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Ever since the virus reared its ugly head and briefly sent the world into despair, the coronavirus has remained a staple, albeit almost sidelined, part of the news cycle. Despite this, the topic has come to the forefront of controversy once again, with an extremely popular <keyword id="20040659" type="General" weightage="20" keywordseo="COVID-19-vaccine" source="keywords">COVID-19 vaccine</keyword> now under scrutiny. Considering that the world is still healing from the scars left behind by the coronavirus tragedy, it is imperative that we gauge the situation to avoid any unwarranted public paranoia. Let’s look at the facts behind the ongoing <keyword id="19910149" type="General" weightage="20" keywordseo="AstraZeneca" source="keywords" meta.keywordsubtype="org" meta.entityname="AstraZeneca" meta.hostid="261" meta.entityid="AstraZeneca">AstraZeneca</keyword> (or <keyword id="19960109" type="General" weightage="100" keywordseo="covishield" source="keywords">Covishield</keyword>, as it is known in India) vaccine controversy, and determine if there really is a cause for worry. <cmsannotation type="cmsannotation" annotationid="What happened?" comment="subhead" text="What happened?">What happened?</cmsannotation> Shortly after receiving the AstraZeneca COVID-19 vaccine in 2021, UK-based <keyword id="21472612" type="General" weightage="20" keywordseo="jamie-scott" source="keywords">Jamie Scott</keyword> experienced a harrowing ordeal. He developed a brain clot and severe bleeding, resulting in permanent brain injury. This condition, known as <keyword id="21475609" type="General" weightage="20" keywordseo="Thrombosis-with-Thrombocytopenia-Syndrome" source="keywords">Thrombosis with Thrombocytopenia Syndrome</keyword> (<keyword id="20218859" type="General" weightage="20" keywordseo="tts" source="keywords">TTS</keyword>), can lead to dangerously low blood clot and platelet levels, posing a grave risk to those affected. Jamie's struggles with memory loss, impaired vision, and diminished cognitive abilities compelled him to seek legal recourse against the pharmaceutical company in 2023. Jamie's legal representative contends that AstraZeneca minimized the potential risks linked to their vaccines. Moreover, reports indicate that over 50 vaccinated individuals experienced similar adverse conditions, with numerous cases resulting in fatalities or severe injuries. Despite these assertions, the pharmaceutical company refutes the allegations, stating that they do not acknowledge a causal relationship between the vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS) on a generic level. However, a year of court wrangling later, legal documents submitted by AstraZeneca have now admitted that their vaccine can cause TTS in very rare cases, although the causal mechanism is still not well known. This revelation has led to renewed uproar against the vaccine’s side-effects. <cmsannotation type="cmsannotation" annotationid="Is there cause for worry?" comment="subhead" text="Is there cause for worry?">Is there cause for worry?</cmsannotation> In short words, not really. Links between the <keyword id="21483117" type="General" weightage="20" keywordseo="AstraZeneca-vaccine" source="keywords">AstraZeneca vaccine</keyword> and vaccine-induced immune TTS have been scientifically identified since early 2021, soon after the first COVID-19 vaccines had come out. However, it is so very rare — a few dozen reported cases among the millions administered — that even the World Health Organisation has deemed the vaccine “safe and effective” for all individuals aged 18 and above. Moreover, even influenza, H1N1 and rabies vaccines can cause TTS in very rare instances. Further, it is important to note that an infection with COVID-19 is itself a major cause for clot, heart attacks and strokes. Being vaccinated actually lowers these risks. There is also the fact that all vaccines or drugs carry potential side-effects, and these medical interventions are only cleared for release after determining that their benefits vastly outweigh any complications. Finally, the <keyword id="21483118" type="General" weightage="20" keywordseo="TTS-side-effects" source="keywords">TTS side-effects</keyword> — which include symptoms such as headaches, blurred vision, chest pain, leg swelling or tiny blood spots under the skin — manifest between 1-6 weeks of vaccination. Considering that most Indians received their Covishield jab a couple of years ago, there should be no reason to panic now. <cmsannotation type="cmsannotation" annotationid="Is it time to consider alternate vaccines?" comment="subhead" text="Is it time to consider alternate vaccines?">Is it time to consider alternate vaccines?</cmsannotation> There is no particular hard evidence that suggests the supremacy of one vaccine over another, considering that they all carry varying degrees of side-effects. That being said, <keyword id="9485939" type="General" weightage="20" keywordseo="covaxin" source="Orion">Covaxin</keyword> boasts a higher efficacy than Covishield, and has better research data among Indian subjects. However, it may also be important to know that the administration of the AstraZeneca vaccine has been discontinued in many countries, mainly due the aforementioned risk of blood clotting in certain age groups. Whatever the choice, the fact of the matter remains that these vaccines have saved millions since their introduction, and it is pertinent that we continue taking them diligently, unless any premier health authorities recommend otherwise.

