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<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>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 testing of <keyword id="8763838" type="UNKNOWN" weightage="20" keywordseo="covid-19">Covid-19</keyword> vaccine being developed by AstraZeneca and University of <keyword id="46985" type="COMPANY" weightage="20" keywordseo="Oxford">Oxford</keyword> has been put on hold due to a serious adverse reaction in a participant in the UK.</li><li>A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said that the company's "standard review process triggered a pause to vaccination to allow review of safety data".</li><li>AstraZeneca only began its Phase 3 trial in the US in late August.</li></ul> The testing of Covid-19 vaccine being developed by AstraZeneca and University of Oxford has been put on hold due to a serious adverse reaction in a participant in the UK. However, Serum Institue of India says, trials of AstraZeneca <keyword id="8973295" type="COMPANY" weightage="20" keywordseo="oxford-vaccine">Oxford vaccine</keyword> have not been paused in India. "We (Serum Institute of India) can't comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all," SII tweeted. Stat News reported that a large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the US has been put on hold due to a suspected serious adverse reaction in a participant in the UK. A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said that the company's "standard review process triggered a pause to vaccination to allow review of safety data". In a follow up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, Stat News reported. The spokesperson described the pause as "a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials". The spokesperson also said that the company is "working to expedite the review of the single event to minimize any potential impact on the trial timeline". An individual familiar with the development said researchers had been told the hold was placed on the trial out of "an abundance of caution". A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway -- as well as on the clinical trials being conducted by other vaccine manufacturers, according to the Stat News report. AstraZeneca only began its Phase 3 trial in the US in late August. The US trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the UK, Brazil, and South Africa. SEE ALSO: <a href="https://www.businessinsider.in/retail/news/reliance-retail-raises-1-billion-from-silver-lake-valuing-the-chain-at-57-billion/articleshow/78009435.cms">Reliance Retail raises $1 billion from Silver Lake valuing the chain at $57 billion</a>

Oxford COVID-19 vaccine human trials to continue in India, says SII

<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>University of <keyword id="46985" type="COMPANY" weightage="20" keywordseo="Oxford">Oxford</keyword> and <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> has started human trials of a new experimental COVID-19 vaccine in Australia. </li><li>SpyBiotech, a UK company created by researchers from Oxford in 2017, has designed the vaccine shot, <a href="https://www.bloomberg.com/news/articles/2020-09-08/new-covid-19-vaccine-from-oxford-begins-early-stage-human-trials?srnd=premium-asia">reported Bloomberg.</a></li><li>This is the second potential coronavirus vaccine from Oxford under trial.</li><li>The Serum Institute of India — which is running the phase I/II trials of SpyBiotech’s shot — is soon going to enrol hundreds of participants. </li></ul>University of Oxford and Serum Institute of India has started human trials of a new experimental COVID-19 vaccine in Australia. SpyBiotech, a UK company created by researchers from Oxford in 2017, has designed the vaccine shot, <a href="https://www.bloomberg.com/news/articles/2020-09-08/new-covid-19-vaccine-from-oxford-begins-early-stage-human-trials?srnd=premium-asia">reported Bloomberg. </a> According to Sumi Biswas, CEO SpyBiotech, the Serum Institute of India — which is running the phase I/II trials of SpyBiotech’s shot — is going to enrol hundreds of participants in the future. “The vaccine uses a virus-like particle from the Hepatitis B antigen as a carrier, employing the company’s proprietary SpyCatcher/SpyTag “superglue” technology to attach the coronavirus spike protein to induce an immune response,” Biswas told Bloomberg in an interview. She further added,” The virus-like-particle has been used for decades in a licensed vaccine against Hepatitis B. SpyBiotech’s technology allows antigens to be bonded to virus-like-particles in a way that enhances stability and effectiveness.” SpyBiotech has reached an exclusive licensing deal with the Serum Institute of India. This is the second potential coronavirus vaccine from Oxford under trial. Oxford-Astrazeneca coronavirus vaccine candidate — ChAdOx1-S — is the most advanced vaccine candidate against COVID-19. ChAdOx1-S is under a Phase III trial in the US. Oxford is likely to end the human trials by November<a href="https://www.livemint.com/news/india/oxford-covid-19-vaccine-human-trials-to-end-by-november-mass-production-from-early-2021-11597314049068.html"> and begin production from early 2021</a>. Oxford has struck a deal with pharma giant Astra Zeneca to mass-produce the vaccine — and provide about 2 billion doses to the world if this trial is successful. SEE ALSO: <a href="https://www.businessinsider.in/india/news/workation-new-trend-in-travel-as-indians-find-unique-new-settings-for-work-from-home/articleshow/77990457.cms">Workation – From private villa at the beach to a pool with a view, Indians are finding unique new settings for ‘work from home’</a>

