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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?

<ul><li>India's expert panel has recommended SII’s Oxford-AstraZeneca COVID-19 vaccine dubbed Covishield in India for emergency use with 'restrictions.'</li><li>The SEC recommendation on Covishield has been forwarded to the Drugs Controller General of India (DCGI), which is likely to take a final call soon.</li><li>The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. </li></ul>An expert panel of India's drug regulator on Friday recommended emergency use approval for Oxford-AstraZeneca vaccine Covishield, being manufactured by the Serum Institute of India, paving the way for the roll-out of the first COVID-19 shot in the country in the next few days.. The SEC recommendation on Covishield has been forwarded to the Drugs Controller General of India (DCGI), which is likely to take a final call soon. The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from SII and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter. While granting the restricted emergency use approval for the Oxford COVID-19 vaccine, the panel imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of 4 to 6 weeks. Further, the SII should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest. Also, the Pune-based firm should submit the safety data including the data on adverse events following immunisation (AEFI) and adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country. The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. The approval comes at a time when the Indian government is wary of the new strain of COVID-19, which has been wreaking havoc in the UK. So far 29 cases of the new mutant variant have been detected in India. As compared to Pfizer and Moderna vaccines, the Oxford-AstraZeneca COVID-19 vaccine is <a href="https://www.businessinsider.in/india/news/india-needs-to-ramp-up-its-cold-storage-facilities-to-accommodate-the-distribution-of-the-covid-19-vaccine-within-the-country/articleshow/79422624.cms">more suited to India’s requirements</a> with storage temperature requirements of between two to eight degrees Celsius. COVID-19 vaccine candidates and the temperatures they need to survive: <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;">Vaccine </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;">Cold chain </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/BioNTech </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;">-70 degrees Celsius </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;">Moderna </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;">-20 degrees Celsius </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;">Oxford/AstraZeneca </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;">2-8 degrees </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;">Johnson and Johnson </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;">2-8 degrees </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;">Novavax </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;">2-8 degrees </td></tr></tbody></table>Source: Respective companies The government is also reportedly in favour of Covishield because it's considerably cheaper than Pfizer and Moderna. According to the SII, the vaccine will only cost the government $3 per dose. Pfizer, on the other hand, is selling its vaccine at $37 per dose. Cost of COVID-19 vaccines: <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;">COVID-19 vaccine candidate </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;">Projected 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;">Covishield </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 </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;">Bharat Biotech </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;">$3-6 </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;">Zydus </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;">$3-6 </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;">Sputnik V </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></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;">$37 </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;"><a href="https://indianexpress.com/article/coronavirus/moderna-covid-19-vaccine-cost-7060816/">Moderna</a> </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;">$25-37 </td></tr></tbody></table> SII CEO Adar Poonawalla <a href="https://www.businessinsider.in/india/news/oxford-covid-19-vaccine-india-approval-likely-to-be-considered-today/articleshow/80025755.cms">told reporters</a> on December 28 that it has 40 to 50 million vaccine doses stockpiled so far, most of which are intended for the Indian market. “We will get some good news this New Year’s… All the data has been submitted and we must respect the process as regulators evaluate data,” he said. The Indian government is also ready to roll out the vaccine having run a <a href="https://www.businessinsider.in/india/news/covid-vaccine-dry-run-prep-up-before-the-actual-vaccine-reaches-you/articleshow/79996397.cms">two-day dry run</a> of its vaccination drive. The mock exercise was aimed at end-to-end testing of Covid-19 vaccination process, including planning and preparations as per the <a href="https://www.businessinsider.in/india/news/covid-19-vaccine-punjab-completes-dry-run-for-vaccination-in-two-districts-amid-concerns-over-new-virus-strain/articleshow/80010928.cms">operational guidelines</a>. SEE ALSO: <a href="https://www.businessinsider.in/science/space/news/isro-chairman-k-sivan-gets-one-year-extension-as-space-secretary/articleshow/80038663.cms">ISRO Chairman K Sivan gets one year extension as Space Secretary</a> <a href="https://www.businessinsider.in/finance/banks/news/cbi-books-hyderabad-based-infra-firm-ivrcl-for-defrauding-eight-public-banks-for-4837-crore/articleshow/80038439.cms" data-type="tilCustomLink">CBI books Hyderabad-based infra firm IVRCL for defrauding eight public banks for ₹4,837 crore</a>

Serum’s Covishield vaccine gets expert panel recommendation, paving the way for first authorized COVID-19 shot in India

