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

The Indian Council of Medical Research Director General Dr Rajiv Bahl on Monday criticised a recently published study on the long-term safety analysis of the <keyword id="9485939" type="General" weightage="100" keywordseo="covaxin" source="Orion">Covaxin</keyword> in adults and adolescents for its poor methodology and design, and clarified the article misleadingly and erroneously "acknowledges" <keyword id="19918794" type="General" weightage="20" keywordseo="ICMR" source="keywords">ICMR</keyword>. Dr Bahl said the study had no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups. Hence, the reported events in the study cannot be linked or attributed to COVID-19 vaccination. He added that the ICMR is not associated with the study and has not provided any financial or technical support for the research. The ICMR DG has written a letter to the authors of the paper and Editor of the journal to immediately remove the acknowledgement to ICMR and publish an erratum. A research paper, titled 'Long-Term Safety Analysis of the BBVl52 <keyword id="21730391" type="General" weightage="20" keywordseo="coronavirus-vaccine" source="keywords">Coronavirus Vaccine</keyword> in Adolescents and Adults: Findings from a l-Year Prospective Study in North India' stated that nearly one-third of the 926 participants in the study who received Bharat Biotech's anti-Covid vaccine Covaxin reported 'adverse events of special interest,' or AESI. Dr Bahl said that ICMR was acknowledged for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable. He stated that ICMR cannot be associated with this poorly designed study which purports to present a "safety analysis" of Covaxin due to several critical flaws. He said the study does not even provide background rates of observed events in the population, making it impossible to assess the change in incidence of observed events in the post-vaccination period. Baseline information of study participants is missing. The study tool used is inconsistent with 'Adverse Events of Special Interest (AESI)' as defined in the reference provided in the paper for AESI. The method of data collection has a high risk of bias, he said. Study participants were contacted telephonically one year after vaccination and their responses were recorded without any confirmation with clinical records or by physician examination, he pointed out. Dr Bahl also noted that similar acknowledgements to ICMR have been made in previous papers without permission, raising concerns about the authors' practices. "The authors have been urged to immediately rectify the acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address the methodological concerns raised. Failure to do so may prompt ICMR to consider legal and administrative action," he said. The Editor has been asked to retract the paper which implicitly makes conclusions on <keyword id="21495684" type="General" weightage="20" keywordseo="vaccine-safety" source="keywords">vaccine safety</keyword> which are not supported by evidence. The study, conducted by researchers from the Banaras Hindu University from January 2022 to August 2023, stated that nearly 50 per cent of 926 study participants in the study complained of infections during the follow-up period, predominated by viral upper respiratory tract infections. Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at long-term safety of the BBV152 (Covaxin) vaccine in adolescents and adults, claimed. The study involved 635 adolescents and 291 adults, who received the BBV152 vaccine.

BHU study on Covaxin side effects poorly designed, critically flawed: ICMR Director General

The domestically developed <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> is effective against the <keyword id="11441054" type="UNKNOWN" weightage="20" keywordseo="delta-plus-variant">Delta plus variant</keyword> of Covid-19, claims Indian Council of Medical Research (ICMR) in its study released on Monday. Covaxin is developed by Bharat Biotech in collaboration with ICMR and National Institute of Pune. The study states: "The sera of individuals who were fully immunized (with 2 doses) didn't show significant fold-reduction in the NAb titer against Delta, Delta AY.1 and B.1.617.3." Delta Plus is a mutated form of the Delta variant and was first discovered in India. It is characterised by increased transmissibility and spike protein mutations. The study points that Delta variant with its characteristic spike protein mutations has mutated further into four sub-lineages with additional mutations which are associated with higher transmission and probable immune escape. Last week, Union Science and Technology Minister Jitendra Singh informed parliament last week that 70 cases of the Delta Plus variant were found by INSACOG, a group of 28 laboratories involved in genome sequencing. Covaxin along with other two vaccines -- Covishield and Russia's Sputnik -- has formed the trio for India's massive vaccination drive against the virus. The research further states, "A significant increase in the NAb titer against the B.1 variant in recovered cases with vaccination and breakthrough cases was observed compared to the Covid-19 native vaccines. Similarly, a significant increase in NAb titer was also observed among these two groups against Delta, Delta AY.1 and B.1.617.3 variants." "This demonstrates the possible role of memory cells in immune boosting with post-infection or infection after immunization. The comparative analysis of all the groups revealed that the B.1.617.3 variant seems to be less susceptible to neutralization followed by Delta AY.1 and Delta variants." The study on efficacy analysis further establishes Covaxin to be 93.4 percent effective against severe symptomatic Covid-19 cases and 63.6 percent protection against asymptomatic Covid-19. SEE ALSO: <a href="https://www.businessinsider.in/business/news/byjus-last-two-acquisitions-and-a-deal-with-disney-reveal-its-american-dream/articleshow/84783749.cms">Byju's last two acquisitions and a deal with Disney reveal its American dream ⁠— one that is anchored in India</a> <a href="https://www.businessinsider.in/personal-finance/news/six-red-flags-for-investors-to-avoid-becoming-a-victim-of-misselling-by-agents-or-financial-advisors/slidelist/84782913.cms">Six red flags for investors to avoid becoming a victim of misselling by agents or financial advisors</a>

