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After <keyword id="10394836" type="COMPANY" weightage="20" keywordseo="pfizer-and-serum-institute">Pfizer and Serum Institute</keyword>, Hyderabad-based <keyword id="10395449" type="UNKNOWN" weightage="20" keywordseo="pharmaceutical-firm-bharat-biotech">pharmaceutical firm Bharat Biotech</keyword> on Monday applied to the central drug regulator seeking emergency use authorisation for its <keyword id="9624640" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine-covaxin">COVID-19 vaccine Covaxin</keyword>, official sources said. Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The Hyderabad-based firm is conducting <keyword id="9510106" type="UNKNOWN" weightage="20" keywordseo="phase-3-clinical-trial">phase-3 clinical trial</keyword> of its vaccine in around 25 places, including Delhi, Mumbai, Patna and Lucknow. The firm, while applying for the phase-3 trial, had stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported. The most common adverse event was transient pain at the injection site, a source said. The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials. An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of <keyword id="10313366" type="COMPANY" weightage="20" keywordseo="pfizer-serum-institute-of-india">Pfizer, Serum Institute of India</keyword> and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates. 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. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. The Serum Institute sought the 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. PLB SMN SMN

Bharat Biotech applies for emergency use approval for its COVID-19 vaccine Covaxin

<ul><li>SII chairperson Cyrus Poonawalla emphasised that a third booster shot of <keyword id="8904563" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine">COVID-19 vaccine</keyword> is a “must” for people with weak immune systems.</li><li>The US government last week approved the third dose of Pfizer-BioNTech and Moderna COVID-19 vaccines for people with weakened immune systems.</li><li>Meanwhile, <keyword id="6366244" type="UNKNOWN" weightage="20" keywordseo="who">WHO</keyword> and SII have confirmed the existence of fake Covishield vials in India and Africa.</li></ul><keyword id="242973" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute">Serum Institute</keyword> of Indi's (SII) chairperson Cyrus Poonawalla has said that a third shot or a ‘booster dose’ of COVID-19 vaccine is desirable six months after taking the second dose of the vaccine. This is especially a “must” for those with weak immune systems, news agency PTI reported. SII makes India's primary COVID-19 vaccine, locally known as Covishield. Poonawalla also revealed that he, along with 7,000 employees of SII, have already taken the third dose of the COVID-19 vaccine as a precautionary measure. “After six months, the antibodies go down and that is why I have taken the third dose. We have given the third dose to our seven to eight thousand SII employees. For those who have completed the second dose, it is my request to take a booster dose (third dose) after six months,” Poonawalla said. This development comes a week after the government of the United States (US) <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/who-is-eligible-third-covid-19-vaccine-dose-us-2021-08-15/">approved</a> the third/booster shot of Pfizer-BioNTech and Moderna vaccines for people with weakened immune systems. Now, Pfizer and BioNTech have also <a href="https://www.cnbc.com/2021/08/16/covid-vaccine-booster-shot-pfizer-submits-data-to-fda-for-approval.html">submitted</a> preliminary clinical data — evaluating the safety and efficacy of a third shot — to US health authorities to seek authorisation for a third dose of COVID-19 vaccine for all Americans and not just the ones with weakened immune systems. "The data we've seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule,'' Albert Bourla, Pfizer’s chairperson and chief executive officer, said in a statement. The menace of fake vaccine vials continues Another major issue that has been surrounding the Indian vaccination drive has been the administration or availability of fake COVID-19 vaccines in India. The <keyword id="6356311" type="UNKNOWN" weightage="20" keywordseo="World-Health-Organisation">World Health Organisation</keyword> (WHO) has <a href="https://www.bbc.com/news/world-asia-india-58253488">identified</a> counterfeit versions of Covishield in India and Africa. As per the BBC report, the doses were seized by authorities in India and Africa between July and August. Even vaccine maker <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> has confirmed, to WHO, that the vaccine was fake. Multiple media reports, published in the past months, have also highlighted the existence of a vaccine scam in India under which victims were given saline water in lieu of the COVID-19 vaccine. Health minister of Maharashtra Rajesh Tope also <a href="https://www.indiatoday.in/cities/mumbai/story/mumbai-covid-vaccination-scam-victims-given-saline-water-antibody-test-first-week-july-1820847-2021-06-29">confirmed</a> the scam, and ensured that the victims would undergo antibody tests and will be administered with two doses of Covishield vaccine. Covishield is the local name of Oxford-AstraZeneca's COVID-19 vaccine and has been administered to more than 48.6 crore Indians, as per government data, as of August 17, 2021. SEE ALSO <a href="https://www.businessinsider.in/retail/news/a-third-of-internet-users-would-be-actively-shopping-online-by-the-end-of-this-decade-offline-retail-to-take-a-back-seat/articleshow/85390712.cms">A third of internet users would be actively shopping online by the end of this decade, offline retail to take a back seat</a> <a href="https://www.businessinsider.in/business/startups/news/with-pharmeasy-mobikwik-and-ixigo-all-set-to-hit-the-public-market-orios-plans-to-go-deeper-into-pre-ipo-bets/articleshow/85359703.cms">With PharmEasy, MobiKwik and ixigo all set to hit the public market, Orios plans to go deeper into pre-IPO bets</a> <a href="https://www.businessinsider.in/business/auto/news/tamil-nadu-government-is-upset-about-losing-money-on-luxury-cars/articleshow/85322536.cms">Tamil Nadu government is upset about losing money on luxury cars</a>