<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>Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations.</li><li>On September 10, the Serum Institute of India had to pause the Phase II/Phase III human trials of Oxford’s <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> candidate across all 17 locations as a precaution, following a show-cause notice.</li><li>However, the Drugs Controller General of India, on September 15, asked the SII to resume human trials. </li><li>Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites. </li></ul>Serum Institute of India (SII) is likely to begin the <keyword id="9978218" type="UNKNOWN" weightage="20" keywordseo="Phase-III-human-trials">phase III human trials</keyword> of Oxford’s coronavirus vaccine at Sassoon General Hospital in Maharashtra on September 22, Hindustan Times <a href="https://www.hindustantimes.com/india-news/phase-3-human-clinical-trial-of-oxford-vaccine-begins-in-pune/story-mpfvHoWiH4lh3I452On7UP.html">reported. </a> “We have started the phase-III trials of the vaccine (candidate <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>). We will administer dose to 150 to 200 volunteers,” said Dr Muralidhar Tambe, Dean, Sassoon General Hospital. Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations. On September 10, the Serum Institute of India had to pause 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<a href="https://www.businesstoday.in/coronavirus/breaking-covid-19-trials-paused-till-further-instructions-says-serum-institute/story/415686.html">, reported Business Today.</a> SII <a href="https://twitter.com/CNBCTV18Live/status/1303981172200882176">sai</a>d there have been no issues in India, and this is a precautionary measure, and it will restart the trial as soon as AstraZeneca does. AstraZeneca has resumed trials in the UK but not yet in the US. Drugs Controller General of India, on September 15, asked the SII to resume human trials. Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites. SII has signed two agreements for the supply of Covid-19 vaccines, the first being AstraZeneca-Oxford's candidate, for which the company has agreed to produce up to 1 billion doses for low and middle-income countries. SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Earlier, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India. The Serum Institute of India would introduce candidate vaccines from AstraZeneca and Novavax for COVID-19 at less than ₹250 per dose in India. The Pune-based institute <a href="https://www.hindustantimes.com/india-news/serum-institute-ties-up-with-bill-gates-foundation-gavi-to-speed-up-covid-19-vaccine-manufacture-process/story-h20YRO9mdooYA8ysqenE9L.html">partnered with </a>Bill &amp; Melinda Gates Foundation to offer up to 100 million doses, with the price capped at $3 for 92 low and middle-income countries (LMIC), including India. There are at least 30 COVID vaccine candidates in preclinical or clinical stages in India. While three of them are in the advanced stage of Phase I/II/III trials and 4 are in the advanced preclinical development stage, Union Health Minister, Dr Harsh Vardhan, told the Parliament. Vardhan believes India <a href="https://www.businessinsider.in/india/news/covid-vaccine-likely-by-early-2021-for-old-high-risk-first-harsh-vardhan/articleshow/78090587.cms">may</a> get a coronavirus vaccine by early 2021. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/lok-sabha-passes-amendments-to-foreign-contribution-regulation-act-makes-aadhaar-mandatory-for-foreign-contribution-towards-ngos/articleshow/78246944.cms">Lok Sabha passes amendments to Foreign Contribution (Regulation) Act — makes Aadhaar mandatory for foreign contribution towards NGOs</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/bhiwandi-building-collapse-death-toll-rises-to-17-including-eight-children/articleshow/78247063.cms">Bhiwandi building collapse: Death toll rises to 17, including eight children</a>

