII shares a long history of successful partnerships with Gavi and pharmaceutical companies to manufacture vaccines that protect against meningitis, severe diarrhoea, pneumonia and measles. This collaboration further underscores India's proven-track record in developing safe and quality vaccines. Renu Swarup, Secretary, Department of Biotechnology said, "India has a proven track record of manufacturing safe and cost-effective vaccines not only for India, but for the world. Over the last decade, Government of India has encouraged innovation, and supported the Indian vaccine industry to manufacture high quality, affordable indigenous tools and products to benefit India and the world. We are very happy to see SII enter this global partnership to respond to the global health crisis posed by Covid-19." Balram Bhargava, Director General of Indian Council of Medical Research (ICMR), commented, "India's has demonstrated consistent capability in delivering on low-cost and high-quality medical research, while also maintaining technical and scientific rigour. ICMR is deeply supportive of our cutting edge vaccine research and manufacturing prowess, of which SII is one prominent example. This partnership signifies yet another step in India's efforts to bolster the fight against this global pandemic." The Gavi Covax AMC, which is currently seeking at least US$ 2 billion in initial seed funding, will meet at least part of the cost of procurement for the vaccine doses. Last week the Gavi Board agreed the final list of 92 countries that will be supported by the AMC. Under the new collaboration, AstraZeneca's candidate vaccine, if successful, will be available to 57 Gavi-eligible countries. Novavax's candidate, if successful, will be available to all 92 countries supported by the AMC The collaboration between Gavi, SII, and the Gates Foundation supports the efforts of the ACT Accelerator's vaccines pillar, also known as COVAX, co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), to accelerate the development of COVID-19 vaccines and ensure rapid, global access to them. Decisions around investment in manufacturing are taken in close collaboration between these three lead organisations of the COVAX pillar. Under the COVAX umbrella, Gavi is leading the COVAX Facility, which provides governments with the opportunity to benefit from a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by more manufacturers across the world, with a bigger market to provide security of demand. The Facility is reinforced by the AMC which provides funding for vaccines for lower income countries. SEE ALSO: <a href="https://www.businessinsider.in/tech/news/the-beirut-explosion-created-a-huge-mushroom-cloud-and-visible-blast-wave-but-nuclear-weapons-experts-say-it-wasnt-an-atomic-blast-heres-why-/articleshow/77362144.cms">The Beirut explosion created a huge mushroom cloud and visible blast wave, but nuclear weapons experts say it wasn't an atomic bomb. Here's why.</a> <a href="https://www.businessinsider.in/business/startups/news/microsoft-for-startups-lathika-pai-says-entrepreneurs-pitching-for-investments-need-to-have-this-one-question-answered-in-their-pitch-decks/articleshow/77352935.cms">Microsoft for Startups’ Lathika Pai says entrepreneurs pitching for investments need to have this one question answered in their pitch decks</a> <a href="https://www.businessinsider.in/careers/news/linkedin-tcs-disney-hotstar-zee-and-other-companies-hiring-right-now-in-india/slidelist/77352775.cms">LinkedIn, TCS, Disney+ Hotstar, Zee and other companies hiring right now in India</a>

Serum Institute of India to produce 100 million doses of COVID-19 vaccine for less than ₹250 a dose

<ul><li>Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the <keyword id="46985" type="COMPANY" weightage="20" keywordseo="Oxford">Oxford</keyword> COVID-19 vaccine candidate in the country</li><li>SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events. </li><li>The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders. </li></ul>Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial. The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be "scrupulously" followed by Serum Institute of India (SII). SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events. The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ''an unexplained illness'' in a participant in the study. On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials were safe. SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, on Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial. According to Tuesday's order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials subject to certain conditions. DSMB, India, also has recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to certain conditions. According to the order, SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants. The Pune-based firm has also submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale. "In view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India and in UK revoke herewith the order dated September 11 issued under Rule 30 of the New Drugs and Clinical Trials Rules, 2019. "You may recommence the clinical trial as recommended by DSMB, India, as per already approved protocol and the provisions laid down under the New Drugs and Clinical Trial Rules, 2019, subject to the conditions mentioned," the order said. SEE ALSO: <a href="https://www.businessinsider.in/science/news/bill-gates-says-the-pandemic-wiped-out-25-years-of-vaccine-progress-in-25-weeks/articleshow/78117898.cms">Bill Gates says the pandemic wiped out 25 years of vaccine progress in 25 weeks</a> <a href="https://www.businessinsider.in/education/news/uks-new-visa-rules-make-it-easier-for-international-students-to-study-and-work-now/articleshow/78127748.cms">UK’s new visa rules make it easier for international students to study and work now</a>

Serum Institute of India can resume clinical trial of Oxford COVID-19 vaccine, says DCGI

