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<ul><li>India's expert panel has recommended SII’s Oxford-AstraZeneca COVID-19 vaccine dubbed Covishield in India for emergency use with 'restrictions.'</li><li>The SEC recommendation on Covishield has been forwarded to the Drugs Controller General of India (DCGI), which is likely to take a final call soon.</li><li>The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. </li></ul>An expert panel of India's drug regulator on Friday recommended emergency use approval for Oxford-AstraZeneca vaccine Covishield, being manufactured by the Serum Institute of India, paving the way for the roll-out of the first COVID-19 shot in the country in the next few days.. The SEC recommendation on Covishield has been forwarded to the Drugs Controller General of India (DCGI), which is likely to take a final call soon. The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from SII and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter. While granting the restricted emergency use approval for the Oxford COVID-19 vaccine, the panel imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of 4 to 6 weeks. Further, the SII should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest. Also, the Pune-based firm should submit the safety data including the data on adverse events following immunisation (AEFI) and adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country. The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. The approval comes at a time when the Indian government is wary of the new strain of COVID-19, which has been wreaking havoc in the UK. So far 29 cases of the new mutant variant have been detected in India. As compared to Pfizer and Moderna vaccines, the Oxford-AstraZeneca COVID-19 vaccine is <a href="https://www.businessinsider.in/india/news/india-needs-to-ramp-up-its-cold-storage-facilities-to-accommodate-the-distribution-of-the-covid-19-vaccine-within-the-country/articleshow/79422624.cms">more suited to India’s requirements</a> with storage temperature requirements of between two to eight degrees Celsius. COVID-19 vaccine candidates and the temperatures they need to survive: <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;">Vaccine </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;">Cold chain </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/BioNTech </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;">-70 degrees Celsius </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;">Moderna </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;">-20 degrees Celsius </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;">Oxford/AstraZeneca </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;">2-8 degrees </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;">Johnson and Johnson </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;">2-8 degrees </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;">Novavax </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;">2-8 degrees </td></tr></tbody></table>Source: Respective companies The government is also reportedly in favour of Covishield because it's considerably cheaper than Pfizer and Moderna. According to the SII, the vaccine will only cost the government $3 per dose. Pfizer, on the other hand, is selling its vaccine at $37 per dose. Cost of COVID-19 vaccines: <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;">COVID-19 vaccine candidate </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;">Projected 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;">Covishield </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 </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;">Bharat Biotech </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;">$3-6 </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;">Zydus </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;">$3-6 </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;">Sputnik V </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></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;">$37 </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;"><a href="https://indianexpress.com/article/coronavirus/moderna-covid-19-vaccine-cost-7060816/">Moderna</a> </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;">$25-37 </td></tr></tbody></table> SII CEO Adar Poonawalla <a href="https://www.businessinsider.in/india/news/oxford-covid-19-vaccine-india-approval-likely-to-be-considered-today/articleshow/80025755.cms">told reporters</a> on December 28 that it has 40 to 50 million vaccine doses stockpiled so far, most of which are intended for the Indian market. “We will get some good news this New Year’s… All the data has been submitted and we must respect the process as regulators evaluate data,” he said. The Indian government is also ready to roll out the vaccine having run a <a href="https://www.businessinsider.in/india/news/covid-vaccine-dry-run-prep-up-before-the-actual-vaccine-reaches-you/articleshow/79996397.cms">two-day dry run</a> of its vaccination drive. The mock exercise was aimed at end-to-end testing of Covid-19 vaccination process, including planning and preparations as per the <a href="https://www.businessinsider.in/india/news/covid-19-vaccine-punjab-completes-dry-run-for-vaccination-in-two-districts-amid-concerns-over-new-virus-strain/articleshow/80010928.cms">operational guidelines</a>. SEE ALSO: <a href="https://www.businessinsider.in/science/space/news/isro-chairman-k-sivan-gets-one-year-extension-as-space-secretary/articleshow/80038663.cms">ISRO Chairman K Sivan gets one year extension as Space Secretary</a> <a href="https://www.businessinsider.in/finance/banks/news/cbi-books-hyderabad-based-infra-firm-ivrcl-for-defrauding-eight-public-banks-for-4837-crore/articleshow/80038439.cms" data-type="tilCustomLink">CBI books Hyderabad-based infra firm IVRCL for defrauding eight public banks for ₹4,837 crore</a>

