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<ul><li>Moderna has received an additional $472 million award from the US government's Biomedical Advanced Research and Development Authority (BARDA) ahead of the expanded Phase-3 <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> of its Covid-19 vaccine candidate beginning on Monday. </li><li>An earlier award from BARDA for up to $483 million was entered into to support the scale up of the Covid-19 vaccine candidate and clinical development, originally with a smaller anticipated number of participants in the Phase-3 clinical trial.</li><li>The additional funding was needed to meet the requirements of the company's late stage clinical development of mRNA-1273, including the execution of the larger Phase 3 study in the US.</li></ul> Pharmaceutical company Moderna has received an additional $472 million award from the US government's Biomedical Advanced Research and Development Authority (BARDA) ahead of the expanded Phase-3 clinical trial of its Covid-19 vaccine candidate beginning on Monday. The expanded Phase-3 study of the company's mRNA vaccine candidate (mRNA-1273) against Covid-19 will include 30,000 participants, Moderna said on Sunday. An earlier award from BARDA for up to $483 million was entered into to support the scale up of the Covid-19 vaccine candidate and clinical development, originally with a smaller anticipated number of participants in the Phase-3 clinical trial. The additional funding was needed to meet the requirements of the company's late stage clinical development of mRNA-1273, including the execution of the larger Phase 3 study in the US. The total value of the award is now approximately $955 million, Moderna said. "We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against Covid-19," said Moderna's Chief Executive Officer <keyword id="9649865" type="PERSON" weightage="20" keywordseo="stephane-bancel">Stephane Bancel</keyword>. "Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks." The Phase 3 COVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). Moderna said it remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the company's internal US manufacturing site and strategic collaboration with Swiss drugmaker Lonza. In addition, Moderna recently announced a collaboration with US-based Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent's biologics facility in Indiana. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the company's most recent public equity offering in May this year. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/coovid-vaccine-from-oxford-serum-institute-and-astrazeneca-shows-promising-immune-response/articleshow/77069321.cms">The COVID-19 vaccine from Oxford and AstraZeneca shows 'promising' results in early human trials</a> <a href="https://www.businessinsider.in/entertainment/news/dil-bechara-kissing-booth-2-and-other-movies-you-can-watch-on-netflix-amazon-prime-disneyhotstar-this-week/slidelist/77142498.cms">Dil Bechara, Kissing Booth 2 and other movies you can watch on Netflix, Amazon Prime, Disney+Hotstar this week</a> <a href="https://www.businessinsider.in/business/startups/news/work-from-home-effect-these-companies-are-shelling-out-for-employees-power-bills-internet-cost-and-more/articleshow/77139229.cms">WFH effect – These companies are paying for employees' power bills, internet cost and more</a>

Moderna gets additional $472 million from US for Covid-19 vaccine trial

New Delhi, May 12 () Glenmark Pharmaceuticals on Tuesday said it has initiated Phase 3 clinical trials on antiviral drug Favipiravir to check its efficacy on COVID-19 patients in India. The Mumbai-based company had received approval from Drug Controller General of India (DCGI) last month to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients. Glenmark Pharmaceuticals is the first company in the country to initiate Phase 3 clinical trials on Favipiravir for COVID-19 patients in India, it said in a statement. Clinical trials have commenced and over ten leading government and private hospitals are being enrolled for the study, it added. Glenmark estimates study completion by July/August 2020, it said. As per the approved clinical trial protocol, 150 subjects with mild to moderate COVID-19 symptoms will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation. "Several health and medical experts, both in and outside of Glenmark are eager to see the effect that Favipiravir has on COVID-19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus," Glenmark Pharmaceuticals Vice President &amp; Head Clinical Development, Global Specialty/Branded Portfolio Monika Tandon said. The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management, she added. The company said it aims to launch a treatment for COVID-19 patients as soon as possible and control the spread of the pandemic. Favipiravir, which is a generic version of Japan-based Fujifilm Toyama Chemical's Avigan, has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. MSS DRRDRR

Glenmark initiates Phase 3 clinical trials on Favipiravir to check efficacy on COVID-19 patients

