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<ul><li>DCGI has approved market authorisation for the COVID-19 vaccine <keyword id="10678894" type="General" weightage="100" keywordseo="covovax" source="Orion">Covovax</keyword> as a heterologous booster dose for adults.</li><li>The DCGI's approval came following recommendations by the <keyword id="3923779" type="General" weightage="50" keywordseo="subject-expert-committee" source="Orion">Subject Expert Committee</keyword> of the Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="50" keywordseo="cdsco" source="Orion">CDSCO</keyword>).</li></ul>The <keyword id="6386816" type="General" weightage="50" keywordseo="drug-controller-general-of-india" source="Orion">Drug Controller General of India</keyword> (DCGI ) has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of <keyword id="9617748" type="General" weightage="50" keywordseo="covishield" source="Orion">Covishield</keyword> or <keyword id="9485939" type="General" weightage="50" keywordseo="covaxin" source="Orion">Covaxin</keyword>, official sources said on Monday. The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO). Prakash Kumar Singh, Director of Government and Regulatory Affairs at the <keyword id="95879" type="General" weightage="50" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword> (<keyword id="52604" type="General" weightage="80" keywordseo="sii" source="Orion">SII</keyword>), had recently written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating COVID-19 pandemic situation in some countries, an official source had said. "The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin," an official source said. The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and in children aged 7- 11 years on June 28 last year subject to certain conditions. Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation. It was granted emergency-use listing by the <keyword id="43588" type="General" weightage="50" keywordseo="world-health-organization" source="Orion">World Health Organization</keyword> (WHO) on December 17, 2021. In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in <keyword id="3658" type="General" weightage="50" keywordseo="india" source="Orion">India</keyword> and low-and-middle-income countries. SEE ALSO: <a href="https://www.businessinsider.in/tech/news/amazon-great-republic-day-sale-2023-best-deals-and-offers-on-tvs/articleshow/96987966.cms">Amazon Great Republic Day Sale 2023 – Best deals and offers on TVs</a> <a href="https://www.businessinsider.in/tech/apps/news/these-audio-setting-tweaks-can-make-music-sound-better-on-spotify/articleshow/96876010.cms">These audio setting tweaks can make music sound better on Spotify</a>

Serum Institute's Covovax gets DCGI approval as a heterologous booster dose

As of now as many as 110 countries have recognized India's Covid vaccines -- <keyword id="9617748" type="General" weightage="20" keywordseo="Covishield" source="Orion">Covishield</keyword> and <keyword id="9485939" type="General" weightage="20" keywordseo="Covaxin" source="Orion">Covaxin</keyword> -- and have agreed to mutual recognition of Covid-19 vaccination certificates with India, said official sources in the Union Health Ministry. A source with the Ministry said that at present, 110 countries have agreed to mutual recognition of vaccination certificates and those who recognise Indian vaccination certificates of travellers fully vaccinated with Covishield or World Health Organisation(WHO)-approved Covid vaccines. As per the new travel guidelines issued by the Union Health Ministry, if a fully vaccinated traveller is coming from a country with which India has reciprocal arrangements for mutual acceptance of WHO-approved Covid-19 vaccines, they will be allowed to leave the airport and must self-monitor their health for 14 days' post arrival. If partially or not vaccinated travellers visit India, they will have to submit their sample for post-arrival Covid-19 test at the point of arrival after which they will be allowed to leave the airport. They will have to be undergo home quarantine for seven days and undertake re-test on the eighth day of arrival in India and if found negative, further self-monitor their health for next seven days. "Travellers artiving from countries excluding those at risk, will be allowed to leave the airport and must self-monitor their health for 14 days' post arrival. This is applicable to travellers from all countries, including with which reciprocal arrangements for mutual acceptance of WHO-approved Covid-19 vaccines also exist," said the new international arrival guidelines. Of eight WHO-approved vaccines against Covid-19 in emergency use listing, two vaccines -- Covaxin and Covishield -- are from India. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/indias-covaxin-77-8-effective-for-covid-19-says-lancet-report/articleshow/87661300.cms">India's Covaxin 77.8% effective for COVID-19, says Lancet Report</a> <a href="https://www.businessinsider.in/science/health/news/ideal-time-for-booster-dose-for-covid-19-vaccine-is-6-months-after-second-dose-says-bharat-biotech-md/articleshow/87629337.cms">Ideal time for COVID-19 booster shot is six months after the second dose, says Bharat Biotech MD</a>