Should you be worried about the potential side-effects of the Covishield vaccine?

<keyword id="19910149" type="General" weightage="100" keywordseo="AstraZeneca" source="keywords" meta.keywordsubtype="org" meta.entityname="AstraZeneca" meta.hostid="261" meta.entityid="AstraZeneca">AstraZeneca</keyword> made headlines on Tuesday as it initiated the global withdrawal of its COVID-19 vaccine. This decision comes weeks after the pharmaceutical giant acknowledged the vaccine's potential to trigger a rare side effect known as <keyword id="21475609" type="General" weightage="20" keywordseo="Thrombosis-with-Thrombocytopenia-Syndrome" source="keywords">Thrombosis with Thrombocytopenia Syndrome</keyword> (TTS). Previously, AstraZeneca had admitted in court filings that its vaccine could lead to side effects like <keyword id="21303970" type="General" weightage="20" keywordseo="blood-clots" source="keywords">blood clots</keyword> and low blood platelet counts. However, the company has now attributed its <keyword id="21572759" type="General" weightage="20" keywordseo="vaccine-withdrawal" source="Orion">vaccine withdrawal</keyword> not to the aforementioned side effects, but to an "oversupply of updated vaccines" since the pandemic. The company also announced its decision to revoke the vaccine Vaxzevria's marketing authorisations within Europe, noting that the oversupply has reduced the demand for Vaxzevria, which is no longer being produced or distributed. According to The Telegraph, AstraZeneca had submitted its application to withdraw the vaccine on March 5, and the withdrawal became effective on May 7. AstraZeneca collaborated with the University of Oxford to develop the Vaxzevria vaccine, while also partnering with the <keyword id="19897707" type="General" weightage="20" keywordseo="Serum-Institute-of-India" source="keywords" meta.keywordsubtype="org" meta.entityname="Serum Institute of India" meta.hostid="261" meta.entityid="Serum Institute of India">Serum Institute of India</keyword> (SII), the world's largest vaccine manufacturer, to supply the Covishield vaccine to the Indian government. The UK-based pharma company is currently facing <keyword id="19982808" type="General" weightage="20" keywordseo="legal-action" source="keywords">legal action</keyword> alleging that its vaccine has caused deaths and severe harm to a few of those who received it. <cmsannotation type="cmsannotation" annotationid="The lawsuits against AstraZeneca" comment="subhead" text="The lawsuits against AstraZeneca">The lawsuits against AstraZeneca</cmsannotation> Families of individuals affected by adverse vaccine reactions continue to pursue legal recourse against AstraZeneca and the Serum Institute of India. <keyword id="21513237" type="General" weightage="20" keywordseo="venugopalan-govindan" source="keywords">Venugopalan Govindan</keyword>, whose daughter Karunya passed away after receiving the Covishield vaccine, expressed his grief and criticised various parties for his daughter's death. He highlighted alleged negligence in responding to early warning signs and cited missed opportunities to prevent tragedies like his daughter's passing. Eight families across India have joined forces to seek justice, emphasising their collective determination to hold accountable those they deem responsible for the tragic loss of their loved ones. Their shared resolve underscores their commitment to achieving justice and preventing similar tragedies from occurring again, he added. In the UK, <keyword id="21472612" type="General" weightage="20" keywordseo="jamie-scott" source="keywords">Jamie Scott</keyword> took legal action last year after suffering from a blood clot and brain bleed following his vaccination in April 2021. AstraZeneca initially denied a causal link between the vaccine and this particular side-effect, but later admitted in court documents that the vaccine could cause TTS in very rare cases. As many as 51 cases have reportedly been filed against AstraZeneca in the British High Court, with affected individuals and families seeking compensation totaling an estimated £100 million. (With inputs from multiple agencies)

