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

<ul class="summary-list"><li>Shares of <keyword id="10479975" type="UNKNOWN" weightage="60" keywordseo="Ocugen">Ocugen</keyword> jumped 27% on Monday after the company announced positive news related to its COVID-19 vaccine.</li><li>The company said Covaxin has shown signs of potential effectiveness against three variants of the <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword>.</li><li>Covaxin is India's COVID-19 vaccine, which Ocugen is codeveloping for the US market.</li></ul>Shares of Ocugen jumped 27% to a near two-month high on Monday after the biopharmaceutical company announced that its COVID-19 vaccine has shown signs of potential effectiveness against three variants of the virus.Covaxin, co-developed with Indian firm Bharat Biotech, demonstrated potential effectiveness against the variant of SARS-CoV-2 first discovered in Brazil.A previous study conducted also suggested that Covaxin was effective against variants first seen in the UK and India, suggesting the vaccine's effectivity against multiple strains of COVID-19. The company has submitted a comprehensive drug master file with the US Food and Drug Administration and is preparing the vaccine's emergency use authorization application, according to Dr. Shankar Musunuri, CEO and co-founder of Ocugen.Currently, there are only <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html">three authorized and recommended vaccines</a> in the US to prevent COVID-19, from Pfizer-BioNTech, Moderna, and Johnson &amp; Johnson.In the recently shared second interim results of the phase 3 clinical trial, Covaxin demonstrated 78% overall efficacy and 100% in severe COVID-19 disease - including hospitalization.

Ocugen jumps 27% after its COVID-19 vaccine shows potential effectiveness against virus variants

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

<keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s <keyword id="9485939" type="COMPANY" weightage="20" keywordseo="covaxin">Covaxin</keyword> has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and65.2 per cent protection against the new Delta variant. The company on Saturday said it concluded the final analysis of Covaxin efficacyfrom Phase3 trials. The efficacy analysis demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic COVID-19 cases while safety analysis shows 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 feeling serious adverse events. The efficacy data demonstrates 63.6 per cent protection against asymptomatic COVID-19, a release from the city-based vaccine maker said. Phase 3 <keyword id="83911" type="ORGANIZATION" weightage="20" keywordseo="Clinical-trials">clinical trials</keyword> of the vaccine was an event driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the second dose, conducted at 25 sites across <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>. The whole virion inactivated vaccine against SARS-CoV2, was developed inpartnership with Indian Council of Medical Research and National Institute ofVirology in Pune. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, "The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever COVID Vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that Innovation from India will now be available to protect global populations." Director General of ICMR, Balram Bhargava said, "I am delighted to note that Covaxin developed by ICMR and BBIL under an effective public private partnership, has demonstrated an overall efficacy of 77.8 per cent in Indias largest COVID phase 3 clinical trial thus far. Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of highest international standards." He further said Covaxin will not only benefit the Indian citizens but would also immensely contribute to protect the global community against the deadly SARS-CoV-2 virus. "I am also pleased to see that Covaxin works well against all variant strains of SARS-CoV-2. The successful development of Covaxin has consolidated the position of Indian academia and Industry in the global arena," Bhargava said. The Phase 3 trials were conducted between November 16, 2020 and January 7, 2021 with 25,798 participants who were randomised to BBV152 or placebo groups. The preprint data of COVAXIN efficacy has not been certified by peer-review, according to Medrxiv in which thedata was published. SEE ALSO - <a href="https://www.businessinsider.in/business/startups/news/bharatpes-banking-licence-digits-funding-mswipes-new-ceo-and-more-mega-deals-and-launches-in-indias-fintech-space-/slidelist/84085401.cms" data-type="tilCustomLink">BharatPe’s banking licence, Digit’s funding, Mswipe’s new CEO and more -- mega deals and launches in India’s fintech space</a> <a href="https://www.businessinsider.in/cryptocurrency/news/google-crypto-tokens-binances-regulatory-troubles-free-nfts-and-more/slidelist/84086617.cms" data-type="tilCustomLink">Google’s crypto tokens, Binance’s regulatory troubles, free NFTs and more — Here’s what happened in the world of crypto this past week</a>

Covaxin shows 77.8% effectiveness against symptomatic COVID-19 cases in phase-3 trials