Covishield and Covaxin are now recognized by 110 countries

<ul><li>The UK is the first country to approve the Oxford-AstraZeneca COVID-19 vaccine for active immunisation. </li><li>The country has ordered 100 million doses of the vaccine and the vaccine is likely to start rolling out by January 4. </li><li>However, European watchdog has warned that there isn’t enough data to be giving the Oxford vaccine approval just yet. </li></ul>The Oxford-AstraZeneca COVID-19 vaccine — also called the ‘jab’ — has been approved for mass vaccination in the UK. The country has already ordered 100 million doses of the vaccine, which are expected to start rolling out the vaccine from January 4. "The government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca's COVID-19 vaccine for use," said the Health and Social Care department spokesperson. MHRA’s authorisation for the emergency supply of Oxford covid vaccine is aimed at the active immunisation of individuals 18 years or older, according to AstraZeneca. What does this mean for India? This could spell good news for India, who has been keeping its eye on the UK, with its own approval of the vaccine is pending. As compared to the Pfizer and Moderna COVID-19 vaccines, the Oxford-AstraZeneca vaccine is more suited to India’s cold storage infrastructure. <table style="border-width: initial; border-style: none; width: 468pt; table-layout: fixed;"></colgroup><tbody><tr><td colspan="2" 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 candidates and the temperatures they need to survive: </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;">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 Serum Institute of India (SII) is hopeful that the India variant, called COVISHIELD, will receive the required regulatory approval in ‘few days.’ "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," said Serum Institute CEO Adar Poonawalla during a press conference on Monday. However, officials at the European Medicines Agency (<a href="https://www.businessinsider.in/science/health/news/oxford-astrazeneca-covid-19-vaccine-approval-is-unthinkable-claims-european-watchdog/articleshow/80022921.cms">EMA</a>) have warned that giving the vaccine approval at this stage is ‘unthinkable’. "The data we have at the moment is not even enough to give the AstraZeneca vaccine a conditional authorisation," they told Belgian newspaper het Nieuwsblad. "We need additional data about the quality of the vaccine. And after that, the company has to formally apply.” As of now, AstraZeneca recommends two doses administered with a gap of between four to 12 weeks. 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>

UK approves Oxford-AstraZeneca COVID-19 vaccine

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

Nepal approves Covishield vaccine for emergency use

India's drug regulator has given approval for a study to be conducted by the <keyword id="93589" type="ORGANIZATION" weightage="20" keywordseo="Christian-Medical-College">Christian Medical College</keyword> (CMC), Vellore on mixing of COVID-19 vaccines <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> and Covishield, official sources said on Wednesday. An expert panel of the <keyword id="170943" type="ORGANIZATION" weightage="20" keywordseo="Central-Drugs-Standard-Control-Organisation">Central Drugs Standard Control Organisation</keyword> (CDSCO) on July 29 had recommended granting permission for conducting the study. The trial will involve 300 healthy volunteers. "The aim of the study is to assess the feasibility on whether a person can be given two different vaccine shots -- one each of Covishield and Covaxin -- to complete the inoculation course," a source said. Separately, a recent study by the Indian Council of Medical Research (ICMR) involving 98 people, 18 of whom had inadvertently received Covishield as the first dose and Covaxin as the second in <keyword id="413944" type="PERSON" weightage="20" keywordseo="uttar">Uttar</keyword> Pradesh, showed that combining these two COVID-19 vaccines elicited better immunogenicity than two doses of the same vaccine. The study also found that immunisation with combination of Covishield and Covaxin was safe and the adverse effects were also found to be similar when compared to the same dose regimen. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/mobile/news/xiaomi-launches-mi-mix-4-its-first-under-display-camera-phone/articleshow/85231596.cms">Xiaomi debuts its first under-display camera on the Mi Mix 4</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/mobile/news/oneplus-teases-a-foldable-phone-announcement-clashing-with-samsungs-unpacked-event/articleshow/85233365.cms">OnePlus teases a foldable phone announcement clashing with Samsung’s Unpacked event</a>

DCGI approves study on mixing of Covaxin and Covishield  COVID-19 doses, say sources