Oxford’s COVID-19 vaccine: Phase III human trials begin in India

New Delhi, <keyword id="6354814" type="UNKNOWN" weightage="20" keywordseo="prime-minister-narendra-modi">Prime Minister Narendra Modi</keyword> said on Monday that the world's biggest inoculation drive against <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword> is set to begin in the country, a day after the drugs regulator approved two vaccines for restricted emergency use. Lauding the scientists and technicians for the 'Made in India' vaccines, he said the country is proud of them. "World's biggest COVID-19 vaccination programme set to begin in India. For this, the country is proud of the contributions of its scientists and technicians," Modi said. India's drugs regulator on Sunday approved Oxford COVID-19 vaccine <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>, manufactured by the <keyword id="242973" type="COMPANY" weightage="20" keywordseo="Serum-Institute">Serum Institute</keyword>, and indigenously developed <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword> of <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> for restricted emergency use in the country, paving the way for a massive inoculation drive. Addressing scientists at the National Metrology Conclave, Modi said it must be ensured that 'Made in India' products not only have global demand but also global acceptance. "Quality is as much important as quantity, our standards should rise with our scale in our quest for Aatmanirbhar Bharat," he said. The prime minister said in any progressive society, research is key and effective and its effects are commercial and social. They also help widen approach and thinking. "Past teaches us that more a country concentrates on science, the more its technology gets strengthened. This technology in turn helps new industries and promotes research. This cycle takes the country ahead," he said. "We do not want to fill the world with Indian products, but we must win the hearts of every customer of Indian products in every corner of the world," he said. Quality of services in our country and products, both public or private sector, will determine India's strength in the world, he stressed. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-beml-hcl-tech-infosys-tech-mahindra-tcs-ril-tata-motors-hero-moto-tvs-and-others/articleshow/80089765.cms">Top stocks to watch — BEML, HCL Tech, Infosys, Tech Mahindra, TCS, RIL, Tata Motors Hero Moto, TVS, and others</a> <a href="https://www.businessinsider.in/business/auto/news/checkout-upcoming-new-cars-in-year-2021/slidelist/80025993.cms">Upcoming new cars in India in 2021 of Maruti, Tata, MG, Audi</a> <a href="https://www.businessinsider.in/international/news/questions-arise-about-jack-ma-whereabouts-as-alibaba-faces-scrutiny-from-the-chinese-government/articleshow/80090457.cms">Where is Jack Ma? Questions arise about the billionaire’s whereabouts as Alibaba faces scrutiny from the Chinese government</a>

India will soon begin world's biggest COVID-19 vaccination programme: PM Modi

<keyword id="18568" type="COMPANY" weightage="20" keywordseo="kathmandu">Kathmandu</keyword>, Ahead of signing a major Covid <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> deal with <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>, probably on Friday, Nepal's Department of Drug Administration (DDA) has given permission for the <keyword id="9156702" type="UNKNOWN" weightage="20" keywordseo="emergency-use">emergency use</keyword> of India-made coronavirus vaccine Covishield in the country. Nepal's Foreign Minister Pradeep Gyawali is currently in New Delhi to take part in the sixth meeting of Nepal-India Joint Commission. One of the major agreements that both sides are likely to ink is on cooperation in Covid vaccine manufactured in India. The vaccine, developed by the <keyword id="30725" type="COMPANY" weightage="20" keywordseo="Oxford-university">Oxford University</keyword> and Astra-Zeneca and produced by the <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword>, has been given conditional permission for emergency use, the department said. The DDA had two days ago called for the registration of vaccines to be used for emergency use. This is the first time that any Covid-19 vaccine has been approved for use in Nepal. Other manufacturing countries like China and Russia were also interested in providing vaccines to Nepal but due to climatic conditions, pricing, logistic facility and ease of import, Nepal preferred the Indian Covid vaccine. India has already permitted the use of Covishield as well as Covaxin of <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>. SEE ALSO: <a href="https://www.businessinsider.in/defense/news/these-amazing-facts-about-the-indian-army-will-make-you-beam-with-pride/slidelist/80270052.cms">Army Day 2021: These amazing facts about the Indian Army will make you beam with pride</a> <a href="https://www.businessinsider.in/business/corporates/news/hcl-tech-clocks-in-nearly-27-jump-in-profit-crosses-the-10-billion-revenue-in-third-quarter-of-year-2020-21/articleshow/80278852.cms">HCL Tech clocks in nearly 27% jump in profit, crosses the $10 billion revenue milestone with one more quarter left</a> <a href="https://www.businessinsider.in/india/news/india-will-begin-its-covid-19-vaccination-drive-tomorrow-heres-everything-you-need-to-know/articleshow/80281740.cms">India will begin its COVID-19 vaccination drive tomorrow — here’s a look at how the world’s largest vaccine rollout is set to take place</a>

