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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

Neutralising antibody responses against the SARS-COV-2 virus and its variants of concern (VoC) are higher among <keyword id="9617748" type="General" weightage="80" keywordseo="covishield" source="Orion">Covishield</keyword> recipients than those who took the indigenously made <keyword id="9485939" type="General" weightage="100" keywordseo="covaxin" source="Orion">Covaxin</keyword>, according to a multi-centre study. The yet-to-be peer-reviewed study, posted on the preprint server MedRxiv on Friday, also found that when compared to the pre-vaccination baseline, both vaccines elicited statistically significant antibody levels in both seronegative individuals and seropositive or those who had recovered from COVID-19 infection. Between June 2021 and January 2022, the researchers enrolled 691 participants in the 18-45 age group across four sites in urban and rural Bengaluru and <keyword id="2094" type="General" weightage="50" keywordseo="pune" source="Orion">Pune</keyword>. Participants received either two doses of Covaxin at 28 days apart or two doses of Covishield at three months apart. The <keyword id="1609796" type="General" weightage="50" keywordseo="omicron" source="Orion">Omicron</keyword> wave in early 2022 overlapped with the second dose of vaccine in two sites and with both doses in one site. Participants were sampled at six timepoints for antibody analyses and at four timepoints for cellular analyses. When compared to pre-vaccination baseline, both vaccines elicited statistically significant antibody levels in both seronegative and seropositive individuals, the researchers found. Covishield elicited immune responses of higher magnitude and breadth than Covaxin in both seronegative individuals and seropositive individuals, across cohorts representing the pre-vaccination immune history of the majority of the vaccinated Indian population. Immunologist Vineeta Bal noted that in young adult population there is a difference in the response to COVID vaccines, if individuals are already infected with SARS-CoV-2 and recovered (seropositives) versus not infected. "In seronegatives, two doses of Covishield lead to higher magnitude of antibody levels in higher proportion of vaccine recipients as compared to Covaxin recipients," Bal, from <keyword id="101852" type="General" weightage="50" keywordseo="indian-institute-of-science-education-and-research" source="Orion">Indian Institute of Science Education and Research</keyword> (IISER), Pune and one of the study authors, told PTI. "In terms of waning of immune response with time also Covishield vaccinated individuals retain antibodies in their blood for longer period in larger proportion of individuals,” she said. The study does not directly look for or document protection from COVID-19 in the recipients. "Levels of neutralising antibodies as well as T cell responses, according to different investigators, are indirect indicators of protection,” Bal said. "The interim results so far show that Covishield vaccination induces robust neutralising antibodies against the original SARS-CoV2; Covaxin also does it but somewhat less efficiently,” she added. "Against later variants of the virus such as Delta and Omicron, especially Omicron, neutralising antibodies triggered by Covishield are not as effective, however, they appear marginally better than in Covaxin recipients," Bal added. Prior studies comparing Covishield and Covaxin were limited to addressing only antibody responses and in particular in the health care worker population who were immunised prior to the Delta wave. There is, however, limited data on cellular immune responses elicited by these vaccines and no direct head to-head comparisons or stratification by pre-vaccination serostatus. Vaccination following exposure to the Delta or Omicron variants of SARS-CoV-2 is likely to affect the quality, quantity and duration of immune responses. For determining future COVID-19 vaccination policy when pan-coronavirus or sarbecovirus vaccines become available, it becomes important to take into account pre-vaccination immune history of the majority of the vaccinated Indian population. "Some unpublished work from other investigators in India seems to suggest that heterologous boosting i.e. Covaxin in Covishield recipients and vice versa works better than homologous boosting," Bal added.

Covishield immune responses against Covid variants higher than Covaxin: Study

German Ambassador to <keyword id="3658" type="General" weightage="20" keywordseo="india" source="Orion">India</keyword> and Bhutan, <keyword id="8098012" type="General" weightage="50" keywordseo="walter-j-lindner" source="Orion">Walter J Lindner</keyword> on Thursday said the government of the European nation will start recognizing <keyword id="149108" type="General" weightage="100" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword>'s COVID-19 vaccine for travel purpose there from June 1. In a tweet, <keyword id="4171576" type="General" weightage="80" keywordseo="lindner" source="Orion">Lindner</keyword> said, Very happy that GER government just decided to recognize WHO-listed Covaxin for travels to GER, starting June 1! This Embassy has been pushing very actively for such decision (because of Covid-backlogs visa sections have longer waiting periods than normal, please have patience). In November last year, the <keyword id="6356311" type="General" weightage="50" keywordseo="world-health-organisation" source="Orion">World Health Organisation</keyword> recommended Emergency Use Listing (EUL) status for Covaxin. Several countries including Australia, Japan and Canada allow passengers vaccinated with Covaxin into those countries. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="http://www.businessinsider.in/india/news/tomatoes-brinjal-and-green-vegetable-prices-soar-and-will-keep-going-up-due-to-rains/articleshow/91802500.cms">Tomatoes, brinjal and green vegetable prices soar and will keep going up due to rains</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="http://www.businessinsider.in/science/environment/news/an-israeli-company-has-partnered-with-an-indian-company-to-locally-produce-a-machine-that-generates-drinking-water-from-air/articleshow/91791365.cms">To help fight water scarcity, a machine that produces drinking water from air has been launched in India</a>

Germany to recognise Bharat Biotech’s 'Covaxin' from June 1

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

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

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

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

<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="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>

