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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

Ever since the virus reared its ugly head and briefly sent the world into despair, the coronavirus has remained a staple, albeit almost sidelined, part of the news cycle. Despite this, the topic has come to the forefront of controversy once again, with an extremely popular <keyword id="20040659" type="General" weightage="20" keywordseo="COVID-19-vaccine" source="keywords">COVID-19 vaccine</keyword> now under scrutiny. Considering that the world is still healing from the scars left behind by the coronavirus tragedy, it is imperative that we gauge the situation to avoid any unwarranted public paranoia. Let’s look at the facts behind the ongoing <keyword id="19910149" type="General" weightage="20" keywordseo="AstraZeneca" source="keywords" meta.keywordsubtype="org" meta.entityname="AstraZeneca" meta.hostid="261" meta.entityid="AstraZeneca">AstraZeneca</keyword> (or <keyword id="19960109" type="General" weightage="100" keywordseo="covishield" source="keywords">Covishield</keyword>, as it is known in India) vaccine controversy, and determine if there really is a cause for worry. <cmsannotation type="cmsannotation" annotationid="What happened?" comment="subhead" text="What happened?">What happened?</cmsannotation> Shortly after receiving the AstraZeneca COVID-19 vaccine in 2021, UK-based <keyword id="21472612" type="General" weightage="20" keywordseo="jamie-scott" source="keywords">Jamie Scott</keyword> experienced a harrowing ordeal. He developed a brain clot and severe bleeding, resulting in permanent brain injury. This condition, known as <keyword id="21475609" type="General" weightage="20" keywordseo="Thrombosis-with-Thrombocytopenia-Syndrome" source="keywords">Thrombosis with Thrombocytopenia Syndrome</keyword> (<keyword id="20218859" type="General" weightage="20" keywordseo="tts" source="keywords">TTS</keyword>), can lead to dangerously low blood clot and platelet levels, posing a grave risk to those affected. Jamie's struggles with memory loss, impaired vision, and diminished cognitive abilities compelled him to seek legal recourse against the pharmaceutical company in 2023. Jamie's legal representative contends that AstraZeneca minimized the potential risks linked to their vaccines. Moreover, reports indicate that over 50 vaccinated individuals experienced similar adverse conditions, with numerous cases resulting in fatalities or severe injuries. Despite these assertions, the pharmaceutical company refutes the allegations, stating that they do not acknowledge a causal relationship between the vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS) on a generic level. However, a year of court wrangling later, legal documents submitted by AstraZeneca have now admitted that their vaccine can cause TTS in very rare cases, although the causal mechanism is still not well known. This revelation has led to renewed uproar against the vaccine’s side-effects. <cmsannotation type="cmsannotation" annotationid="Is there cause for worry?" comment="subhead" text="Is there cause for worry?">Is there cause for worry?</cmsannotation> In short words, not really. Links between the <keyword id="21483117" type="General" weightage="20" keywordseo="AstraZeneca-vaccine" source="keywords">AstraZeneca vaccine</keyword> and vaccine-induced immune TTS have been scientifically identified since early 2021, soon after the first COVID-19 vaccines had come out. However, it is so very rare — a few dozen reported cases among the millions administered — that even the World Health Organisation has deemed the vaccine “safe and effective” for all individuals aged 18 and above. Moreover, even influenza, H1N1 and rabies vaccines can cause TTS in very rare instances. Further, it is important to note that an infection with COVID-19 is itself a major cause for clot, heart attacks and strokes. Being vaccinated actually lowers these risks. There is also the fact that all vaccines or drugs carry potential side-effects, and these medical interventions are only cleared for release after determining that their benefits vastly outweigh any complications. Finally, the <keyword id="21483118" type="General" weightage="20" keywordseo="TTS-side-effects" source="keywords">TTS side-effects</keyword> — which include symptoms such as headaches, blurred vision, chest pain, leg swelling or tiny blood spots under the skin — manifest between 1-6 weeks of vaccination. Considering that most Indians received their Covishield jab a couple of years ago, there should be no reason to panic now. <cmsannotation type="cmsannotation" annotationid="Is it time to consider alternate vaccines?" comment="subhead" text="Is it time to consider alternate vaccines?">Is it time to consider alternate vaccines?</cmsannotation> There is no particular hard evidence that suggests the supremacy of one vaccine over another, considering that they all carry varying degrees of side-effects. That being said, <keyword id="9485939" type="General" weightage="20" keywordseo="covaxin" source="Orion">Covaxin</keyword> boasts a higher efficacy than Covishield, and has better research data among Indian subjects. However, it may also be important to know that the administration of the AstraZeneca vaccine has been discontinued in many countries, mainly due the aforementioned risk of blood clotting in certain age groups. Whatever the choice, the fact of the matter remains that these vaccines have saved millions since their introduction, and it is pertinent that we continue taking them diligently, unless any premier health authorities recommend otherwise.

Should you be worried about the potential side-effects of the Covishield vaccine?