Nepal approves Covishield vaccine for emergency use

Neutralising antibody responses against the SARS-COV-2 virus and its variants of concern (VoC) are higher among <keyword id="9617748" type="General" weightage="80" keywordseo="covishield" source="Orion">Covishield</keyword> recipients than those who took the indigenously made <keyword id="9485939" type="General" weightage="100" keywordseo="covaxin" source="Orion">Covaxin</keyword>, according to a multi-centre study. The yet-to-be peer-reviewed study, posted on the preprint server MedRxiv on Friday, also found that when compared to the pre-vaccination baseline, both vaccines elicited statistically significant antibody levels in both seronegative individuals and seropositive or those who had recovered from COVID-19 infection. Between June 2021 and January 2022, the researchers enrolled 691 participants in the 18-45 age group across four sites in urban and rural Bengaluru and <keyword id="2094" type="General" weightage="50" keywordseo="pune" source="Orion">Pune</keyword>. Participants received either two doses of Covaxin at 28 days apart or two doses of Covishield at three months apart. The <keyword id="1609796" type="General" weightage="50" keywordseo="omicron" source="Orion">Omicron</keyword> wave in early 2022 overlapped with the second dose of vaccine in two sites and with both doses in one site. Participants were sampled at six timepoints for antibody analyses and at four timepoints for cellular analyses. When compared to pre-vaccination baseline, both vaccines elicited statistically significant antibody levels in both seronegative and seropositive individuals, the researchers found. Covishield elicited immune responses of higher magnitude and breadth than Covaxin in both seronegative individuals and seropositive individuals, across cohorts representing the pre-vaccination immune history of the majority of the vaccinated Indian population. Immunologist Vineeta Bal noted that in young adult population there is a difference in the response to COVID vaccines, if individuals are already infected with SARS-CoV-2 and recovered (seropositives) versus not infected. "In seronegatives, two doses of Covishield lead to higher magnitude of antibody levels in higher proportion of vaccine recipients as compared to Covaxin recipients," Bal, from <keyword id="101852" type="General" weightage="50" keywordseo="indian-institute-of-science-education-and-research" source="Orion">Indian Institute of Science Education and Research</keyword> (IISER), Pune and one of the study authors, told PTI. "In terms of waning of immune response with time also Covishield vaccinated individuals retain antibodies in their blood for longer period in larger proportion of individuals,” she said. The study does not directly look for or document protection from COVID-19 in the recipients. "Levels of neutralising antibodies as well as T cell responses, according to different investigators, are indirect indicators of protection,” Bal said. "The interim results so far show that Covishield vaccination induces robust neutralising antibodies against the original SARS-CoV2; Covaxin also does it but somewhat less efficiently,” she added. "Against later variants of the virus such as Delta and Omicron, especially Omicron, neutralising antibodies triggered by Covishield are not as effective, however, they appear marginally better than in Covaxin recipients," Bal added. Prior studies comparing Covishield and Covaxin were limited to addressing only antibody responses and in particular in the health care worker population who were immunised prior to the Delta wave. There is, however, limited data on cellular immune responses elicited by these vaccines and no direct head to-head comparisons or stratification by pre-vaccination serostatus. Vaccination following exposure to the Delta or Omicron variants of SARS-CoV-2 is likely to affect the quality, quantity and duration of immune responses. For determining future COVID-19 vaccination policy when pan-coronavirus or sarbecovirus vaccines become available, it becomes important to take into account pre-vaccination immune history of the majority of the vaccinated Indian population. "Some unpublished work from other investigators in India seems to suggest that heterologous boosting i.e. Covaxin in Covishield recipients and vice versa works better than homologous boosting," Bal added.

