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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

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

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

An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of <keyword id="44612" type="COMPANY" weightage="20" keywordseo="Pfizer">Pfizer</keyword>, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> candidates, official sources said on Monday night. The decision was taken late on Monday evening after the Hyderabad-based Bharat Biotech became the <keyword id="10394896" type="UNKNOWN" weightage="20" keywordseo="third-pharmaceutical-firm">third pharmaceutical firm</keyword> to apply to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously developed COVID-19 vaccine <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword>. The Indian arm of US pharmaceutical giant Pfizer had on December 4 sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. The Pune-based Serum Institute of India sought such a nod for the Oxford COVID-19 vaccine, <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>, on December 6. "DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said. At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/oxford-covid-19-vaccine-serum-institute-seeks-emergency-use-nod-for-covishield-vaccine-in-india/articleshow/79600349.cms" data-type="tilCustomLink">Oxford COVID-19 vaccine: Serum Institute seeks emergency use nod for Covishield vaccine in India</a> <a href="https://www.businessinsider.in/india/news/section-144-extended-across-noida-and-greater-noida-till-january-2/articleshow/79600323.cms" data-type="tilCustomLink">Section 144 extended across Noida and Greater Noida till January 2</a>

COVID-19 vaccine in India: Expert panel to review Pfizer, Serum and Bharat Biotech's emergency use application tomorrow

<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

As the country awaits the UK's approval to the AstraZeneca-Oxford vaccine before giving nod for Emergency Use Authorisation to its Indian counterpart developed by Pune-based <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII), a top European drug official has claimed that the vaccine is not even ready for a conditional approval at the moment. Noel Wathion, number two at the European Medicines Agency, told Belgian newspaper Het Nieuwsblad on Tuesday that the approval for AstraZeneca-Oxford vaccine is still "unthinkable" and Europe is not going to approve the vaccine with "winning formula" for the time being. "They haven't even submitted an application to us yet," Wathion was quoted as saying in the report. The UK aims to start rolling out the British AstraZeneca/Oxford vaccine from January 4. According to Wathion, "The data we have at the moment is not even enough to give the AstraZeneca vaccine a conditional authorisation". "We need additional data about the quality of the vaccine. And after that, the company has to formally apply," Wathion added. Pune-based Serum Institute of India on Monday expressed hope at the possibility of its vaccine called Covishield receiving the regulatory approval in "few days", while emphasising that the company has a massive stockpile of 40-50 million doses. "We have 40-50 million doses of Covishield stockpiled. Once we get regulatory approvals in a few days, it will be down to the government to decide how much they can take and how fast. We will be producing around 300 million doses by July 2021," Serum Institute CEO Adar Poonawalla said during a press conference. India currently has eight Covid-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials which could be ready for authorisation in near future. Serum Institute-Oxford's Covishield, Bharat Biotech's Covaxin and Pfizer vaccine are in the fray for emergency use authorisation. 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 comorbidities. Two days of dry run for the vaccination process was also successfully carried out in four states. SEE ALSO: <a href="https://www.businessinsider.in/india/news/india-detects-14-new-cases-of-uk-covid-19-strain-putting-the-tally-at-20/articleshow/80020163.cms">India detects 14 new cases of mutated COVID-19 strain in UK returnees, putting the tally at 20</a> <a href="https://www.businessinsider.in/business/corporates/news/three-anil-ambani-companies-accused-of-fraud-ten-times-more-than-vijay-mallya/articleshow/80002892.cms">Three Anil Ambani companies have reportedly been accused of fraud by banks⁠ — the amount at stake is nearly ten times more than what Mallya owed</a> <a href="https://www.businessinsider.in/india/news/new-strain-of-uk-covid-19-virus-is-a-lot-more-contagious-warns-indias-health-ministry/articleshow/80011618.cms">The new strain of COVID-19 is a lot more contagious, warns India's Health Ministry</a>

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

BI India Bureau

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

PTI

COVID-19 vaccine in India: Expert panel to review Pfizer, Serum and Bharat Biotech's emergency use application tomorrow

PTI

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-AstraZeneca COVID-19 vaccine approval is 'unthinkable', claims European watchdog

IANS

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