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<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

<ul class="summary-list"><li>Michael McCaman cofounded a small biotech business when he was 68.</li><li>Many baby boomers like him are starting businesses late in life for things like more flexibility.</li></ul>For nearly a decade, Michael McCaman had an idea for a company — he just needed the right opportunity.Two years ago, when he was 68, that opportunity arose: McCaman cofounded Orion Therapeutics, a small company developing new ways for RNA medicine to reach specific areas of the human body.McCaman is among the older Americans who are rethinking retirement and starting businesses instead. Among people 55 and older who started a business in 2023, 44% said they wanted more flexibility in their work schedule, and 41% said they believed they had a business opportunity, according to data shared with Business Insider by Gusto, a payroll services company for small businesses.Gusto surveyed 1,345 new business owners of all ages between late January and early March using its payroll platform.McCaman, now 70, is the vice president and chief strategy officer at Orion Therapeutics. McCaman said Orion's biotech field is risky yet meaningful and received particular interest after the development of the COVID-19 vaccines.He works remotely outside Frederick, Maryland, while the rest of his team is based in Knoxville, Tennessee. McCaman is passionate about staying engaged with his interests and said remote work has enabled him to extend his career."Call it semi-retired if you want," McCaman said. "It's actually a fun time to sit back and go, 'Okay, what can I do? What is still fun to do?'"<h2 id="9a46e042-ed02-4896-8c3e-d646c14d1cd5">Starting a business at 68 and finding purpose in 'semi-retirement'</h2>McCaman studied chemistry at the University of California San Diego before earning his Ph.D. in biochemistry from the University of California, Davis. He enjoyed a decadeslong career working in biotech in California.Yet, in 2011, McCaman was looking for a new job and said he needed a change. McCaman and his wife packed up their things and drove across the country, with McCaman chasing potential job offers.That year, he landed a position at Lonza, a manufacturing company in Maryland, where he worked as head of cell development. After four years, he switched jobs again. From 2015 until 2020, McCaman was vice president of process development at Intellia Therapeutics, a biotech company.He said his time at Intellia reinvigorated his passion for scientific research, and in March 2020, McCaman quit his job and began consulting."As the consulting picked up, it was like, 'Oh, the world is still out there, and I can be a part of it,'" he said.In 2021, McCaman met Trey Fischer, then a recent Ph.D. graduate at the University of Tennessee. McCaman and Fischer launched Orion with Deidra Mountain, a University of Tennessee professor, and Jennifer Zachry, a graduate student.McCaman put up the first $10,000 investment for Orion and, in July, the company <a target="_blank" href="https://www.knoxnews.com/story/news/local/2024/07/09/university-of-tennessee-chooses-orion-therapeutics-first-for-5m-fund/74330014007/">received $300,000</a> from the University of Tennessee Research Foundation and Launch Tennessee, a nonprofit that supports tech startups in the state. The $300,000 is part of a $5 million fund to fuel startups that help bring research from the University of Tennessee to the market.However, McCaman is not on the payroll. He said he earns enough from his consulting work and prefers to keep Orion's budget lean.Orion is his passion project, and he said he hopes the company takes off so colleagues like Fischer can develop it into a full-time career."I think being part of a movement — it's not a political movement, it's a technology movement — but being an enthusiast and being a participant, there's just an adrenaline rush," he said.<h2 id="62a2c296-35a1-4ac7-bb15-320810351430">Working into his 70s makes him feel active</h2>McCaman said the experience of working in his 70s helps him feel mentally engaged. Additionally, working at Orion gives him an opportunity to mentor and work with a younger generation.Working remotely also gives him work-life balance, something he feels passionate about after recent health crises. In 2022, McCaman was hit by a motorcyclist while he was riding a John Deere lawnmower. McCaman broke both of his legs and said he needed a wheelchair for months. While recovering, he was diagnosed with prostate cancer, which has since been treated, and in February, he had a stroke.Working at Orion also lets McCaman set his own schedule so he can build in time for family, like his grandchildren.McCaman said he doesn't have a retirement date in sight. He said it's hard to stop when he's passionate about what he does."I can't run the mile the way I used to, so I'll walk that mile," he said. "But I'll still do it, and I'll still go see things."Are you a baby boomer who founded a small business? This reporter wants to hear your story. Please reach out at <a target="_blank" class="" href="mailto:jtowfighi@businessinsider.com">jtowfighi@businessinsider.com</a>

A 68-year-old cofounded a biotech business instead of retiring. He's not getting paid for his work but values staying 'mentally engaged.'