India’s Covaxin effective against Delta Plus variant of COVID-19, reveals ICMR study

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

<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

Indian Council of Medical Research (<keyword id="6364396" type="COMPANY" weightage="20" keywordseo="ICMR">ICMR</keyword>) said on Monday <keyword id="8904563" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine">Covid-19 vaccine</keyword> <keyword id="9485939" type="COMPANY" weightage="20" keywordseo="covaxin">Covaxin</keyword> neutralises <keyword id="9380721" type="UNKNOWN" weightage="20" keywordseo="multiple-variants">multiple variants</keyword> of SARS-CoV-2 and effectively neutralises the double mutant strain as well. ICMR cited the findings of a study carried out by them. Covaxin is developed locally by Hyderabad-based Bharat Biotech International Ltd. in collaboration with the ICMR -- the apex body in India for the formulation, coordination and promotion of biomedical research. ICMR-National Institute of Virology has successfully isolated and cultured multiple variants of concern of SARS-CoV-2 virus: B.1.1.7 (the UK variant), B.1.1.28 (Brazil variant ) and B.1.351 (South Africa variant), said the apex health research body. "ICMR study shows Covaxin neutralises against multiple variants of SARS-CoV-2 and effectively neutralises the double mutant strain as well," the ICMR said in a tweet. They have also demonstrated the neutralisation potential of Covaxin against the UK variant and Brazil variant. ICMR-NIV recently has been successful in isolating and culturing the double mutant strain B.1.617 SARS-CoV-2 identified in certain regions of India and several other countries. "Covaxin has been found to effectively neutralise the double mutant strain as well," it said. The study was published in the Journal for Travel Medicine in March where it highlighted that Covaxin is effective against the UK variants as well as other strains of Covid-19. "It was reassuring from the PRNT50 data generated in our laboratory that the indigenous BBV152/ COVAXIN, following its roll out in vaccination program, could be expected to work against the new UK-variant," the study said. SEE ALSO: <a href="https://www.businessinsider.in/tech/news/facebook-in-the-crosshairs-yet-again-this-time-indias-cybersecurity-agency-issues-an-advisory-to-indian-users/articleshow/82177573.cms">Facebook in the crosshairs yet again – this time, India’s cybersecurity agency issues an advisory to Indian users</a> <a href="https://www.businessinsider.in/india/news/covishield-vaccine-priced-at-400-and-600-for-state-hospitals-and-private-hospitals-respectively/articleshow/82176762.cms">Covishield vaccine priced at ₹400 and ₹600 for state hospitals and private hospitals respectively, to be available in medical stores after 4-5 months</a> <a href="https://www.businessinsider.in/tech/news/apple-privacy-oriented-ios-14-5-update-can-impact-on-facebook-ad-revenue/articleshow/82176041.cms">Apple will roll out the privacy-oriented iOS 14.5 update next week that has Facebook worried</a>

COVID-19 vaccine 'Covaxin' is effective against double mutant strain found in India, says ICMR

