{"id":10723,"date":"2021-09-03T06:00:57","date_gmt":"2021-09-03T06:00:57","guid":{"rendered":"https:\/\/i3tk.org\/demo2\/?p=10723"},"modified":"2021-09-03T06:00:59","modified_gmt":"2021-09-03T06:00:59","slug":"pune-based-gennova-to-use-siis-covishield-vaccine-as-the-comparator","status":"publish","type":"post","link":"https:\/\/i3tk.org\/demo2\/world-news\/resources\/pune-based-gennova-to-use-siis-covishield-vaccine-as-the-comparator\/","title":{"rendered":"Pune-based Gennova to use SII&#8217;s Covishield vaccine as the comparator"},"content":{"rendered":"\n<p>Pune-based Gennova Biopharmaceuticals, a subsidiary of Emcure Pharma, is set to soon start phase-2 and 3 trials of India\u2019s first mRNA based vaccine for Covid-19. \u201cThey have got regulatory approvals and the last-stage trials are expected to start soon. The company will soon start enrolment for the trials,\u201d said a senior government official.<\/p>\n\n\n\n<p>The study will be conducted at 10-15 sites in phase-2 and 22-27 sites in phase-3. To assess the immunogenicity of the mRNA vaccine, Gennova will have to use&nbsp;<a href=\"https:\/\/health.economictimes.indiatimes.com\/tag\/covishield\">Covishield<\/a>&nbsp;\u2014 an existing vaccine \u2014 as a comparator, as the regulator has disallowed use of a placebo for the trials.<\/p>\n\n\n\n<p>Placebo is an inactive drug or treatment used in clinical trials.<\/p>\n\n\n\n<p>\u201cThe regulator has done away with the placebo arm in the trials. A comparator, in this case Covishield, will be used to compare the new vaccine,\u201d added the official. Vaccines developed for Covid are based on different platform technologies, making a comparison difficult.<\/p>\n\n\n\n<p>Gennova should ideally be compared with an approved vaccine from the same platform technology. \u201cHowever, in the absence of these vaccines in India, it will have to be compared with the available vaccine,\u201d the official said.<\/p>\n\n\n\n<p>Public health experts however advise caution. \u201cWe cannot compare two vaccines when trials were at different times, with different variants and different levels of immunity and susceptibility in the population,\u201d said K Srinath Reddy, president of the Public Health Foundation of India.<\/p>\n\n\n\n<p>Government officials said they expect the launch of the mRNA vaccine by the end of the year.<\/p>\n\n\n\n<p>While the mRNA vaccines of Moderna and&nbsp;<a href=\"https:\/\/health.economictimes.indiatimes.com\/tag\/pfizer\">Pfizer<\/a>&nbsp;are required to be kept at very low temperatures, Gennova\u2019s experimental vaccine will be stable between 2 and 8 degrees. Earlier, the department of biotechnology had said Gennova had submitted the interim clinical data of the vaccine\u2019s phase-1 study to the Central Drugs Standard Control Organisation.<\/p>\n\n\n\n<p>The Vaccine Subject Expert Committee reviewed the interim data and found that the HGCO19 vaccine was safe, tolerable and immunogenic in the participants of the study, it said.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>To assess the immunogenicity of the mRNA vaccine, Gennova will have to use Covishield \u2014 an existing vaccine \u2014 as a comparator, as the regulator has disallowed use of a placebo for the trials.<\/p>\n","protected":false},"author":1,"featured_media":10288,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[87],"tags":[],"class_list":["post-10723","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-resources"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v18.8 (Yoast SEO v27.4) - 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