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<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

<keyword id="95879" type="General" weightage="50" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword>'s Chief Executive Officer <keyword id="383467" type="General" weightage="50" keywordseo="adar-poonawalla" source="Orion">Adar Poonawalla</keyword> has said their <keyword id="10678894" type="General" weightage="100" keywordseo="covovax" source="Orion">Covovax</keyword> vaccine will get approval as a booster against COVID-19 in the next 10 to 15 days. The vaccine works very well against the <keyword id="1609796" type="General" weightage="50" keywordseo="omicron" source="Orion">Omicron</keyword> variant of coronavirus, <keyword id="25607" type="General" weightage="80" keywordseo="poonawalla" source="Orion">Poonawalla</keyword> told reporters on the sidelines of an event at the Bharti Vidyapeeth University here on Sunday. Asked about states and districts not getting Covishield vaccine, he said there is ample stock with the Union government for supply. "Covovax will be approved as a booster in the next 10-15 days. It is actually the best booster because it works very well against Omicron, more than Covishield," he said. Poonawalla said everyone was looking at India, not just in terms of healthcare but because the country managed to take care of a huge and diverse population and also helped 70 to 80 nations during the COVID-19 pandemic. "This was all possible because of the leadership of our central government, our state governments, healthcare workers, manufacturers, all of whom worked together with one common goal," he said. On the occasion, Poonawalla was conferred with the first Dr Pantangrao Kadam Memorial Award at the hands of Nationalist Congress Party (NCP) chief Sharad Pawar and Maharashtra Deputy Chief Minister Devendra Fadnavis. The event was held to mark the birth anniversary of Kadam, the late minister and education baron from western Maharashtra. Appealing to students who wished to pursue education abroad, Poonawalla said there was no place like India to fulfil dreams due to the presence of institutions like Bharti Vidyapeeth and others. "Even if you have to go abroad, come back as soon as possible," he said. SEE ALSO: <a href="https://www.businessinsider.in/thelife/personalities/news/gautam-adani-aap-ki-adalat-interview-dhirubhai-ambani-is-my-role-model-mukesh-ambani-a-very-good-friend/articleshow/96828407.cms">Dhirubhai Ambani is my role model and Mukesh Ambani a very good friend, says Gautam Adani</a> <a href="https://www.businessinsider.in/tech/news/online-mental-health-company-uses-chatgpt-to-help-respond-to-users-in-experiment-raising-ethical-concerns-around-healthcare-and-ai-technology/articleshow/96821802.cms">Online mental health company uses ChatGPT to help respond to users in experiment — raising ethical concerns around healthcare and AI technology</a>

Covovax vaccine to get approval as a booster in 10-15 days: Adar Poonawalla

<keyword id="242973" type="General" weightage="20" keywordseo="serum-institute" source="Orion">Serum Institute</keyword> of India (SII) plans to launch a COVID vaccine for children in the next six months, the company's CEO <keyword id="383467" type="General" weightage="20" keywordseo="adar-poonawalla" source="Orion">Adar Poonawalla</keyword> said on Tuesday. Participating in an industry conference, Poonawalla said the vaccine '<keyword id="10678894" type="General" weightage="20" keywordseo="covovax" source="Orion">Covovax</keyword>' is under trial and would offer protection to children all the way down till three years. Currently, <keyword id="9617748" type="General" weightage="20" keywordseo="covishield" source="Orion">Covishield</keyword> and other COVID vaccines are approved for people above the age of 18 years. "We haven't seen a lot of severe disease in children. Fortunately, the panic is not there for children. However, we will be launching a vaccine in six months for children, hopefully down to the age of three," Poonawalla said. He noted that already there are two companies in India who are licensed and their vaccines will be available soon. "I think yes, you should take and get your children vaccinated. There is no harm, these vaccines have been proven to be safe and efficacious and all of that. If you feel you want to get your children vaccinated by all means wait for government announcements on that and you go ahead with that. "Our vaccine Covovax will be launched for children in six months," Poonawalla said, adding that Covovax is under trial and has shown excellent data all the way down to the age group of three years. Further, Poonawalla said there was enough data to show that the vaccines will work and protect the children against the infectious disease. He pointed out that so far nothing can be said about the <keyword id="1609796" type="General" weightage="50" keywordseo="omicron" source="Orion">Omicron</keyword> variant as to how it would impact the children. "I don't know what will happen with Omicron but so far the children have not been affected very badly with this (COVID) virus. I think their body, cells and their lungs recover better," he said. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/delhi-reports-four-new-cases-of-omicron-covid-19-variant-says-health-minister/articleshow/88274332.cms">Delhi reports four new cases of Omicron COVID-19 variant, says Health Minister</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/international/news/china-reports-first-case-of-omicron-variant-in-the-port-city-of-tianjin-say-media-reports/articleshow/88273319.cms">China reports first case of Omicron variant in the port city of Tianjin, say media reports</a>

