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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

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

<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

<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

Hubballi (Karnataka), Jan 19 (IANS) Allaying fears over the side-effects of Covaxin, Karnataka Health Minister K. Sudhakar on Tuesday defended the vaccine of from Hyderabad-based Bharat Biotech and said that it is safe for use. "Covishield and Covaxin are equally safe for use. No need for any apprehension against Covaxin. The Drug Controller General of India (DCGI) had approved both the vaccines for administering them to the beneficiaries," Sudhakar told the media here. Covishield is manufactured by Pune-based Serum Institute of India. Responding to concerns expressed by an association of government doctors on using Covaxin in six districts and Covishield in the remaining 24 districts across the state, Sudhakar said the Bharat Biotech vaccine was tested on over 30,000 volunteers during trials, the highest in the country. "As analysing the data takes time, the regulator (DCGI) has given permission for its (Covaxin) emergency use only after satisfying itself of its efficacy," Sudhakar, a medical doctor by profession, asserted. The six districts in which Covaxin is being administered to the Covid warriors are Ballari, Chamarajanagar, Chikkamagalur, Davangere, Hassan and Shivamogga since January 16, when the vaccination drive was launched with much fanfare across the country. Clarifying that no health worker would be forced to take the vaccine, as it is voluntary, the minister said Karnataka had the highest number of healthcare and frontline warriors (16 lakh) taking the vaccine in the country. "We have 8,14,500 doses of vaccines for the first phase. The second dose will be given 28 days after the first shot. Senior citizens above 50 years and persons with comorbidities will be given the vaccine in the second phase," said Sudhakar. In a letter to Sudhakar, the association of house surgeons, post-graduates and super specialty residents of state-run medical and dental colleges said that resident doctors in some districts are concerned that they are being given Covaxin, while their counterparts in other districts are getting Covishield, whose Phase 3 trials were completed and the reports were submitted to the regulator. "Doctors receiving Covaxin are made to give an undertaking that its clinical efficacy is yet to be established," said the association's president Dayanand Sagar in the letter. In an oblique reference to the association's letter and the concerns of the doctors, Sudhakar said that maximum number of Covid warriors took the vaccine on Sunday across the state and no side-effects were reported since then. According to the state health department, 66,392 healthcare workers have been vaccinated till Monday across the state, accounting for 49 per cent of the targeted beneficiaries. --IANS fb/arm

K'taka health minister defends Covaxin, says it's safe

<keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>'s first indigenous vaccine against COVID-19, <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword>, is safe and generates immune response without any serious side effects, according to the interim results of the phase 2 trials published in The <keyword id="6361830" type="COMPANY" weightage="20" keywordseo="lancet">Lancet</keyword> Infectious Diseases journal. The authors of the study noted that the phase 2 results did not asses the efficacy of the vaccine codenamed BBV152. Developed by <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> in collaboration with the Indian Council of Medical Research (ICMR) and the <keyword id="6375751" type="COMPANY" weightage="20" keywordseo="national-institute-of-virology">National Institute of Virology</keyword> (NIV), Pune, the vaccine has been granted emergency use authorisation in clinical trial mode by the Indian government. Covaxin had initially raised concerns among experts over its emergency approval by India's drug regulator. The latest study comes a week after Bharat Biotech announced that the vaccine has shown 81 per cent efficacy in the third phase of clinical trials, the results of which are yet to be published. The phase 2 trial to evaluate the immunogenicity and safety of BBV152 vaccine was conducted in healthy adults and adolescents aged 12-65 years at nine hospitals across nine states in India. Two intramuscular doses of vaccine were administered on day 0 and day 28. The primary outcome was assessed in all participants who had received both doses of the vaccine. Safety was assessed in participants who received at least one dose of the vaccine. Between September 5 and 12, last year, 921 potential participants were screened, 380 of whom were enrolled. "We report interim findings of the phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose on day 28," the authors of the study said. In the phase 1 trial, published in the same journal last month, BBV152 induced high neutralising antibody responses that remained elevated in all participants three months after the second vaccination. In the phase 2 trial, BBV152 showed better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses -- two main mechanisms within the adaptive immune system -- compared with the phase 1 trial. Adaptive immunity occurs after exposure to an antigen either from a pathogen or a vaccination. Reactogenicity refers to the property of a vaccine of being able to produce common, adverse reactions, especially excessive <keyword id="1441458" type="DOMAIN" weightage="20" keywordseo="immunological">immunological</keyword> responses and associated signs and symptoms, including fever and sore arm at the injection site. Covaxin is an inactivated vaccine developed by chemically treating novel coronavirus samples to make them incapable of reproduction. This process leaves the viral proteins, including the spike protein of the coronavirus, which it uses to enter the human cells, intact. Given as two doses, three weeks apart, the viral proteins in the vaccine activate the immune system and prepare people for future infections with the actual infectious virus. "The results reported in this study do not permit efficacy assessments. The evaluation of safety outcomes requires extensive phase 3 clinical trials," the authors of the Lancet study said. "We were unable to assess other immune responses in convalescent serum samples due to the low quantity," they said. Even though direct comparisons between the phase 1 and 2 trials cannot be made, the reactogenicity assessments reported in this study were substantially better in the phase 2 trial than the phase 1 trial and other trials with a placebo group, according to the authors. Also, the proportion of participants reporting adverse events in the phase 2 trial were lower than in the phase 1 trial, they noted. "This study enrolled a small number of participants aged 12-18 years and 55-65 years. Follow-on studies are required to establish immunogenicity in children and in those aged 65 years and older," the authors added. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/craftsman-automation-has-fixed-a-price-band-of-14881490-a-share-for-its-150-crore-ipo/articleshow/81408729.cms">Auto components maker Craftsman Automation’s ₹150 crore IPO to hit the capital markets next week — price band fixed at ₹1,488–1,490</a> <a href="https://www.businessinsider.in/india/news/india-is-using-the-quad-alliance-to-get-help-from-the-us-japan-and-australia-to-match-chinas-covid-19-vaccine-push/articleshow/81408044.cms">India is asking the QUAD for money to boost vaccine production and counter China’s moves on the global stage</a> <a href="https://www.businessinsider.in/business/corporates/news/elon-musks-net-worth-has-eroded-60-billion-in-just-two-months-as-teslas-market-cap-falls-35/articleshow/81407453.cms">Elon Musk’s wealth has eroded $60 billion in just two months as Tesla's market cap falls 35%</a>

Covaxin phase two data shows vaccine safe, induces immune response, says Lancet 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 "Covaxin side effects" and got 8 results

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