Best printers for Home

Best Mixer Grinder

Best wired Earphones

Best 43 Inch TV in India

Best Wi Fi Routers

Best Home Theatre in India

Smart Watch under 5000

Best Laptops for Education

Best Laptop for Students

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

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

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

<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="146915" type="COMPANY" weightage="20" keywordseo="Pfizer-India">Pfizer India</keyword> has become the <keyword id="10389973" type="UNKNOWN" weightage="20" keywordseo="first-pharmaceutical-firm">first pharmaceutical firm</keyword> to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain. The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under <keyword id="10188407" type="COMPANY" weightage="20" keywordseo="the-new-drugs-and-clinical-trials-rules">the New Drugs and Clinical Trials Rules</keyword>, 2019, <keyword id="233909" type="POSITION" weightage="20" keywordseo="official-sources">official sources</keyword> said. "Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its COVID-19 vaccine in India," a source said. "The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech's COVID-19 mRNA vaccine BNT162b2 in the country," the source said, citing the application. The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorisation for its emergency use. The British regulator said the jab, which claims to offer up to 95 per cent protection against COVID-19, is safe for roll-out. Bahrain on Friday also announced that it has granted an EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine. The extreme low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said. When contacted, Pfizer said it remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country. "During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval," the global pharma major said in a statement. Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial. Drug firm <keyword id="72130" type="COMPANY" weightage="20" keywordseo="Zydus-Cadila">Zydus Cadila</keyword> has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine. Dr Reddy's Laboratories and <keyword id="9667533" type="COMPANY" weightage="20" keywordseo="the-russian-direct-investment-fund">the Russian Direct Investment Fund</keyword> (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India, Also, Biological E. Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate. 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>

Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

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

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

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

You Searched For "pfizer and serum institute" and got 7 results

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

PTI

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

PTI

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

IANS

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

BI India Bureau

Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

PTI

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

IANS

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

Prabhjote Gill

Popular Keywords

Buying Guides

Cookies on Business Insider India

You Searched For "pfizer and serum institute" and got 7 results

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

PTI

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

PTI

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

IANS

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

BI India Bureau

Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

PTI

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

IANS

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

Prabhjote Gill

Popular Keywords

Buying Guides