Two doses of <keyword id="9485939" type="General" weightage="20" keywordseo="Covaxin" source="Orion">Covaxin</keyword> are 50 per cent effective against symptomatic COVID-19, according to the first real-world assessment of India's indigenous coronavirus vaccine published in <keyword id="456544" type="General" weightage="20" keywordseo="The-Lancet" source="Orion">The Lancet</keyword> Infectious Diseases journal. The results of an interim study recently published in The Lancet showed that two doses of Covaxin, also known as BBV152, had 77.8 per cent efficacy against symptomatic disease and present no serious safety concerns. The latest study assessed 2,714 hospital workers at the <keyword id="6365231" type="General" weightage="20" keywordseo="All-India-Institute-of-Medical-Sciences" source="Orion">All India Institute of Medical Sciences</keyword> (AIIMS) in Delhi, from April 15 May 15, who were symptomatic and underwent RT-PCR test for COVID-19 detection. Researchers noted that the Delta variant was the dominant strain in India during the study period, accounting for approximately 80 per cent of all confirmed COVID-19 cases. Covaxin, developed by Hyderabad-based <keyword id="149108" type="General" weightage="20" keywordseo="Bharat-Biotech" source="Orion">Bharat Biotech</keyword> in collaboration with the National Institute of Virology, Indian Council of Medical Research (NIV-ICMR), Pune, is an inactivated whole virus vaccine administered in a two-dose regimen, 28 days apart. In January this year, Covaxin was approved for emergency use in India for people aged 18 and above. The World Health Organization (WHO) added the vaccine to its list of approved emergency use COVID-19 vaccines earlier this month. The latest study was conducted during India's second COVID-19 surge and in healthcare workers who were primarily offered Covaxin. "Our study offers a more complete picture of how BBV152 (Covaxin) performs in the field and should be considered in the context of COVID-19 surge conditions in India, combined with the possible immune evasive potential of the Delta variant," said Manish Soneja, Additional Professor of Medicine at AIIMS New Delhi. "Our findings add to the growing body of evidence that rapid vaccine rollout programmes remain the most promising path to pandemic control while public health policies must continue to include additional protective measures, such as mask-wearing and social distancing," Soneja said in a statement. The COVID-19 vaccination centre at AIIMS New Delhi exclusively offered Covaxin beginning January 16 this year to all of its 23,000 employees. Researchers evaluated the effectiveness of the vaccine against symptomatic RT-PCR confirmed SARS-CoV-2 infection. Of the 2,714 employees in the study population, 1,617 people tested positive for SARS-CoV-2, the virus that causes COVID-19, and 1,097 tested negative. Positive cases were matched to negative RT-PCR tests (controls). The odds of vaccination with Covaxin were compared between cases and controls and adjusted for occupational exposure to COVID-19, previous SARS-CoV-2 infection, and infection dates. The study found that the vaccine effectiveness against symptomatic COVID-19 after two doses of Covaxin with the second dose administered 14 or more days before undergoing RT-PCR testing was 50 per cent. The effectiveness of two vaccine doses remained stable over the seven-week follow-up period, the researchers said. The adjusted vaccine effectiveness of the first dose, estimated after seven and 21 days, was low, which is consistent with the performance of other preventives against the Delta variant, they said. "Findings from the study confirm previous research indicating that two doses of BBV152 are required to achieve maximum protection and that all vaccine roll-out plans must follow the recommended dosing schedule," said Parul Kodan, Assistant Professor of Medicine at AIIMS New Delhi. "More research is needed to better understand how these findings translate to BBV152's effectiveness against delta and other variants of concern, especially related to severe COVID-19 infection, hospitalisation, and deaths," Kodan said. The authors acknowledge that the vaccine <keyword id="12595121" type="General" weightage="20" keywordseo="effectiveness-of-Covaxin" source="Orion">effectiveness of Covaxin</keyword> estimated in this study is lower than the efficacy reported by the recently published phase 3 trial. They noted that several factors may be responsible for the lower vaccine effectiveness in the latest study. The researchers said this study population only included hospital employees who may have a higher risk of exposure to COVID-19 infection than the general population. The research was conducted during the peak of India's second wave of COVID-19 with high test positivity rates for both hospital employees and residents of Delhi, they said. Prevalence of circulating variants of concern, especially Delta, may have also contributed to the vaccine's lower effectiveness, according to the researchers. The authors acknowledge several limitations to their study. The study does not estimate the vaccine effectiveness against hospitalisation, severe disease, and death, which require further assessment, they noted. Also, the study was not designed to estimate vaccine effectiveness for different time intervals after vaccination or to determine if vaccine effectiveness changed over time, the researchers added. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/stock-market/news/url-go-fashion-ipo-allotment-tomorrow-and-gmp-is-falling-every-day/articleshow/87876496.cms">Go Fashion IPO allotment tomorrow; GMP on a downward trend</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/stock-market/news/if-you-missed-tarson-products-ipo-allotment-heres-what-you-should-know/articleshow/87870822.cms">If you missed Tarson Products’ IPO allotment, here’s what you should know</a>