AstraZeneca continues to face legal action even after withdrawing its COVID vaccine! Know all about it here

<ul><li>DCGI has approved market authorisation for the COVID-19 vaccine <keyword id="10678894" type="General" weightage="100" keywordseo="covovax" source="Orion">Covovax</keyword> as a heterologous booster dose for adults.</li><li>The DCGI's approval came following recommendations by the <keyword id="3923779" type="General" weightage="50" keywordseo="subject-expert-committee" source="Orion">Subject Expert Committee</keyword> of the Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="50" keywordseo="cdsco" source="Orion">CDSCO</keyword>).</li></ul>The <keyword id="6386816" type="General" weightage="50" keywordseo="drug-controller-general-of-india" source="Orion">Drug Controller General of India</keyword> (DCGI ) has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of <keyword id="9617748" type="General" weightage="50" keywordseo="covishield" source="Orion">Covishield</keyword> or <keyword id="9485939" type="General" weightage="50" keywordseo="covaxin" source="Orion">Covaxin</keyword>, official sources said on Monday. The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO). Prakash Kumar Singh, Director of Government and Regulatory Affairs at the <keyword id="95879" type="General" weightage="50" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword> (<keyword id="52604" type="General" weightage="80" keywordseo="sii" source="Orion">SII</keyword>), had recently written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating COVID-19 pandemic situation in some countries, an official source had said. "The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin," an official source said. The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and in children aged 7- 11 years on June 28 last year subject to certain conditions. Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation. It was granted emergency-use listing by the <keyword id="43588" type="General" weightage="50" keywordseo="world-health-organization" source="Orion">World Health Organization</keyword> (WHO) on December 17, 2021. In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in <keyword id="3658" type="General" weightage="50" keywordseo="india" source="Orion">India</keyword> and low-and-middle-income countries. SEE ALSO: <a href="https://www.businessinsider.in/tech/news/amazon-great-republic-day-sale-2023-best-deals-and-offers-on-tvs/articleshow/96987966.cms">Amazon Great Republic Day Sale 2023 – Best deals and offers on TVs</a> <a href="https://www.businessinsider.in/tech/apps/news/these-audio-setting-tweaks-can-make-music-sound-better-on-spotify/articleshow/96876010.cms">These audio setting tweaks can make music sound better on Spotify</a>

Serum Institute's Covovax gets DCGI approval as a heterologous booster dose

<ul><li>The <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> has paused the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations. </li><li>The Drug Control General of India (DCGI) issued a show-cause notice, seeking an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear. </li><li>The notice was issued after <keyword id="6409874" type="COMPANY" weightage="20" keywordseo="astrazeneca">AstraZeneca</keyword> halted the late-trials of its coronavirus vaccine over safety concerns. </li></ul>The Serum Institute of India has paused the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations as a precaution, following a show-cause notice. SII<a href="https://twitter.com/CNBCTV18Live/status/1303981172200882176"> says</a> there have been no issues in India. It is a precautionary measure, and it will restart the trial as soon as AstraZeneca does. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front," SII said. The Drug Control General of India (DCGI), VG Somani, issued a show-cause notice to it asking for an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear. "The Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns," <a href="https://www.deccanchronicle.com/nation/in-other-news/100920/dcgi-issues-notice-to-serum-institute-over-astrazenecas-trial-suspens.html">the notice by DGCI read.</a> The DGCI further asked the institute as to why the authority did not suspend the permission given to SII for the clinical trials of Covishield. The notice was issued after AstraZeneca halted the late-trials of its coronavirus vaccine over safety concerns. According to<a href="https://www.businessinsider.com/astrazeneca-covid-19-vaccine-trial-paused-after-potential-adverse-reaction-2020-9?IR=T"> reports</a>, one of the participants in the United Kingdom reported a severe adverse reaction after being administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and the University of Oxford, on Tuesday. AstraZeneca was conducting human trials at over 60 locations including the US, Brazil and South Africa. SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Last month, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India. SEE ALSO: <a href="https://www.businessinsider.com/astrazeneca-covid-19-vaccine-trial-paused-after-potential-adverse-reaction-2020-9?IR=T">AstraZeneca's phase 3 coronavirus vaccine trial was just put on pause because a participant may have had an adverse reaction</a>

