{"id":13638,"date":"2020-08-31T18:31:02","date_gmt":"2020-08-31T18:31:02","guid":{"rendered":"https:\/\/www.africa-press.com\/kenya\/?p=13638"},"modified":"2020-08-31T18:31:02","modified_gmt":"2020-08-31T18:31:02","slug":"us-floats-idea-of-early-approval-for-eventual-vaccine","status":"publish","type":"post","link":"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine","title":{"rendered":"US floats idea of early approval for eventual vaccine"},"content":{"rendered":"<p><strong>Author:\u00a0AFP\u00a0<\/strong><br \/>\n<strong>AfricaPress-Kenya:<\/strong> The head of the US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against the coronavirus might be given emergency approval before the end of trials designed to ensure its safety and effectiveness.<\/p>\n<p>A request for such extraordinary approval would have to come from the vaccine developer, Stephen Hahn told the Financial Times.<\/p>\n<p>&#8220;If they do that before the end of Phase Three,&#8221; which involves large-scale human testing, &#8220;we may find that appropriate. We may find that inappropriate, we will make a determination.\u201d<\/p>\n<p>But Hahn insisted he was not acting under pressure from President Donald Trump, who has been pushing hard for a vaccine, saying one might be ready before US elections November 3.<\/p>\n<p>&#8220;This is going to be a science, medicine, data decision,&#8221; Hahn said. &#8220;This is not going to be a political decision.&#8221;\u00a0Three Western drugs makers are well along with their Phase 3 clinical trials, involving tens of thousands of participants.<\/p>\n<p>The three are AstraZeneca, which is partnering with Oxford University in England; Moderna, collaborating with the US National Institutes of Health, and the Pfizer\/BioNTech alliance.\u00a0By the nature of the trials it is difficult to predict when reliable results will emerge.<\/p>\n<ul class=\"list-group readmore my-3\">\n<li style=\"list-style-type: none\"><\/li>\n<\/ul>\n<p>Half of the participants in such trials receive an experimental vaccine, while the other half are given a placebo.<\/p>\n<p>Under normal procedures, test administrators must wait &#8212; probably for months &#8212; to see whether there is a statistically significant difference in the infection rate of the two groups.<\/p>\n<p>As the world desperately awaits an effective vaccine against the deadly virus, China and Russia have already approved vaccines without waiting for the conclusion of trials &#8212; drawing criticism from public health officials in other countries, including the US.<\/p>\n<p>Hahn also said that an emergency authorization would not necessarily cover everyone &#8212; it might be granted for specific, high-risk groups.<\/p>\n<p>&#8220;Our emergency use authorization is not the same as a full approval,&#8221; he said.\u00a0Hahn has faced mounting criticism from the medical community that he has given in to political pressure from the Trump administration, largely involving two incidents.<\/p>\n<p>In March, the FDA gave emergency authorization for the use of hydroxychloroquine to treat Covid-19 after Trump repeatedly praised its use; the authorization had to be withdrawn in June after serious side effects emerged.<\/p>\n<p>More recently, Hahn delivered a far too optimistic appraisal, during a news conference with Trump, of the effectiveness of convalescent plasma against the virus.<\/p>\n<p>He said it could save 35 out of 100 patients; the more likely number, experts said, is five in 100.\u00a0&#8220;It is f-ing outrageous to expedite *any* approval of a #SARSCoV2 vaccine, irrespective of @SteveFDA&#8217;s subservience to Trump,&#8221; Eric Topol, director of the Scripps Research Translational Institute, said on Twitter.\u00a0&#8220;We will not know about safety for many months.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Author:\u00a0AFP\u00a0 AfricaPress-Kenya: The head of the US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against the coronavirus might be given emergency approval before the end of trials designed to ensure its safety and effectiveness. A request for such extraordinary approval would have to come from the [&hellip;]<\/p>\n","protected":false},"author":84,"featured_media":13034,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2,8,9],"tags":[939,3215,1539],"class_list":["post-13638","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-all-news","category-homepage-english","category-miscellaneous","tag-coronavirus","tag-coronavirus-vaccine","tag-covid-19"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.1 (Yoast SEO v27.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US floats idea of early approval for eventual vaccine - kenya<\/title>\n<meta name=\"description\" content=\"The head of the US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US floats idea of early approval for eventual vaccine\" \/>\n<meta property=\"og:description\" content=\"The head of the US Food and Drug Administration raised the possibility in an interview published Sunday that a future vaccine against\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine\" \/>\n<meta property=\"og:site_name\" content=\"kenya\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/AfricaPressTunisiaa\" \/>\n<meta property=\"article:published_time\" content=\"2020-08-31T18:31:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/static.africa-press.net\/kenya\/sites\/28\/2020\/08\/kenya_among_countrie5f3c3be225173.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"500\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"cfeditoren\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"cfeditoren\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine\"},\"author\":{\"name\":\"cfeditoren\",\"@id\":\"https:\/\/www.africa-press.net\/kenya\/#\/schema\/person\/068c7ab4e9634ae78ec5d54ec46598bb\"},\"headline\":\"US floats idea of early approval for eventual vaccine\",\"datePublished\":\"2020-08-31T18:31:02+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine\"},\"wordCount\":476,\"commentCount\":0,\"image\":{\"@id\":\"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine#primaryimage\"},\"thumbnailUrl\":\"https:\/\/static.africa-press.net\/kenya\/sites\/28\/2020\/08\/kenya_among_countrie5f3c3be225173.jpg\",\"keywords\":[\"Coronavirus\",\"Coronavirus Vaccine\",\"COVID-19\"],\"articleSection\":[\"all news\",\"homepage-english\",\"miscellaneous\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine\",\"url\":\"https:\/\/www.africa-press.net\/kenya\/miscellaneous\/us-floats-idea-of-early-approval-for-eventual-vaccine\",\"name\":\"US floats idea of early approval for eventual vaccine - 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