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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

India's drug regulator has given approval for a study to be conducted by the <keyword id="93589" type="ORGANIZATION" weightage="20" keywordseo="Christian-Medical-College">Christian Medical College</keyword> (CMC), Vellore on mixing of COVID-19 vaccines <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> and Covishield, official sources said on Wednesday. An expert panel of the <keyword id="170943" type="ORGANIZATION" weightage="20" keywordseo="Central-Drugs-Standard-Control-Organisation">Central Drugs Standard Control Organisation</keyword> (CDSCO) on July 29 had recommended granting permission for conducting the study. The trial will involve 300 healthy volunteers. "The aim of the study is to assess the feasibility on whether a person can be given two different vaccine shots -- one each of Covishield and Covaxin -- to complete the inoculation course," a source said. Separately, a recent study by the Indian Council of Medical Research (ICMR) involving 98 people, 18 of whom had inadvertently received Covishield as the first dose and Covaxin as the second in <keyword id="413944" type="PERSON" weightage="20" keywordseo="uttar">Uttar</keyword> Pradesh, showed that combining these two COVID-19 vaccines elicited better immunogenicity than two doses of the same vaccine. The study also found that immunisation with combination of Covishield and Covaxin was safe and the adverse effects were also found to be similar when compared to the same dose regimen. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/mobile/news/xiaomi-launches-mi-mix-4-its-first-under-display-camera-phone/articleshow/85231596.cms">Xiaomi debuts its first under-display camera on the Mi Mix 4</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/mobile/news/oneplus-teases-a-foldable-phone-announcement-clashing-with-samsungs-unpacked-event/articleshow/85233365.cms">OnePlus teases a foldable phone announcement clashing with Samsung’s Unpacked event</a>

DCGI approves study on mixing of Covaxin and Covishield  COVID-19 doses, say sources

New Delhi, As India gets readied for a <keyword id="10424473" type="UNKNOWN" weightage="20" keywordseo="massive-covid-vaccination-programme">massive Covid vaccination programme</keyword>, heath experts on Sunday said that 21 days is an ideal gap between the first and the <keyword id="10424474" type="UNKNOWN" weightage="20" keywordseo="second-booster-dose">second booster dose</keyword>, and those who get vaccinated have to maintain the same health hygiene as they are supposed to do sans vaccine for a certain time period. Union Health Ministry Secretary Rajesh Bhushan had said that 30 crore people have been listed in prioritised population groups, which involves one crore healthcare workers, two crore personnel from the police department, armed forces, home guard, civil defence organisation and 27 crore people above the age of 50 and below 50 with co-morbidities. The government is expected to roll out its <keyword id="9849917" type="UNKNOWN" weightage="20" keywordseo="first-vaccines">first vaccines</keyword> in the next few weeks with at least three candidates under the <keyword id="6681091" type="UNKNOWN" weightage="20" keywordseo="active-consideration">active consideration</keyword> of India's drug regulator. According to Dr Manoj Goel, Director, Pulmonology at Fortis Hospital in Gurugram, after taking the first dose, the second dose has to be ideally taken on the 21st day. "After the vaccination, one can resume their normal day to day activities. In between also, there are no guidelines to sit at home and people can carry on their usual activities by taking the basic precautions like social distancing, wearing a mask and frequent sanitising of hands," Goel told IANS. The Union Health Ministry had said that 1.54 lakh vaccinators or auxiliary nurse midwives will administer the <keyword id="8763838" type="UNKNOWN" weightage="20" keywordseo="covid-19">Covid-19</keyword> vaccine to people under the universal immunisation programme when the vaccination process begins. According to Dr Jyoti Mutta, Senior Consultant, Microbiology at Sri Balaji Action Medical Institute in New Delhi, there are a number of vaccines which have different schedules and these vaccine schedules are determined by clinical trials. "Talking about Pfizer vaccine in this regard, two doses are suggested 21 days apart and two doses 28 days apart for AstraZeneca vaccine. Also, the proper rest and precautions are suggested during this period in order to avoid infection and proper care," she told IANS. Dr Mutta also stressed that staying at home is not particularly defined as a precautionary measure but complete care is recommended. "Taking precautions like wearing a mask, social distancing and hand hygiene is important to avoid infection," she noted. Dr Neha Gupta, Infectious Diseases Physician at Medanta Hosptial in Gurugram told IANS: "Vaccine requires two doses 21 days apart and usually the protective efficacy is seven days after the second dose. So, patients need to continue precautions after the first dose of vaccine." There are as many as eight <keyword id="8983421" type="UNKNOWN" weightage="20" keywordseo="Covid-vaccine">Covid vaccine</keyword> candidates under different stages of clinical trials which could be ready for authorisation in near future. The vaccines include Covaxin, Astrazeneca and Oxford university developed and Serum Institute of India manufactured <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>, ZyCoV-D by Zydus Cadila, Russian vaccine candidate Sputnik-V, NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabelled vaccines - Recombinant Protein antigen-based vaccine by Biological E Limited and Inactivated rabies vector platform by <keyword id="7330627" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech-Limited">Bharat Biotech Limited</keyword>. Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have already applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their potential Covid-19 vaccines. SEE ALSO: <a href="https://www.businessinsider.in/science/space/news/dos-and-donts-during-solar-eclipse-surya-grahan/articleshow/76436997.cms">The do’s and don’ts of a Solar Eclipse — here what you need to know to protect yourself</a> <a href="https://www.businessinsider.in/science/space/news/solar-eclipse-december-2020-time-date-everything-you-need-to-know/articleshow/79697355.cms">The total solar eclipse and its 'diamond rings' won't be visible in India on December 14</a>