Serum Institute to roll out COVID-19 vaccine for children in six months, says CEO Adar Poonawalla

<keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword>, the <keyword id="6354507" type="UNKNOWN" weightage="20" keywordseo="World">world</keyword>'s biggest <keyword id="8763838" type="UNKNOWN" weightage="20" keywordseo="covid-19">Covid-19</keyword> vaccine maker, is hopeful to launch <keyword id="10678894" type="UNKNOWN" weightage="20" keywordseo="covovax">Covovax</keyword> by September this year, CEO <keyword id="383467" type="PERSON" weightage="20" keywordseo="Adar-Poonawalla">Adar Poonawalla</keyword> announced on Saturday. "Covovax trials finally begin in India; the vaccine is made through a partnership with <keyword id="323030" type="COMPANY" weightage="20" keywordseo="Novavax">Novavax</keyword> and Serum Institute of <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>," said Adar Poonawalla. He further said that it has been tested against African and UK variants of Covid-19 and has an overall efficacy of 89 per cent. "Hope to launch by September 2021!" the CEO of world's biggest Covid-19 vaccine maker said. Covovax is the protein-based Covid-19 vaccine developed by Novavax, headquartered in the US. In August 2020, the two companies announced an agreement under which Novavax had given SII the licence to manufacture and supply the vaccine in low- and middle-income countries. SEE ALSO: <a href="https://www.businessinsider.in/science/space/news/asteroid-apophis-wont-be-hitting-earth-for-at-least-another-century/articleshow/81719171.cms">‘God of Chaos’ asteroid Apophis won’t be crashing into Earth for at least another century</a> <a href="https://www.businessinsider.in/science/health/news/making-vaccines-available-to-indians-may-not-be-enough-it-depends-on-how-judiciously-we-employ-them/articleshow/81720507.cms">Making vaccines available to Indians may not be enough, it depends on how judiciously we employ them</a> <a href="https://www.businessinsider.in/policy/news/government-mandates-companies-to-disclose-cryptocurrency-holdings-from-april-1/articleshow/81704174.cms">Indian companies will have to disclose cryptocurrency holdings from April 1 – industry insiders welcome decision</a>

Serum Institute's second COVID-19 vaccine 'Covavax' likely to be launched in September

New Delhi, Nov 12 () The Pune-based Serum Institute of India (SII) and <keyword id="6364555" type="COMPANY" weightage="20" keywordseo="Indian-Council-of-Medical-Research">Indian Council of Medical Research</keyword> (ICMR) on Thursday announced the completion of enrolment of <keyword id="10217269" type="UNKNOWN" weightage="20" keywordseo="phase-3-clinical-trials">phase-3 clinical trials</keyword> for <keyword id="10262473" type="UNKNOWN" weightage="20" keywordseo="potential-covid-19-vaccine-covishield">potential COVID-19 vaccine Covishield</keyword> in India. The ICMR and SII have collaborated for the clinical development of Covovax developed by Novavax, US and upscaled by SII, a statement said. "The partnership is a stellar example of private-public institutes collaborating to mitigate the dire consequences of the pandemic outbreak," the ICMR said in the statement. While the ICMR has funded the clinical trial site fees, SII has funded other expenses for Covishield. At present, SII and ICMR are conducting phase 2/3 clinical trials of Covishield at 15 different centres across the country. It had completed the enrolment of all 1,600 participants on October 31. "The promising results of the trials so far gives confidence that Covishield could be a realistic solution to the deadly pandemic. Covishield is by far the most advanced vaccine in human testing in India," the ICMR said. "Based on the phase 2/3 trial results, SII with the help of ICMR will pursue the early availability of this product for India. SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI," <keyword id="9258740" type="COMPANY" weightage="20" keywordseo="the-apex-health-research-body">the apex health research body</keyword> said. Covishield has been developed at SII Pune laboratory with a master seed from Oxford University/AstraZeneca. The vaccine made in <keyword id="938315" type="LOCATION" weightage="20" keywordseo="the-United-Kingdom">the United Kingdom</keyword> is currently being tested in large efficacy trials in the UK, Brazil, South Africa and the US, the statement said. Novavax has initiated its late phase trials in South Africa and in the UK and will soon commence the same in the US. SII has received the bulk vaccine and Matrix-M adjuvant from Novavax and will soon fill and finish them in vials. This vaccine formulated at SII (Covovax) will be tested in a phase 3 trial in India. An application for the same to regulatory authorities will be made soon by the ICMR and SII. Commenting on the association, <keyword id="383467" type="PERSON" weightage="20" keywordseo="Adar-Poonawalla">Adar Poonawalla</keyword>, CEO of SII, world's largest vaccine manufacturer by volume, said, "ICMR has played a huge role in coming forward and strengthening India's fight against COVID-19. The collaboration will further aid us in putting India at the forefront of developing an immunogenic and efficacious vaccine." "The pandemic has presented a chance to foster structural reforms in building robust public healthcare infrastructure. The partnership further testifies the importance of private-public institutes coming together in scaling up the management and containing the spread of the virus," he said. Balram Bhargava, director general of ICMR said at present, India plays a prominent role in vaccine development and manufacturing globally. Buoyed by the latest technology and well-equipped facilities, SII has continually proven its research and manufacturing prowess. "The partnership is our contribution to lending our expertise and support to bolster our fight against the global pandemic," he said. The partnership will see scientists of both the entities facilitate the advancement of regulatory approvals for <keyword id="10262472" type="COMPANY" weightage="20" keywordseo="covishield-and-covovax">Covishield and Covovax</keyword> while ensuring strict adherence to all the requisite scientific, ethical and regulatory standards. SEE ALSO: <a href="https://www.businessinsider.in/policy/economy/news/indian-government-approves-the-pli-scheme-for-10-sectors/articleshow/79172901.cms" data-type="tilCustomLink">Indian government approves the Production Linked Incentive scheme for 10 sectors worth ₹2 lakh crore</a> <a href="https://www.businessinsider.in/business/corporates/news/spicejet-shrink-its-losses-to-112-59-crore-in-the-second-quarter-ended-september-30/articleshow/79172678.cms" data-type="tilCustomLink">Spicejet is losing one rupee where it was losing four thanks to cheaper fuel and cut in rentals</a>