Serum’s Covishield vaccine gets expert panel recommendation, paving the way for first authorized COVID-19 shot in India

Neutralising antibody responses against the SARS-COV-2 virus and its variants of concern (VoC) are higher among <keyword id="9617748" type="General" weightage="80" keywordseo="covishield" source="Orion">Covishield</keyword> recipients than those who took the indigenously made <keyword id="9485939" type="General" weightage="100" keywordseo="covaxin" source="Orion">Covaxin</keyword>, according to a multi-centre study. The yet-to-be peer-reviewed study, posted on the preprint server MedRxiv on Friday, also found that when compared to the pre-vaccination baseline, both vaccines elicited statistically significant antibody levels in both seronegative individuals and seropositive or those who had recovered from COVID-19 infection. Between June 2021 and January 2022, the researchers enrolled 691 participants in the 18-45 age group across four sites in urban and rural Bengaluru and <keyword id="2094" type="General" weightage="50" keywordseo="pune" source="Orion">Pune</keyword>. Participants received either two doses of Covaxin at 28 days apart or two doses of Covishield at three months apart. The <keyword id="1609796" type="General" weightage="50" keywordseo="omicron" source="Orion">Omicron</keyword> wave in early 2022 overlapped with the second dose of vaccine in two sites and with both doses in one site. Participants were sampled at six timepoints for antibody analyses and at four timepoints for cellular analyses. When compared to pre-vaccination baseline, both vaccines elicited statistically significant antibody levels in both seronegative and seropositive individuals, the researchers found. Covishield elicited immune responses of higher magnitude and breadth than Covaxin in both seronegative individuals and seropositive individuals, across cohorts representing the pre-vaccination immune history of the majority of the vaccinated Indian population. Immunologist Vineeta Bal noted that in young adult population there is a difference in the response to COVID vaccines, if individuals are already infected with SARS-CoV-2 and recovered (seropositives) versus not infected. "In seronegatives, two doses of Covishield lead to higher magnitude of antibody levels in higher proportion of vaccine recipients as compared to Covaxin recipients," Bal, from <keyword id="101852" type="General" weightage="50" keywordseo="indian-institute-of-science-education-and-research" source="Orion">Indian Institute of Science Education and Research</keyword> (IISER), Pune and one of the study authors, told PTI. "In terms of waning of immune response with time also Covishield vaccinated individuals retain antibodies in their blood for longer period in larger proportion of individuals,” she said. The study does not directly look for or document protection from COVID-19 in the recipients. "Levels of neutralising antibodies as well as T cell responses, according to different investigators, are indirect indicators of protection,” Bal said. "The interim results so far show that Covishield vaccination induces robust neutralising antibodies against the original SARS-CoV2; Covaxin also does it but somewhat less efficiently,” she added. "Against later variants of the virus such as Delta and Omicron, especially Omicron, neutralising antibodies triggered by Covishield are not as effective, however, they appear marginally better than in Covaxin recipients," Bal added. Prior studies comparing Covishield and Covaxin were limited to addressing only antibody responses and in particular in the health care worker population who were immunised prior to the Delta wave. There is, however, limited data on cellular immune responses elicited by these vaccines and no direct head to-head comparisons or stratification by pre-vaccination serostatus. Vaccination following exposure to the Delta or Omicron variants of SARS-CoV-2 is likely to affect the quality, quantity and duration of immune responses. For determining future COVID-19 vaccination policy when pan-coronavirus or sarbecovirus vaccines become available, it becomes important to take into account pre-vaccination immune history of the majority of the vaccinated Indian population. "Some unpublished work from other investigators in India seems to suggest that heterologous boosting i.e. Covaxin in Covishield recipients and vice versa works better than homologous boosting," Bal added.