Covishield immune responses against Covid variants higher than Covaxin: Study

<keyword id="9626040" type="UNKNOWN" weightage="20" keywordseo="Covishield-vaccine">Covishield vaccine</keyword> offers protection from double mutant variant of novel coronavirus, shows a study by the <keyword id="395778" type="COMPANY" weightage="20" keywordseo="Centre-for-Cellular-and-Molecular-Biology">Centre for Cellular and Molecular Biology</keyword> (CCMB). CCMB Director Rakesh K. Mishra termed this as a very preliminary but encouraging result. "Early results using in vitro neutralisation assay show that both convalescent (prior infection) sera and <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword> vaccinated sera offer protection against the B.1.617 variant, aka double mutant," he said in a tweet. The CCMB's finding came close on the heels of an announcement by the Indian Council of Medical Research (ICMR) that Covaxin neutralises multiple variants of SARS-CoV-2 and effectively works against the double mutant strain as well. Covaxin is India's first indigenous Covid vaccine developed by Bharat Biotech in collaboration with ICMR. Covishield has been developed by Oxford-Astrazeneca and is being produced by <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword>, <keyword id="2094" type="COMPANY" weightage="20" keywordseo="Pune">Pune</keyword>. Both Covaxin and Covishield are part of India's ongoing Covid vaccination programme. The 'double mutant' (B.1.617) is said to be responsible for the current surge in Covid-19 cases in <keyword id="13126" type="COMPANY" weightage="20" keywordseo="Maharashtra">Maharashtra</keyword> and other states in India. Scientists earlier feared that vaccines may not offer protection from 'double mutant' as it may escape the immune system. After the CCMB's latest announcement that Covishield too offers protection from 'double mutant', experts say this again underscore the need for people to get vaccinated. CCMB scientist Divya Tej Sowpati tweeted that the convalescent sera is from September 2020, hence most likely of an infection of a variant which is not B.1.617. He also pointed to misinformation and confusion about the circulating SARS-CoV-2 variants in India. Though B.1.617 is called 'double mutant', it is characterised by more than 15 mutations. "It got dubbed the 'double mutant' because of two <keyword id="16898" type="COMPANY" weightage="20" keywordseo="Spike">spike</keyword> mutations, L452R and E484Q, which were mutations of concern because of their immune escape properties, and possible high infectivity," wrote Sowpati, who is leading Covid-19 genomics at CCMB. According to him, B.1.618 is not the 'triple mutant'. "Triple Mutant: Again, WRONG name, because it has many more defining mutations. Dubbed 'triple' because in addition to the two mutations, it also has V382L in its Spike. This is a sub-lineage of B.1.617, found mainly in MH samples and also a bit in other states." He also clarified that B.1.618 which was first sampled in West Bengal in late October 2020, has nothing to do with B.1.617, except for a couple of shared variants that all SARS-CoV-2 strains have at this point such as D614G. According to him, the main concern with B.1.618 is that it is found in growing proportions in West Bengal and has the spike del145-146 as well as E484K, both of which are known immune escape mutations. The scientist said that the names of "double" and "triple" mutants are wrong and misleading and that they have no connection to the lineage seen in West Bengal. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/environment/news/worsening-air-quality-amid-the-surging-covid-19-cases-could-add-to-the-pressure-on-indias-healthcare-system/articleshow/82213498.cms">Air pollution is back with a vengeance as industries play catch up — and that could further worsen the COVID-19 pandemic</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/checkout-in-images-how-oxygen-is-being-transported-across-the-country-by-air-rail-and-road/slidelist/82212220.cms">By air, rail and road – how oxygen is being transported across India amidst a severe COVID-19 crisis</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/aiims-icmr-new-guidelines-for-treatment-of-covid-19-patients-with-moderate-case/articleshow/82211333.cms">Simplified: AIIMS, ICMR new guidelines for treatment of patients with ‘moderate’ case of COVID-19</a>

Covishield vaccine also protects from 'double mutant' strain of COVID-19, says CCMB

<keyword id="92247" type="COMPANY" weightage="20" keywordseo="Johnson-Johnson">Johnson &amp; Johnson</keyword>'s <keyword id="11735066" type="UNKNOWN" weightage="20" keywordseo="single-dose">single-dose</keyword> COVID-19 vaccine has been given Emergency Use approval in <keyword id="3658" type="COUNTRY" weightage="20" keywordseo="India">India</keyword>, <keyword id="700200" type="ORGANIZATION" weightage="20" keywordseo="Union-Health">Union Health</keyword> minister Mansukh Mandaviya said on Saturday. He said this will further boost the country's collective fight against the novel coronavirus infection. "India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has five <keyword id="2503801" type="ORGANIZATION" weightage="20" keywordseo="EUA">EUA</keyword> vaccines. This will further boost our nation's collective fight against #COVID19," the minister tweeted. The US-based pharmaceutical company had applied for <keyword id="9408526" type="UNKNOWN" weightage="20" keywordseo="emergency-use-authorisation">Emergency Use Authorisation</keyword> for its jab on Friday and was granted the approval the same day by the Drugs Controller General of India (DCGI). The five vaccines granted Emergency Use Authorisation in India are Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, Moderna and now Johnson &amp; Johnson. SEE ALSO <a href="https://www.businessinsider.in/tech/news/google-is-now-using-chrome-as-another-security-layer-for-account-sign-ins/articleshow/84975356.cms">Google is now using Chrome as an added security layer for account sign-ins</a> <a href="https://www.businessinsider.in/stock-market/news/how-to-check-allotment-status-of-glenmark-life-sciences-ipo/articleshow/84978486.cms">Glenmark Life Sciences IPO: How to check allotment status, listing date and more</a>

You Searched For "Covishield coronavirus vaccine" and got 9 results

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

Ankush Banerjee

Serum’s Covishield vaccine gets expert panel recommendation, paving the way for first authorized COVID-19 shot in India

BI India Bureau

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

Dr. Vipin M. Vashishtha

Oxford’s COVID-19 vaccine: Phase III human trials begin in India

BI India Bureau

India will soon begin world's biggest COVID-19 vaccination programme: PM Modi

PTI

Nepal approves Covishield vaccine for emergency use

IANS

Covishield immune responses against Covid variants higher than Covaxin: Study

PTI

Covishield vaccine also protects from 'double mutant' strain of COVID-19, says CCMB

IANS

India now has a fifth vaccine. Johnson & Johnson's single-dose COVID-19 shot gets government nod.

PTI

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