Covaxin shows 50% effectiveness against symptomatic COVID-19 in real-world assessment, says Lancet study

The supply price of <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword> to the government of <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword> at ₹150 a dose is a non-competitive price and clearly not sustainable in the long run. Hence a higher price in private markets is required to offset part of the costs, <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> said on Tuesday. It said there are live examples of such pricing policies where Human Papilloma virus vaccine is priced for GAVI supplies at $4.5/dose (₹320), but is also available in the private market at ₹3,500. Rotavirus vaccines are supplied to the Govt of India at ₹60/dose, but is also available in the private market at ₹1,700/dose. The prices for COVID-19 vaccines internationally have varied between $10 to $37/dose, (₹730 - ₹2,700/dose). On why Coaxin is more expensive for the private sector, Bharat Biotech said another key point of discussion has been about pricing our vaccines for private sector players which is significantly higher than that given to governments and large procurement agencies. This is purely due to fundamental business reasons, ranging from low procurement volumes, high distribution costs and retail margins among few others. As directed by the Govt of India, less than 10% of our total production of Covaxin to date has been supplied to private hospitals, while most of the remaining quantity was supplied to State and Central Governments. In such a scenario the weighted average price of Covaxin for all supplies realized by Bharat Biotech is less than ₹250/dose. Going forward, 75% of the capacity will be supplied to State and Central Governments with only 25% going to private hospitals. Unlike most medicines and therapeutics, vaccines are provided free of cost by the Govt of India to all eligible Indian citizens. "Thus, the procurement of vaccines by private hospitals is optional and not mandatory, albeit it gives a choice to citizens who are willing to pay for better convenience. In our view, the question of product pricing is only of extraneous interest to all concerned, especially when the same vaccine is made available free of cost", Bharat Biotech said that for the private sector it is optional. Bharat Biotech has so far invested over ₹500 crores at risk from its own resources for product development, clinical trials and setting up of manufacturing facilities for Covaxin. The support from The Indian Council of Medical Research (ICMR) was with respect to provision of the SARS CoV2 virus, animal studies, virus characterization, test kits and partial funding for clinical trial sites. In return for this valuable support, Bharat Biotech will pay royalties to ICMR and the National Institute of Virology (NIV), based on product sales. Royalties are also payable to Virovax towards the licensure of IMDG agonist molecules, it said. Bharat Biotech is investing in new facilities and repurposing existing ones across several states in India for enhancing the production of Covaxin. It is pertinent to mention here that the urgent need to set up a significant number of manufacturing facilities and to divert existing ones for Covaxin has resulted in reduced production of other vaccines at our facilities, leading to loss in revenues. It added that low product price realization dispirits domestic R&amp;D. Companies such as Bharat Biotech, which are innovators with specialized expertise in product development, and large scale manufacturing, should be allowed to maintain a differential pricing strategy for Governments and private hospitals. It is distressing to see that a large country like India has a very basic level of innovation in vaccines and pharmaceutical products, it added. It may well be argued that the low-price realization for home-grown innovators constraints innovation and product development in India. In the absence of a dual pricing system, Indian vaccine and pharmaceutical companies risk being reduced to mere contract manufacturers with intellectual property licensed from other nations, the company said. SEE ALSO <a target="_blank" class="c-link" href="https://www.businessinsider.in/stock-market/news/adani-group-under-sebi-scanner-on-market-manipulation/articleshow/83501698.cms">Gautam Adani loses over $7 billion in net worth after questions over the meteoric rise in group stocks</a> <a target="_blank" class="c-link" href="https://www.businessinsider.in/stock-market/news/adani-group-pnb-coal-india-tcs-and-other-stocks-to-watch-out-for-on-june-14/slidelist/83499937.cms">Adani group, PNB, Coal India, TCS and other stocks to watch out for on June 14</a> <a target="_blank" class="c-link" href="https://www.businessinsider.in/cryptocurrency/news/weekly-crypto-roundup-wazirx-under-scrutiny-el-salvador-makes-bitcoin-legal-tender-and-more/slidelist/83478577.cms">Weekly crypto roundup: WazirX under scrutiny, El Salvador makes Bitcoin legal tender and more</a>

