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The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation's (CDSCO) Subject Expert Committee and their next meeting will be held on January 1. The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII and Bharat Biotech Private Ltd. Further time was requested on behalf of Pfizer, while the additional data and information presented by the SII and Bharat Biotech was perused and analysed by the SEC. "The analysis of the additional data and information is going on. SEC will convene again on 1st January 2021 (Friday)," the Centre said in a statement. America's Pfizer was the first one to apply for the accelarated approval on December 4, followed by the SII and Bharat Biotech who applied on December 6 and 7, respectively. On December 9, the Subject Expert Committee had asked the SII and Bharat Biotech to submit more data and information to get approval. The expert panel had then recommended the SII to submit outcome of the assessment of UK regulatoe for grant of emergency use approval, the updated safety data of the Phase 2/3 clinical trial and immunogenicity data from the clinical trials in UK and India. Bharat Biotech was recommended to present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration. Their applications were reviewed again earlier on Wednesday, hours after the UK accepted the recommendation of the Medicines and Healthcare Regulatory Agency (MHRA) to authorise Oxford University-AstraZeneca's Covid-19 vaccine, named Covishield, for emergency use. The authorization was significant for India as the Pune-based SII had tied up with the company to conduct clinical trials and manufacture the vaccine. Besides, Bharat Biotech is developing country's indigenous coronavirus vaccine - Covaxin - in collaboration with the Indian Council of Medical Research. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities. Covishield uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the coronavirus if it later infects the body. The vaccine can be stored, transported and handled at normal refrigerated conditions at two to eight degrees Celsius for at least six months and administered within existing healthcare settings. Its interim analysis for efficacy showed that the vaccine was 70.4 per cent effective at preventing symptomatic COVID-19 occurring more than 14 days after receiving two doses of the vaccine. The SII has already made 40 to 50 million doses of the shot. "We have 40-50 million doses of Covishield stockpiled. We will be producing around 300 million doses by July 2021," its CEO Adar Poonawalla had recently said. Besides this, Bharat Biotech's Covaxin is India's indigenous vaccine and is being developed in collaboration with the ICMR's National Institute of Virology. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility SEE ALSO: <a href="https://www.businessinsider.in/personal-finance/income-tax/news/income-tax-returns-filing-deadline-extended-to-january-10/articleshow/80029154.cms">Relief for taxpayers: Deadline to file income tax returns extended further to January 10</a> <a href="https://www.businessinsider.in/science/health/news/uk-approves-oxford-astrazeneca-covid-19-vaccine-for-emergency-use/articleshow/80023778.cms">UK approves Oxford-AstraZeneca COVID-19 vaccine</a> <a href="https://www.businessinsider.in/tech/apps/news/google-is-testing-a-shortcut-feature-for-tiktok-and-instagram-videos/articleshow/80021865.cms">Google is testing a shortcut feature for TikTok and Instagram videos</a>.

India continues to mull over SII and Bharat Biotech's COVID-19 vaccine candidates

<keyword id="15862275" type="General" weightage="20" keywordseo="Bharat-Biotechs-intranasal-Covid-vaccine" source="Orion">Bharat Biotech's intranasal Covid vaccine</keyword> has been approved by the Union Health Ministry for inclusion in the vaccination programme as a booster dose for those above 18 years of age, official sources said on Thursday. The needle-free vaccine will be available at private centres. It will be introduced on the Co-WIN platform on Friday evening, they said. The <keyword id="383216" type="General" weightage="20" keywordseo="nasal-vaccine" source="Orion">nasal vaccine</keyword> -- BBV154 -- received approval of the Drugs Controller General of India in November for restricted use in an emergency situation for those above 18 as a heterologous booster dose. The approval for the vaccine comes amid a spurt in <keyword id="8764262" type="General" weightage="100" keywordseo="covid" source="Orion">Covid</keyword> cases in China and some other countries. Prime Minister Narendra Modi had on Thursday cautioned people against complacency and urged them to wear masks in crowded places, while also directing officials to strengthen surveillance measures, especially at international airports. SEE ALSO: <a href="https://www.businessinsider.in/international/news/police-officers-were-seen-guarding-a-crematorium-in-beijing-amid-reports-of-overflowing-funeral-homes-due-to-a-resurgence-in-covid-infections-bloomberg/articleshow/96369408.cms">Police officers were seen guarding a crematorium in Beijing amid reports of overflowing funeral homes due to a resurgence in COVID infections: Bloomberg</a> <a href="https://www.businessinsider.in/india/news/pm-modi-to-review-covid-19-situation-at-high-level-meeting-today/articleshow/96417240.cms">PM Modi to review Covid-19 situation at high-level meeting today</a> <a href="https://www.businessinsider.in/science/health/3-cases-of-omicron-subvariant-bf-7-driving-chinas-covid-surge-detected-in-india/articleshow/96397261.cms">3 cases of Omicron subvariant BF.7, driving China's Covid surge, detected in India</a>