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

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

<ul><li>Hyderabad-based <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> released phase 3 results of its Covid-19 vaccine — Covaxin — today</li><li>Covaxin is one of two coronavirus vaccines approved by the India drug regulator.</li><li>Earlier, the Indian drug regulator's approval triggered a row of criticism from experts pointing to a lack of efficacy data at that time.</li><li>Check out the latest news and updates on <a href="https://www.businessinsider.in/">Business Insider</a>.</li></ul>Hyderabad-based Bharat Biotech released phase 3 results of its Covid-19 vaccine — Covaxin — today. The vaccine demonstrated 81% interim efficacy in preventing COVID-19, in those without prior infection, after the second dose. "Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of Covaxin in additional secondary study endpoints," the company said in a statement. <table style="border-width: initial; border-style: none;"></colgroup><tbody><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Vaccines </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Efficacy rate </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">SII’s Covishield </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">62% </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Moderna’s COVID-19 vaccine </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">92.10% </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Pfizer’s COVID-19 vaccine </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">91.60% </td></tr></tbody></table> This comes two days after Indian Prime Minister Narendra Modi was administered a dose of Covaxin as he kicked off the largest phase of COVID-19 vaccination in India. Covaxin is one of two coronavirus vaccines approved by the India drug regulator. The drug had earlier received clearance for emergency use. Bharat Biotech conducted a study on 25,800 participants who received a vaccine or placebo in a 1:1 ratio. The results showed that the vaccine candidate was well tolerated. It conducted the trials in partnership with India’s medical research organisation, ICMR. Earlier, the Indian drug regulator's approval triggered a row of criticism from experts pointing to a lack of efficacy data at that time. The Drugs Controller General of India (DCGI) also came under flak from various quarters for approving Covaxin even before the completion of Phase 3 trials. Critics wondered how the regulator could approve the vaccine in the absence of the data from Phase 3. Allaying the apprehensions associated with the vaccine's safety, S. Eswara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organisation (CDSCO), had then clarified that Covaxin has satisfactory efficacy levels and there is nothing to worry about. Indicating at Covaxin's efficacy meeting the WHO standard, Reddy <a href="https://www.businessinsider.in/india/news/covaxin-efficacy-meets-who-standards-safe-to-use-joint-drugs-controller/articleshow/80305797.cms">had then said,</a> "We assure that the vaccine is safe and the efficacy (of Covaxin) is to the satisfaction." The country has so far <a href="https://www.businessinsider.in/india/news/citizens-face-issues-in-availability-of-slots-and-major-technical-glitches-on-the-co-win-app-as-india-kicks-off-its-largest-vaccination-drive-ever/articleshow/81294033.cms">administered </a>nearly 1.48 crores doses of COVID-19 vaccines. SEE ALSO: <a href="https://www.businessinsider.in/tech/news/instagram-accidentally-hid-likes-for-some-users-after-expanding-long-running-test-feature-says-cnn-report/articleshow/81308217.cms">Instagram accidentally hid likes for some users after expanding long-running test feature, says CNN report</a><a href="https://www.businessinsider.in/tech/news/instagram-accidentally-hid-likes-for-some-users-after-expanding-long-running-test-feature-says-cnn-report/articleshow/81308217.cms"></a> <a href="https://www.businessinsider.in/careers/news/paypal-which-had-shut-down-domestic-operations-in-india-now-plans-to-hire-1000-engineers/articleshow/81307572.cms">PayPal, which had shut down domestic operations in India, now plans to hire 1,000 engineers</a>