Covaxin supply to government at ₹150 per dose is not sustainable, says Bharat Biotech

Experts of the <keyword id="6364396" type="General" weightage="20" keywordseo="ICMR" source="Orion">ICMR</keyword>'s National Task Force on COVID-19 for the fourth time have unanimously rejected the inclusion of <keyword id="9385138" type="General" weightage="20" keywordseo="anti-viral-drug" source="Orion">anti-viral drug</keyword> <keyword id="10880838" type="General" weightage="20" keywordseo="Molnupiravir" source="Orion">Molnupiravir</keyword> in the coronavirus treatment guidelines saying its "known and unknown harms far outweigh its claimed benefit". Responding to a question over Molnupiravir's inclusion in the treatment guidelines amid doctors prescribing it, ICMR Director General Dr Balram Bhargava said experts have had extensive debate and discussions and reviewed the data available from three trials on the drug on Monday. "We had extensive deliberation and the final conclusion was that Molnupiravir has certain risks that warrant caution in its use. Experts present in the meeting opined that there is a rampant and irrational use of Molnupiravir. Efforts should be made to restrict its use as known and unknown harms far outweigh its claimed benefit," he said on Wednesday. "The currently available synthesised evidence was reviewed and the members unanimously agreed that it does not merit the inclusion of Molnupuravir in the national treatment guidelines for COVID-19," Bhargava said. The emerging evidence will constantly be reviewed, he added. "And lastly it was further highlighted the current clinical window of application appears extremely narrow for Molnupiravir with relevance only to the following --elderly, unvaccinated, with other comorbidities. "There was no evidence of benefit in diabetes and those who were previously infected with COVID-19 or were vaccinated," he said. India's drug regulator on December 28 had approved the anti-Covid pill for restricted use in emergency situations. Molnupiravir is an antiviral that inhibits SARS-CoV-2 replication by viral mutagenesis, the health ministry earlier had said in a statement. The UK MHRA on December 4 granted approval for Molnupiravir under special condition for treatment of mild to moderate COVID-19 in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness. The USFDA on December 23 granted Emergency Use Authorisation (EUA) for Molnupiravir for treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalisation or death, and for whom alternative <keyword id="8918466" type="General" weightage="20" keywordseo="COVID-19-treatment" source="Orion">COVID-19 treatment</keyword> options authorised by the FDA are not accessible or clinically appropriate. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/study-shows-booster-dose-of-covaxin-has-neutralising-effect-on-omicron-delta-variants-says-bharat-biotech/articleshow/88867266.cms">Study shows booster dose of Covaxin has neutralising effect on Omicron, Delta variants, says Bharat Biotech</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/enterprise/news/tcs-vs-infosys-vs-wipro-how-indias-three-it-giants-stack-up-against-each-other/slidelist/88860676.cms">TCS vs Infosys vs Wipro Q3 results – here’s how India’s three IT giants stack up against each other</a>

ICMR experts reject inclusion of Molnupiravir in COVID-19 treatment guidelines for fourth time citing safety concerns

