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Pinkmartini

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- PinkmartiniPinkmartini
  ·2021-11-24
  Tell me your opinion about this news...
  Chamath Palihapitiya says he will increase stake in Clover Health
  Social Capital CEO Chamath Palihapitiya said that the venture capital firm will increase its investm
  Chamath Palihapitiya says he will increase stake in Clover Health
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- PinkmartiniPinkmartini
  ·2021-11-08
  Tell me your opinion about this news...
  Toplines Before US Market Open on Monday
  U.S. futures rose slightly on Monday as traders geared for a string of earnings reports from technol
  Toplines Before US Market Open on Monday
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- PinkmartiniPinkmartini
  ·2021-10-25
  👍
  非常抱歉，此主贴已删除
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- PinkmartiniPinkmartini
  ·2021-10-25
  👍
  @TheMilkyWay：
  Here’s why the $Merck(MRK)$Covid 19 pill WILLNOT make the $Novavax(NVAX)$Covid 19 vaccine irrelevant.Novavax was saved from the brink of bankruptcy by successfully formulating a non-mRNA Covid 19 vaccine with high efficacy. Its stock price was running high for the most part of 2020 - 2021. That was until the news of the Merck Covid 19 pill made headlines in Sep/ Oct 2021. While public confidence in Novavax started to waver months earlier due to the pharmaceutical company’s repeated delays in filing for emergency use authorisation (EUA) from the U.S. Food & Drug Administration (FDA) for its Covid 19 vaccine & the company’s stock price went through some wild fluctuations, there was no plunge
  Here’s why the $Merck(MRK)$Covid 19 pill WILLNOT make the $Novavax(NVAX)$Covid 19 vaccine irrelevant.Novavax was saved from the brink of bankruptcy by successfully formulating a non-mRNA Covid 19 vaccine with high efficacy. Its stock price was running high for the most part of 2020 - 2021. That was until the news of the Merck Covid 19 pill made headlines in Sep/ Oct 2021. While public confidence in Novavax started to waver months earlier due to the pharmaceutical company’s repeated delays in filing for emergency use authorisation (EUA) from the U.S. Food & Drug Administration (FDA) for its Covid 19 vaccine & the company’s stock price went through some wild fluctuations, there was no plunge
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- PinkmartiniPinkmartini
  ·2021-10-20
  Heard that this was old news by Politico, causing the dip of the shares.
  Novavax plunged over 20% in premarket trading
  (Oct 20) Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr
  Novavax plunged over 20% in premarket trading
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a market observations letter he posted ...</p>\n\n<a href=\"https://seekingalpha.com/news/3772693-chamath-palihapitiya-he-will-increase-stake-in-clover-health\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"CLOV":"Clover Health Corp"},"source_url":"https://seekingalpha.com/news/3772693-chamath-palihapitiya-he-will-increase-stake-in-clover-health","is_english":true,"share_image_url":"https://static.laohu8.com/5a36db9d73b4222bc376d24ccc48c8a4","article_id":"1113618972","content_text":"Social Capital CEO Chamath Palihapitiya said that the venture capital firm will increase its investment in Clover Health Investments(NASDAQ:CLOV), according to a market observations letter he posted on his Twitter page.\nHe cited life sciences, climate science, and alternate finance as areas \"ripe for opportunity.\"\nTo build cash reserves and fund new investments, he is selling 15% of the firm's stake in SoFi Technologies(NASDAQ:SOFI).\nHe is 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headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1635163753,"share":"https://www.laohu8.com/m/news/1137044759?lang=&edition=full","pubTime":"2021-10-25 20:09","market":"us","language":"en","title":"Toplines Before US Market Open on Monday","url":"https://stock-news.laohu8.com/highlight/detail?id=1137044759","media":"Tiger Newspress","summary":"U.S. futures rose slightly on Monday as traders geared for a string of earnings reports from technol","content":"<p>U.S. futures&nbsp;rose slightly&nbsp;on Monday as traders geared for a string of earnings reports from technology heavyweights including <a href=\"https://laohu8.com/S/FB\">Facebook</a> Inc., while keeping in mind inflation concerns and rising Covid-19 risks.