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

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="General" weightage="80" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword> on Wednesday said a study has demonstrated that a booster dose of <keyword id="9485939" type="General" weightage="80" keywordseo="covaxin" source="Orion">Covaxin</keyword> has a neutralising effect on the <keyword id="1609796" type="General" weightage="80" keywordseo="omicron" source="Orion">Omicron</keyword> and <keyword id="6383835" type="General" weightage="80" keywordseo="delta" source="Orion">Delta</keyword> variants of COVID-19. The study conducted at Emory University demonstrated that subjects who received a booster dose of Covaxin (BBV152) six months after getting a primary two-dose series have witnessed neutralising of the SARS-CoV-2 Omicron and Delta variants, the vaccine major said in a statement. Earlier studies had demonstrated the neutralising potential of Covaxin against other SARS-CoV-2 variants -- Alpha, Beta, Delta, Zeta and Kappa, it added. Citing the study results, Bharat Biotech noted that more than 90 per cent of all individuals boosted with Covaxin showed neutralising antibodies. "As the dominant COVID-19 variant throughout the world, Omicron poses a serious public health concern. Data from this preliminary analysis show individuals receiving a booster dose of Covaxin have a significant immune response to both the Omicron and Delta variants. "These findings suggest that a booster dose has the potential to reduce disease severity and hospitalizations," Emory Vaccine Center Assistant Professor Mehul Suthar, who led the laboratory analysis, noted. Bharat Biotech Chairman and Managing Director <keyword id="238082" type="General" weightage="20" keywordseo="krishna-ella" source="Orion">Krishna Ella</keyword> said the vaccine major is in a continuous state of innovation and product development for Covaxin. "The positive neutralization responses against the Omicron and Delta variants, validates our hypothesis of a multi-epitope vaccine generating both humoral and cell mediated immune responses. "Our goals of developing a global vaccine against COVID-19 have been achieved with the use of Covaxin as a universal vaccine for adults and children," he added. The study conducted at Emory Vaccine Center in Atlanta was sponsored by Ocugen, Inc. Bharat Biotech provided the sera of the subjects from the Phase 2 study. SEE ALSO: <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> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/stock-market/news/tata-motors-tcs-paytm-and-other-hot-stocks-on-january-13/slidelist/88866954.cms">Tata Motors, TCS, Paytm, and other hot stocks on January 13</a>

Study shows booster dose of Covaxin has neutralising effect on Omicron, Delta variants, says Bharat Biotech