Oxford COVID-19 vaccine: SII pauses trials in India following show-cause notice

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

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

<ul><li>The Serum Institute of India (SII) has launched India’s first and only <keyword id="10507934" type="UNKNOWN" weightage="20" keywordseo="indigenous-pneumonia-vaccine">indigenous pneumonia vaccine</keyword> at $3 per dose, which is around ₹220, for the government. </li><li>For private purchase, the vaccine will cost about $10 — around ₹735 — which is still at least 50% cheaper than GSK and Pfizer’s pneumonia vaccines.</li><li>All four doses required to immunise a child against pneumonia from SII would cost less than ₹3,200, which is cheaper than a single dose of the Pfizer vaccine at ₹3,600. </li></ul>The Serum Institute of India (SII) has launched India’s <keyword id="10507932" type="UNKNOWN" weightage="20" keywordseo="first-homegrown-pneumonia">first homegrown pneumonia</keyword> vaccine called Pneumosil. CEO Adar Poonawalla Roughly stated that SII’s pneumococcal conjugate vaccine will cost the government around $3 dose, which is approximately ₹220. "It is the first vaccine made in India to protect children against the pneumonia disease in India. It is also the most affordable vaccine for pneumonia, in the whole world," he said. SII’s <keyword id="1240147" type="PERSON" weightage="20" keywordseo="Pneumonia-vaccine">pneumonia vaccine</keyword> versus GSK and Pfizer Each child has to be given four doses — at 6 weeks, 10 weeks and 14 weeks followed by a booster dose at nine months — of the vaccine for full protection. The cumulative four doses of SII’s pneumonia vaccine at ₹ 1,200 would cost less than a <a href="https://www.thehindu.com/sci-tech/science/serums-pneumococcal-vaccine-once-approved-could-be-cheaper-option-in-the-private-market/article30502005.ece">single dose</a> from its competitors. <table style="border-width: initial; border-style: none; width: 468pt; table-layout: fixed;"></colgroup><tbody><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Company </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Serotypes </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Price per dose </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">GSK </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">10 </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹1,600 </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Pfizer </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">13 </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">₹3,600 </td></tr></tbody></table>Source: Reports Even in the private market, the vaccine will cost around $10 per dose, around ₹735. That’s still at least 50% cheaper than GSK and the whole process would still cost less than a single dose of Pfizer’s pneumonia vaccine. "We hope to achieve 70% to 80% coverage over the next two to three years," said Poonawalla. He explained that the company has multiple strategies planned for the private market and government avenues as well to help spread the vaccine across the country as far as possible. The vaccine is critical for a country like India, which saw the highest number of children under five years of age die due to pneumonia in 2019 — second only to Nigeria. According to the United Nations, the total death toll is pegged at 127,000. According to Union Health Minister Harsh Vardhan, the vaccine symbolises that India is well equipped to handle any health crisis, including the current COVID-19 pandemic. “This is symbolic that India can make any vaccine in an affordable way without compromising on safety and quality,” he said. SEE ALSO: <a href="https://www.businessinsider.in/science/space/news/indian-space-startup-skyroot-aerospace-successfully-test-fires-first-solid-rocket-propulsion-stage-demonstrator-called-kalam-5/articleshow/79988975.cms">India’s first-ever privately designed and developed rocket is a step closer to becoming a reality in 2021</a> <a href="https://www.businessinsider.in/business/corporates/news/jack-ma-ant-group-asked-to-overhaul-its-business-model-by-china-central-bank/articleshow/79987683.cms">China's central bank wants Jack Ma's Ant Group to overhaul its business model</a> <a href="https://www.businessinsider.in/science/environment/news/top-10-most-expensive-natural-disasters-of-2020-in-the-world/slidelist/79986294.cms">Cyclone Amphan was the most expensive cyclone of 2020 and the fourth most expensive natural disaster overall</a>