Oxford and Serum Institute of India begin human trials of a new COVID-19 vaccine in Australia

New Delhi, A new type of "<keyword id="18985759" type="General" weightage="20" keywordseo="inverse-vaccine" source="Orion">inverse vaccine</keyword>" has been shown in the lab setting to completely reverse autoimmune diseases like <keyword id="23087" type="General" weightage="20" keywordseo="multiple-sclerosis" source="Orion">multiple sclerosis</keyword> and type 1 <keyword id="6359018" type="General" weightage="20" keywordseo="diabetes" source="Orion">diabetes</keyword>, all without shutting down the rest of the immune system, according to a study. A typical <keyword id="24209" type="General" weightage="20" keywordseo="vaccine" source="Orion">vaccine</keyword> teaches the human immune system to recognise a virus or bacteria as an enemy that should be attacked. However, the new vaccine developed by researchers at the University of Chicago's Pritzker School of Molecular Engineering (PME) in the US does just the opposite: it removes the immune system's memory of one molecule. While such immune memory erasure would be unwanted for infectious diseases, it can stop autoimmune reactions like those seen in multiple sclerosis, type I diabetes, or rheumatoid arthritis, in which the immune system attacks a person's healthy tissues, the researchers said. The vaccine, described in the journal Nature Biomedical Engineering, takes advantage of how the liver naturally marks molecules from broken-down cells with "do not attack" flags to prevent autoimmune reactions to cells that die by natural processes. The team coupled an antigen-a molecule being attacked by the immune system-with a molecule resembling a fragment of an aged cell that the liver would recognise as friend, rather than an enemy. The team showed how the vaccine could successfully stop the autoimmune reaction associated with a multiple-sclerosis-like disease. "In the past, we showed that we could use this approach to prevent autoimmunity," said <keyword id="18985758" type="General" weightage="50" keywordseo="jeffrey-hubbell" source="Orion">Jeffrey Hubbell</keyword>, the Eugene Bell Professor in Tissue Engineering and lead author of the new paper. "But what is so exciting about this work is that we have shown that we can treat diseases like multiple sclerosis after there is already ongoing inflammation, which is more useful in a real-world context," Hubbell said. Today, autoimmune diseases are generally treated with drugs that broadly shut down the immune system. "These treatments can be very effective, but you're also blocking the immune responses necessary to fight off infections and so there are a lot of side effects," said Hubbell. "If we could treat patients with an inverse vaccine instead, it could be much more specific and lead to fewer side effects," he added. Initial phase I safety trials of a antigen therapy based on this preclinical work have already been carried out in people with celiac disease, an autoimmune disease that is associated with eating wheat, barley and rye, and phase I safety trials are under way in multiple sclerosis, the researchers said. Those trials are conducted by Swiss pharmaceutical company Anokion SA, which helped fund the new work and which Hubbell cofounded and is a consultant, board member, and equity holder. "There are no clinically approved inverse vaccines yet, but we are incredibly excited about moving this technology forward," Hubbell added.

New 'inverse vaccine' shows potential to treat multiple sclerosis, diabetes: Study