WHO confirms existence of fake Covishield vaccines in India; Serum Institute pushes for a booster shot

<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

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

Geneva, The <keyword id="43588" type="COMPANY" weightage="20" keywordseo="World-Health-Organization">World Health Organization</keyword> (WHO) has listed two versions of the AstraZeneca/Oxford Covid-19 vaccine for emergency use including the one produced by the <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword>. The other version is produced by AstraZeneca-SKBio (<keyword id="105814" type="LOCATION" weightage="20" keywordseo="Republic-of-Korea">Republic of Korea</keyword>), the WHO said on Monday. The approval of these vaccines means giving the green light for them to be rolled out globally through COVAX. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines. "Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility's goal of equitable vaccine distribution," Mariangela Simao, WHO Assistant-Director General for Access to Medicines and Health Products, said in a statement. 'But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do that, we need two things -- a scale-up of manufacturing capacity, and developers' early submission of their vaccines for WHO review." In the case of the two AstraZeneca/Oxford vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements. The process took under four weeks. The AstraZeneca/Oxford product is a viral vectored vaccine called ChAdOx1-S (recombinant). It is being produced at several manufacturing sites, as well as in the Republic of Korea and India. ChAdOx1-S has been found to have 63.09 per cent efficacy and is suitable for low- and middle-income countries due to easy storage requirements. The WHO earlier approved the Pfizer-BioNTech Covid-19 vaccine for emergency use. --IANS gb/in

WHO approves AstraZeneca-Oxford's COVID-19 vaccines for emergency use

<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

New Delhi, Hyderabad-based <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> will make a presentation before the <keyword id="3923779" type="COMPANY" weightage="20" keywordseo="subject-expert-committee">Subject Expert Committee</keyword> of the Central Drug Standard Control Organisation (CDSCO) on Wednesday evening for approval of its <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> - Covaxin, government sources. Earlier on Wednesday, the <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII)'s application for emergency use authorisation of its Covid-19 vaccine was also considered by the Subject Expert Committee. The development came hours after the United Kingdom accepted the recommendation of the Medicines and Healthcare Regulatory Agency (MHRA) to authorise the Oxford University-AstraZeneca's Covid-19 vaccine, <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>, for emergency approval use. The authorisation was significant for India as the Pune-based Serum Institute of India had tied up with Oxford University-AstraZeneca to manufacture the vaccine in India. America's Pfizer was the first to apply on December 4, followed by Serum Institute of India and Bharat Biotech, who applied on December 6 and 7, respectively. Pfizer has, however, requested more time to make its presentation before the committee. On December 9, the Subject Expert Committee had, however, asked Serum Institute of India and Bharat Biotech to submit more data and information to get emergency use approval (EUA) for their vaccine candidates. The expert panel had then asked SII to submit the outcome of the assessment of UK-MHRA for grant of emergency use approval, the updated safety data of the Phase-II/III clinical trials and immunogenecity data from the clinical trial in the UK and India. Bharat Biotech was recommended to present the safety and efficacy data from the ongoing Phase-III clinical trial in the country for further consideration. Both the firms had again submitted their applications last week seeking approval of the vaccine. The Central government plans to vaccinate nearly 30 crore <keyword id="6360040" type="UNKNOWN" weightage="20" keywordseo="people">people</keyword> in the first phase of the vaccine drive. It would be offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly people, mostly above 50 years with comorbidities. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-sbi-hdfc-bank-wipro-ril-future-retail-tcs-jindal-stainless-upl-irctc-and-others/articleshow/80019871.cms">Top stocks to watch — SBI, HDFC Bank, Wipro, RIL, Future Retail, TCS, Jindal Stainless, UPL, IRCTC, and others</a> <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 UK COVID-19 strain, putting the tally at 20India detects 14 new cases of UK COVID-19 strain, putting the tally at 20</a> <a href="https://www.businessinsider.in/business/startups/news/2021-could-finally-be-the-year-of-indias-tech-ipos-as-startups-like-zomato-delhivery-policybazaar-head-for-the-public-markets/slidelist/80019978.cms">2021 could finally be the year of India’s tech IPOs as startups like Zomato, Delhivery, Policybazaar head for the public markets</a>

After SII's Covishield, Bharat Biotech plans to put its COVID-19 vaccine for approval before expert panel

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>

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

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>

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Bharat Biotech applies for emergency use approval for its COVID-19 vaccine Covaxin

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

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WHO approves AstraZeneca-Oxford's COVID-19 vaccines for emergency use

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

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After SII's Covishield, Bharat Biotech plans to put its COVID-19 vaccine for approval before expert panel

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

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

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