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After <keyword id="10394836" type="COMPANY" weightage="20" keywordseo="pfizer-and-serum-institute">Pfizer and Serum Institute</keyword>, Hyderabad-based <keyword id="10395449" type="UNKNOWN" weightage="20" keywordseo="pharmaceutical-firm-bharat-biotech">pharmaceutical firm Bharat Biotech</keyword> on Monday applied to the central drug regulator seeking emergency use authorisation for its <keyword id="9624640" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine-covaxin">COVID-19 vaccine Covaxin</keyword>, official sources said. Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The Hyderabad-based firm is conducting <keyword id="9510106" type="UNKNOWN" weightage="20" keywordseo="phase-3-clinical-trial">phase-3 clinical trial</keyword> of its vaccine in around 25 places, including Delhi, Mumbai, Patna and Lucknow. The firm, while applying for the phase-3 trial, had stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported. The most common adverse event was transient pain at the injection site, a source said. The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials. An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of <keyword id="10313366" type="COMPANY" weightage="20" keywordseo="pfizer-serum-institute-of-india">Pfizer, Serum Institute of India</keyword> and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates. At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. The Serum Institute sought the nod for the Oxford COVID-19 vaccine, <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>, on December 6. "DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said. PLB SMN SMN

Bharat Biotech applies for emergency use approval for its COVID-19 vaccine Covaxin

An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of <keyword id="44612" type="COMPANY" weightage="20" keywordseo="Pfizer">Pfizer</keyword>, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> candidates, official sources said on Monday night. The decision was taken late on Monday evening after the Hyderabad-based Bharat Biotech became the <keyword id="10394896" type="UNKNOWN" weightage="20" keywordseo="third-pharmaceutical-firm">third pharmaceutical firm</keyword> to apply to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously developed COVID-19 vaccine <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword>. The Indian arm of US pharmaceutical giant Pfizer had on December 4 sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. The Pune-based Serum Institute of India sought such a nod for the Oxford COVID-19 vaccine, <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>, on December 6. "DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said. At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/oxford-covid-19-vaccine-serum-institute-seeks-emergency-use-nod-for-covishield-vaccine-in-india/articleshow/79600349.cms" data-type="tilCustomLink">Oxford COVID-19 vaccine: Serum Institute seeks emergency use nod for Covishield vaccine in India</a> <a href="https://www.businessinsider.in/india/news/section-144-extended-across-noida-and-greater-noida-till-january-2/articleshow/79600323.cms" data-type="tilCustomLink">Section 144 extended across Noida and Greater Noida till January 2</a>

COVID-19 vaccine in India: Expert panel to review Pfizer, Serum and Bharat Biotech's emergency use application tomorrow

New Delhi, Nov 19 () Private equity firm Advent International has signed an agreement to acquire a majority stake in biopharmaceutical firm Bharat Serums and Vaccines.
 "With this transaction, OrbiMed PE and Kotak PE, two private equity firms that previously held minority positions in Bharat Serums, will fully exit their investments in the company," Advent International said in a statement.
 The Daftary family, which founded Bharat Serums and Vaccines (BSV), is retaining a 'meaningful equity' stake in the business and is partnering with Advent on the company's next stage of growth, it added.
 The acquisition is expected to close by the end of this year, Advent International said.
 The company however did not disclose the financial terms of the definitive agreement.
 "Drawing on our deep experience in pharmaceuticals and our global platform, we see significant opportunity to further strengthen the company's leadership position in India, particularly in women's health, and scale its presence in emerging markets around the world," Shweta Jalan, Managing Director and Head of India at Advent International said.
 Advent's high level of investment activity in India this year demonstrates the attractiveness of the market and Advent's commitment to investing here, she added.
 "The partnership with Advent is another major milestone in BSV's growth story," Gautam V Daftary, a member of the founding family of Bharat Serums said.
 Innergize Solutions acted as strategic advisor to BSV on the transaction, the statement said.
 Founded in 1971, in Mumbai, Bharat Serums is a biopharmaceutical companies in India. BSV researches, develops, manufactures and markets specialised injectable medicines with a portfolio focused on biotech and biological products. AKT DRR