Bharat Biotech’s Covaxin shows 81% efficacy after second dose in phase 3 trials

The <keyword id="83655" type="General" weightage="50" keywordseo="union-health-ministry" source="Orion">Union Health Ministry</keyword> on Thursday rejected media reports that <keyword id="9485939" type="General" weightage="100" keywordseo="covaxin" source="Orion">Covaxin</keyword> manufacturer <keyword id="149108" type="General" weightage="80" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword> skipped certain processes and accelerated clinical trials due to political pressure, calling them "completely misleading, fallacious and ill-informed". "The government of India and the national regulator Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="80" keywordseo="cdsco" source="Orion">CDSCO</keyword>) have followed a scientific approach and prescribed norms in approving the Covid-19 vaccines for emergency use authorization," the Ministry said. The media reports had claimed that Bharat Biotech, manufacturer of the indigenous Covaxin, "had to skip certain processes" and "speed" up clinical trials due to political pressure. They also alleged that there were several irregularities in the three phases of the clinical trials. The Ministry said that the Subject Expert Committee (<keyword id="6362470" type="General" weightage="80" keywordseo="sec" source="Orion">SEC</keyword>) of CDSCO met on January 1-2, 2021 and after due deliberations, made the recommendations in respect of the proposal for Restricted Emergency Approval of the vaccine. "Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains," it added. The SEC's approval for the commencement of phase 3 clinical trial of the proposed dose of Covaxin was based on scientific data and established practices in this regard. "Moreover, the purported unscientific changes' in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI." The Ministry added that based on the further submission made by Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of the vaccine in 'clinical trial mode' was removed on March 11, 2021. "Authorisation of Covid-19 vaccines, including Covaxin, for restricted use in an emergency situation with various conditions and restrictions was granted by the national regulator only on the recommendations of the SEC. "The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, and internal medicine," it added. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/novel-artificial-enzymes-could-help-kill-covid-virus-study/articleshow/95575741.cms">Novel artificial enzymes could help 'kill' Covid virus: Study</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/eating-disorders-can-be-detected-earlier-using-electrolytes-as-diagnostic-tool/articleshow/95573008.cms">Eating disorders can be detected earlier using electrolytes as diagnostic tool</a>

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

The 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

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

<ul><li>The Indian government is booking 300 million doses of <keyword id="11371132" type="UNKNOWN" weightage="20" keywordseo="biological-e">Biological-E</keyword>’s <keyword id="8904563" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine">COVID-19 vaccine</keyword> in advance in the face of a massive shortage.</li><li>Biological-E’s candidate will be the second ‘made-in-India’ <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> to hit the market after <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>.</li><li>The government is shelling out a massive ₹1500 crore to secure the doses.</li></ul>In a bid to meet the increasing demand for the Coronavirus vaccine, the Indian government is shelling out ₹1,500 crore to secure 300 million doses of Biological-E’s COVID-19 vaccine in advance. The price of Biological-E’s vaccine is not publicly known, but according to the company, it is aiming to be one of the ‘<a href="https://www.timesnownews.com/india/article/bcm-biological-e-vaccine-will-be-robust-against-multiple-covid-19-variants-dr-peter-hotez/764275">most affordable</a>’ options in the country. This will be the second domestically developed vaccine to hit the market, once approved, after Bharat Biotech’s Covaxin. The vaccine candidate, which is modelled after the Hepatitis E vaccine, is currently undergoing Phase III of its clinical trials. “The proposal of M/s Biological-E was examined and recommended for approval after due diligence by National Expert Group on Vaccine Administration for COVID-19 (NEGVAC),” said the <keyword id="191419" type="COMPANY" weightage="20" keywordseo="Ministry-of-Health-and-Family-Welfare">Ministry of Health and Family Welfare</keyword> (MoHFW) in a statement. Biological-E is developing the vaccine in association with the Baylor College of Medicine in the US and already has two agreements in place to manufacture the vaccine in India — one with Canada-based Providence Therapeutics Holdings and another with <keyword id="92247" type="COMPANY" weightage="20" keywordseo="Johnson-Johnson">Johnson &amp; Johnson</keyword>. Bharat Biotech and the <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII) also received advances to book vaccine doses for the Indian government, but that was only after the nation-wide vaccine drive was in full swing in April. According to India’s Ministry of Health and Family Welfare (MoHFW), the Hyderabad-based pharmaceutical company will start manufacturing and stockpiling doses somewhere between August and December 2021. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/news/huawei-announces-first-devices-with-harmonyos-set-to-take-on-apple-and-google-with-its-in-house-operating-system/articleshow/83195689.cms">Huawei announces first devices with HarmonyOS — set to take on Apple and Google with its in-house operating system</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/mobile/news/oneplus-nord-ce-5g-mobile-phone-full-specifications-leaked-days-ahead-of-launch/articleshow/83195375.cms">OnePlus Nord CE 5G full specifications leaked days ahead of launch – heavily inspired by the original Nord</a>

You Searched For "bharat biotech developed vaccine" and got 11 results

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

A 68-year-old cofounded a biotech business instead of retiring. He's not getting paid for his work but values staying 'mentally engaged.'

John Towfighi

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

PTI

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

PTI

Bharat Biotech’s Covaxin shows 81% efficacy after second dose in phase 3 trials

BI India Bureau

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

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

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

PTI

The Indian government is doling out ₹1500 crore to reserve 300 million of Biological-E’s COVID-19 vaccine doses

Prabhjote Gill

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