<ul><li>The <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII) hopes the Oxford COVID-19 vaccine will be available in Indian markets by the end of the year. </li><li>Last month, SII signed a deal with AstraZeneca to exclusively manufacture the Oxford vaccine for India.</li><li>SII CEO Adar Poonawalla told The Tribune that the vaccine is currently in Phase II of clinical trials. </li></ul>The Oxford COVID-19 vaccine, which is reportedly safe for people with weak immunity, may be available in the market by the end of the year, according to the Serum Institute of India (SII) — the world’s largest vaccine manufacturer. SII CEO Adar Poonawalla told <a href="https://www.tribuneindia.com/news/nation/oxford-vaccine-by-yr-end-partner-firm-107843">The Tribune</a> that clinical trials of the vaccine being developed by the University of Oxford — called AstraZeneca — have progressed to Phase III. “I hope that AstraZeneca Oxford vaccine will be available towards the end of the year,” he said based on the results highlighting that more than a 100 vaccine candidates are currently at different stages of clinical trials. Last month, on June 13, SII signed the deal with AstraZeneca to exclusively manufacture for India and countries in the Gavi Vaccine Alliance. SII will supply one billion doses for low and middle-income countries, with a commitment to provide <a href="https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-takes-next-steps-towards-broad-and-equitable-access-to-oxford-universitys-covid-19-vaccine.html">400 million doses</a> before the end of 2020. Safe for people with weak immunity Professor Saraf Gilbert from Oxford University’s Nuffield Department of Medicine recently <a href="https://www.businessinsider.in/india/news/oxford-covid-19-vaccine-safe-for-people-with-weak-immunity/articleshow/76728237.cms">told ambassadors of UN member states</a> that the vaccine is safe even for people with a weak immune system. “Because it is still a live virus, it is good at inducing a strong immune response after vaccination,” she said. According to AstraZeneca, the vaccine may not work but the company is progressing the clinical programme with speed and scaling up manufacturing despite the risk. 5,000 volunteers have begun participating in Brazil’s first clinical trials of the Oxford vaccine. “We plan to start production in nearly two months and have invested more than $100 on this facility,” Poonawalla told the Tribune. If the risk pays off, Poonawalla promises the vaccine will be affordable. SEE ALSO: <a href="https://www.businessinsider.in/india/news/an-indian-covid-19-vaccine-made-by-bharat-biotech-is-set-to-enter-human-trials/articleshow/76702286.cms">An Indian COVID-19 vaccine made by Bharat Biotech is set to enter human trials</a> <a href="https://www.businessinsider.in/india/news/oxford-covid-19-vaccine-safe-for-people-with-weak-immunity/articleshow/76728237.cms">Oxford COVID-19 vaccine safe for people with weak immunity says Oxford Professor Sarah Gilbert</a> <a href="https://www.businessinsider.in/india/news/potential-covid-19-vaccine-by-zydus-cadila-gets-dcgi-nod-for-human-clinical-trials/articleshow/76762771.cms">Potential COVID-19 vaccine by Zydus Cadila gets DCGI nod for human clinical trials</a>

Oxford COVID-19 vaccine may hit the Indian market by the end of the year if successful, says CEO of world’s largest vaccine manufacturer

The <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (<keyword id="52604" type="COMPANY" weightage="20" keywordseo="SII">SII</keyword>) has applied to the Drug Controller General of India (<keyword id="172241" type="COMPANY" weightage="20" keywordseo="DCGI">DCGI</keyword>) seeking permission to manufacture COVID-19 vaccine <keyword id="9739267" type="PERSON" weightage="20" keywordseo="Sputnik-V">Sputnik V</keyword> in the country, sources said on Thursday. The Pune-based firm has also sought approval for test analysis and examination. Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories. "The <keyword id="242973" type="COMPANY" weightage="20" keywordseo="Serum-Institute">Serum Institute</keyword> of India (SII) put up an application to the <keyword id="282629" type="COMPANY" weightage="20" keywordseo="Drugs-Controller">Drugs Controller</keyword> General of India (DCGI) on Wednesday seeking permission to manufacture the COVID-19 vaccine, Sputnik V, in India," a source said. The SII has already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States. The vaccine was given emergency use authorisation (<keyword id="2503801" type="COMPANY" weightage="20" keywordseo="EUA">EUA</keyword>) by the DCGI in April. A consignment of 30 lakh doses of Sputnik V landed in Hyderabad on Tuesday. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/the-indian-government-is-doling-out-1500-crore-to-reserve-300-million-of-biological-es-covid-19-vaccine-doses/articleshow/83196362.cms">The Indian government is doling out ₹1500 crore to reserve 300 million of Biological-E’s COVID-19 vaccine doses</a> <a href="https://www.businessinsider.in/tech/news/huawei-announces-first-devices-with-harmonyos-set-to-take-on-apple-and-google-with-its-in-house-operating-system/articleshow/83195689.cms">Huawei announces first devices with HarmonyOS — set to take on Apple and Google with its in-house operating system</a> <a href="https://www.businessinsider.in/tech/mobile/news/oneplus-nord-ce-5g-mobile-phone-full-specifications-leaked-days-ahead-of-launch/articleshow/83195375.cms">OnePlus Nord CE 5G full specifications leaked days ahead of launch – heavily inspired by the original Nord</a> <a href="https://www.businessinsider.in/business/startups/news/top-five-fintech-ideas-that-are-drawing-the-most-amount-of-money/slidelist/83194276.cms">Five fintech ideas that are raking in the most amount of money</a>

You Searched For "sii" and got 8 results

India continues to mull over SII and Bharat Biotech's COVID-19 vaccine candidates

IANS

SII launches India's first indigenous pneumonia vaccine at $3 per dose

Prabhjote Gill

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

BI India Bureau

Oxford COVID-19 vaccine: SII pauses trials in India following show-cause notice

BI India Bureau

Serum Institute of India to produce 100 million doses of COVID-19 vaccine for less than ₹250 a dose

IANS

Serum Institute of India can resume clinical trial of Oxford COVID-19 vaccine, says DCGI

PTI

Oxford COVID-19 vaccine may hit the Indian market by the end of the year if successful, says CEO of world’s largest vaccine manufacturer

BI India Bureau

Serum Institute of India seeks permission from DCGI to manufacture 'Sputnik V' COVID-19 vaccine in the country

PTI

Popular Keywords

Buying Guides