Advent International to acquire majority stake in Bharat Serums and Vaccines

<ul><li>Early trials show that Chinese COVID vaccine, CoronaVac triggers a quick immune response</li><li>Vladimir Putin calls for a joint effort by the BRICS countries on the development of the coronavirus vaccines, suggesting that Sputnik V vaccine could be produced in China and India.</li><li>Moderna’s COVID-19 vaccine shows over 94% efficacy, Indian government is in talks with the US biotech giant.</li><li>Vaccine maker Bharat Biotech has started Phase III trials of Covaxin, India's first indigenous vaccine for COVID-19.</li></ul>After registering over 48 million COVID-19 infections, the World Health Organisation is <a href="https://www.livemint.com/science/health/who-expects-to-see-covid-19-vaccine-by-end-of-2020-at-earliest-11602548070399.html">finally expecting</a> a COVID-19 vaccine by the end of 2020 or early 2021. It takes a decade or two to design, test, and launch an effective vaccine that can protect billions of people from diseases. However, COVID-19 has forced researchers to fast-track the vaccine making process. Here’s a look at COVID-19 vaccine updates from around the world — Early trials show that Chinese COVID vaccine, CoronaVac triggers a quick immune response Preliminary trial results show that Sinovac Biotech’s COVID-19 vaccine CoronaVac triggers a quick immune response. However the level of antibodies produced was lower than in people who recovered from the disease, <a href="https://in.reuters.com/article/us-health-coronavirus-sinovac/sinovacs-covid-19-vaccine-induces-quick-immune-response-study-idUSKBN27X354">Reuters </a>reported. The research that was published in a Lancet study shows that the vaccine is safe and could provide sufficient protection. Russian President: Sputnik V vaccine could be produced in India and China Russian President Vladimir Putin called for a joint effort by the BRICS countries on the development of the coronavirus vaccines as he suggested that Russia's Sputnik V vaccine against COVID-19 could be produced in China and India, which are members of the five-nation bloc. "We believe it is important to speed up the establishment of the centre for development and research of BRICS vaccines, which we agreed to do two years ago, upon the initiative of our South African friends," Putin said while addressing the 12th BRICS summit via videoconferencing. Moderna’s COVID-19 vaccine shows over 94% efficacy, Indian government is in talks with the US biotech giant. India is in dialogue with the US-based biotech giant Moderna over the progress in the clinical trials of its coronavirus vaccine candidate, which the firm said has shown 94.5 percent efficacy, official sources said on Monday. "We are in dialogue not only with Moderna, but also with Pfizer, Serum Institute, Bharat Biotech and Zydus Cadila over the progress of the clinical trials of each of the vaccine candidates and where their vaccines stand in terms safety, immunogenicity and efficacy, and regulatory approvals," a source said. On Monday, <a href="https://www.businessinsider.in/science/health/news/moderna-says-its-coronavirus-vaccine-is-94-5-effective-against-covid-19-a-crucial-victory-in-the-fight-against-the-pandemic/articleshow/79247349.cms">Moderna </a>said that its vaccine candidate against COVID-19 was found to have an efficacy of 94.5 percent. Bharat Biotech begins phase III trials for Covaxin Vaccine maker <a href="https://www.businessinsider.in/india/news/indias-first-vaccine-candidate-covaxins-phase-3-trials-begin/articleshow/79249854.cms">Bharat Biotech</a> has started Phase III trials of Covaxin, India's first indigenous vaccine for COVID-19. The Phase III trials, which involve 26,000 volunteers across India, are being conducted in partnership with the Indian Council of Medical Research (ICMR). According to a <a href="https://in.reuters.com/article/health-coronavirus-india-vaccine/exclusive-india-made-covid-19-vaccine-could-be-launched-as-early-as-february-government-scientist-idINKBN27L0WU">Reuters report</a>, Bharat Biotech COVAXIN could be launched as early as February as studies have so far shown it is safe and effective. Bharat Biotech had earlier hoped to launch it only in the second quarter of next year. EU signs a deal with German biotech firm CureVac According to a <a href="https://in.reuters.com/article/health-coronavirus-eu-curevac/eu-to-okay-deal-with-curevac-for-supply-of-up-to-405-million-covid-vaccines-idINKBN27W1Z5">Reuters </a>report, the European Union has signed a deal with German biotech firm CureVac to buy upto 405 million doses of its potential COVID-19 vaccine. European Commission President Ursula von der Leyen said this deal takes the total supplies secured by the bloc to nearly 2 billion doses. The deal with CureVac follows EU supply agreements with AstraZeneca, Johnson &amp; Johnson, Sanofi, and Pfizer for a combined 1.4 billion doses of their potential vaccines Pfizer’s COVID vaccine is 90% effective The latest data from t<a href="https://www.businessinsider.in/science/health/news/pfizers-covid-19-vaccine-is-90-effective-in-preventing-coronavirus-in-those-who-havent-been-infected-ever-before/articleshow/79130097.cms">he US pharmaceutical giant Pfizer</a> and German biotech firm BioNTech late-stage vaccine trial shows that their COVID-19 vaccine is <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against">90% more effective</a> in preventing infection if a person has never come in contact with it before. This means that those who get the vaccine will be protected within 28 days of the first dose — and there is only a two-dose schedule. Eli Lilly gets USFDA nod for COVID antibody drug in emergency use The US Food and Drug Administration (USFDA) on Monday has granted emergency approval to a synthetic <a href="https://www.bloombergquint.com/onweb/eli-lilly-covid-19-antibody-therapy-gets-emergency-fda-clearance">antibody treatment against COVID-19 developed by Eli Lilly</a>. The drug was shown to reduce the risk of hospitalization and emergency room visits. The drug, Bamlanivimab, is the first major drug to be approved that was designed specifically against the coronavirus. SEE ALSO:<a href="https://www.businessinsider.in/science/health/news/moderna-says-its-coronavirus-vaccine-is-94-5-effective-against-covid-19-a-crucial-victory-in-the-fight-against-the-pandemic/articleshow/79247349.cms" data-type="tilCustomLink"> Moderna says its coronavirus vaccine is 94.5% effective against COVID-19, a crucial victory in the fight against the pandemic</a> <a href="https://www.businessinsider.in/stock-market/news/dow-soars-375-points-to-near-record-as-modernas-vaccine-update-boosts-investor-optimism/articleshow/79249468.cms" data-type="tilCustomLink">Dow soars 450 points to new record as Moderna's vaccine update boosts investor optimism</a>