Covishield immune responses against Covid variants higher than Covaxin: Study

<ul><li>Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations.</li><li>On September 10, the Serum Institute of India had to pause the Phase II/Phase III human trials of Oxford’s <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> candidate across all 17 locations as a precaution, following a show-cause notice.</li><li>However, the Drugs Controller General of India, on September 15, asked the SII to resume human trials. </li><li>Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites. </li></ul>Serum Institute of India (SII) is likely to begin the <keyword id="9978218" type="UNKNOWN" weightage="20" keywordseo="Phase-III-human-trials">phase III human trials</keyword> of Oxford’s coronavirus vaccine at Sassoon General Hospital in Maharashtra on September 22, Hindustan Times <a href="https://www.hindustantimes.com/india-news/phase-3-human-clinical-trial-of-oxford-vaccine-begins-in-pune/story-mpfvHoWiH4lh3I452On7UP.html">reported. </a> “We have started the phase-III trials of the vaccine (candidate <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>). We will administer dose to 150 to 200 volunteers,” said Dr Muralidhar Tambe, Dean, Sassoon General Hospital. Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations. On September 10, the Serum Institute of India had to pause 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<a href="https://www.businesstoday.in/coronavirus/breaking-covid-19-trials-paused-till-further-instructions-says-serum-institute/story/415686.html">, reported Business Today.</a> SII <a href="https://twitter.com/CNBCTV18Live/status/1303981172200882176">sai</a>d there have been no issues in India, and this is a precautionary measure, and it will restart the trial as soon as AstraZeneca does. AstraZeneca has resumed trials in the UK but not yet in the US. Drugs Controller General of India, on September 15, asked the SII to resume human trials. Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites. SII has signed two agreements for the supply of Covid-19 vaccines, the first being AstraZeneca-Oxford's candidate, for which the company has agreed to produce up to 1 billion doses for low and middle-income countries. SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Earlier, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India. The Serum Institute of India would introduce candidate vaccines from AstraZeneca and Novavax for COVID-19 at less than ₹250 per dose in India. The Pune-based institute <a href="https://www.hindustantimes.com/india-news/serum-institute-ties-up-with-bill-gates-foundation-gavi-to-speed-up-covid-19-vaccine-manufacture-process/story-h20YRO9mdooYA8ysqenE9L.html">partnered with </a>Bill &amp; Melinda Gates Foundation to offer up to 100 million doses, with the price capped at $3 for 92 low and middle-income countries (LMIC), including India. There are at least 30 COVID vaccine candidates in preclinical or clinical stages in India. While three of them are in the advanced stage of Phase I/II/III trials and 4 are in the advanced preclinical development stage, Union Health Minister, Dr Harsh Vardhan, told the Parliament. Vardhan believes India <a href="https://www.businessinsider.in/india/news/covid-vaccine-likely-by-early-2021-for-old-high-risk-first-harsh-vardhan/articleshow/78090587.cms">may</a> get a coronavirus vaccine by early 2021. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/lok-sabha-passes-amendments-to-foreign-contribution-regulation-act-makes-aadhaar-mandatory-for-foreign-contribution-towards-ngos/articleshow/78246944.cms">Lok Sabha passes amendments to Foreign Contribution (Regulation) Act — makes Aadhaar mandatory for foreign contribution towards NGOs</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/bhiwandi-building-collapse-death-toll-rises-to-17-including-eight-children/articleshow/78247063.cms">Bhiwandi building collapse: Death toll rises to 17, including eight children</a>

Oxford’s COVID-19 vaccine: Phase III human trials begin in India

<keyword id="9265079" type="COMPANY" weightage="20" keywordseo="the-serum-institute-of-india">The Serum Institute of India</keyword> on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large, official sources said. A day earlier, the Indian arm of US pharmaceutical giant Pfizer became the first to seek a similar approval from India's drug regulator for its own COVID-19 vaccine in the country, after securing such clearance in the UK and Bahrain. The phase-three clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the Pune-based Serum Institute of India on Sunday (SII), co-sponsored by <keyword id="6364555" type="COMPANY" weightage="20" keywordseo="Indian-Council-of-Medical-Research">Indian Council of Medical Research</keyword> (ICMR), in various parts of the country in addition to clinical studies being carried out by <keyword id="9605255" type="COMPANY" weightage="20" keywordseo="oxford-astrazeneca">Oxford-AstraZeneca</keyword> in the UK and Brazil. Based on phase two and three clinical trial results, the SII with the help of the ICMR will pursue early availability of the vaccine for India, the country's apex health research body had said last month. According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI. Official sources, citing the SII application, said the firm has stated that data from four clinical studies, two in the UK and one each in Brazil and India, shows that Covishield is highly efficacious against symptomatic and most importantly against severe COVID-19 infections. The results are in line with other anti-coronavirus vaccines and because of the huge disease burden, Covishield is predicted to alleviate substantial COVID-19 mortality and morbidity, the firm is learnt to have said. "In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae. "Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield," a source said quoting the application. In order to introduce an urgently needed vaccine against COVID-19 in India, SII, the world's largest vaccine manufacturer, has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine. The SII has also submitted 12 batches of the vaccine to <keyword id="9576145" type="COMPANY" weightage="20" keywordseo="the-central-drugs-laboratory">the Central Drugs Laboratory</keyword> (CDL) in Kasauli for testing, a source said. "In line with our philosophy we assure you that for COVID-19 vaccines also, we are committed to make our country 'aatmanirbhar' (self-reliant) and fulfil our prime minister's clarion call of 'vocal for local' and 'making in India' for the world," stated the application signed by Prakash Kumar Singh, Additional Director, <keyword id="2344259" type="COMPANY" weightage="20" keywordseo="Government-and-Regulatory-Affairs">Government and Regulatory Affairs</keyword> at Serum Institute of India (SII). In view of all these facts and unmet medical needs in the interest of the public at large to save millions of people in the country and across the globe, early availability of a vaccine against COVID-19 is a necessity, it stated. "So, in the national interest, we request you to grant us emergency use authorisation of Covishield based on our application and in view of immediate need for a safe, effective, programmatically suitable and affordable vaccine for our country," the application read. According to sources, this vaccine is logistically feasible for distribution in the country's both urban and rural parts as it can be stored at two to eight degrees Celsius, which is an ideal temperature for being kept in cold storages in the country. As a rapid regulatory response, the DCGI on August 2 had given nod to SII for conducting the combined phase two and three human clinical trials of the Oxford COVID-19 vaccine in the country. PLB BJ NSD NSD NSD