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

<keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> got an approval for its COVID-19 vaccine and along with it came a lot of flak from critics who believe that the process was rushed for no valid reason. Dr Krishna Ella, the founder and chairman of Bharat Biotech, retaliated blaming everyone from the media to rival vaccine makers, except that his arguments hold no water. The drug regulator's approval for any new drug or vaccine is based on the understanding that the drug or vaccine's benefits outweigh its risks. However, considering that he admitted that Phase-III trials are still underway, there is no final estimate of <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword>’s efficacy, and without that number, the approval should not have been granted. Benefits like how effective the vaccine is in preventing disease, and risks such as high mortality rate if the vaccine is not given or vaccine side-effects, are critical data that inform the approval. This benefit-to-risk ratio changes based on the vaccine and disease being considered, but there is no escaping the need for this data. It is, therefore, strange that the vaccine candidate being explored by Bharat Biotech-ICMR, Covaxin, has<a href="https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1685678"> received</a> permission "for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains." Bharat Biotech has<a href="https://www.medrxiv.org/content/10.1101/2020.12.11.20210419v1"> shared</a> findings from their Phase I/II clinical trials as a pre-print on MedRxiv. These studies indicate safety and immunogenicity (i.e., the vaccine candidate's ability to generate an immune response) in human beings. However, Bharat Biotech<a href="https://www.livemint.com/science/health/bharat-biotech-begins-phase-3-trials-of-covid-19-vaccine-covaxin-in-india-11605570981150.html"> began</a> Phase III trials demonstrating the vaccine's efficacy instead of a placebo only on November 16. By December 22 they had<a href="https://www.business-standard.com/article/current-affairs/bharat-biotech-recruits-13-000-volunteers-for-covaxin-phase-3-trials-120122200562_1.html"> recruited</a> only 13,000 volunteers of the target 25,800 participants. The endpoints for the data collection on efficacy are Day 42 to Month 12, as per information<a href="http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=48057&amp;EncHid=&amp;userName=CTRI/2020/11/028976"> submitted</a> to CTRI. It is therefore unlikely that any robust data about the effectiveness of the vaccine is available. Reports<a href="https://theprint.in/health/bharat-biotechs-covaxin-given-conditional-nod-based-on-incomplete-phase-3-trial-results-data/578389/"> suggest</a> that approval was based on immunogenicity data for 10,000 people after they have received the first dose of the vaccine and for 10,000 people after two doses. However, none of this data is available in the public domain, nor has it been peer-reviewed by independent experts. The Subject Expert Committee (SEC) made the recommendation of approval – however, very little is known about the composition of the Committee or the process followed for this approval. It will be premature to determine that Covaxin's benefits outweigh the risks without data on its efficacy. The opaqueness of the approval process adds to the scepticism that is forming around this vaccine. On the other hand, the US Food and Drug Administration has been very transparent with their evaluation of approved vaccines. Its<a href="https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19"> announcement</a> for the Pfizer vaccine, for example, gave details on how many people had received the vaccine and placebo, the effectiveness of the vaccine, and, most importantly, the limitations of the vaccine. It provided a plan for vaccine monitoring and demarcated the company's responsibilities in the future. The discussions of the advisory panel that recommended approval of the vaccines were also<a href="https://www.statnews.com/2020/12/17/moderna-vaccine-fda-panel/"> made</a> public. Both Emergency Use Authorizations (EUA) were given based on Phase III data. In addition, both Moderna and Pfizer have published their trial data in peer-reviewed journals. China and Russia - which approved vaccines with insufficient Phase III data – have<a href="https://www.businesstoday.in/sectors/pharma/covid-19-crisis-scientists-flag-concerns-over-vaccines-from-russia-china/story/414747.html"> attracted</a> scepticism over this process. The constraints placed on the Indian economy and health crisis created by COVID-19 demand expedited approval processes; however, lack of efficacy data cannot be substituted in this fast-tracking process. So what more information do we need? Bharat Biotech and ICMR need to demonstrate the efficacy of the vaccine through published data. Phase III trials can take time, but it will be the correct and ethical way to get the vaccine approval. The government needs to be transparent on how approvals were given and what data were presented. Also, in future, government laws need to be clear on minimum standards that drugs/vaccines need to adhere to for approval. For example, FDA had mandated a minimum efficacy of 50% as a prerequisite for the EUA. It is therefore questionable how Covaxin was approved if Indian authorities followed a similar benchmark. A pandemic requires expedited decision-making, but moving the goalposts for different vaccines is not advisable. The government also needs to clarify the terminology used in their approval, primarily, the terms "restricted", "abundant precaution", and "clinical trial mode". A clinical trial requires constant follow up with participants, a special consent form explaining the risks of the vaccine, and a placebo group. It is unclear how those deemed eligible for Covaxin will be divided into these two groups or how the data will be collected and analysed. It is also unclear who will be responsible for this monitoring. The claim that the Bharat Biotech vaccine is more likely to be effective against mutant coronavirus strains is theoretical and needs to be backed by data. In this case, Bharat Biotech first needs to show efficacy against the original strain as well. In the absence of this data, investment in the vaccine may lead to no positive public health outcomes in India. It may be better to wait for the Phase III interim data and make an informed decision on including it for emergency use. The demand for vaccine efficacy data is not an attack on Bharat Biotech or its vaccine, it is simple scientific requirement that needs to be fulfilled. The impact of this opacity in regulation should go beyond Covaxin and Bharat Biotech. India is the largest vaccine manufacturer in the world. But we are behind in the technology and expertise in creating vaccines. For India to be a world leader in public health, we need to be ahead on indigenous vaccine research and manufacture. However, the scepticism generated by the ambiguity and double standards of the current approval process reduces confidence and credibility in locally made vaccines. The author, Shambhavi Naik, has a PhD in Cancer Biology and is a Fellow at Takshashila Institution, Bengaluru. SEE ALSO: <a href="https://www.businessinsider.in/india/news/bharat-biotech-sees-rivals-conspiracy-in-all-the-criticism-for-the-approval-for-covaxin/articleshow/80099818.cms">Bharat Biotech sees rivals’ conspiracy in all the criticism for the approval for Covaxin</a>

You Searched For "effectiveness of Covaxin" and got 9 results

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OPINION: No matter what Bharat Biotech says, Covaxin is just not ready for approvals

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