</p>\n<p>At 8:00 a.m. ET, Dow e-minis were up&nbsp;3&nbsp;points, or 0.01%, S&amp;P 500 e-minis were up&nbsp;5.75&nbsp;points, or 0.13%, and <a href=\"https://laohu8.com/S/NDAQ\">Nasdaq</a> 100 e-minis were&nbsp;up&nbsp;44.25&nbsp;points, or 0.29%.<img src=\"https://static.tigerbbs.com/92e0a1d5cd73c51f28ccb00c8d4f071c\" tg-width=\"553\" tg-height=\"265\" referrerpolicy=\"no-referrer\"><b>Stocks making the biggest moves in the premarket:</b></p>\n<p><a href=\"https://laohu8.com/S/PINS\">Pinterest, Inc.</a> (PINS) – Pinterest shares tumbled 13.2% in premarket trading after&nbsp;PayPal said it was&nbsp;not pursuing an acquisition&nbsp;of the social media company at this time. Its statement came in response to reports that it was pursuing an acquisition of Pinterest for as much as $45 billion. <a href=\"https://laohu8.com/S/PYPL\">PayPal</a> shares jumped 6.1%.</p>\n<p><a href=\"https://laohu8.com/S/TSLA\">Tesla Motors</a> (TSLA) – Tesla raised prices on certain versions of its Model X and Model S cars, according to the company’s website. Additionally, car rental giant Hertz has reportedly ordered 100,000 Tesla vehicles for its fleet. Tesla shares rallied 4.3% in the premarket.</p>\n<p><a href=\"https://laohu8.com/S/KMB\">Kimberly-Clark</a> (KMB) – The consumer products company’s stock slid 3% in premarket trading after quarterly earnings came in 3 cents a share below estimates at $1.62 per share. Revenue was slightly above forecasts, but <a href=\"https://laohu8.com/S/KMB\">Kimberly-Clark</a>’s results were hit by higher inflation and supply chain issues.</p>\n<p><a href=\"https://laohu8.com/S/QSR\">Restaurant</a> (QSR) – The restaurant operator&nbsp;reported quarterly profit of $1.52 per share, 2 cents a share above estimates. Revenue was slightly below Wall Street forecasts, with Covid-19 contributing to supply chain and labor pressures for the parent of Tim Hortons, Burger King and Popeyes. The stock added 1.2% in the premarket.</p>\n<p><a href=\"https://laohu8.com/S/OTIS\">Otis Worldwide Corp</a> (OTIS) – Otis came in 4 cents a share above estimates, with quarterly earnings of 77 cents per share. Revenue also topped analysts’ projections. The company best known for its flagship elevators also raised its full-year outlook.</p>\n<p><a href=\"https://laohu8.com/S/FB\">Facebook</a> (FB) – Facebook continues to be embroiled in controversy, with a Wall Street Journal story this morning detailing internal arguments over the handling of right-leaning content. The stock fell 5% Friday, breaking a four-session win streak. Its shares dropped another 1.5% in the premarket.</p>\n<p><a href=\"https://laohu8.com/S/KNX\">Knight Transportation</a> (KNX) – The trucking and logistics company’s stock rose 1.5% in the premarket after UBS upgraded the stock to “buy” from “neutral.” The firm said Knight-Swift’s non-trucking business is expanding faster than it had anticipated.</p>\n<p><a href=\"https://laohu8.com/S/HSBC\">HSBC Holdings PLC</a> (HSBC) – HSBC&nbsp;reported better-than-expected quarterly profit, with a 74% rise from a year earlier, and the bank also announced a $2 billion share buyback.</p>\n<p><a href=\"https://laohu8.com/S/SWX\">Southwest Gas</a> (SWX) – Investor Carl Icahn is calling on <a href=\"https://laohu8.com/S/OKSB\">Southwest</a> Gas tofirst offer shares to existing shareholders, amid the energy producer’s plans to sell up to $1 billion in equity as part of financing to buy pipeline company <a href=\"https://laohu8.com/S/STR\">Questar</a>. Icahn – who holds a significant stake in the company – is against the deal, and is moving ahead with a tender offer to buy the shares he doesn’t already own for $75 per share.</p>\n<p><a href=\"https://laohu8.com/S/WHR\">Whirlpool</a> (WHR) – Whirlpool was downgraded to “underperform” from “sector perform” at RBC Capital, which cites a number of factors including the appliance maker’s loss of market share in North America. The stock slid 1.4% in premarket trading.</p>\n<p><a href=\"https://laohu8.com/S/PFE\">Pfizer</a> (PFE),<a href=\"https://laohu8.com/S/BNTX\">BioNTech SE</a> (BNTX) – The Covid-19 vaccine made by Pfizer and BioNTech showed 90.7% effectiveness in children aged 5-11. Health officials say a rollout of the vaccine for kids could come as soon as early November.