Experts believe COVID-19 vaccine doses need a at least a 21-day gap between them

New Delhi, Days before the <keyword id="23914" type="PERSON" weightage="20" keywordseo="commencement">commencement</keyword> of the <keyword id="10584544" type="UNKNOWN" weightage="20" keywordseo="nationwide-covid-19-vaccination-drive">nationwide Covid-19 vaccination drive</keyword>, the <keyword id="83655" type="COMPANY" weightage="20" keywordseo="Union-health-ministry">Union Health Ministry</keyword> said on Tuesday that 1.1 crore <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword> and 55 lakh <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> vaccines have been procured at a cost of ₹200 and ₹206 per dose, respectively. "As many as 110 lakh (1.1 crore) doses of Covishield vaccine are being procured from the <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> at a cost of ₹200 per dose, excluding taxes. A total of 55 lakh doses of Covaxin vaccine are being procured from <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>," Union Health Secretary Rajesh Bhushan said during a press conference.2 The cost of 38.5 lakh doses of Covaxin is ₹295 per dose, excluding taxes. Bharat Biotech is providing 16.5 lakh doses of Covaxin free of cost to the Central government. Hence, the cost of Covaxin comes to ₹206 per dose," he added. Vaccines have already reached some states. Till 4 p.m., about 54,72,000 doses were received by the states and <keyword id="390245" type="LOCATION" weightage="20" keywordseo="Union-Territories">Union Territories</keyword>. By January 14, 100% doses will be received. The much-awaited Covid-19 vaccination drive will kick-off on January 16. The Central government plans to vaccinate nearly 30 crore people in the first phase of the drive. Priority will be given to the healthcare and frontline workers who are estimated to be around three crore, followed by those above 50 years of age and the under-50 population with comorbidities numbering around 27 crore. On January 3, two vaccines -- Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield manufactured by the Serum Institute of India -- were approved for 'restricted emergency use'. Few more vaccines are in the pipeline and are conducting trials. SEE ALSO: <a href="https://www.businessinsider.in/tech/apps/how-to/how-to-backup-and-restore-messages-in-signal-app/articleshow/80226649.cms">How to backup and restore messages in Signal app</a> <a href="https://www.businessinsider.in/tech/apps/news/whatsapp-says-your-privacy-wont-be-affected-if-you-dont-use-these-features/articleshow/80225748.cms">WhatsApp says your privacy won't be affected if you don't use these two optional features</a> <a href="https://www.businessinsider.in/india/news/supreme-court-puts-indias-three-farm-laws-on-hold-forms-a-five-member-panel-to-resolve-the-deadlock/articleshow/80229881.cms">India's top court puts three new farm laws on hold — forms a five-member panel to resolve the deadlock</a>

Indian government procures over 1 crore Covidshield vaccine doses for ₹200 apiece and 55 lakh Covaxin doses for ₹206

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

As of now as many as 110 countries have recognized India's Covid vaccines -- <keyword id="9617748" type="General" weightage="20" keywordseo="Covishield" source="Orion">Covishield</keyword> and <keyword id="9485939" type="General" weightage="20" keywordseo="Covaxin" source="Orion">Covaxin</keyword> -- and have agreed to mutual recognition of Covid-19 vaccination certificates with India, said official sources in the Union Health Ministry. A source with the Ministry said that at present, 110 countries have agreed to mutual recognition of vaccination certificates and those who recognise Indian vaccination certificates of travellers fully vaccinated with Covishield or World Health Organisation(WHO)-approved Covid vaccines. As per the new travel guidelines issued by the Union Health Ministry, if a fully vaccinated traveller is coming from a country with which India has reciprocal arrangements for mutual acceptance of WHO-approved Covid-19 vaccines, they will be allowed to leave the airport and must self-monitor their health for 14 days' post arrival. If partially or not vaccinated travellers visit India, they will have to submit their sample for post-arrival Covid-19 test at the point of arrival after which they will be allowed to leave the airport. They will have to be undergo home quarantine for seven days and undertake re-test on the eighth day of arrival in India and if found negative, further self-monitor their health for next seven days. "Travellers artiving from countries excluding those at risk, will be allowed to leave the airport and must self-monitor their health for 14 days' post arrival. This is applicable to travellers from all countries, including with which reciprocal arrangements for mutual acceptance of WHO-approved Covid-19 vaccines also exist," said the new international arrival guidelines. Of eight WHO-approved vaccines against Covid-19 in emergency use listing, two vaccines -- Covaxin and Covishield -- are from India. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/indias-covaxin-77-8-effective-for-covid-19-says-lancet-report/articleshow/87661300.cms">India's Covaxin 77.8% effective for COVID-19, says Lancet Report</a> <a href="https://www.businessinsider.in/science/health/news/ideal-time-for-booster-dose-for-covid-19-vaccine-is-6-months-after-second-dose-says-bharat-biotech-md/articleshow/87629337.cms">Ideal time for COVID-19 booster shot is six months after the second dose, says Bharat Biotech MD</a>

You Searched For "two doses of covishield" and got 6 results

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

PTI

DCGI approves study on mixing of Covaxin and Covishield COVID-19 doses, say sources

PTI

Experts believe COVID-19 vaccine doses need a at least a 21-day gap between them

IANS

Indian government procures over 1 crore Covidshield vaccine doses for ₹200 apiece and 55 lakh Covaxin doses for ₹206

IANS

Covishield immune responses against Covid variants higher than Covaxin: Study

PTI

Covishield and Covaxin are now recognized by 110 countries

IANS

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