COVID-19 vaccine latest updates: Sinovac’s CoronaVac safe, early trial results show that vaccine triggers immune response

Hyderabad, Amid the gloom caused by COVID-19, one sector which provided a ray of hope was life sciences and turning the challenge into an opportunity, Hyderabad fortified its position as a global force in the world of pharmaceuticals. This southern city, already recognised as a global information technology destination, proved its prowess in the field of pharmaceuticals and biotechnology and emerged as the vaccine capital of the world. Already known as the bulk drug capital of India, Hyderabad witnessed manufacturing of lifesaving COVID-19 drugs like Remdesivir, Hydroxychloroquine and Favipiravir by some of the top pharma companies based here. This was followed by hectic efforts in the city to develop COVID-19 vaccine. In fact, Hyderabad has emerged as the nerve centre of all research and development activities in the country for COVID-19 vaccines and has even attracted international attention. Today, almost all the vaccines being developed in the country for the pandemic have a Hyderabad connect. Four of the six companies developing COVID vaccines in India are based in Hyderabad. <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> is currently conducting Phase III clinical trials of India's first indigenous COVID-19 vaccine Covaxin. Covaxin is being developed in collaboration with <keyword id="1256547" type="COMPANY" weightage="20" keywordseo="The-Indian-Council-of-Medical-Research">the Indian Council of Medical Research</keyword> (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is being developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility at Genome Valley here. According to Bharat Biotech, Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results. The Phase III human clinical trials of the vaccine began in November, involving 26,000 volunteers across India. This is India's first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. "Covaxin has garnered interest from several countries worldwide for supplies and introduction," said Suchitra Ella, Joint Managing Director of Bharat Biotech. In April, Bharat Biotech announced development of CoroFlu, an intranasal vaccine for <keyword id="8698690" type="COMPANY" weightage="20" keywordseo="coronavirus-">Coronavirus.</keyword> University of Wisconsin–Madison and vaccine company FluGen along with Bharat Biotech began the development and testing of CoroFlu. The Hyderabad based company will produce almost 300 million doses of vaccine for global distribution. In May, Bharat Biotech and Thomas Jefferson University of Philadelphia signed an exclusive deal to develop a new vaccine candidate for COVID-19 invented at Jefferson. The novel vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins. Bharat Biotech claimed to have excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications. The company has so far developed vaccines for H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world's first conjugated vaccine for Typhoid. It has delivered more than four billion doses of vaccines worldwide. It is also the largest Rabies vaccine manufacturer in the world. Another city-based firm Biological E last month initiated clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DCGI). BE is making the vaccine in collaboration with <keyword id="5289395" type="COMPANY" weightage="20" keywordseo="dynavax-technologies-corporation">Dynavax Technologies Corporation</keyword> (Dynavax), a US-based vaccine focused biopharmaceutical company, and <keyword id="503459" type="COMPANY" weightage="20" keywordseo="Baylor-College-of-Medicine">Baylor College of Medicine</keyword>, a health sciences university in Houston. Biological E has also signed an agreement with Johnson &amp; Johnson to produce the latter's vaccine at its vaccine production facilities and sell them both in India and export across various global markets. Indian Immunologicals, a human and animal vaccines maker, too is developing a vaccine for COVID. Hyderabad-based pahrma major Dr Reddy's Laboratories is conducting clinical trials of Russian COVID-19 vaccine, Sputnik V. Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, has collaborated with Dr Reddy's to conduct clinical trials and distribute the vaccine in India. Hyderabad was under spotlight with the recent visits by Prime Minister Narendra Modi and ambassadors of more than 60 countries to the facilities of Bharat Biotech and Biological E in Genome Valley Telangana's industry minister K. T. Rama Rao believes that Hyderabad has cemented its position as the vaccine capital of the world. He pointed out that Hyderabad is already manufacturing more than two billion doses of vaccines every year, which is one-third of the global vaccine output. The city, with its strong ecosystem, has played a critical role in making India not only self-sufficient in the medicine manufacture but also turned it into the pharmacy capital of the world. It accounts for 40 per cent of the total Indian bulk drugs and 50 per cent of the bulk drug exports. Industry leaders believe that Hyderabad will be an integral part of the global efforts to vaccinate the world against COVID. Even if no vaccine is developed in the city, the city will still have a big role to play in global vaccination efforts with the sheer vaccine manufacturing capacity it houses. Hyderabad has the largest US FDA approved vaccine facilities. They have the capacity to manufacture millions of doses with world-class standards. "India's vaccine sector will play a critical role in developing and producing vaccine at scale for distribution across the world. Hyderabad's importance in the global vaccine landscape is only growing," K.T. Rama Rao said. Telangana government has assured the companies that it will play the enabling role in global vaccination efforts against COVID-19. The Hyderabad airport announced few days ago that has developed necessary infrastructure to handle the exports. As per the industry insights, most of India's vaccine export will be to Africa, Latin America and Asian destinations. Hyderabad is already home to more than 800 life sciences companies and the sector employs over 1,20,000 pharmaceutical professionals. It is said to be the only city in the country to house more than 20 incubation centres focused only on life sciences and health-tech. More than 200 start-ups are also working on innovative solutions in healthcare. Genome Valley is India's first organised cluster for life sciences R&amp;D activities spread across 600 square kilometers. Set up in 1999, it has world-class infrastructure facilities in the form of <keyword id="10464926" type="COMPANY" weightage="20" keywordseo="industrial-/-knowledge">Industrial / Knowledge</keyword> parks, Special Economic Zones (SEZs), Multi-tenanted dry and wet laboratories and incubation facilities. It is home to more than 200 companies including presence of the marquee global names like Novartis, GlaxoSmithKline, Ferring Pharma, Chemo, DuPont, Ashland, United States Pharmacopeia and Lonza. With <keyword id="4920024" type="LOCATION" weightage="20" keywordseo="Hyderabad-Pharma-City">Hyderabad Pharma City</keyword> also likely to be operational soon, the city is looking to ramp-up production of Active Pharmaceutical Ingredients (APIs) and thus develop a cluster to help the country compete with China. The new project is expected to create 1,70,000 direct jobs and 5,60,000 indirect jobs. SEE ALSO: <a href="https://www.businessinsider.in/tech/enterprise/news/wistron-apple-iphone-manufacturer-could-face-these-penalties-if-found-guilty/articleshow/79790319.cms">If investigators find Wistron management guilty, here's what is at stake for the company</a> <a href="https://www.businessinsider.in/stock-market/news/heres-what-analysts-say-if-you-should-subscribe-or-not-to-the-300-crore-ipo-of-antony-waste-handling-cell/articleshow/79790998.cms">Antony Waste Handling Cell ₹300-crore IPO will open on Monday— these are the risks and opportunities</a> <a href="https://www.businessinsider.in/business/news/ikea-india-cfo-says-she-still-has-3500-crore-to-be-spent-in-india-the-pandemic-has-changed-targets-but-not-the-investment-plan/articleshow/79790938.cms">INTERVIEW: Ikea CFO says she still has ₹3,500 crore to be spent in India⁠— the pandemic has changed targets but not the investment plan</a>