</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Toplines Before US Market Open on Monday</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nToplines Before US Market Open on Monday\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-25 20:09</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>U.S. futures&nbsp;rose slightly&nbsp;on Monday as traders geared for a string of earnings reports from technology heavyweights including <a href=\"https://laohu8.com/S/FB\">Facebook</a> Inc., while keeping in mind inflation concerns and rising Covid-19 risks.</p>\n<p>At 8:00 a.m. ET, Dow e-minis were up&nbsp;3&nbsp;points, or 0.01%, S&amp;P 500 e-minis were up&nbsp;5.75&nbsp;points, or 0.13%, and <a href=\"https://laohu8.com/S/NDAQ\">Nasdaq</a> 100 e-minis were&nbsp;up&nbsp;44.25&nbsp;points, or 0.29%.<img src=\"https://static.tigerbbs.com/92e0a1d5cd73c51f28ccb00c8d4f071c\" tg-width=\"553\" tg-height=\"265\" referrerpolicy=\"no-referrer\"><b>Stocks making the biggest moves in the premarket:</b></p>\n<p><a href=\"https://laohu8.com/S/PINS\">Pinterest, Inc.</a> (PINS) – Pinterest shares tumbled 13.2% in premarket trading after&nbsp;PayPal said it was&nbsp;not pursuing an acquisition&nbsp;of the social media company at this time. Its statement came in response to reports that it was pursuing an acquisition of Pinterest for as much as $45 billion. <a href=\"https://laohu8.com/S/PYPL\">PayPal</a> shares jumped 6.1%.</p>\n<p><a href=\"https://laohu8.com/S/TSLA\">Tesla Motors</a> (TSLA) – Tesla raised prices on certain versions of its Model X and Model S cars, according to the company’s website. Additionally, car rental giant Hertz has reportedly ordered 100,000 Tesla vehicles for its fleet. Tesla shares rallied 4.3% in the premarket.</p>\n<p><a href=\"https://laohu8.com/S/KMB\">Kimberly-Clark</a> (KMB) – The consumer products company’s stock slid 3% in premarket trading after quarterly earnings came in 3 cents a share below estimates at $1.62 per share. Revenue was slightly above forecasts, but <a href=\"https://laohu8.com/S/KMB\">Kimberly-Clark</a>’s results were hit by higher inflation and supply chain issues.</p>\n<p><a href=\"https://laohu8.com/S/QSR\">Restaurant</a> (QSR) – The restaurant operator&nbsp;reported quarterly profit of $1.52 per share, 2 cents a share above estimates. Revenue was slightly below Wall Street forecasts, with Covid-19 contributing to supply chain and labor pressures for the parent of Tim Hortons, Burger King and Popeyes. The stock added 1.2% in the premarket.</p>\n<p><a href=\"https://laohu8.com/S/OTIS\">Otis Worldwide Corp</a> (OTIS) – Otis came in 4 cents a share above estimates, with quarterly earnings of 77 cents per share. Revenue also topped analysts’ projections. The company best known for its flagship elevators also raised its full-year outlook.</p>\n<p><a href=\"https://laohu8.com/S/FB\">Facebook</a> (FB) – Facebook continues to be embroiled in controversy, with a Wall Street Journal story this morning detailing internal arguments over the handling of right-leaning content. The stock fell 5% Friday, breaking a four-session win streak. Its shares dropped another 1.5% in the premarket.</p>\n<p><a href=\"https://laohu8.com/S/KNX\">Knight Transportation</a> (KNX) – The trucking and logistics company’s stock rose 1.5% in the premarket after UBS upgraded the stock to “buy” from “neutral.” The firm said Knight-Swift’s non-trucking business is expanding faster than it had anticipated.</p>\n<p><a href=\"https://laohu8.com/S/HSBC\">HSBC Holdings PLC</a> (HSBC) – HSBC&nbsp;reported better-than-expected quarterly profit, with a 74% rise from a year earlier, and the bank also announced a $2 billion share buyback.</p>\n<p><a href=\"https://laohu8.com/S/SWX\">Southwest Gas</a> (SWX) – Investor Carl Icahn is calling on <a href=\"https://laohu8.com/S/OKSB\">Southwest</a> Gas tofirst offer shares to existing shareholders, amid the energy producer’s plans to sell up to $1 billion in equity as part of financing to buy pipeline company <a href=\"https://laohu8.com/S/STR\">Questar</a>. Icahn – who holds a significant stake in the company – is against the deal, and is moving ahead with a tender offer to buy the shares he doesn’t already own for $75 per share.</p>\n<p><a href=\"https://laohu8.com/S/WHR\">Whirlpool</a> (WHR) – Whirlpool was downgraded to “underperform” from “sector perform” at RBC Capital, which cites a number of factors including the appliance maker’s loss of market share in North America. The stock slid 1.4% in premarket trading.