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The Drugs Controller General of <keyword id="3658" type="General" weightage="50" keywordseo="india" source="Orion">India</keyword> (DCGI) on Tuesday approved the restricted emergency use authorisation (EUA) to Bharat Biotech's Covaxin for children between the age of 6-12 years, sources said. The <keyword id="704367" type="General" weightage="50" keywordseo="dgci" source="Orion">DGCI</keyword> has asked vaccine manufacturer to submit safety data including the data on adverse event with due analysis every 15 days for the first two months and monthly thereafter upto 5 months, said the source familiar with the development. This development comes after the <keyword id="3923779" type="General" weightage="50" keywordseo="subject-expert-committee" source="Orion">Subject Expert Committee</keyword> (<keyword id="6362470" type="General" weightage="80" keywordseo="sec" source="Orion">SEC</keyword>) discussed recommendations for the restricted emergency use of Covaxin in children aged between 2-12 years. However, the SEC, after a meeting on Thursday, had recommended restricted emergency use of Biological E's Covid-19 vaccine, Corbevax, in children aged 5-12 years. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/politics/india/news/real-time-payments-are-forecast-to-boost-indian-gdp-by-us-45-9-billion-in-2026/articleshow/91093163.cms">Real-time payments are forecast to boost Indian GDP by US $45.9 billion in 2026</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/25-40-of-people-with-covid-19-develop-long-covid-reporting-symptoms-that-affect-multiple-organs-and-cause-mental-health-issues-study/articleshow/91093962.cms">25-40% of people with COVID-19 develop long Covid, reporting symptoms that affect organs and cause mental health issues : Study</a>

DCGI gives nod to Bharat Biotech's Covaxin for 6-12 age group 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

<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

<keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s COVID-19 vaccine <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword> was on Tuesday recommended by an expert panel for <keyword id="6393270" type="UNKNOWN" weightage="20" keywordseo="phase">phase</keyword> II/III <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> on those aged between two to 18 years, official sources said. The trial will take place in 525 subjects at various sites, including <keyword id="40458" type="COMPANY" weightage="20" keywordseo="AIIMS">AIIMS</keyword>, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur. The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (<keyword id="6375144" type="COMPANY" weightage="20" keywordseo="cdsco">CDSCO</keyword>) on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years. "After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source said. Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol. Covaxin, indigenously developed by Bharat Biotech in collaboration with the <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>n Council of Medical Research (ICMR), is being used in adults in India's ongoing COVID-19 vaccination drive. SEE ALSO: <a href="https://www.businessinsider.in/tech/apps/news/whatsapp-responds-to-privacy-criticism-by-alleging-other-apps-like-zomato-ola-aarogya-setu-zoom-google-and-other-apps/articleshow/82570897.cms">WhatsApp responds to privacy criticism by alleging that other apps and tech companies also show disdain for user privacy</a> <a href="https://www.businessinsider.in/business/telecom/news/vodafone-idea-adds-subscribers-for-the-first-time-in-15-months/articleshow/82568343.cms">Vodafone Idea shares up by 10% as it adds subscribers for the first time in 15 months – Airtel, Reliance Jio expand their user base</a>

Bharat Biotech's COVAXIN reportedly recommended by expert panel for phase 2 and 3 clinical trials on 2-18 year-olds

The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation's (CDSCO) Subject Expert Committee and their next meeting will be held on January 1. The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII and Bharat Biotech Private Ltd. Further time was requested on behalf of Pfizer, while the additional data and information presented by the SII and Bharat Biotech was perused and analysed by the SEC. "The analysis of the additional data and information is going on. SEC will convene again on 1st January 2021 (Friday)," the Centre said in a statement. America's Pfizer was the first one to apply for the accelarated approval on December 4, followed by the SII and Bharat Biotech who applied on December 6 and 7, respectively. On December 9, the Subject Expert Committee had asked the SII and Bharat Biotech to submit more data and information to get approval. The expert panel had then recommended the SII to submit outcome of the assessment of UK regulatoe for grant of emergency use approval, the updated safety data of the Phase 2/3 clinical trial and immunogenicity data from the clinical trials in UK and India. Bharat Biotech was recommended to present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration. Their applications were reviewed again earlier on Wednesday, hours after the UK accepted the recommendation of the Medicines and Healthcare Regulatory Agency (MHRA) to authorise Oxford University-AstraZeneca's Covid-19 vaccine, named Covishield, for emergency use. The authorization was significant for India as the Pune-based SII had tied up with the company to conduct clinical trials and manufacture the vaccine. Besides, Bharat Biotech is developing country's indigenous coronavirus vaccine - Covaxin - in collaboration with the Indian Council of Medical Research. 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 co-morbidities. Covishield uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the coronavirus if it later infects the body. The vaccine can be stored, transported and handled at normal refrigerated conditions at two to eight degrees Celsius for at least six months and administered within existing healthcare settings. Its interim analysis for efficacy showed that the vaccine was 70.4 per cent effective at preventing symptomatic COVID-19 occurring more than 14 days after receiving two doses of the vaccine. The SII has already made 40 to 50 million doses of the shot. "We have 40-50 million doses of Covishield stockpiled. We will be producing around 300 million doses by July 2021," its CEO Adar Poonawalla had recently said. Besides this, Bharat Biotech's Covaxin is India's indigenous vaccine and is being developed in collaboration with the ICMR's National Institute of Virology. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility SEE ALSO: <a href="https://www.businessinsider.in/personal-finance/income-tax/news/income-tax-returns-filing-deadline-extended-to-january-10/articleshow/80029154.cms">Relief for taxpayers: Deadline to file income tax returns extended further to January 10</a> <a href="https://www.businessinsider.in/science/health/news/uk-approves-oxford-astrazeneca-covid-19-vaccine-for-emergency-use/articleshow/80023778.cms">UK approves Oxford-AstraZeneca COVID-19 vaccine</a> <a href="https://www.businessinsider.in/tech/apps/news/google-is-testing-a-shortcut-feature-for-tiktok-and-instagram-videos/articleshow/80021865.cms">Google is testing a shortcut feature for TikTok and Instagram videos</a>.