Hyderabad : Vaccine capital of the world

<keyword id="6355226" type="LOCATION" weightage="20" keywordseo="brazil">Brazil</keyword> has suspended the clinical studies of <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s COVID-19 vaccine, <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> following termination of the company's agreement with its partner there, the South American Country's health regulator said. Bharat Biotech on Friday announced cancellation of the MoU it signed with <keyword id="11709868" type="UNKNOWN" weightage="20" keywordseo="precisa-medicamentos-and-envixia-pharmaceuticals">Precisa Medicamentos and Envixia Pharmaceuticals</keyword> LL.C for its COVID-19 vaccine Covaxin for the Brazilian market. The termination of the pact comes after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country. "In the Coordination of Clinical Research at Anvisa (<keyword id="11709869" type="UNKNOWN" weightage="20" keywordseo="copec/ggmed">Copec/GGMED</keyword>) determined this Friday (23/7) the precautionary suspension of clinical studies of the Covaxin vaccine in Brazil The suspension was carried out as a result of a statement from the Indian company Bharat <keyword id="11709867" type="UNKNOWN" weightage="20" keywordseo="biotech-limited-international">Biotech Limited International</keyword>, sent to Anvisa on Friday (23/7), Anvisa, the Brazilian health regulator, said on Friday. Precisa Medicamentos was <keyword id="10347805" type="COMPANY" weightage="20" keywordseo="bharat-biotechs">Bharat Biotechs</keyword> partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others. Following the graft allegations, the Brazilian government has suspended Covaxin's order temporarily. SEE ALSO - <a href="https://www.businessinsider.in/business/news/reliance-retail-the-cash-cow-for-mukesh-ambanis-ril-may-be-hit-by-the-second-wave-of-the-pandemic/articleshow/84644924.cms">Reliance Retail, the cash cow for Mukesh Ambani’s RIL, may be hit by the second wave of the pandemic</a> <a href="https://www.businessinsider.in/tech/news/zomato-paytm-sony-liv-disneyhotstar-down-as-massive-internet-outage-sweeps-across-many-countries/articleshow/84653441.cms">Zomato, Paytm, Sony LIV, Disney+Hotstar back up after glitch takes down internet</a>

Brazil suspends Covaxin trials, weeks after graft allegations surfaced

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

In a major shift of narrative, the government has now not disapproved the <keyword id="962031" type="PERSON" weightage="20" keywordseo="authorisation">authorisation</keyword> of <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s Covid vaccine to people below 18 years of age whereas earlier, it was approved for children above the age of 12 years by the Drugs Controller General of India (DCGI). A letter from the office of additional secretary at the <keyword id="83655" type="COMPANY" weightage="20" keywordseo="Union-health-ministry">union health ministry</keyword> carrying a comparative factsheet for the two Covid vaccines approved for emergency authorisation revealed that the government has "not recommended" their authorisation to people below 18 years of age. The DCGI, after approving Bharat Biotech's <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> for EUA, had allowed its authorization to children above 12 years of age. The document of permission to the Hyderabad-based pharmaceutical firm signed by the DCGI clearly states that "active immunization against Corona Virus Disease (Covid-19) for age above 12 years when administered in two doses interval of day 0 and day 28". At the same time, another Corona vaccine, Covishield by <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII), was permitted to people above 18 years of age, permission letter to the SII showed. However, when IANS approached CDSCO with the query upon this, the officials said that the provision was soon withdrawn and revised by the drug licensing authority. The sources privy to the development told IANS that this certain condition approved for Covaxin was flagged to the drug regulatory authority and soon it was rebuked. "We were flagged about the provision and soon it was revised with a condition that the vaccines would only be administered to beneficiaries above 18 years of age," a senior official said. Covaxin has been in the spotlight of controversy since it was recommended for restricted emergency use by the subject expert committee of CDSCO. It's approval for Covid immunization programme has drawn flak from public health advocacy groups, researchers, scientists and activists in the <keyword id="54611" type="PERSON" weightage="20" keywordseo="domain">domain</keyword>. The concern with the Coxaxin largely remains on its approval without the data from phase III clinical trials which determine efficacy of the drug. So far, any data proving the vaccine's efficacy has not been published in the public domain, including any results of an interim analysis. Meanwhile, a series of allegations involving violation of various protocols of human clinical trials have been put forth by trial volunteers of Covaxin in Bhopal's People's Medical College and Hospital, one of the 26 clinical trial sites of the Bharat Biotech's vaccine's phase III trials. Trial participants in Bhopal, who, incidentally, are also victims of the 1984 gas tragedy, have alleged "severe violations" of the model code of conduct pertaining to trials including absence of consent and no follow-up on their health after developing adverse reactions post the first dose by a particular clinical trial site. Notably, a 45-year-old trial participant in Bhopal also died nine days after he got the first jab at the People's Hospital, on December 21. However, Bharat Biotech, in a statement, said that the death had been "thoroughly investigated" and was found "not related to vaccine or placebo". The Madhya Pradesh government panel, too, ruled out any "lapses" from the hospital in the death case. --IANS str/rt

You Searched For "pharmaceutical firm bharat biotech" and got 8 results

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