<keyword id="9485939" type="General" weightage="100" keywordseo="covaxin" source="Orion">Covaxin</keyword>, India's first indigenous vaccine for Covid-19, has been found to be 77.8 per cent effective, according to the safety and efficacy analysis data from Phase III clinical trials peer reviewed and published in reputed medical journal The Lancet. Hyderabad-based <keyword id="149108" type="General" weightage="20" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword> said the Lancet peer-review confirms the efficacy analysis which demonstrates Covaxin to be effective against Covid-19. The vaccine maker Covaxin is the only Covid-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the Delta variant at 65.2 per cent. A"The efficacy analysis demonstrates Covaxin to be 77.8 per cent effective against symptomatic Covid-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group," the company said. The efficacy analysis also demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic Covid-19 "Safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects experiencing serious adverse events," it said The efficacy data also shows 63.6 per cent protection against asymptomatic Covid-19, 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta and 70.8 per cent protection against all variants of SARS-CoV-2 virus. Covaxin was developed under a partnership with the Indian Council of Medical Research (ICMR) and the <keyword id="6375751" type="General" weightage="20" keywordseo="national-institute-of-virology" source="Orion">National Institute of Virology</keyword>, with Bharat Biotech receiving the SARS-COV-2 strains through this collaboration. Bharat Biotech had established an ongoing collaboration with ViroVax since 2019, through the Indo-US Vaccine Action Program, to develop and evaluate IMDG (Alhydroxiquim-II), a novel TLR7/8 agonist molecule, which is formulated as part of the adjuvant in Covaxin. The Adjuvant Program of the US National Institute of Allergy and Infectious Diseases (NIAID) has supported ViroVax since 2009. "The peer-review of Covaxin phase III clinical trial data in The Lancet, an authoritative voice in global medicine validates our commitment to data transparency and meeting the stringent peer-review standards of world leading medical journals," said Krishna Ella, CMD of Bharat Biotech. He said the data from their product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published Covid-19 vaccines in the world. The phase 3 trial Efficacy and Safety Study involving 25,800 volunteers across 25 sites in India is India's largest ever clinical trial conducted for a Covid-19 vaccine. "I am delighted to see that the phase III efficacy data has also been published in The Lancet, one of the most reputed journals worldwide. This itself speaks high about the strong position of Covaxin amongst other global front-runners Covid-19 vaccines.A The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of Atmanirbhar Bharat along with the Indian academia and industry in fighting against the odds and carving a niche in the global community," said Balram Bhargava, Director General of the ICMR. Recently, the <keyword id="43588" type="General" weightage="20" keywordseo="world-health-organization" source="Orion">World Health Organization</keyword> granted emergency use listing to Covaxin enabling countries to expedite their regulatory approval to import and administer doses. It has also received emergency use authorizations in several countries with applications in process in more than 50 countries worldwide. Bharat Biotech has partnered with Ocugen to obtain approvals for Covaxin in the US and Canada. With more than 150 million doses manufactured, supplied, and with an excellent safety and efficacy profile, Covaxin is a major contributor to the global fight against the Covid-19 pandemic. The vaccine is currently being evaluated in controlled clinical trials in children 2-18 years of age, with results expected during Q4 2021. Bharat Biotech said it was poised to achieve its goal of an annualized capacity of Aabout 1 billion doses of Covaxin by the end of 2021. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/space/news/nasas-spacex-crew-3-successfully-arrives-at-the-international-space-station/slidelist/87660900.cms">All you need to know about NASA’s SpaceX Crew-3 space flight</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/environment/news/in-pics-the-tamil-nadu-floods-have-sent-1700-people-into-relief-camps/slidelist/87660150.cms">In pics: The Tamil Nadu floods have sent 1,700 people into relief camps</a>

You Searched For "ICMR COVAXIN" and got 9 results

BHU study on Covaxin side effects poorly designed, critically flawed: ICMR Director General

PTI

India’s Covaxin effective against Delta Plus variant of COVID-19, reveals ICMR study

IANS

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

PTI

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

PTI

COVID-19 vaccine 'Covaxin' is effective against double mutant strain found in India, says ICMR

IANS

Covaxin shows 50% effectiveness against symptomatic COVID-19 in real-world assessment, says Lancet study

PTI

Covaxin supply to government at ₹150 per dose is not sustainable, says Bharat Biotech

IANS

ICMR experts reject inclusion of Molnupiravir in COVID-19 treatment guidelines for fourth time citing safety concerns

PTI

India's Covaxin 77.8% effective for COVID-19, says Lancet Report

IANS

Popular Keywords

Buying Guides