{"id":52500,"date":"2022-03-07T19:53:35","date_gmt":"2022-03-08T00:53:35","guid":{"rendered":"https:\/\/thelehighacresgazette.com\/news\/?p=52500"},"modified":"2022-03-07T19:53:40","modified_gmt":"2022-03-08T00:53:40","slug":"fda-rejects-non-mrna-covid-19-vaccine-for-children-company","status":"publish","type":"post","link":"https:\/\/thelehighacresgazette.com\/news\/2022\/03\/fda-rejects-non-mrna-covid-19-vaccine-for-children-company\/","title":{"rendered":"FDA Rejects Non-mRNA COVID-19 Vaccine for Children: Company"},"content":{"rendered":"\n<p>By&nbsp;Jack Phillips<\/p>\n\n\n\n<p>Ocugen said the U.S. Food and Drug Administration (FDA) declined to issue an emergency use authorization for&nbsp;Covaxin, the&nbsp;<a href=\"https:\/\/www.theepochtimes.com\/t-covid-19\" target=\"_blank\" rel=\"noreferrer noopener\">COVID-19<\/a>&nbsp;vaccine developed by its Indian partner Bharat Biotech, for children.<\/p>\n\n\n\n<p>The biopharmaceutical company said it intends to continue working with the FDA to evaluate the process for getting an emergency use authorization for pediatric use of Covaxin, it&nbsp;<a href=\"https:\/\/finance.yahoo.com\/news\/ocugen-provides-covaxin-pediatric-2-120100111.html\" target=\"_blank\" rel=\"noreferrer noopener\">said<\/a>&nbsp;in a March 4 statement that announced the health agency\u2019s decision. The company had sought to authorize the shot for children aged 2 to 18.<\/p>\n\n\n\n<p>Ocugen had entered into a deal with vaccine maker Bharat in late 2020, under which it would develop, supply, and commercialize Covaxin for the U.S. market.<\/p>\n\n\n\n<p>Covaxin, which isn\u2019t cleared for any age group in the United States, is one of the two most widely used COVID vaccines in India and also has an emergency use listing from the World Health Organization.<\/p>\n\n\n\n<p>A&nbsp;<a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(21)02000-6\/fulltext\" target=\"_blank\" rel=\"noreferrer noopener\">large-scale clinical trial<\/a>&nbsp;found that the vaccine provided decent protection against COVID-19, although it was carried out before the spread of the Omicron variant, which began to spread in the United States in late 2021.<\/p>\n\n\n\n<p>Covaxin, unlike Moderna or Pfizer, doesn\u2019t use mRNA technology; it&nbsp;<a href=\"https:\/\/www.newsnationnow.com\/health\/coronavirus\/vaccine\/covaxin-india-covid-vaccine\/\" target=\"_blank\" rel=\"noreferrer noopener\">uses<\/a>&nbsp;inactivated coronavirus technology similar to Johnson &amp; Johnson\u2019s single-shot vaccine.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"750\" height=\"406\" src=\"https:\/\/thelehighacresgazette.com\/news\/wp-content\/uploads\/2022\/03\/OCGN-0205-1-750x406-1.jpg\" alt=\"\" class=\"wp-image-52501\" srcset=\"https:\/\/thelehighacresgazette.com\/news\/wp-content\/uploads\/2022\/03\/OCGN-0205-1-750x406-1.jpg 750w, https:\/\/thelehighacresgazette.com\/news\/wp-content\/uploads\/2022\/03\/OCGN-0205-1-750x406-1-300x162.jpg 300w\" sizes=\"(max-width: 750px) 100vw, 750px\" \/><figcaption>COVID-19 Coronavirus Vaccine and Syringe with flag of India Concept Image. 3d illustration.<\/figcaption><\/figure>\n\n\n\n<p>The FDA has only fully authorized Pfizer\u2019s two-shot mRNA vaccine for children aged 5 to 17. There are currently no COVID-19 vaccines authorized for children under 5.<\/p>\n\n\n\n<p>Ocugen said it\u2019s continuing to seek full approval for the vaccine within the United States; the company previously said it would start enrolling adult U.S. volunteers for a clinical trial.<\/p>\n\n\n\n<p>Some health experts have argued that most healthy children should not receive the vaccine, as a number of studies and data have shown that children have an extremely low chance of dying from COVID-19 or developing severe symptoms.<\/p>\n\n\n\n<p>The Centers for Disease Control and Prevention (CDC) currently recommends that children aged 5 and older receive the Pfizer COVID-19 vaccine.<\/p>\n\n\n\n<p>On March 7,&nbsp;<a href=\"https:\/\/www.theepochtimes.com\/t-florida\" target=\"_blank\" rel=\"noreferrer noopener\">Florida<\/a>&nbsp;Surgeon General Joseph Ladapo told reporters that his state&nbsp;\u201cis going to be the first state to officially recommend against the COVID-19 vaccines for healthy children.\u201d<\/p>\n\n\n\n<p>Florida Gov. Ron DeSantis said during the same event that there\u2019s \u201ca failure to weigh costs and benefits, whether that\u2019s lockdowns, whether that\u2019s school closures, or whether that\u2019s even something about whether a healthy 7-year-old kid should get the COVID vaccines.\u201d<\/p>\n\n\n\n<p>COVID-19 is the illness caused by the&nbsp;<a href=\"https:\/\/www.theepochtimes.com\/giving-the-right-name-to-the-virus-causing-a-worldwide-pandemic-2_3277200.html\" target=\"_blank\" rel=\"noreferrer noopener\">CCP (Chinese Communist Party) virus<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>By&nbsp;Jack Phillips Ocugen said the U.S. Food and Drug Administration (FDA) declined to issue an emergency use authorization for&nbsp;Covaxin, the&nbsp;COVID-19&nbsp;vaccine developed by its Indian partner Bharat Biotech, for children. The&hellip; <\/p>\n","protected":false},"author":8,"featured_media":52501,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[128],"tags":[1129],"_links":{"self":[{"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/posts\/52500"}],"collection":[{"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/comments?post=52500"}],"version-history":[{"count":1,"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/posts\/52500\/revisions"}],"predecessor-version":[{"id":52502,"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/posts\/52500\/revisions\/52502"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/media\/52501"}],"wp:attachment":[{"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/media?parent=52500"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/categories?post=52500"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thelehighacresgazette.com\/news\/wp-json\/wp\/v2\/tags?post=52500"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}