</p>\n<p><a href=\"https://laohu8.com/S/PFE\">Pfizer</a> (PFE),<a href=\"https://laohu8.com/S/BNTX\">BioNTech SE</a> (BNTX) – The Covid-19 vaccine made by Pfizer and BioNTech showed 90.7% effectiveness in children aged 5-11. Health officials say a rollout of the vaccine for kids could come as soon as early November.</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"PFE":"辉瑞","BNTX":"BioNTech SE","HSBC":"汇丰","TSLA":"特斯拉",".DJI":"道琼斯","SWX":"Southwest Gas Corp","OTIS":"奥的斯","KMB":"金佰利","WHR":"惠而浦","PINS":"Pinterest, Inc.","QSR":"餐饮品牌国际","KNX":"Knight Transportation Inc"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1137044759","content_text":"U.S. futures rose slightly on Monday as traders geared for a string of earnings reports from technology heavyweights including Facebook Inc., while keeping in mind inflation concerns and rising Covid-19 risks.\nAt 8:00 a.m. ET, Dow e-minis were up 3 points, or 0.01%, S&P 500 e-minis were up 5.75 points, or 0.13%, and Nasdaq 100 e-minis were up 44.25 points, or 0.29%.Stocks making the biggest moves in the premarket:\nPinterest, Inc. (PINS) – Pinterest shares tumbled 13.2% in premarket trading after PayPal said it was not pursuing an acquisition of the social media company at this time. Its statement came in response to reports that it was pursuing an acquisition of Pinterest for as much as $45 billion. PayPal shares jumped 6.1%.\nTesla Motors (TSLA) – Tesla raised prices on certain versions of its Model X and Model S cars, according to the company’s website. Additionally, car rental giant Hertz has reportedly ordered 100,000 Tesla vehicles for its fleet. Tesla shares rallied 4.3% in the premarket.\nKimberly-Clark (KMB) – The consumer products company’s stock slid 3% in premarket trading after quarterly earnings came in 3 cents a share below estimates at $1.62 per share. Revenue was slightly above forecasts, but Kimberly-Clark’s results were hit by higher inflation and supply chain issues.\nRestaurant (QSR) – The restaurant operator reported quarterly profit of $1.52 per share, 2 cents a share above estimates. Revenue was slightly below Wall Street forecasts, with Covid-19 contributing to supply chain and labor pressures for the parent of Tim Hortons, Burger King and Popeyes. The stock added 1.2% in the premarket.\nOtis Worldwide Corp (OTIS) – Otis came in 4 cents a share above estimates, with quarterly earnings of 77 cents per share. Revenue also topped analysts’ projections. The company best known for its flagship elevators also raised its full-year outlook.\nFacebook (FB) – Facebook continues to be embroiled in controversy, with a Wall Street Journal story this morning detailing internal arguments over the handling of right-leaning content. The stock fell 5% Friday, breaking a four-session win streak. Its shares dropped another 1.5% in the premarket.\nKnight Transportation (KNX) – The trucking and logistics company’s stock rose 1.5% in the premarket after UBS upgraded the stock to “buy” from “neutral.” The firm said Knight-Swift’s non-trucking business is expanding faster than it had anticipated.\nHSBC Holdings PLC (HSBC) – HSBC reported better-than-expected quarterly profit, with a 74% rise from a year earlier, and the bank also announced a $2 billion share buyback.\nSouthwest Gas (SWX) – Investor Carl Icahn is calling on Southwest Gas tofirst offer shares to existing shareholders, amid the energy producer’s plans to sell up to $1 billion in equity as part of financing to buy pipeline company Questar. Icahn – who holds a significant stake in the company – is against the deal, and is moving ahead with a tender offer to buy the shares he doesn’t already own for $75 per share.\nWhirlpool (WHR) – Whirlpool was downgraded to “underperform” from “sector perform” at RBC Capital, which cites a number of factors including the appliance maker’s loss of market share in North America. The stock slid 1.4% in premarket trading.