SII launches India's first indigenous pneumonia vaccine at $3 per dose

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

<ul><li>Poonawalla has rented out a mansion in Mayfair, London from Polish billionaire Dominika Kulczyk.</li><li>His new neighbours would be billionaires from around the world – a Chinese heiress, businessman John Caudwell who owns the phone retail company Phones 4u.</li><li>But there’s more to Mayfair’s history.</li></ul><keyword id="383467" type="PERSON" weightage="20" keywordseo="Adar-Poonawalla">Adar Poonawalla</keyword> is a busy man, after all he’s the man behind Serum Institute of India (SII) -- the largest vaccine manufacturer in the world that has most recently made the Oxford-Astrazeneca COVID-19 vaccine. Poonawalla, who belongs to one of India’s richest families, has a new address. Poonawalla has reportedly <a href="https://www.bloombergquint.com/business/ceo-rents-london-mansion-for-69-000-a-week-in-mayfair-record">rented out</a> a mansion in Mayfair, one of the most expensive residential areas in the world. Mayfair is in the city of Westminster, which falls within the greater London area. Poonawalla is shelling out $69,000 or just over ₹50 lakh as rent per week for his new house. Poonawalla is renting the property from Polish billionaire Dominika Kulczyk. The home is one of the biggest in the district and spreads across 25,000 square feet – which is <a href="https://www.ndtv.com/india-news/adar-poonawalla-rents-uk-mansion-for-69-000-a-week-report-2398321">reportedly </a>as much as 24 average homes, put together, in the UK. Poonawalla, who is an alumnus of the University of Westminster, has often referred to London as his second home. The billionaire’s rental in London comes at a time when the city’s real estate is recovering fast after the COVID-19 induced lull. According to real estate consulting firm Knight Frank, the total number of prospective buyers who are looking at over £10 million properties had doubled by January 2021, as compared to the year before. His new neighbours would be billionaires from around the world – a <a href="https://www.dailymail.co.uk/femail/article-9290657/Chinese-heiress-24-rents-five-bedroom-Mayfair-townhouse-record-breaking-130-000-MONTH.html">Chinese</a> heiress, businessman John Caudwell, who owns the phone retail company Phones 4u, among others. <cmsannotation type="cmsannotation" annotationid="Home to history" comment="subhead" text="Home to history">Home to history</cmsannotation> Poonawalla’s new Mayfair home also houses historic significance. The area is home to British royalty, dukes and duchesses. In fact, according to reports, of the 227 houses built in the area, hundreds of years ago, 117 belonged to those who had titles. The area also has some of the most <a href="https://www.thesun.co.uk/news/12391019/britains-most-expensive-homes-250m-mayfair-mega-mansion/">expensive homes</a> in Britain. Mayfair also houses the first bachelor pad of Britain’s former Prime Minister Winston Churchill. It was there that Churchill laid the foundation of his political career and was also the place where he wrote his first book Ian Hamilton’s March. So, of course, Mayfair properties don’t come cheap. As per Knight Frank, houses in Mayfair was sold for an average of £7.3 million in 2020. And for Poonawalla this isn’t the first historic or major real estate splurge. Poonawalla, who already owns some of the biggest and luxurious homes in India, had also <a href="https://qz.com/india/501268/record-breaking-sale-a-billionaire-has-bought-the-former-us-consulate-in-mumbai-for-113-million/">made news</a> in 2015 when he bought out the Mumbai mansion, which was once the address for the US consulate. He had paid a whopping $113 million for the home. SEE ALSO: <a href="https://www.businessinsider.in/business/startups/news/khatabook-acquires-saas-business-management-app-biz-analyst-for-10-million/articleshow/81683288.cms">Khatabook acquires SaaS business management app Biz Analyst for $10 million</a>

India’s vaccine king Adar Poonawalla will pay $69,000 a week to live on the same neighbourhood as Winston Churchill once did

The <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (<keyword id="52604" type="COMPANY" weightage="20" keywordseo="SII">SII</keyword>) has applied to the Drug Controller General of India (<keyword id="172241" type="COMPANY" weightage="20" keywordseo="DCGI">DCGI</keyword>) seeking permission to manufacture COVID-19 vaccine <keyword id="9739267" type="PERSON" weightage="20" keywordseo="Sputnik-V">Sputnik V</keyword> in the country, sources said on Thursday. The Pune-based firm has also sought approval for test analysis and examination. Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories. "The <keyword id="242973" type="COMPANY" weightage="20" keywordseo="Serum-Institute">Serum Institute</keyword> of India (SII) put up an application to the <keyword id="282629" type="COMPANY" weightage="20" keywordseo="Drugs-Controller">Drugs Controller</keyword> General of India (DCGI) on Wednesday seeking permission to manufacture the COVID-19 vaccine, Sputnik V, in India," a source said. The SII has already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States. The vaccine was given emergency use authorisation (<keyword id="2503801" type="COMPANY" weightage="20" keywordseo="EUA">EUA</keyword>) by the DCGI in April. A consignment of 30 lakh doses of Sputnik V landed in Hyderabad on Tuesday. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/the-indian-government-is-doling-out-1500-crore-to-reserve-300-million-of-biological-es-covid-19-vaccine-doses/articleshow/83196362.cms">The Indian government is doling out ₹1500 crore to reserve 300 million of Biological-E’s COVID-19 vaccine doses</a> <a 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 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> <a href="https://www.businessinsider.in/business/startups/news/top-five-fintech-ideas-that-are-drawing-the-most-amount-of-money/slidelist/83194276.cms">Five fintech ideas that are raking in the most amount of money</a>