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

<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

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="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

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

<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

New Delhi, <keyword id="40458" type="COMPANY" weightage="20" keywordseo="AIIMS">AIIMS</keyword> Director <keyword id="209402" type="PERSON" weightage="20" keywordseo="Randeep-Guleria">Randeep Guleria</keyword> on Monday allayed apprehensions about the <keyword id="8901548" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccines">coronavirus vaccines</keyword> and assured that the side-effects will not result in death of the beneficiary. The nationwide Covid vaccination drive had commenced on January 16 and a total of 447 adverse events following immunisation (AEFI) were reported during the first two days, with most of them being minor along with three cases of hospitalisation. "Even if a person takes Crocin or Paracetamol, they may develop allergic reactions. There is nothing to worry about. There is no side-effect which would result in death," Dr Guleria said. He added, "Main side-effects are body ache, fever, pain at injection site which subside in 1-2 days and take place in less than 10 per cent of people. If the side-effects are severe, there could be skin rashes, nausea, difficulty in breathing." The AIIMS Director said that people must come forth to get vaccinated if they want <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword> to come out of the Covid-19 pandemic, decrease the mortality rate, bring the economy back on track and reopen schools. On January 16, moments after Prime Minister Narendra Modi launched the vaccination drive across the country, the jab was administered to the AIIMS chief on live telecast. Dr Guleria was the third person to take the shot in the institute. "I have no side-effects. I am feeling perfectly alright," he told the media, two days after taking the jab, in a bid to allay fears and apprehensions about the safety of the coronavirus vaccines. The rollout of Oxford's 'Covishield' vaccine, manufactured by <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword>, and <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s '<keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword>' began in the country amid apprehensions about the safety of the latter. Covaxin is currently undergoing late-stage clinical trials which are crucial to determining the efficacy of the shot. 'Covaxin' has been in the spotlight ever since it received the green signal from the drug regulator for restricted emergency use. The approval without adequate efficacy data drew flak from public health advocacy groups, researchers, scientists and activists. Meanwhile, as many as 2,24,311 beneficiaries have received doses of Covid-19 vaccines in the last two days. Only 17,072 beneficiaries were vaccinated in six states on Day 2. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/how-rakesh-jhunjhunwala-backed-nazara-technologies-is-preparing-for-its-big-ipo-debut/articleshow/80321946.cms">The startup behind Chhota Bheem, Motu Patlu and Shikari Shambhu is back with an IPO plan ⁠⁠— after a series of acquisitions and fundraisings</a> <a href="https://www.businessinsider.in/stock-market/news/heres-what-analysts-have-to-say-about-the-4634-crore-indian-railway-finance-corporation-irfc-ipo/articleshow/80323479.cms?upcache=2">The ₹4,600 crore IPO from IRFC is ‘attractive,’ and the best thing about the borrowing arm for Indian Railways is the assured margin</a> <a href="https://www.businessinsider.in/stock-market/news/how-to-apply-for-indian-railway-finance-corporation-irfc-ipo/articleshow/80327303.cms">How to apply for IRFC IPO? Check the details and online application process here</a> <a href="https://www.businessinsider.in/business/startups/news/cure-fit-strengthens-its-us-offering-by-acquiring-digital-trainer-and-workout-app-onyx/articleshow/80326857.cms">Cure.fit strengthens its US offering by acquiring digital trainer and workout app Onyx</a>

'Vaccine won't kill you': AIIMS Director allays fears

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

Mild adverse event following immunisation (AEFI) like headache, fatigue, myalgia (pain in muscle), injection site tenderness, malaise (weakness), pyrexia, chills, arthralgia, and nausea are among the symptoms that may occur following Covisheld <keyword id="54639" type="ORGANIZATION" weightage="20" keywordseo="vaccination">vaccination</keyword>. As per a <keyword id="46535" type="COMPANY" weightage="20" keywordseo="Health-ministry">Health Ministry</keyword> communication, paracetamol maybe given in these adverse reactions. Very rare cases of demylenating have been reported following this vaccination. For <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword>, use of chroloquine and corticosteroids may impair antibody response. In addition, some mild AEFIs like injection site pain, headache, fatique, fever, body ache, abdominal pain, nausea and vomiting, giddiness-dizzyness, tremor, sweating, cold, cough and injection site sweating may occur. Both the vaccines are not recommended for those younger than 18 years, lactating mothers women and during pregnancy. Covid-19 vaccine and other vaccines may be separated by 14 days. Interchanegability of vaccine is not permitted and the same vaccine has to be taken twice. The temporary contraindications are active Covid infection, infected persons who have been given plasma and those acutely unwell and hospitalised due to any illness. Those with chronic diseases are not contraindicated including renal, metabolic, cardia, malignancies, pulmonary and neurological. The Health Ministry has issued this advisory to the states as the vaccination starts from January 16 and states have received the vaccine doses. SEE ALSO:<a href="https://www.businessinsider.in/tech/apps/news/the-indian-government-may-call-whatsapp-to-explain-why-its-new-data-sharing-terms-apply-in-india-but-not-in-europe/articleshow/80262586.cms" data-type="tilCustomLink"> The Indian government may call WhatsApp to explain why its new data privacy policy applies in India but not in Europe</a> <a href="https://www.businessinsider.in/politics/world/news/trump-becomes-first-president-to-be-impeached-twice-as-house-charges-him-with-inciting-an-insurrection/articleshow/80260200.cms" data-type="tilCustomLink">Trump becomes first president to be impeached twice as House charges him with inciting an insurrection</a>

COVID-19 vaccination in India: Health Ministry releases list of potential side effects

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

You Searched For "effectiveness of Covaxin" and got 12 results

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

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Should you be worried about the potential side-effects of the Covishield vaccine?

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

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

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

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

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Covishield immune responses against Covid variants higher than Covaxin: Study

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

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'Vaccine won't kill you': AIIMS Director allays fears

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

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COVID-19 vaccination in India: Health Ministry releases list of potential side effects

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Covishield and Covaxin are now recognized by 110 countries

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