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

The Central Drugs Standard Control Organisation's Subject Expert Committee on Wednesday asked the <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> and <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> to submit more data and information to get emergency use authorisation (EUA) for their Covid-19 vaccine candidates. According to the minutes of the meeting, the committee recommended the Serum Institute of India to submit the updated safety data of the Phase 2/3 clinical trials, immunogenicity data from the clinical trial in UK and India, and outcome of the assessment of UK-MHRA for grant of EUA. During the meeting, the SII presented their proposal for grant of EUA of COVISHIELD, along with the interim safety data from Phase 3 clinical trial and interim safety and efficacy results of Phase 2/3 and Phase 3 clinical trials carried out in UK, other countries and India, before the committee. In the case of Bharat Biotech, the firm presented their proposal for grant of EUA, along with the interim safety and immunogenicity data of Phase 1 and 2 clinical trial carried out in the country before the committee. "After detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration," the minutes of the meeting showed. America's Pfizer was the first to apply on December 4, followed by Pune-based SII and Hyderabad-based Bharat Biotech who applied on December 6 and 7, respectively. Pfizer has, however, requested more time to make presentation before the committee. Emergency Use Authorisation is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies. Such an approval was given to Covid-19 drugs - remdesivir and favipiravir in June and itolizumab in July. On Tuesday, the Union Health Ministry informed that as many as eight Covid-19 vaccine candidates are under different stages of clinical trials which could be ready for authorization in near future. Theus includes Astrazeneca and Oxford University developed and Serum Institute of India manufactured Covishield, Covaxin by Bharat Biotech, ZyCoV-D by Zydus Cadila, Russian vaccine candidate Sputnik-V, NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabeled vaccines - the Recombinant Protein Antigen based vaccine by Biological E Ltd, and Inactivated rabies vector platform by Bharat Biotech. SEE ALSO: <a href="https://www.businessinsider.in/careers/news/icertis-helps-google-microsoft-and-apple-manage-their-contracts-is-hiring-for-techies-and-people-in-sales/articleshow/79640659.cms">EXCLUSIVE: This Indian unicorn helping Google, Microsoft and Apple manage their contracts is hiring⁠— it needs techies as well as people in sales</a> <a href="https://www.businessinsider.in/tech/news/what-is-pm-wani-public-wifi-platform-launched-by-union-cabinet/articleshow/79642267.cms">Government’s plan for public Wi-Fi lets anyone from the kirana store owner to tea shop stalls sign up to provide the internet</a> <a href="https://www.businessinsider.in/business/corporates/news/the-33-billion-itc-one-of-indias-most-trolled-stock-in-recent-weeks-seems-to-have-turned-a-corner/articleshow/79641456.cms">The $33 billion ITC, one of India’s most-trolled stock in recent weeks, seems to have turned a corner</a>

COVID-19 vaccine: SII and Bharat Biotech asked to submit more data for emergency approval

<ul class="summary-list"><li>Inovio tumbled nearly 30% on Friday after the company said the government will stop funding a late-stage study of its COVID-19 <keyword id="24209" type="PERSON" weightage="60" keywordseo="vaccine">vaccine</keyword> candidate. </li><li>Inovio said the decision stems from the 'rapid deployment of vaccines' and isn't a reflection on its INO-4800 candidate. </li><li>The biotech firm said it will work with its global partners on the Phase 3 vaccine trial. </li></ul><a href="https://markets.businessinsider.com/stocks/ino-stock">Inovio Pharmaceuticals</a> shares were chopped down by nearly a third on Friday after the US government said it will discontinue funding for a late-phase trial of the company's COVID-19 vaccine candidate. The biotech company said it was informed that it will lose federal financial support for the phase three segment of its Innovate trial for INO-4800. The DNA vaccine candidate is aimed at preventing infection from SARS-CoV-2, the coronavirus behind the COVID-19 disease."The decision results from the changing environment of COVID-19 with the rapid deployment of vaccines," said Inovio in a statement. "This decision is not a reflection of the awardee or product, rather a fast-moving environment associated with the former Operation Warp Speed on decisions related to future products."Shares of the company dropped as much as 29% to $6.49 then slightly pared the loss to 25%. The moves put the stock down by roughly 22% since the start of 2021.The government will complete the funding for the phase 2 trial of INO-4800, the company said, which added that the phase 3 funding decision does not impact its other work with the US government.The US has been ramping up the nationwide rollout of COVID-19 vaccines made by <a href="https://markets.businessinsider.com/stocks/pfe-stock">Pfizer</a> and <a href="https://markets.businessinsider.com/stocks/mrna-stock">Moderna</a>. This week, President Joe Biden said his administration reached its goal of completing 200 million vaccine shots during his first 100 days in office.Inovio will continue working with other global partners on the late-stage study of INO-4800, including Advaccine Biopharmaceuticals, its partner in China.Inovio also said it will keep evaluating its pan-COVID variant vaccine, INO-4802, and assessing boosting capabilities for INO-4800."Inovio remains well-positioned to support both pandemic and endemic vaccine needs with INO-4800 and INO-4802," it said.

You Searched For "sii stops vaccine trials" and got 9 results

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

BI India Bureau

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

PTI

Oxford COVID-19 vaccine human trials to continue in India, says SII

IANS

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

BI India Bureau

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