\nPfizer (PFE),BioNTech SE (BNTX) – The Covid-19 vaccine made by Pfizer and BioNTech showed 90.7% effectiveness in children aged 5-11. Health officials say a rollout of the vaccine for kids could come as soon as early November.","news_type":1},"isVote":1,"tweetType":1,"viewCount":426,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":856808141,"gmtCreate":1635166163293,"gmtModify":1635166163416,"author":{"id":"3585729847029660","authorId":"3585729847029660","name":"Pinkmartini","avatar":"https://static.tigerbbs.com/25f5b3287ef2fcae826d428294e908e8","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"👍","listText":"👍","text":"👍","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":5,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/856808141","repostId":"1137044759","repostType":4,"isVote":1,"tweetType":1,"viewCount":351,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":856801556,"gmtCreate":1635166123276,"gmtModify":1635166123394,"author":{"id":"3585729847029660","authorId":"3585729847029660","name":"Pinkmartini","avatar":"https://static.tigerbbs.com/25f5b3287ef2fcae826d428294e908e8","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"👍","listText":"👍","text":"👍","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/856801556","repostId":"851921142","repostType":1,"repost":{"id":851921142,"gmtCreate":1634865151633,"gmtModify":1635053291354,"author":{"id":"3583318222987864","authorId":"3583318222987864","name":"TheMilkyWay","avatar":"https://static.tigerbbs.com/190d59bcbcc876e15543cbd430d8c1f2","crmLevel":4,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"Here’s why the <a href=\"https://laohu8.com/S/MRK\">$Merck(MRK)$</a>Covid 19 pill WILLNOT make the <a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>Covid 19 vaccine irrelevant.Novavax was saved from the brink of bankruptcy by successfully formulating a non-mRNA Covid 19 vaccine with high efficacy. Its stock price was running high for the most part of 2020 - 2021. That was until the news of the Merck Covid 19 pill made headlines&nbsp;in Sep/ Oct 2021.&nbsp;While public confidence in Novavax started to waver months earlier due to the pharmaceutical company’s repeated delays in filing for emergency use authorisation (EUA) from the U.S. Food &amp; Drug Administration (FDA) for its Covid 19 vaccine &amp; the company’s&nbsp;stock price went through some wild fluctuations, there was no plunge","listText":"Here’s why the <a href=\"https://laohu8.com/S/MRK\">$Merck(MRK)$</a>Covid 19 pill WILLNOT make the <a href=\"https://laohu8.com/S/NVAX\">$Novavax(NVAX)$</a>Covid 19 vaccine irrelevant.Novavax was saved from the brink of bankruptcy by successfully formulating a non-mRNA Covid 19 vaccine with high efficacy. Its stock price was running high for the most part of 2020 - 2021. That was until the news of the Merck Covid 19 pill made headlines&nbsp;in Sep/ Oct 2021.&nbsp;While public confidence in Novavax started to waver months earlier due to the pharmaceutical company’s repeated delays in filing for emergency use authorisation (EUA) from the U.S. Food &amp; Drug Administration (FDA) for its Covid 19 vaccine &amp; the company’s&nbsp;stock price went through some wild fluctuations, there was no plunge","text":"Here’s why the $Merck(MRK)$Covid 19 pill WILLNOT make the $Novavax(NVAX)$Covid 19 vaccine irrelevant.Novavax was saved from the brink of bankruptcy by successfully formulating a non-mRNA Covid 19 vaccine with high efficacy. Its stock price was running high for the most part of 2020 - 2021. That was until the news of the Merck Covid 19 pill made headlines in Sep/ Oct 2021. While public confidence in Novavax started to waver months earlier due to the pharmaceutical company’s repeated delays in filing for emergency use authorisation (EUA) from the U.S. Food & Drug Administration (FDA) for its Covid 19 vaccine & the company’s stock price went through some wild fluctuations, there was no plunge","images":[],"top":1,"highlighted":2,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/851921142","isVote":1,"tweetType":1,"viewCount":0,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},"isVote":1,"tweetType":1,"viewCount":615,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":859408655,"gmtCreate":1634718204697,"gmtModify":1634718404868,"author":{"id":"3585729847029660","authorId":"3585729847029660","name":"Pinkmartini","avatar":"https://static.tigerbbs.com/25f5b3287ef2fcae826d428294e908e8","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false},"themes":[],"htmlText":"Heard that this was&nbsp;old news by Politico, causing the dip of the shares.&nbsp;","listText":"Heard that this was&nbsp;old news by Politico, causing the dip of the shares.