Coronavirus vaccine Covishield completes enrolment of phase-3 clinical trials under ICMR, Serum Institute's partnership

Almost 90 per cent of people in <keyword id="1334" type="General" weightage="50" keywordseo="china" source="Orion">China</keyword>'s third most populous province have now been infected with Covid-19, a top local official has said, as the country battles an unprecedented surge in cases, media reported. <keyword id="16007465" type="General" weightage="80" keywordseo="kan-quancheng" source="Orion">Kan Quancheng</keyword>, director of the health commission for central <keyword id="451813" type="General" weightage="20" keywordseo="henan-province" source="Orion">Henan province</keyword>, told a press conference that "as of January 6, 2023, the province's Covid infection rate is 89 per cent," The Guardian reported. With a population of 99.4 million, the figures suggest about 88.5 million people in <keyword id="380346" type="General" weightage="20" keywordseo="henan" source="Orion">Henan</keyword> may now have been infected. Visits to fever clinics peaked on December 19, <keyword id="215638" type="General" weightage="80" keywordseo="kan" source="Orion">Kan</keyword> said, "after which it showed a continuous downward trend." The opening of China's borders on Sunday was one of the last steps in the dismantling of the country's zero-Covid regime, which began last month after historic protests and has led to a huge wave of infections. Covid cases are expected to soar further as the country celebrates lunar new year later this month, with millions set to travel from big cities to visit vulnerable older relatives in the countryside, The Guardian reported. In the first wave of pre-holiday travel, official data showed 34.7 million people travelled domestically on Saturday - up by more than a third compared with last year, according to state media. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/covovax-vaccine-to-get-approval-as-a-booster-in-10-15-days-adar-poonawalla/articleshow/96843527.cms">Covovax vaccine to get approval as a booster in 10-15 days: Adar Poonawalla</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/indian-generic-drug-paxlovid-in-high-demand-in-china-amid-covid-surge/articleshow/96848877.cms">Indian generic drug Paxlovid in high demand in China amid Covid surge</a>

90% of people in China's Henan province infected with Covid says a report by The Guardian