Bharat Biotech's intranasal Covid vaccine approved by govt, to be available on CO-WIN

(Eds: With file pics) Hyderabad, Two major vaccine makers from Hyderabad, <keyword id="1379126" type="General" weightage="20" keywordseo="Biological-E" source="Orion">Biological E</keyword> Ltd and <keyword id="149108" type="General" weightage="100" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword>, together are holding about 250 million doses of COVID-19 vaccines ready to dispatch as and when orders are received. According to respective company sources, Biological E is holding 200 million doses of its COVID-19 vaccine <keyword id="11370342" type="General" weightage="80" keywordseo="corbevax" source="Orion">Corbevax</keyword> while Bharat Biotech is sitting on a stockpile of 50 million doses of Covaxin. Dr Vikram Paradkar, Executive Vice President (Manufacturing), Biological E, said the firm produced about 30 crore doses of Corbevax in total, abiding by the vaccine manufacturing commitment to the Central government. In March '22, Biological E successfully supplied 10 crore doses to the government. "Currently, we have approximately 20 crore (200 million) doses that are fully tested and ready for supply, as and when we receive orders. Additionally, we manufactured 20 crore doses equivalent of the antigen which will help us ramp up the manufacturing of the Corbevax finished product quickly," Paradkar told PTI. The vaccine has been developed by Biological E in collaboration with Texas Children's Hospital Center for Vaccine Development (Texas Children's CVD) and Baylor College of Medicine (Baylor) in Houston, Texas, USA. He further said Biological E can begin with the additional vaccine supplies within eight weeks of future orders and can manufacture and supply approximately 10 crore doses of Corbevax on a monthly basis as per its qualified manufacturing capacity. Bharat Biotech sources said the vaccine maker has more than 50 million doses of Covaxin readily available in vials, and over 200 million doses as drug substance. "Additional production capacity is also available to meet product demand," they said adding fresh stocks of the vaccine are available and ready for supplies. Covaxin, India's indigenous COVID-19 vaccine, was developed in collaboration with the <keyword id="6364555" type="General" weightage="50" keywordseo="indian-council-of-medical-research" source="Orion">Indian Council of Medical Research</keyword> (ICMR) - National Institute of Virology (NIV). Due to lack of product demand, production stoppage of Covaxin was initiated earlier this year and also the 50 million doses in vials are set to expire during early 2023, resulting in losses to the company, sources had earlier said. SEE ALSO: <a href="https://www.businessinsider.in/india/news/rise-in-active-covid-19-cases-in-bihar-no-need-for-panic-says-expert/articleshow/96561025.cms">Rise in active COVID-19 cases in Bihar; no need for panic, says expert</a> <a href="https://www.businessinsider.in/science/health/news/covid-19-nasal-vaccine-bharat-biotechs-incovacc-is-the-first-approved-intranasal-vaccine-in-the-world/slidelist/96542239.cms">All you need to know about the world’s first Covid-19 nasal vaccine - iNCOVACC</a>

Biological E, Bharat Biotech together sitting on stockpile of 250 million COVID vaccine doses

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

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

The Drugs Controller General of <keyword id="3658" type="General" weightage="50" keywordseo="india" source="Orion">India</keyword> (DCGI) on Tuesday approved the restricted emergency use authorisation (EUA) to Bharat Biotech's Covaxin for children between the age of 6-12 years, sources said. The <keyword id="704367" type="General" weightage="50" keywordseo="dgci" source="Orion">DGCI</keyword> has asked vaccine manufacturer to submit safety data including the data on adverse event with due analysis every 15 days for the first two months and monthly thereafter upto 5 months, said the source familiar with the development. This development comes after the <keyword id="3923779" type="General" weightage="50" keywordseo="subject-expert-committee" source="Orion">Subject Expert Committee</keyword> (<keyword id="6362470" type="General" weightage="80" keywordseo="sec" source="Orion">SEC</keyword>) discussed recommendations for the restricted emergency use of Covaxin in children aged between 2-12 years. However, the SEC, after a meeting on Thursday, had recommended restricted emergency use of Biological E's Covid-19 vaccine, Corbevax, in children aged 5-12 years. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/politics/india/news/real-time-payments-are-forecast-to-boost-indian-gdp-by-us-45-9-billion-in-2026/articleshow/91093163.cms">Real-time payments are forecast to boost Indian GDP by US $45.9 billion in 2026</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/25-40-of-people-with-covid-19-develop-long-covid-reporting-symptoms-that-affect-multiple-organs-and-cause-mental-health-issues-study/articleshow/91093962.cms">25-40% of people with COVID-19 develop long Covid, reporting symptoms that affect organs and cause mental health issues : Study</a>