Chinese vaccine maker <keyword id="9550548" type="PERSON" weightage="20" keywordseo="anhui-zhifei-longcom-biopharmaceutical">Anhui Zhifei Longcom Biopharmaceutical</keyword> Co., Ltd. has commenced the phase-3 clinical trials for its Covid-19 vaccine, planning to recruit 29,000 volunteers across the world. This is China's first phase-3 efficacy study for a recombinant subunit COVID-19 vaccine candidate, the company said in a statement on Thursday. Jointly developed by the company and the Institute of Microbiology under the Chinese Academy of Sciences, the vaccine was issued with a clinical research permit from the National Medical Products Administration on June 19, reports Xinhua news agency. Researchers started phase-1 and phase-2 clinical trials on June 23, which were randomized, double-blind and placebo-controlled. Volunteers, aged between 18 and 59 from Beijing, Chongqing and Hunan, received the vaccine to determine whether it is safe for use on humans. The results of the early-stage trials support the safety and immunogenicity of this vaccine, suggesting the potential for further clinical tests. The Chinese drug regulator granted the developers permission to conduct global multi-centre research on November 4. The company said the research, which plans to enroll up to 29,000 adults aged 18 and up, was launched on Wednesday in Xiangtan county, Hunan province. Global trials are expected to begin in Uzbekistan late this month, followed by trials in Indonesia, Pakistan and Ecuador. A Covid-19 vaccine manufacturing plant of the company was put into use in September. The annual production capacity for the Covid-19 vaccine will top 300 million doses, according to the company. A Foreign Ministry spokesperson said on Wednesday that China had five Covid-19 vaccine candidates undergoing phase-3 trials in the United Arab Emirates, Brazil, Pakistan and Peru. SEE ALSO: <a href="https://www.businessinsider.in/tech/news/mumbais-massive-power-cut-last-month-may-have-been-the-work-of-hackers/articleshow/79318282.cms">Mumbai’s massive power cut last month may have been the work of hackers</a> <a href="https://www.businessinsider.in/stock-market/news/vodafone-idea-shares-jump-after-selling-stake-in-indus-towers-for-3760-crore/articleshow/79316662.cms">Vodafone Idea soars nearly 5% on fund infusion from Indus Towers stake sale</a> <a href="https://www.businessinsider.in/tech/apps/news/pubg-mobile-india-was-supposed-to-launch-today/articleshow/79315462.cms">PUBG Mobile India was rumoured to launch today — but there is no official update from the company</a>

Another Chinese Covid-19 vaccine enters late-stage human trials with a plan to produce 300 million doses annually

A <keyword id="9316529" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine-candidate">Covid-19 vaccine candidate</keyword> developed by a Beijing unit of <keyword id="8779112" type="COMPANY" weightage="20" keywordseo="china-national-biotec-group">China National Biotec Group</keyword> (CNBG) has shown positive results in early human trials, the company said on Sunday. According to the company, all 1,120 volunteers in the phase-1 and phase-2 clinical trials produced high-titer antibodies against Covid-19 after accepting two doses of the vaccine, the Global Times reported. The clinical trials which started on April 27 in <keyword id="9481138" type="LOCATION" weightage="20" keywordseo="shangqiu-county">Shangqiu county</keyword> in China's Henan province have shown the vaccine to be effective and safe, said CNBG. The trials were designed as randomised, double-blind and placebo-controlled studies. This is not the first Covid-19 vaccine candidate from CNBG, which is affiliated to the state-owned China National Pharmaceutical Group (Sinopharm). In the middle of this month, another institute under CNBG in Wuhan announced the results of phase-1 and Phase-2 clinical trials of an inactivated Covid-19 vaccine candidate it developed. These trials, which started on April 12, also involved 1,120 volunteers and the results revealed a good safety record, with no cases of severe adverse effects found in the clinical trials. CNBG on June 23 announced an agreement with authorities in <keyword id="3446125" type="LOCATION" weightage="20" keywordseo="The-United-Arab-Emirates">the United Arab Emirates</keyword> to start phase-3 clinical trials for inactivated vaccine candidates. It is not clear which of CNBG's Covid-19 vaccine candidates will be tested in the phase-3 trial in the UAE. SEE ALSO: <a href="https://www.businessinsider.in/india/news/dgcas-showcause-notice-to-airasia-india-over-safety-norm-violation/articleshow/76681713.cms" data-type="tilCustomLink">DGCA's showcause notice to AirAsia India over 'safety norm violation'</a> <a href="https://www.businessinsider.in/india/news/locust-attacks-in-up-jhansi-chitrakoot-prayagraj-pratapgarh-bhadohi-azamgarh-and-ambedkar-nagar/articleshow/76669556.cms" data-type="tilCustomLink">Swarms of locusts reach Uttar Pradesh, several districts put on alert</a>