<ul><li>Government allows emergency use of Covovax Covid-19 vaccine developed by the <keyword id="95879" type="General" weightage="20" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword> and Cobevax by Biological E</li><li>The DCGI office had granted SII permission to manufacture and stock Covovax on May 17.</li><li>The vaccine will be used for treatment of mild-to-moderate COVID-19 cases</li></ul>An expert panel of the country's central drug authority has recommended granting emergency use authorisation to Serum Institute of India's COVID-19 vaccine Covovax and Biological E's vaccine Corbevax with certain conditions, official sources said on Monday. The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday also recommended granting permission to manufacture and market <keyword id="12826599" type="General" weightage="20" keywordseo="anti-covid-pill-molnupiravir" source="Orion">anti-Covid pill Molnupiravir</keyword> for restricted emergency use for the treatment of adult patients with SpO2 93 per cent and who have a high risk of progression of the disease, including hospitalisation or death, subject to certain conditions. All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval. The SEC on COVID-19 of the CDSCO, which reviewed the emergency use authorisation (EUA) applications of Serum Institute of India (SII) for the second time on Monday, after detailed deliberation has recommended granting EUA to Covovax. "The committee noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO," an official source said. Prakash Kumar Singh, director, government and regulatory affairs at SII, had submitted an application to the DCGI in October for grant of market authorisation for Covovax for restricted use in emergency situations. The DCGI office had granted SII permission to manufacture and stock Covovax on May 17. Based on DCGI approval, till now, the Pune-based firm has manufactured and stockpiled the vaccine doses. In August 2020, US-based vaccine maker Novavax Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India. The <keyword id="6356311" type="General" weightage="20" keywordseo="world-health-organisation" source="Orion">World Health Organisation</keyword> (WHO) had on December 17 issued an emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease. As for Biological E's Corbevax, in light of the recommendations of the SEC meeting held on December 10, the firm submitted a proposal for grant of marketing authorisation to the vaccine for restricted emergency use in adults along with the updated interim safety and immunogenicity data of phase 2/3 clinical trial and updated interim safety and immunogenicity data of phase 3 active comparator trial. The committee noted that the firm has submitted six months safety follow up post-second dose from phase-1 clinical trial, 90 days safety from the phase -2 part and 60 days safety data from phase 2/3 and phase 3 active comparator study. The firm has submitted interim immunogenicity data from phase-3 active comparator trial which showed superiority against the comparator with respect to viral neutralization antibody titres, the official source said. "After detailed deliberation, the committee recommended for grant of marketing authorisation permission of SARS-CoV-2 (Covid-19) Vaccine containing RBD antigen of SARS-CoV-2 for restricted use in an emergency situation subject to various regulatory provisions," the source said. The vaccine should be administered intramuscularly in two doses of 0.5 ml each with intervals of 28 days (Day 0 and 28) and has to be stored between 2 degrees Celsius to 8 degrees celsius, the source added. The SEC on Monday also recommended granting permission to manufacture and market anti- Covid pill Molnupiravir for restricted emergency use for the treatment of adult COVID-19 patients with SpO2 93 per cent and who have a high risk of progression of the disease, subject to certain conditions. Dr Reddy's Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and Sun pharma had presented their proposal for approval of Molnupiravir 200mg capsules for approval in the emergency situation along with various supporting documents. including clinical data in the country, official sources said. As per conditions, the drug should be sold by retail only under the prescription of medical specialists. According to the conditions, the drug is not authorised for use in patients less than 18 years and for initiation of treatment in patients requiring immediate hospitalisation due to COVID-19 at that stage. However, if it was initiated before hospitalisation due to <keyword id="8764728" type="General" weightage="100" keywordseo="covid-19" source="Orion">COVID 19</keyword>, it may be continued, sources said. It is not authorised for use for longer than five consecutive days and for pre-exposure or post exposure prophylaxis for prevention of COVID-19 for pregnant women. The US Food and Drug Administration recently authorised Merck's Molnupiravir for treatment of mild-to-moderate COVID-19 cases in adults who are at risk for severe disease. Before that in November Britain granted conditional authorisation to Merck's coronavirus antiviral, the first pill shown to successfully treat Covid-19. The pill is intended to be taken twice a day for five days by people at home with mild to moderate Covid-19. In a clinical trial of high-risk people during the early course of illness, Merck's drug was shown to reduce hospitalisations and deaths by around 30 per cent.

India allows emergency use of Merck's new drug Molnupiravir for treatment of mild-to-moderate COVID-19 cases

<ul><li>India recorded a single-day rise of 10,158 coronavirus cases on Thursday. </li><li>The daily positivity rate was recorded at 4.42% while the weekly positivity rate was 4.02%. </li><li>The demand for booster doses has also gone up in the last few weeks, and the country is administering a few hundred shots per day. </li><li>Kerala, Haryana, Uttar Pradesh and more states have made masks mandatory in public places and UP has also re-started screening international travellers. </li></ul>India recorded a single-day rise of 10,158 coronavirus cases, the highest in nearly eight months, according to the Union Health Ministry data. The number of active cases has increased to 44,998, the data updated on Thursday showed. India had reported 7,830 coronavirus infections on Wednesday. The daily positivity rate was recorded at 4.42% while the weekly positivity rate was 4.02%. The active cases now constitute 0.1% of the total infections. The nationwide Covid-19 recovery rate has been recorded at 98.7%, according to the health ministry website. The case fatality rate was recorded at 1.19%. The number of people who have recuperated from the disease rose to 4,42,10,127. According to the ministry's website, 220.66 crore doses of Covid vaccine have been administered in the country. The demand for booster doses has also gone up in the last few weeks. The country has been administering a few hundred booster vaccine shots per day in the last few weeks and there are 146 active vaccination sites across the country. Adar Poonawalla, chief executive officer of Serum Institute of India, which is one of world’s largest vaccine manufacturers, said that the company was re-starting the production of Covidshield vaccine. He said the company already has six million booster doses of Covovax vaccine available and adults must take the booster shot. "Just as a precaution, at risk we have done it so that people have Covishield as a choice if they want it," Poonawalla told PTI on restarting manufacturing of the vaccine. He further said Serum Institute of India will make 6-7 million doses of Covishield available in 90 days and it could take up to nine months to further build up the stock based on demand. The company had stopped manufacturing Covishield in December 2021. Mask mandates come back To tackle the growing number of Covid infections, state governments have taken various measures – including advising the elderly, comorbid and pregnant women to mask up. In the same month last year, the government relaxed its mask norms, and made them optional instead of mandatory. Kerala, Haryana, Uttar Pradesh and more states have made masks mandatory in public places and UP has also re-started screening international travellers. Mumbai municipality, on the other hand, has made masks mandatory for all — staff and visitors at civic hospitals. It has also advised senior citizens to mask up. Kerala, Maharashtra, Haryana and Gujarat have been reporting the highest number of cases in the last few weeks. As many as 68 people have passed away across the country in the last one week due to the disease. (With PTI inputs)