&nbsp;","text":"Heard that this was old news by Politico, causing the dip of the shares.","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":8,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/859408655","repostId":"1174375951","repostType":4,"repost":{"id":"1174375951","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634717661,"share":"https://www.laohu8.com/m/news/1174375951?lang=&edition=full","pubTime":"2021-10-20 16:14","market":"us","language":"en","title":"Novavax plunged over 20% in premarket trading","url":"https://stock-news.laohu8.com/highlight/detail?id=1174375951","media":"Tiger Newspress","summary":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the pr","content":"<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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}\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nNovavax plunged over 20% in premarket trading\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-10-20 16:14</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>(Oct 20)&nbsp; <a href=\"https://laohu8.com/S/NVAX\">Novavax</a>&nbsp;may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.</p>\n<p><img src=\"https://static.tigerbbs.com/f3995877f1c786d310a457ababf9ee9e\" tg-width=\"1043\" tg-height=\"564\" referrerpolicy=\"no-referrer\">The world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.</p>\n<p>But the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.</p>\n<p>The delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.</p>\n<p>The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.</p>\n<p>Although Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.</p>\n<p>The Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, <a href=\"https://laohu8.com/S/AONE.U\">one</a> of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.</p>\n<p>COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.</p>\n<p>“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the <a href=\"https://laohu8.com/S/DRE\">Duke</a> Global Health Innovation Center.</p>\n<p>The global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.</p>\n<p>Between Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.</p>\n<p>In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.</p>\n<p>“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.</p>\n<p>The White House and the Department of Health and Human Services did not respond to multiple requests for comment.</p>\n<p>But three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.</p>\n<p>Novavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.</p>\n<p>Unlike <a href=\"https://laohu8.com/S/PFE\">Pfizer</a> and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.</p>\n<p>The revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.</p>\n<p>That includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.</p>\n<p>Novavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson &amp; Johnsonhalted work at a Baltimore facilityrun by contract manufacturer <a href=\"https://laohu8.com/S/EBS\">Emergent BioSolutions</a> after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.</p>\n<p>J&amp;J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.</p>\n<p>“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”</p>\n<p>Unlike Johnson &amp; Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.</p>\n<p>Yet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.</p>\n<p>The contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.</p>\n<p>But even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.</p>\n<p>In particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.</p>\n<p>“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”</p>\n<p>Taylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.</p>\n<p>Company executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.</p>\n<p>“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”</p>\n<p>U.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&amp;J’s vaccine at the Emergent plant earlier this year, those people said.</p>\n<p>And even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.</p>\n<p>Several vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.</p>\n<p>“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1174375951","content_text":"(Oct 20)  Novavax may delay the delivery of 1 billion doses of coronavirus vaccine because of the production problems.\nThe world’s vaccine distributor has been counting on U.S. companies to provide more than 2 billion doses to lower and middle-income countries by the end of 2022 — a crucial step in ending the Covid-19 pandemic.