Potential Covid-19 vaccine from China shows promise in human trials

The Central Drugs Standard Control Organisation's Subject Expert Committee on Wednesday asked the <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> and <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> to submit more data and information to get emergency use authorisation (EUA) for their Covid-19 vaccine candidates. According to the minutes of the meeting, the committee recommended the Serum Institute of India to submit the updated safety data of the Phase 2/3 clinical trials, immunogenicity data from the clinical trial in UK and India, and outcome of the assessment of UK-MHRA for grant of EUA. During the meeting, the SII presented their proposal for grant of EUA of COVISHIELD, along with the interim safety data from Phase 3 clinical trial and interim safety and efficacy results of Phase 2/3 and Phase 3 clinical trials carried out in UK, other countries and India, before the committee. In the case of Bharat Biotech, the firm presented their proposal for grant of EUA, along with the interim safety and immunogenicity data of Phase 1 and 2 clinical trial carried out in the country before the committee. "After detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration," the minutes of the meeting showed. America's Pfizer was the first to apply on December 4, followed by Pune-based SII and Hyderabad-based Bharat Biotech who applied on December 6 and 7, respectively. Pfizer has, however, requested more time to make presentation before the committee. Emergency Use Authorisation is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies. Such an approval was given to Covid-19 drugs - remdesivir and favipiravir in June and itolizumab in July. On Tuesday, the Union Health Ministry informed that as many as eight Covid-19 vaccine candidates are under different stages of clinical trials which could be ready for authorization in near future. Theus includes Astrazeneca and Oxford University developed and Serum Institute of India manufactured Covishield, Covaxin by Bharat Biotech, ZyCoV-D by Zydus Cadila, Russian vaccine candidate Sputnik-V, NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabeled vaccines - the Recombinant Protein Antigen based vaccine by Biological E Ltd, and Inactivated rabies vector platform by Bharat Biotech. SEE ALSO: <a href="https://www.businessinsider.in/careers/news/icertis-helps-google-microsoft-and-apple-manage-their-contracts-is-hiring-for-techies-and-people-in-sales/articleshow/79640659.cms">EXCLUSIVE: This Indian unicorn helping Google, Microsoft and Apple manage their contracts is hiring⁠— it needs techies as well as people in sales</a> <a href="https://www.businessinsider.in/tech/news/what-is-pm-wani-public-wifi-platform-launched-by-union-cabinet/articleshow/79642267.cms">Government’s plan for public Wi-Fi lets anyone from the kirana store owner to tea shop stalls sign up to provide the internet</a> <a href="https://www.businessinsider.in/business/corporates/news/the-33-billion-itc-one-of-indias-most-trolled-stock-in-recent-weeks-seems-to-have-turned-a-corner/articleshow/79641456.cms">The $33 billion ITC, one of India’s most-trolled stock in recent weeks, seems to have turned a corner</a>

COVID-19 vaccine: SII and Bharat Biotech asked to submit more data for emergency approval