India’s fresh Covid cases shoot up to 8-month high, states issue mask guidelines

As <keyword id="8764262" type="General" weightage="100" keywordseo="covid" source="Orion">Covid</keyword> cases in <keyword id="1334" type="General" weightage="80" keywordseo="china" source="Orion">China</keyword> continue to rise, Beijing will soon start distributing Pfizer's Covid-19 drug <keyword id="12474541" type="General" weightage="80" keywordseo="paxlovid" source="Orion">Paxlovid</keyword> to the community health centres in the coming days, the CNN reported citing state media. According to the state-run China News Service, after getting trained, community doctors would dispense the medicine to Covid-19 patients and also disseminate information on how to use it. "We have received a notice from officials but it is not clear when the drug will arrive," CNN cited a worker at a local community health centre in Beijing's Xicheng district as saying. Paxlovid remains the only foreign Covid drug that has been approved by China's regulator for nationwide use, but access to the medicine is a challenging process. China's National Health Security Administration informed on Sunday that Pfizer's Paxlovid oral medicine, which is used to deal with Covid-19, couldn't be included in the "register of drugs in the basic medical insurance", as the corporate's citation was too excessive, media reports said. Meanwhile, the demand for Indian generic drugs has shot up in China amid the ongoing Covid surge in the country, with specialists cautioning that dubious variations of those drugs were flooding the market. Due to the large and quick supply of Paxlovid, demand for Indian generic variations via Chinese e-commerce platforms has gone up. "On the Chinese e-commerce platforms... At least four generic Covid drugs produced in India -- Primovir, <keyword id="16008657" type="General" weightage="50" keywordseo="paxista" source="Orion">Paxista</keyword>, Molnunat, and <keyword id="16008658" type="General" weightage="50" keywordseo="molnatris" source="Orion">Molnatris</keyword> -- have been listed for sale in recent weeks. Primovir and Paxista are both generic versions of Paxlovid, while the other two are generic versions of Molnipiravir," Chinese media outlet Sixth Tone reported. Following countrywide demonstrations over its 'Zero Covid' policy, China abruptly abandoned it last month after nearly three years of lockdowns, quarantines, and mass testing. The rapid policy change has triggered panic buying of fever and cold medications, resulting in significant shortages at pharmacies and online shopping platforms. Long lineups have become the norm outside fever clinics and hospital wards in the country's capital, Beijing, and elsewhere, according to CNN. After China abandoned its 'Zero Covid' policy about two weeks ago, regional numbers of infected persons with coronavirus point to explosive outbreaks and overstretched healthcare systems, wrote Chang Che, Asia technology correspondent for The New York Times (NYT). However, the intensity and magnitude of the country's first nationwide outbreak have remained a mystery as official figures from the central government remain low. China's healthcare system, catering to 1.4 billion people, is reportedly under tremendous strain because of the steep prices of drugs manufactured by multinational pharmaceutical giants. As things stand, the hospitals are all full, whether government or private, a report said, adding that there is no place for more patients to get admission. Getting a bed is out of the question, while walkways and aisles are full of patients lying on damp floors, the report said. The majority of the patients are left to their fates outside of the government health apparatus, the report said, adding that millions do not have access to medicine, oxygen, respiratory machines or other medical equipment. The only thing they access is a medical drip, it said. Fears of the elderly losing their lives either to the infection or their comorbidities are growing because of these inadequacies, reported The HK Post, adding that most of the elderly patients are developing other health complications, especially lung infections. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/covovax-vaccine-to-get-approval-as-a-booster-in-10-15-days-adar-poonawalla/articleshow/96843527.cms">Covovax vaccine to get approval as a booster in 10-15 days: Adar Poonawalla</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/online-schools-back-in-lucknow-as-cold-wave-intensifies/articleshow/96845569.cms">Online schools back in Lucknow as cold wave intensifies</a>