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

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="242973" type="General" weightage="20" keywordseo="serum-institute" source="Orion">Serum Institute</keyword> of India (SII) plans to launch a COVID vaccine for children in the next six months, the company's CEO <keyword id="383467" type="General" weightage="20" keywordseo="adar-poonawalla" source="Orion">Adar Poonawalla</keyword> said on Tuesday. Participating in an industry conference, Poonawalla said the vaccine '<keyword id="10678894" type="General" weightage="20" keywordseo="covovax" source="Orion">Covovax</keyword>' is under trial and would offer protection to children all the way down till three years. Currently, <keyword id="9617748" type="General" weightage="20" keywordseo="covishield" source="Orion">Covishield</keyword> and other COVID vaccines are approved for people above the age of 18 years. "We haven't seen a lot of severe disease in children. Fortunately, the panic is not there for children. However, we will be launching a vaccine in six months for children, hopefully down to the age of three," Poonawalla said. He noted that already there are two companies in India who are licensed and their vaccines will be available soon. "I think yes, you should take and get your children vaccinated. There is no harm, these vaccines have been proven to be safe and efficacious and all of that. If you feel you want to get your children vaccinated by all means wait for government announcements on that and you go ahead with that. "Our vaccine Covovax will be launched for children in six months," Poonawalla said, adding that Covovax is under trial and has shown excellent data all the way down to the age group of three years. Further, Poonawalla said there was enough data to show that the vaccines will work and protect the children against the infectious disease. He pointed out that so far nothing can be said about the <keyword id="1609796" type="General" weightage="50" keywordseo="omicron" source="Orion">Omicron</keyword> variant as to how it would impact the children. "I don't know what will happen with Omicron but so far the children have not been affected very badly with this (COVID) virus. I think their body, cells and their lungs recover better," he said. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/delhi-reports-four-new-cases-of-omicron-covid-19-variant-says-health-minister/articleshow/88274332.cms">Delhi reports four new cases of Omicron COVID-19 variant, says Health Minister</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/international/news/china-reports-first-case-of-omicron-variant-in-the-port-city-of-tianjin-say-media-reports/articleshow/88273319.cms">China reports first case of Omicron variant in the port city of Tianjin, say media reports</a>

Serum Institute to roll out COVID-19 vaccine for children in six months, says CEO Adar Poonawalla

<keyword id="95879" type="General" weightage="50" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword>'s Chief Executive Officer <keyword id="383467" type="General" weightage="50" keywordseo="adar-poonawalla" source="Orion">Adar Poonawalla</keyword> has said their <keyword id="10678894" type="General" weightage="100" keywordseo="covovax" source="Orion">Covovax</keyword> vaccine will get approval as a booster against COVID-19 in the next 10 to 15 days. The vaccine works very well against the <keyword id="1609796" type="General" weightage="50" keywordseo="omicron" source="Orion">Omicron</keyword> variant of coronavirus, <keyword id="25607" type="General" weightage="80" keywordseo="poonawalla" source="Orion">Poonawalla</keyword> told reporters on the sidelines of an event at the Bharti Vidyapeeth University here on Sunday. Asked about states and districts not getting Covishield vaccine, he said there is ample stock with the Union government for supply. "Covovax will be approved as a booster in the next 10-15 days. It is actually the best booster because it works very well against Omicron, more than Covishield," he said. Poonawalla said everyone was looking at India, not just in terms of healthcare but because the country managed to take care of a huge and diverse population and also helped 70 to 80 nations during the COVID-19 pandemic. "This was all possible because of the leadership of our central government, our state governments, healthcare workers, manufacturers, all of whom worked together with one common goal," he said. On the occasion, Poonawalla was conferred with the first Dr Pantangrao Kadam Memorial Award at the hands of Nationalist Congress Party (NCP) chief Sharad Pawar and Maharashtra Deputy Chief Minister Devendra Fadnavis. The event was held to mark the birth anniversary of Kadam, the late minister and education baron from western Maharashtra. Appealing to students who wished to pursue education abroad, Poonawalla said there was no place like India to fulfil dreams due to the presence of institutions like Bharti Vidyapeeth and others. "Even if you have to go abroad, come back as soon as possible," he said. SEE ALSO: <a href="https://www.businessinsider.in/thelife/personalities/news/gautam-adani-aap-ki-adalat-interview-dhirubhai-ambani-is-my-role-model-mukesh-ambani-a-very-good-friend/articleshow/96828407.cms">Dhirubhai Ambani is my role model and Mukesh Ambani a very good friend, says Gautam Adani</a> <a href="https://www.businessinsider.in/tech/news/online-mental-health-company-uses-chatgpt-to-help-respond-to-users-in-experiment-raising-ethical-concerns-around-healthcare-and-ai-technology/articleshow/96821802.cms">Online mental health company uses ChatGPT to help respond to users in experiment — raising ethical concerns around healthcare and AI technology</a>

You Searched For "covishield approval" and got 10 results

Serum Institute's Covovax gets DCGI approval as a heterologous booster dose

PTI

Covishield and Covaxin are now recognized by 110 countries

IANS

UK approves Oxford-AstraZeneca COVID-19 vaccine

Prabhjote Gill

Nepal approves Covishield vaccine for emergency use

IANS

DCGI approves study on mixing of Covaxin and Covishield COVID-19 doses, say sources

PTI

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

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

Serum Institute to roll out COVID-19 vaccine for children in six months, says CEO Adar Poonawalla

PTI

Covovax vaccine to get approval as a booster in 10-15 days: Adar Poonawalla

PTI

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