Union Health Minister <keyword id="196226" type="PERSON" weightage="20" keywordseo="Harsh-Vardhan">Harsh Vardhan</keyword> clarified on Sunday that the government is yet to take a final decision on phase-3 trials of the Russian COVID-19 vaccine candidate Sputnik V. "This issue is still under consideration and no final decision on Sputnik V vaccine developed by Russia has been taken as yet," he stated while addressing his social media audience during his weekly programme 'Sunday Samvaad'. The clarification by the minister has come after a pharmaceutical giant, which partnered with Russia's sovereign wealth fund in September to conduct final trials and distribution of the Sputnik V, sought permission for the same from <keyword id="682334" type="COMPANY" weightage="20" keywordseo="Drugs-Controller-General-of-India">Drugs Controller General of India</keyword> (DCGI) on Friday. Hyderabad-based drugmaker Dr Reddy's Laboratories (DRL) had partnered the <keyword id="1397612" type="COMPANY" weightage="20" keywordseo="Russian-Direct-Investment-Fund">Russian Direct Investment Fund</keyword> (RDIF) last month to conduct final-stage human trials and distribution of Russia's Sputnik V Covid-19 vaccine in India. Two days ago, the DRL had applied to the DCGI for permission to conduct the phase-3 human clinical trials of Sputnik. Upon regulatory approval in India, RDIF will supply Dr Reddy's 100 million doses of the vaccine, the firm had said last month. The trials of Sputnik V are mired in controversy. The Russian government registered Sputnik V as a COVID-19 vaccine without conducting final clinical trials. Besides, the phase I and II of the trials involved merely 76 participants. The Indian scientists and medical experts are also of the opinion that the Indian government should conduct phase-2 trials of the vaccine to prove its safety and efficacy. Russia, had announced in August that it has developed the world's first <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword> vaccine. However, the country had made the announcement before completion of phase-3 trials. A vaccine is deemed safe to be commercially available only after a larger efficacy trial which involves thousands of participants in the phase-3. However, the study of Sputnik trials published in The Lancet declared the vaccine as "Safe, well-tolerated, and does not cause serious adverse events in <keyword id="10049599" type="UNKNOWN" weightage="20" keywordseo="healthy-adult-volunteers">healthy adult volunteers</keyword>." As per the study, two small trials were conducted on two groups involving 38 healthy adults between the ages of 18 and 60, each. They were given a two-part immunisation. Each participant was given a dose of the first part of the vaccine, and then a booster with the second part, 21 days later. These volunteers were monitored over 42 days, and it was found that all of them developed antibodies against the virus within three weeks. After widespread criticism of conducting relatively small and early trials before registering Sputnik V as a COVID-19 vaccine, Russia said that a more rigorous phase-3 <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> has been planned with the involvement of 40,000 volunteers "from different age and risk groups". SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/latest-update-on-covid-19-vaccine-in-india/articleshow/78422652.cms" data-type="tilCustomLink">India COVID-19 vaccine updates — Zydus, Biotech enter clinical trials, Dr Reddy’s yet to apply for Sputnik V phase-III trials</a> <a href="https://www.businessinsider.in/stock-market/news/investors-must-brace-for-a-turbulent-october-in-the-stock-market-but-they-should-hold-on-for-a-strong-4th-quarter-finish-a-senior-wall-street-strategist-says/articleshow/78477243.cms" data-type="tilCustomLink">Investors must brace for a turbulent October in the stock market — but they should hold on for a strong 4th-quarter finish, a senior Wall Street strategist says</a>

Centre yet to decide on phase-3 trials of Russian COVID-19 vaccine Sputnik V, says Health Minister Harsh Vardhan

<keyword id="146915" type="COMPANY" weightage="20" keywordseo="Pfizer-India">Pfizer India</keyword> has become the <keyword id="10389973" type="UNKNOWN" weightage="20" keywordseo="first-pharmaceutical-firm">first pharmaceutical firm</keyword> to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain. The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under <keyword id="10188407" type="COMPANY" weightage="20" keywordseo="the-new-drugs-and-clinical-trials-rules">the New Drugs and Clinical Trials Rules</keyword>, 2019, <keyword id="233909" type="POSITION" weightage="20" keywordseo="official-sources">official sources</keyword> said. "Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its COVID-19 vaccine in India," a source said. "The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech's COVID-19 mRNA vaccine BNT162b2 in the country," the source said, citing the application. The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorisation for its emergency use. The British regulator said the jab, which claims to offer up to 95 per cent protection against COVID-19, is safe for roll-out. Bahrain on Friday also announced that it has granted an EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine. The extreme low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said. When contacted, Pfizer said it remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country. "During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval," the global pharma major said in a statement. Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial. Drug firm <keyword id="72130" type="COMPANY" weightage="20" keywordseo="Zydus-Cadila">Zydus Cadila</keyword> has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine. Dr Reddy's Laboratories and <keyword id="9667533" type="COMPANY" weightage="20" keywordseo="the-russian-direct-investment-fund">the Russian Direct Investment Fund</keyword> (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India, Also, Biological E. Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate. 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>

Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

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

You Searched For "phase 3 clinical trial" and got 8 results

Moderna gets additional $472 million from US for Covid-19 vaccine trial

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Glenmark initiates Phase 3 clinical trials on Favipiravir to check efficacy on COVID-19 patients

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Another Chinese Covid-19 vaccine enters late-stage human trials with a plan to produce 300 million doses annually

IANS

Potential Covid-19 vaccine from China shows promise in human trials

IANS

COVID-19 vaccine: SII and Bharat Biotech asked to submit more data for emergency approval

IANS

Centre yet to decide on phase-3 trials of Russian COVID-19 vaccine Sputnik V, says Health Minister Harsh Vardhan

IANS

Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

PTI

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

PTI

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