Indian generic drug Paxlovid in high demand in China amid Covid surge

US-based biotechnology company <keyword id="323030" type="COMPANY" weightage="20" keywordseo="Novavax">Novavax</keyword>'s protein-based vaccine has shown overall 90 per cent efficacy against Covid-19, results of Phase-3 trials have shown. The vaccine NVX-CoV2373 is already being locally manufactured by the company's <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword> partner Pune-based <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII) under the brand name Covovax. In the US-based Phase-3 trials, NVX-CoV2373 also demonstrated 100 per cent protection against moderate and severe disease. "Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional Covid-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe Covid-19 infection," said Stanley C Erck, President and Chief Executive Officer, Novavax, in a statement. "Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines," Erck added. In August 2020, Novavax and SII announced an agreement under which the US biotechnology company had given SII the licence to manufacture and supply the vaccine in low- and middle-income countries. In March 2021, CEO <keyword id="383467" type="PERSON" weightage="20" keywordseo="Adar-Poonawalla">Adar Poonawalla</keyword> said Covovax will be launched by September this year. "Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and Serum Institute of India," said Adar Poonawalla. "Hope to launch by September 2021!" the CEO of the world's biggest Covid-19 vaccine maker said. The US-based Phase-3 trials began in December 2020 and enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease. The study "confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile", said Gregory M Glenn, MD, President of Research and Development, Novavax. The company will file for regulatory authorisations in the third quarter. After receiving the approvals, Novavax will reach a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021, the statement said. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies. It contains purified protein antigen and can neither replicate, nor can it cause Covid-19. The vaccine can be stored at 2 to 8 degrees Celsius, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials. The two-shot vaccine is also being evaluated in Phase 3 trials in the UK that demonstrated efficacy of 96.4 per cent against the original virus strain, 86.3 per cent against the B117 (Alpha) variant and 89.7 per cent overall. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55 per cent efficacy overall in HIV-negative participants and 48.6 per cent efficacy against the B1351 (Beta) variant, and a Phase 1/2 study in the US and Australia. The company is also conducting trials in adolescents between ages 12 and 18. SEE ALSO <a target="_blank" class="c-link" href="https://www.businessinsider.in/stock-market/news/adani-group-under-sebi-scanner-on-market-manipulation/articleshow/83501698.cms">Gautam Adani loses over $7 billion in net worth after questions over the meteoric rise in group stocks</a> <a target="_blank" class="c-link" href="https://www.businessinsider.in/stock-market/news/adani-group-pnb-coal-india-tcs-and-other-stocks-to-watch-out-for-on-june-14/slidelist/83499937.cms">Adani group, PNB, Coal India, TCS and other stocks to watch out for on June 14</a> <a target="_blank" class="c-link" href="https://www.businessinsider.in/cryptocurrency/news/weekly-crypto-roundup-wazirx-under-scrutiny-el-salvador-makes-bitcoin-legal-tender-and-more/slidelist/83478577.cms">Weekly crypto roundup: WazirX under scrutiny, El Salvador makes Bitcoin legal tender and more</a>