\nBut the campaign run by the international consortium known as COVAX, which has already been delayed significantly because of production lags, is now likely to fall short by more than 1 billion doses as a key supplier faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards, according to three people with direct knowledge of the company’s problems.\nThe delay, which was confirmed by three other people familiar with the discussions between Maryland-based Novavax and the Biden administration, represents a major setback in the effort to vaccinate the world in the wake of new, more transmissible variants.\nThe U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. All spoke on the condition of anonymity to discuss sensitive company conversations.\nAlthough Novavax recently attested to some of its analytics and testing issues in aquarterly filing with the Securities and Exchange Commission, the company’s issues are more concerning than previously understood, according to two of the people with direct knowledge of the matter.\nThe Food and Drug Administration works out purity levels with each manufacturer according to June 2020 guidance for coronavirus vaccines, but it is generally understood that each vaccine batch should reach at least 90 percent. The company has struggled to attain anywhere close to that, one of the people with direct knowledge of the situation said. Another person familiar with the company’s manufacturing process said Novavax has recently shown purity levels hovering around 70 percent. Low purity levels increase the chance that contaminants or unnecessary substances are in the final product, rendering the vaccine less effective or introducing the chance that patients could react to unknown ingredients.\nCOVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion doses, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic.\n“COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center.\nThe global coalition is already behind on hundreds of millions of planned doses this month, having shipped just 371 million of its 700 million dose target for October. It is now also at risk of missing its already downgraded 2021 target.\nBetween Novavax and other manufacturers’ hurdles, “COVAX has had to scramble to revise its supply strategy significantly in real time,” Udayakumar said. As a result, global health groups are emphasizing more donations to cover immediate needs, he added.\nIn a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO that the company’s analytical testing methods have been “validated” — but did not answer questions about whether the FDA had signed off on them. The company still plans on filing an emergency use authorization by the end of the year, Taylor said.\n“The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the US and globally,” Taylor said.\nThe White House and the Department of Health and Human Services did not respond to multiple requests for comment.\nBut three people familiar with the matter said they are not confident that the company has the resources needed to reproduce a high-quality vaccine on a consistent basis — a benchmark Novavax must meet before that time. Those same people said Novavax could potentially fix its manufacturing issues and reach full licensure by the end of 2022.\nNovavax — which has never produced a vaccine before — declined to answer specific questions about its product’s purity levels and whether it had been successful in addressing its longstanding manufacturing issues.\nUnlike Pfizer and Moderna, the first manufacturers to launch vaccines using rapidly produced messenger RNA, Novavax is employing the previously used but complicated approach of creating the key ingredient with bug cells. While the process, which involves infecting the cells to produce spike proteins, is familiar to scientists, it is difficult to scale.\nThe revelations about Novavax’s continued manufacturing problems come at a time when only 36 percent of the world is vaccinated and as leaders of developing nations continue to pressure the U.S. to deliver more doses. In Africa alone, only 4.4 percent of the population is vaccinated.\nThat includes some of the continent’s most populous nations, like Nigeria and Uganda, where about 1 percent of citizens are fully vaccinated.