Oxford COVID-19 vaccine: Serum Institute seeks emergency use nod for Covishield vaccine in India

<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

<keyword id="18568" type="COMPANY" weightage="20" keywordseo="kathmandu">Kathmandu</keyword>, Ahead of signing a major Covid <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> deal with <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>, probably on Friday, Nepal's Department of Drug Administration (DDA) has given permission for the <keyword id="9156702" type="UNKNOWN" weightage="20" keywordseo="emergency-use">emergency use</keyword> of India-made coronavirus vaccine Covishield in the country. Nepal's Foreign Minister Pradeep Gyawali is currently in New Delhi to take part in the sixth meeting of Nepal-India Joint Commission. One of the major agreements that both sides are likely to ink is on cooperation in Covid vaccine manufactured in India. The vaccine, developed by the <keyword id="30725" type="COMPANY" weightage="20" keywordseo="Oxford-university">Oxford University</keyword> and Astra-Zeneca and produced by the <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword>, has been given conditional permission for emergency use, the department said. The DDA had two days ago called for the registration of vaccines to be used for emergency use. This is the first time that any Covid-19 vaccine has been approved for use in Nepal. Other manufacturing countries like China and Russia were also interested in providing vaccines to Nepal but due to climatic conditions, pricing, logistic facility and ease of import, Nepal preferred the Indian Covid vaccine. India has already permitted the use of Covishield as well as Covaxin of <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>. SEE ALSO: <a href="https://www.businessinsider.in/defense/news/these-amazing-facts-about-the-indian-army-will-make-you-beam-with-pride/slidelist/80270052.cms">Army Day 2021: These amazing facts about the Indian Army will make you beam with pride</a> <a href="https://www.businessinsider.in/business/corporates/news/hcl-tech-clocks-in-nearly-27-jump-in-profit-crosses-the-10-billion-revenue-in-third-quarter-of-year-2020-21/articleshow/80278852.cms">HCL Tech clocks in nearly 27% jump in profit, crosses the $10 billion revenue milestone with one more quarter left</a> <a href="https://www.businessinsider.in/india/news/india-will-begin-its-covid-19-vaccination-drive-tomorrow-heres-everything-you-need-to-know/articleshow/80281740.cms">India will begin its COVID-19 vaccination drive tomorrow — here’s a look at how the world’s largest vaccine rollout is set to take place</a>

You Searched For "Covishield coronavirus vaccine" and got 6 results

Serum’s Covishield vaccine gets expert panel recommendation, paving the way for first authorized COVID-19 shot in India

BI India Bureau

Covishield immune responses against Covid variants higher than Covaxin: Study

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Oxford’s COVID-19 vaccine: Phase III human trials begin in India

BI India Bureau

Oxford COVID-19 vaccine: Serum Institute seeks emergency use nod for Covishield vaccine in India

PTI

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

BI India Bureau

Nepal approves Covishield vaccine for emergency use

IANS

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