US-based biotechnology company Novavax’s COVID-19 shot is 90% effective

<ul><li>At the current rate (0.67 million per day), it will take at least 5.6 years to vaccinate the entire population with a single dose.</li><li>India needs to ban the export of <keyword id="79555" type="TECHNOLOGY" weightage="20" keywordseo="Vaccines">vaccines</keyword> manufactured in India to ramp-up vaccine distribution.</li><li>A massive effort is needed to vaccinate at least 10 million people per day that may have some dent in the virus’s ongoing intense transmission.</li></ul> The fact that the second wave of <keyword id="8763838" type="UNKNOWN" weightage="20" keywordseo="covid-19">Covid-19</keyword> pandemic has arrived in India can neither be denied nor overlooked. And the new wave seems to be more severe both in terms of infectivity and lethality if one goes by the initial data gathered from the states severely affected by this recent surge. More than 55,000 cases and 250 deaths have been<a href="https://www.businessinsider.in/india/news/india-reports-59118-new-covid-19-cases-in-last-24-hours-highest-single-spike-since-october-last-year/articleshow/81701772.cms"> reported</a> as of March 26 — the highest so far this year. Why the second surge? Opinions may be divided on the exact reason behind this resurgence. Still, as more and more data are emanating, it seems the advent of the new and more infectious variants, mainly the UK variant having N501Y substitution and 69/70 deletion, may be the main reason behind these outbreaks in a few states. The limited gene sequencing data have already pointed toward the presence of two distinct variants, the UK and South African in Maharashtra and Punjab, the two most severely affected states. The other reason could be laxity by both the Government and public in adhering to the non-pharmacological mitigation measures like masking, social distancing, avoiding gathering, etc. Another important reason could be the secular changes in the epidemiology of the SARS-CoV-2 virus since the first 3-4 months of the year favours the dissemination of respiratory viruses in some Indian states like Maharashtra, Gujarat, etc. One should remember that globally also, many waves of Covid-19 outbreaks have been observed. What impact did <keyword id="8764262" type="UNKNOWN" weightage="20" keywordseo="covid">Covid</keyword> vaccines have? Now, it brings us to the critical question. What role did the Covid vaccines have in India’s ongoing fight with the virus? India gave emergency use authorisation to two Covid vaccines — <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword> and <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword> — in the first week of January 2021 and started the first inoculation phase from 16th January. So far,<a href="https://news.google.com/covid19/map?hl=en-GB&amp;mid=%2Fm%2F03rk0&amp;state=7&amp;gl=GB&amp;ceid=GB%3Aen"> around</a> 50 million doses have been administered, and 8 million people have received both doses. At the current rate (0.67 million per day), it will take at least 5.6 years to vaccinate the entire population with a single dose. Even if we add the already infected (i.e., 12 million) to the tally, 4.4 years would be needed to vaccinate everyone. We all know that the current threshold to achieve herd immunity is 70%, provided vaccines offer 100% protection and prevent asymptomatic transmission. Also, this estimate is based on the old circulation variant (D614G). Even this target (70%) would be reached in four years even with a single dose, and more than 20 years with the current pace. This means the impact of vaccination would be minimal until we cover a sizable proportion of our population. And by that time, the pandemic would have run its course. So, in all probability, the role of mass-scale vaccination would become redundant. Globally also barring one country,<a href="https://www.aljazeera.com/news/2021/3/25/half-of-israelis-fully-vaccinated-palestinians-lag"> Israel</a>, that has vaccinated more than 51% of its population with two doses, no other country has shown significant Covid vaccination. In the UK, where the new variant has caused a massive second wave in the last quarter of 2020, it was a strict lockdown that had maximum impact on the pace of the pandemic, though vaccination had some effect on the older population. Similarly, in the US, the virus’s natural epidemiological variation led to the waning of the third wave of their epidemic. However, one can ascribe the minimal impact of mass vaccination in large countries like the UK and US with a partial vaccination of the susceptible population. The most glaring example of the failure of large-scale vaccination is offered by<a href="https://www.nbcnews.com/news/latino/chile-critical-grip-second-covid-wave-one-best-vaccination-rates-rcna505"> Chile</a>, where despite vaccinating one-third of its people with a single dose and lying in the top three countries as far as vaccination per capita is concerned, it suffered another massive surge. <div type="image" title="Representative image." msid="81720961" hostid="261" caption="&amp;lt;p&amp;gt;Representative image.&amp;lt;/p&amp;gt;"></div> How to make vaccines relevant to our fight against the Covid pandemic? So, will Covid vaccines fail to curb the ongoing pandemic? No, it depends on how judiciously we employ them. There is an intense competition between the pace of vaccination and the steady speed of virus spread. So far, the virus seems to be having the upper hand, and it is propelled by the assistance offered by its ongoing evolutions into more efficient forms. As far as India, the second-most-populous country in the world, is concerned, it seems handicapped by its inability to vaccinate quickly. Following measures may help to make vaccinations count as an effective intervention against the ongoing pandemic rather than as a redundant exercise: 1. Ramping up considerably the pace of vaccination: As described above, the current vaccination rate is sluggish. A massive effort is needed to vaccinate at least 10 million people per day that may have some dent in the virus’s ongoing intense transmission. At this rate, we can vaccinate a sizeable chunk of our population within 3-4 months that may halt the ongoing transmission. India can do this -- during the polio supplementary immunisation activities, India had vaccinated around<a href="https://www.bbc.co.uk/news/world-asia-india-25708715"> 170 million children</a> during a round of vaccination. The vaccination at the current pace will lead to significant immunity gaps that may facilitate viral mutations. 