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

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 ideal time for a <keyword id="2825536" type="General" weightage="20" keywordseo="booster-dose" source="Orion">booster dose</keyword> for COVID-19 vaccine is six months after the second dose, <keyword id="10494595" type="General" weightage="20" keywordseo="Bharat-Biotech-Chairman" source="Orion">Bharat Biotech Chairman</keyword> and Managing Director Krishna Ella said on Wednesday, and also emphasised the importance of having a nasal vaccine. He also pointed out that his company was the first in the world to develop a <keyword id="3225534" type="General" weightage="20" keywordseo="Zika-vaccine" source="Orion">Zika vaccine</keyword>. Taking the <keyword id="9485939" type="General" weightage="50" keywordseo="covaxin" source="Orion">Covaxin</keyword> vaccine by the Prime Minister Narendra Modi showed confidence in Indian Science, he said at the Times Now Summit 2021. "The ideal time for a booster dose is six months after the second dose," Ella stated. <keyword id="149108" type="General" weightage="100" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword> is also looking at nasal vaccine as a booster dose as its scaling up capacity is very easy when compared with Covaxin, he added. About the importance of nasal vaccine, he said the entire world is looking at nasal vaccines. That is the only way to stop transmission. Everyone is trying to figure out the immunology and fortunately, Bharat Biotech has figured it out. "We are coming out with a nasal vaccine, we are thinking that Covaxin can be given as first dose, the second dose can be given a nasal, that is also strategically, scientifically very important because with the second dose, if it is a nasal one, you stop the transmission of the virus...," Ella said. Nasal vaccine works well if someone has been infected or if someone has been vaccinated with one dose, he added. About the PM taking the Covaxin shot, he said, "What would a scientist like to have? A country head taking his vaccine. That is the best satisfaction a scientist can get... It shows confidence in the Indian science, confidence in the startup, and confidence in our innovation...". Speaking about a vaccine for Zika, Ella said Bharat Biotech is ready with a vaccine for Zika virus. Phase I is complete. The government has to take up more trials because there are more cases now. "We were the first company in the world to develop the Zika vaccine in 2014... We were the first one to file for a global patent for Zika vaccine", he added. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/mobile/news/heres-how-you-can-protect-your-smartphone-from-exploding/slidelist/87625685.cms">Here’s how you can protect your smartphone from exploding</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/union-cabinet-approves-declaration-of-november-15-as-janjatiya-gaurav-diwas/articleshow/87629229.cms">Union Cabinet approves declaration of November 15 as Janjatiya Gaurav Diwas</a>

Ideal time for COVID-19 booster shot is six months after the second dose, says Bharat Biotech MD

Fortis Healthcare on Thursday announced that Sputnik V vaccine against Covid-19 will be available at two of its hospitals as part of a limited pilot roll-out from June 19. The two-dose Covid shot will be available at <keyword id="1120186" type="COMPANY" weightage="20" keywordseo="Fortis-Memorial-Research-Institute">Fortis Memorial Research Institute</keyword>, Gurugram and Fortis Hospital, <keyword id="13178" type="PERSON" weightage="20" keywordseo="Mohali">Mohali</keyword>. It will be extended at more Fortis hospitals across 11 cities. The price per dose for Sputnik V (as fixed by the government) including administrative charges is ₹1,145. "Till date, our units were only providing <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> and <keyword id="9617748" type="LOCATION" weightage="20" keywordseo="covishield">Covishield</keyword>. We are pleased to announce that Fortis, in collaboration with Dr Reddy's Laboratories, is among the first to provide a third vaccine option, with the dual objective of expanding and scaling up the vaccination drive and lowering the infection risks to future mutations of the virus," Fortis Healthcare MD and CEO, Dr Ashutosh Raghuvanshi, said, in a statement. "We urge all Indian citizens to vaccinate themselves and help make the drive successful -- only if we get ourselves vaccinated and follow Covid appropriate behaviour, can the chain of infections and community transmission be broken. It is essential that we follow all recommended measures by the government to protect ourselves, our families and loved ones and prevent a possible third wave," he added. Sputnik V is the third vaccine to be cleared for immunisation programme in <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword> after Covaxin and Covishield. Developed by Russia's Gamaleya National Center, Sputnik V uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots. With an efficacy of 91.6 per cent, Sputnik V, released in August last year, became the first vaccine against Covid-19 in the world. SEE ALSO: <a href="https://www.businessinsider.in/tech/enterprise/news/oneplus-officially-announces-its-integration-with-oppo/articleshow/83596714.cms">OnePlus officially announced its integration with Oppo — this is what it could mean for users</a> <a href="https://www.businessinsider.in/careers/news/how-learning-foreign-languages-can-help-you-get-better-jobs/articleshow/83601709.cms">Learning foreign languages can help you get better jobs — here’s how</a> <a href="https://www.businessinsider.in/cryptocurrency/news/chinas-crypto-miners-are-looking-at-texas-amid-the-great-mining-migration/articleshow/83601284.cms">Crypto’s ‘great mining migration’ has Chinese miners looking at Texas</a> <a href="https://www.businessinsider.in/cryptocurrency/news/tether-is-a-cryptocurrency-thats-not-volatile-and-pegged-against-the-us-dollar/articleshow/83604895.cms">Tether is a cryptocurrency that's not volatile and pegged against the US Dollar — here's everything you need to know</a>

Fortis Healthcare to roll out Sputnik V COVID-19 vaccine from June 19

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>

You Searched For "covaxin covid 19 covaxin" and got 13 results

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

PTI

Covishield immune responses against Covid variants higher than Covaxin: Study

PTI

Germany to recognise Bharat Biotech’s 'Covaxin' from June 1

IANS

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

IANS

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

IANS

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

IANS

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

PTI

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

PTI

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

IANS

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

IANS

Ideal time for COVID-19 booster shot is six months after the second dose, says Bharat Biotech MD

PTI

Fortis Healthcare to roll out Sputnik V COVID-19 vaccine from June 19

IANS

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

PTI

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