\nNovavax is just the latest vaccine maker to run into core production problems after promising to serve as a major vaccine contributor to the developing world. In April, Johnson & Johnsonhalted work at a Baltimore facilityrun by contract manufacturer Emergent BioSolutions after it found that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.\nJ&J’s manufacturing process has been slow to recover, and to date it has produced just a fraction of the 200 million shots it initially pledged to COVAX by the end of the year, according to records kept by UNICEF.\n“Overpromising and underdelivering is the name of the game for these manufacturers,” said Asia Russell, executive director of international advocacy group Health GAP. “And that’s the infrastructure of the global response, which is terrifying.”\nUnlike Johnson & Johnson, Novavax is a novice in the vaccine world. It has never successfully launched a vaccine, and had struggled financially prior to the pandemic. After a string of drug development failures, it sold its manufacturing facilities in 2019 — a deal that also included parting with 100 employees. In May of that year, Novavax’s stock price dropped as low as 36 cents per share.\nYet the company’s fortunes shifted as Covid-19 took hold. Amid a scramble early in the pandemic to develop a range of vaccine candidates, the Trump administration awarded Novavax $1.6 billion to aid work on its Covid-19 shot — the largest deal given to any Covid-19 vaccine maker at that time.\nThe contract represented a major vote of confidence in Novavax’s capabilities — and a bet that appeared to pay off after late-stage trials showed the vaccine was 90 percent effective against the virus.\nBut even then, senior Trump administration officials on Operation Warp Speed — a group tasked with accelerating vaccine development — repeatedly warned the company that it risked running into problems in scaling up manufacturing of the shot, two people with direct knowledge of those discussions said.\nIn particular, they worried that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s rigorous quality standards once the vaccine went into mass production — the exact problem that has now stymied the company for months.\n“They rushed the process,” one of the people with knowledge of the matter said. “It’s hard to make. And they can’t make it.”\nTaylor, the Novavax spokesperson, said in a statement that it has incorporated feedback from regulators and has made “tremendous progress with the scale-up of our commercial manufacturing processes.” The company is still on track to produce 150 million doses a month by the end of the year, she said, and has stockpiled tens of millions of doses ahead of regulatory filings in the U.S. and internationally.\nCompany executives in recent presentations to investors have struck a similarly optimistic tone, downplaying the manufacturing snags and predicting it will soon be cleared to begin distributing doses. During aSept. 29 investor event, Chief Commercial Officer John Trizzino said the company had “resolved” its problems and was close to submitting a final regulatory application.\n“We’re really moving along with testing our lots now,” added Gregory Glenn, president of Novavax’s research and development, referring to batches of its vaccine. “We think that this is shortly going to come to a close.”\nU.S. officials working with the company are not as confident, according to three people with knowledge of the matter. Novavax’s manufacturing problems are seen as far more difficult to fix than the sanitary and design concerns that halted production of J&J’s vaccine at the Emergent plant earlier this year, those people said.\nAnd even as the company begins to seek regulatory approval in other countries, there remains doubt in the U.S. that it has solved the fundamental vaccine purity flaws that the people with knowledge said have affected its ability to make doses at plants around the world.\nSeveral vaccine batches have already been discarded, and four people with knowledge of the matter say U.S. officials now no longer expect the company to win FDA sign-off on the vaccine until next year at the earliest.\n“At some level, I think the efficacy was never going to outweigh the risk associated with the impurity that was in there,” said one of the people with knowledge of the matter. “I’m not surprised this is where we are.”","news_type":1},"isVote":1,"tweetType":1,"viewCount":449,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0}],"defaultTab":"posts","isTTM":false}