2. Ban on export of vaccines manufactured in India: A critical hindrance to the rapid ramp-up of vaccine distribution would be the limited supply of vaccines. India may need at least 1.5 billion doses for its domestic use. On March 25th, India put a temporary <a href="https://www.bbc.com/news/world-asia-india-56513371">hold </a>on all major exports of two indigenously produced vaccines. This is a step in the right direction considering ongoing intense viral transmission. However, another important vaccine, Covovax, originally developed by <keyword id="323030" type="COMPANY" weightage="20" keywordseo="Novavax">Novavax</keyword> and produced here by the <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword>, is also needed to be prioritised for domestic use, and export should be deferred. This candidate has proved to have excellent efficacy and ease of production with tremendous scalability. Owing to these essential virtues, this candidate is the key to vaccinating the entire globe, not the mRNA or vector-based vaccines. 3. Need to fast-track the regulatory approval of Covid vaccines: Currently, Indian regulators have made it mandatory to conduct bridging studies in India for emergency use authorisation of even a proven product. Though this may add a certain value, this may prove to delay the vaccines’ roll-out amid an intense outbreak. Those vaccines that have already proven their efficacy amongst different populations need to provide a waiver. For example, few key vaccines like Novavax’s protein sub-unit, Sputnik-V and Janssen’s Ad26 vector vaccines, are being produced here by some Indian companies. All these vaccines have proven their efficacy globally, and two of them are in use in many countries. They should be made available for domestic use. 4. Rescheduling the administration schedule: Recently, the government of India announced a prolonged time interval between the first and second<a href="https://qz.com/india/1987681/india-increases-covishield-dose-gap-amid-delayed-shipments-to-uk/"> dose</a> of the Covishield vaccine from 4 weeks to 6-8 weeks. However, the<a href="https://www.thehindubusinessline.com/news/science/covishield-is-813-efficacious-if-two-doses-administered-12-weeks-apart-lancet-study/article34025087.ece"> recent trial</a> of the Covishield demonstrates that a 12 weeks interval provides a higher efficacy (up to 81%) than at 6-8 weeks (60-64%). Furthermore, even single-dose protection may last up to 12 weeks with a reasonably good efficacy (76%). Similarly, the dosing schedule of inactivated vaccine, Covaxin, can be prolonged to 8 weeks since immunologically, a higher interval between two doses provides better immunity. Hence, it would be more fruitful to delay the second dose administration to enable a massive inoculation drive in the shortest possible time. 5. Abolish prioritisation for vaccination: The current government strategy, which is based on the WHO directive, is providing hindrance to rapid vaccination of the entire susceptible population. Covid immunisation should be made accessible for all on a war footing level. 6. Spread vaccine delivery points: Though the existing government distribution system can vaccinate 10 million individuals per day, nevertheless expanding the vaccine delivery booths at certain entry points like at airports, bus, railway stations, etc., may expedite this drive. Even mobile vaccine booths can be developed across the country. 7. Speeding up the genetic sequencing: Currently, only a few thousand samples have been sequenced genetically. Only a few hundred samples are taken up for genetic sequencing in a few large states like UP. Following the confirmation of a few variants in the country, there is an urgent need to ramp up the sequencing and study the vaccine efficacy against these emerging variants. The above-listed measures may help deliver Covid vaccines to a significant proportion of the population in the shortest possible time. To vaccinate the entire country over a few years may not serve any purpose. We need to utilise vaccines' availability to serve the purpose for which they were produced in a record time to end this pandemic. Dr. Vipin M. Vashishtha is the former convener at the Indian Academy of Pediatrics (IAP) Committee on Immunisation, and a Pediatrician at Mangla Hospital and Research Centre in Bijnor, Uttar Pradesh SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/barbeque-nation-ipo-gets-subscribed-almost-6-times-and-allotment-will-announced-on-1st-april/articleshow/81707826.cms" data-type="tilCustomLink" target="_blank">Indian dining chain Barbeque Nation’s IPO gets subscribed almost 6 times</a> <a href="https://www.businessinsider.in/business/news/ever-given-the-ship-blocking-the-suez-canal-is-costing-billions-of-dollars-for-people-around-the-world/articleshow/81708146.cms" data-type="tilCustomLink" target="_blank">Ever Given, the ship blocking the Suez Canal, is costing billions of dollars for people around the world</a>

You Searched For "covovax" and got 11 results

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

PTI

Covovax vaccine to get approval as a booster in 10-15 days: Adar Poonawalla

PTI

Serum Institute to roll out COVID-19 vaccine for children in six months, says CEO Adar Poonawalla

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Serum Institute's second COVID-19 vaccine 'Covavax' likely to be launched in September

IANS

Coronavirus vaccine Covishield completes enrolment of phase-3 clinical trials under ICMR, Serum Institute's partnership

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90% of people in China's Henan province infected with Covid says a report by The Guardian

IANS

India allows emergency use of Merck's new drug Molnupiravir for treatment of mild-to-moderate COVID-19 cases

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India’s fresh Covid cases shoot up to 8-month high, states issue mask guidelines

Katya Naidu

Indian generic drug Paxlovid in high demand in China amid Covid surge

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US-based biotechnology company Novavax’s COVID-19 shot is 90% effective

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Making vaccines available to Indians may not be enough, it depends on how judiciously we employ them

Dr. Vipin M. Vashishtha

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