India continues to mull over SII and Bharat Biotech's COVID-19 vaccine candidates

The <keyword id="83655" type="General" weightage="50" keywordseo="union-health-ministry" source="Orion">Union Health Ministry</keyword> on Thursday rejected media reports that <keyword id="9485939" type="General" weightage="100" keywordseo="covaxin" source="Orion">Covaxin</keyword> manufacturer <keyword id="149108" type="General" weightage="80" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword> skipped certain processes and accelerated clinical trials due to political pressure, calling them "completely misleading, fallacious and ill-informed". "The government of India and the national regulator Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="80" keywordseo="cdsco" source="Orion">CDSCO</keyword>) have followed a scientific approach and prescribed norms in approving the Covid-19 vaccines for emergency use authorization," the Ministry said. The media reports had claimed that Bharat Biotech, manufacturer of the indigenous Covaxin, "had to skip certain processes" and "speed" up clinical trials due to political pressure. They also alleged that there were several irregularities in the three phases of the clinical trials. The Ministry said that the Subject Expert Committee (<keyword id="6362470" type="General" weightage="80" keywordseo="sec" source="Orion">SEC</keyword>) of CDSCO met on January 1-2, 2021 and after due deliberations, made the recommendations in respect of the proposal for Restricted Emergency Approval of the vaccine. "Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains," it added. The SEC's approval for the commencement of phase 3 clinical trial of the proposed dose of Covaxin was based on scientific data and established practices in this regard. "Moreover, the purported unscientific changes' in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI." The Ministry added that based on the further submission made by Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of the vaccine in 'clinical trial mode' was removed on March 11, 2021. "Authorisation of Covid-19 vaccines, including Covaxin, for restricted use in an emergency situation with various conditions and restrictions was granted by the national regulator only on the recommendations of the SEC. "The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, and internal medicine," it added. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/novel-artificial-enzymes-could-help-kill-covid-virus-study/articleshow/95575741.cms">Novel artificial enzymes could help 'kill' Covid virus: Study</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/eating-disorders-can-be-detected-earlier-using-electrolytes-as-diagnostic-tool/articleshow/95573008.cms">Eating disorders can be detected earlier using electrolytes as diagnostic tool</a>

Health Ministry rejects claim 'Covaxin was rushed due to political pressure'

The Central Drug Standard Control Organisation's (CDSCO)Subject Expert Committee has asked Dr Reddy's Laboratories to present additional data of immunogenicity while reviewing its <keyword id="6355821" type="UNKNOWN" weightage="20" keywordseo="application">application</keyword> for Emergency Use Authorisation (EUA) of Russian Covid vaccine <keyword id="9739267" type="PERSON" weightage="20" keywordseo="Sputnik-V">Sputnik V</keyword> in India, sources said. Dr Reddy's had applied for EUA before the CDSCO, and its application was reviewed by the SEC on Wednesday, a source told. Meanwhile, the committee has also asked Hyderabad-based <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> to submit efficacy data of <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> before seeking its <keyword id="42907" type="PERSON" weightage="20" keywordseo="trial">trial</keyword> on children. The firm had sought permission from the Drug Controller General of India to conduct vaccine's trial on the children. In September 2020, Dr Reddy's partnered with the <keyword id="1397612" type="COMPANY" weightage="20" keywordseo="Russian-Direct-Investment-Fund">Russian Direct Investment Fund</keyword> (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine is currently undergoing the Phase 3 clinical trial in India. SEE ALSO: <a href="https://www.businessinsider.in/defense/news/dassault-aviation-has-an-india-it-services-unit-offering-defence-msmes-a-digital-trial-room-where-they-can-test-their-products-to-bag-more-contracts/articleshow/81183313.cms">INTERVIEW: Dassault Aviation has an India IT services unit offering defence MSMEs a digital ‘trial room’ where they can test their products to bag more contracts</a> <a href="https://www.businessinsider.in/india/news/these-indian-states-now-require-you-to-carry-a-covid-19-negative-test-report-for-entry-after-rising-coronavirus-cases/slidelist/81185478.cms">These Indian states now require you to carry a COVID-19 negative test report for entry</a> <a href="https://www.businessinsider.in/stock-market/news/vested-finance-ceo-shares-his-guide-to-us-stock-investing-for-indians/articleshow/81185944.cms">Vested Finance CEO shares his guide to US stock investing for Indians</a> <a href="https://www.businessinsider.in/careers/news/global-consulting-firm-zs-says-it-plans-to-hire-3000-employees-in-india-this-year/articleshow/81188160.cms">Global consulting firm ZS says it plans to hire 3000 employees in India this year</a>

You Searched For "subject expert committee" and got 7 results

DCGI gives nod to Bharat Biotech's Covaxin for 6-12 age group in India

IANS

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

IANS

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

PTI

Bharat Biotech's COVAXIN reportedly recommended by expert panel for phase 2 and 3 clinical trials on 2-18 year-olds

PTI

India continues to mull over SII and Bharat Biotech's COVID-19 vaccine candidates

IANS

Health Ministry rejects claim 'Covaxin was rushed due to political pressure'

IANS

India's drug regulator asks Dr Reddy's for more data, as it reviews emergency use of Covid-19 vaccine Sputnik V

IANS

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