Serum Institute of India seeks permission from DCGI to manufacture 'Sputnik V' COVID-19 vaccine in the country

<ul><li>Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the <keyword id="46985" type="COMPANY" weightage="20" keywordseo="Oxford">Oxford</keyword> COVID-19 vaccine candidate in the country</li><li>SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events. </li><li>The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders. </li></ul>Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial. The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be "scrupulously" followed by Serum Institute of India (SII). SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events. The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ''an unexplained illness'' in a participant in the study. On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials were safe. SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, on Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial. According to Tuesday's order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials subject to certain conditions. DSMB, India, also has recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to certain conditions. According to the order, SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants. The Pune-based firm has also submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale. "In view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India and in UK revoke herewith the order dated September 11 issued under Rule 30 of the New Drugs and Clinical Trials Rules, 2019. "You may recommence the clinical trial as recommended by DSMB, India, as per already approved protocol and the provisions laid down under the New Drugs and Clinical Trial Rules, 2019, subject to the conditions mentioned," the order said. SEE ALSO: <a href="https://www.businessinsider.in/science/news/bill-gates-says-the-pandemic-wiped-out-25-years-of-vaccine-progress-in-25-weeks/articleshow/78117898.cms">Bill Gates says the pandemic wiped out 25 years of vaccine progress in 25 weeks</a> <a href="https://www.businessinsider.in/education/news/uks-new-visa-rules-make-it-easier-for-international-students-to-study-and-work-now/articleshow/78127748.cms">UK’s new visa rules make it easier for international students to study and work now</a>

Serum Institute of India can resume clinical trial of Oxford COVID-19 vaccine, says DCGI

<ul><li>The testing of <keyword id="8763838" type="UNKNOWN" weightage="20" keywordseo="covid-19">Covid-19</keyword> vaccine being developed by AstraZeneca and University of <keyword id="46985" type="COMPANY" weightage="20" keywordseo="Oxford">Oxford</keyword> has been put on hold due to a serious adverse reaction in a participant in the UK.</li><li>A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said that the company's "standard review process triggered a pause to vaccination to allow review of safety data".</li><li>AstraZeneca only began its Phase 3 trial in the US in late August.</li></ul> The testing of Covid-19 vaccine being developed by AstraZeneca and University of Oxford has been put on hold due to a serious adverse reaction in a participant in the UK. However, Serum Institue of India says, trials of AstraZeneca <keyword id="8973295" type="COMPANY" weightage="20" keywordseo="oxford-vaccine">Oxford vaccine</keyword> have not been paused in India. "We (Serum Institute of India) can't comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all," SII tweeted. Stat News reported that a large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the US has been put on hold due to a suspected serious adverse reaction in a participant in the UK. A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said that the company's "standard review process triggered a pause to vaccination to allow review of safety data". In a follow up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, Stat News reported. The spokesperson described the pause as "a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials". The spokesperson also said that the company is "working to expedite the review of the single event to minimize any potential impact on the trial timeline". An individual familiar with the development said researchers had been told the hold was placed on the trial out of "an abundance of caution". A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway -- as well as on the clinical trials being conducted by other vaccine manufacturers, according to the Stat News report. AstraZeneca only began its Phase 3 trial in the US in late August. The US trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the UK, Brazil, and South Africa. SEE ALSO: <a href="https://www.businessinsider.in/retail/news/reliance-retail-raises-1-billion-from-silver-lake-valuing-the-chain-at-57-billion/articleshow/78009435.cms">Reliance Retail raises $1 billion from Silver Lake valuing the chain at $57 billion</a>

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