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

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

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

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

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

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

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

<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>

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

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

The interim findings of phase 1 clinical trial of COVID-19 vaccine <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword>, indigenously developed by <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> in collaboration with the ICMR, showed that it was was well tolerated in all dose groups with no serious or adverse events. The vaccine induced robust binding and neutralising antibody responses which were comparable to those observed in the convalescent serum collected from patients who had recovered from COVID-19, according to the findings which have appeared on medRxiv, a preprint server. A preprint is a version of a scientific manuscript posted on a public server prior to formal peer review. One serious adverse event was reported, which was found to be unrelated to vaccination, the findings showed. It was a double-blind randomised controlled phase 1 clinical trial to evaluate the safety and immunogenicity of Covaxin (BBV152). The document mentions that BBV152 is stored between 2 degrees Celsius and 8 degrees Celsius, which is compatible with all national immunisation programme cold chain requirements and further efficacy trials are underway. According to the "A Phase 1: Safety and Immunogenicity Trial of an Inactivated SARS-CoV-2 Vaccine BBV152", after the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved rapidly, without any prescribed medication. A similar trend was observed after the second shot was administered. Pain at the injection site was the most common local adverse event. "One serious adverse event was reported. The participant was vaccinated on July 30. Five days later, the participant reported symptoms of COVID-19 and was found to be positive for SARS-CoV-2," according to the findings. "The symptoms were mild in nature, but the patient was admitted to the hospital on August 15. The participant was discharged on August 22 following a negative nucleic acid result. The event was not causally associated with the vaccine," the findings showed. To ensure generalisability, the trial was conducted on volunteers from diverse geographic locations and socioeconomic conditions, enrolling 375 participants across 11 hospitals. "Despite the fact that enrolment occurred during a national lockdown, which led to several operational challenges, the overall participant retention rate was 97 per cent," the findings showed. The sample size was intentionally large to enable the inference of meaningful conclusions regarding immunogenicity and safety, the document said. BBV152 induced robust binding and neutralising antibody responses that were similar to those induced by other SARS-CoV-2 inactivated vaccine candidates, it said. Two doses of the vaccine were administered at a volume of 0.5 mL/dose intramuscularly on days zero and 14. The follow-up visits were scheduled on days 7, 28, 42, 104, and 194. SEE ALSO: <a href="https://www.businessinsider.in/thelife/personalities/news/facebook-ceo-mark-zuckerberg-and-reliance-industries-mukesh-ambani-spoke-but-had-no-chemistry/articleshow/79739547.cms">Zuckerberg spoke to Ambani but there was no chemistry — even with a multi-million dollar partnership between them</a> <a href="https://www.businessinsider.in/defense/news/india-inaugurates-new-railway-line-with-bangladesh-to-save-its-chickens-neck-from-china-on-vijay-diwas/articleshow/79750869.cms">After 55 years, India will inaugurate a new railway line with Bangladesh to save its ‘Chicken’s Neck’ from China</a> <a href="https://www.businessinsider.in/science/environment/news/supercomputer-shows-tropical-cyclones-hitting-india-are-going-get-more-destructive-that-is-until-the-flooding-starts/articleshow/79764803.cms">Supercomputer shows tropical cyclones hitting India are going get more destructive — that is until the flooding starts</a>

Bharat Biotech's COVID-19 vaccine COVAXIN is well tolerated with no serious adverse events as per phase 1 trial results

<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>

You Searched For "bharat biotech covid 19 vacine" and got 12 results

India continues to mull over SII and Bharat Biotech's COVID-19 vaccine candidates

IANS

Bharat Biotech's intranasal Covid vaccine approved by govt, to be available on CO-WIN

PTI

Biological E, Bharat Biotech together sitting on stockpile of 250 million COVID vaccine doses

PTI

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

IANS

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

IANS

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

PTI

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

IANS

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

IANS

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

Shambhavi Naik

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

PTI

Bharat Biotech's COVID-19 vaccine COVAXIN is well tolerated with no serious adverse events as per phase 1 trial results

PTI

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

PTI

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