{"id":429474,"date":"2021-02-04T16:19:48","date_gmt":"2021-02-04T21:19:48","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=429474"},"modified":"2021-02-04T16:19:48","modified_gmt":"2021-02-04T21:19:48","slug":"novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/","title":{"rendered":"Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li style=\"margin-bottom:8pt\">\n          <em>Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada<\/em><br \/>\n          \n        <\/li>\n<\/ul>\n<p align=\"justify\">GAITHERSBURG, Md., Feb.  04, 2021  (GLOBE NEWSWIRE) &#8212; Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations.<\/p>\n<p align=\"justify\">\u201cThe rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide,\u201d said Gregory M. Glenn, MD, President of Research and Development, Novavax. \u201cWe appreciate the agencies\u2019 confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination.\u201d<\/p>\n<p align=\"justify\">To date, Novavax has begun the rolling review process with several regulatory agencies worldwide, including the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data.<\/p>\n<p align=\"justify\">Novavax\u2019 recombinant protein-based vaccine candidate is currently in Phase 3 clinical development in both the U.K. and U.S. for the prevention of COVID-19. It was the first vaccine to <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=aSGKQiHOYY9p46MnElT7RrIbqLUd1UUkNpAcAaHlwDRVxVVM3JnaQQSSziCa9cTDYO-vUcUAyjRJXVXnFBvo3A0FIhXl8AuhK9xV6l_f70kL8DJphAQq4sbeZilLGqCc91iUWD2OuljiHUNmS_tgdurnTPHoIhHesDYfQY1Txk_RO5NiXmN89Sc9A7aT2vnCb0-XMRYt47LnE0Btwb2L7g==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">demonstrate<\/a> clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa.<\/p>\n<p align=\"justify\">\n        <strong>About NVX-CoV2373<\/strong>\n      <\/p>\n<p align=\"justify\">NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax\u2019 recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax\u2019 patented saponin-based Matrix-M\u2122 to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1\/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1\/2 continuation in the U.S. and Australia.<\/p>\n<p>\n        <strong>About Matrix-M\u2122<\/strong><br \/>\n        <br \/>Novavax\u2019 patented saponin-based Matrix-M\u2122 adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.<\/p>\n<p align=\"justify\">\n        <strong>About Novavax<\/strong><br \/>\n        <br \/>Novavax, Inc.\u202f(Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company\u2019s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax\u202fis conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu\u2122, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax\u2019 proprietary saponin-based Matrix-M\u2122 adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.<\/p>\n<p align=\"justify\">For more information, visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=UQn75GquH25rLcgFdxF9y9BxjNxjMoEpD2iuAm6at9afuj-CHWH1HE_RbPA8o0XnywfBOThfcd_X2TpgYoFNiA==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.novavax.com<\/a> and connect with us on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=_nnYobZz42_lq5ZixhW6wH-nhUCFRC9Ukgo4JsiwP6uZ1HEELuSIthWrhZdIXQhyrUJTZFcFRpLbcDAIgwL72w==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">Twitter<\/a> and <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=64nUhbLxzoxqprsRAX3oDeBsnmdFMnGHmze-1Va_xqUUlIUv8CfG1eyjwmjTGvW4eJ1O9qVnUQhphM62DTCW1w_Z9irdxxLv0mwIvpz7xbE=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">LinkedIn<\/a>.<\/p>\n<p>\n        <strong>Novavax Forward Looking Statements<\/strong>\n      <\/p>\n<p align=\"justify\">Statements herein relating to the future of\u00a0Novavax\u00a0and the ongoing development of its vaccine and adjuvant products are forward-looking statements.\u00a0Novavax\u00a0cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading \u201cRisk Factors\u201d in the Novavax Annual Report on Form 10-K for the year ended\u00a0December 31, 2019, and Quarterly Report on Form\u00a010-Q\u00a0for the period ended\u00a0September 30, 2020, as filed with the\u00a0Securities and Exchange Commission\u00a0(SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the\u00a0SEC, available at\u00a0sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE0Nzc1MSMzOTYyMDEzIzIwMTkwMzM=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/4a5585d9-b200-4a7e-ba26-0ff03a72071c\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\">\n<pre>Contacts:\r\n\r\nInvestors\r\nNovavax, Inc.\r\nErika Schultz | 240-268-2022\r\nir@novavax.com\r\n\r\nSolebury Trout\r\nJennifer Porcelli | 617-974-8659\r\njporcelli@soleburytrout.com\r\n\r\nMedia\r\nAmy Speak | 617-420-2461\r\nLaura Keenan | 410-419-5755\r\nmedia@novavax.com<\/pre>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada GAITHERSBURG, Md., Feb. 04, 2021 (GLOBE NEWSWIRE) &#8212; Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations. \u201cThe rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-429474","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization - Market Newsdesk<\/title>\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.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada GAITHERSBURG, Md., Feb. 04, 2021 (GLOBE NEWSWIRE) &#8212; Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations. \u201cThe rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective &hellip; Continue reading &quot;Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-02-04T21:19:48+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE0Nzc1MSMzOTYyMDEzIzIwMTkwMzM=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization\",\"datePublished\":\"2021-02-04T21:19:48+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\\\/\"},\"wordCount\":856,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODE0Nzc1MSMzOTYyMDEzIzIwMTkwMzM=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\\\/\",\"name\":\"Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization - 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(Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations. \u201cThe rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective &hellip; Continue reading \"Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/","og_site_name":"Market Newsdesk","article_published_time":"2021-02-04T21:19:48+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE0Nzc1MSMzOTYyMDEzIzIwMTkwMzM=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization","datePublished":"2021-02-04T21:19:48+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/"},"wordCount":856,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE0Nzc1MSMzOTYyMDEzIzIwMTkwMzM=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/novavax-announces-start-of-rolling-review-by-multiple-regulatory-authorities-for-covid-19-vaccine-authorization\/","name":"Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization - 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