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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="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="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

<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>

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

<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)

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

PTI

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

PTI

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

PTI

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

Dr. Vipin M. Vashishtha

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

Katya Naidu

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