U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

StreetInsider2021-06-09

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for ...

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Comments

CYLiew
2021-06-09
CYLiew
Wow good news
Nn9876543
2021-06-09
Nn9876543
Pls like n comment
1Man2Stonks
2021-06-09
1Man2Stonks
Wow good
e13v3n
2021-06-09
e13v3n
pls like n comment
- Nn9876543:
  Pls like n comment
- 1Man2Stonks:
  ok
Skylarthe财神
2021-06-09
Skylarthe财神
life ah
- carmenngReplySkylarthe财神:
  八八八发发发
- Skylarthe财神:
  Heng ong huat
- Skylarthe财神:
  Life tough ah haja
- carmenng:
  im so sleepy grasshopper
- carmenngReplySkylarthe财神:
  i help u massage
Happyfish
2021-06-09
Happyfish
Pfizer..
- 杰力安心睡大觉:
  ??????
- 杰力安心睡大觉:
  Buck up
- Nn9876543:
  Pls like n comment

Leave a comment

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}\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\">\nU.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-06-09 07:12 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.streetinsider.com/dr/news.php?id=18536653><strong>StreetInsider</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for ...</p>\n\n<a href=\"https://www.streetinsider.com/dr/news.php?id=18536653\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"PFE","symbol_name":"辉瑞","start_time":0,"source_url":"https://www.streetinsider.com/dr/news.php?id=18536653","article_id":"2142956692","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2142956692","pubTimestamp":1623193920,"sourceInfo":{"source_id":"highlight_streetinsider","name":"StreetInsider"},"weMediaInfo":null,"summary":"First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the ma","collect":0,"end_time":0,"defaultTopTitle":"streetinsider.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"PFE":"辉瑞"},"translate_title":"美国FDA批准辉瑞PREVNAR 20™肺炎球菌20价结合疫苗用于18岁或18岁以上成人","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PFE":0.9},"content_text":"First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S.Helps protect against more serotypes of pneumococcal disease than any other conjugate vaccineBuilds on Pfizer’s more than 20-year legacy and innovation in developing pneumococcal conjugate vaccinesNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in adults.PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD),8,9,10,11,12 and have been associated with high case-fatality rates,13,14,15,16 antibiotic resistance,4,17,18 and/or meningitis.19,20“Today’s approval of PREVNAR 20 marks a significant step forward in our ongoing fight to help address the burden of pneumococcal disease, including pneumonia in adults, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccines,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “With a single injection, PREVNAR 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world.”In the United States, more than half of all cases of invasive pneumococcal disease (IPD) – which include bacteremia and meningitis – in adults ages 65 or older are due to the 20 serotypes in PREVNAR 20.21 In the United States, these 20 serotypes are estimated to cause up to 250,000 cases of IPD (including bacteremia and meningitis) and community-acquired pneumonia and more than 10,000 deaths in adults ages 18 or older.22 Overall, the seven additional serotypes in PREVNAR 20 account for approximately 40 percent of all pneumococcal disease cases and deaths in the U.S.23“Adult vaccinations play a pivotal role in helping protect our health and wellness, especially as we age and our immune systems begin to naturally weaken,” said Jane Barratt, Ph.D., Secretary General, International Federation on Ageing (IFA). “We are delighted with today’s approval as it addresses a critical need to continually expand coverage to meet the changing burden of disease. We encourage all adults to speak with their healthcare professionals about vaccinations.”The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. More than 6,000 adult subjects 18 years and older participated in the three Phase 3 trials, including adults 65 years of age and older, vaccine-naïve adults, and adults with prior pneumococcal vaccination.23,24“PREVNAR 20 builds on Pfizer’s legacy of more than two decades of experience in developing and supplying innovative pneumococcal conjugate vaccines that have had a tangible impact on global disease burden,” said Nanette Cocero, Ph.D., Global President of Pfizer Vaccines. “We are thrilled with this approval as it furthers our mission to expand protection against disease-causing bacteria serotypes to help prevent potentially serious respiratory infections like pneumococcal pneumonia throughout the year.”About 20-Valent Pneumococcal Conjugate Vaccine Regulatory ReviewOn September 20, 2018, Pfizer announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older. Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).25 Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, which may include more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.26The FDA previously granted Fast Track designation for PREVNAR 20 in September 2017 for use in adults aged 18 years or older.27 The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.25On February 26, 2021, the European Medicines Agency (EMA) accepted for review Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by S. pneumoniae serotypes in the vaccine in adults ages 18 years and older. The formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) currently is ongoing.INDICATIONS FOR PREVNAR 20™PREVNAR 20™ is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and olderThe indication for preventing pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved based on immune responses. Continued approval may depend on a supportive study.U.S. IMPORTANT SAFETY INFORMATIONPREVNAR 20™ should not be given to anyone with a history of severe allergic reaction to any component of PREVNAR 20™ or to diphtheria toxoidAdults with weakened immune systems may have a lower response to PREVNAR 20™. Safety data are not available for these groups. Your healthcare provider can tell you if PREVNAR 20™ is right for youIn adults 18 years of age and older, the most common side effects were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Additionally, injection site swelling was also common in adults 18 through 59 years of ageAsk your healthcare provider about the risks and benefits of PREVNAR 20™. Only a healthcare provider can decide if PREVNAR 20™ is right for youPlease see full prescribing information for PREVNAR 20™,INDICATIONS FOR PREVNAR 13® IN ADULTSPrevnar 13® is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and olderPrevnar 13® is not 100% effective and will only help protect against the 13 strains included in the vaccineU.S. IMPORTANT SAFETY INFORMATIONPrevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccineAdults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune responseIn adults, the most common side effects were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rashAsk your healthcare provider about the risks and benefits of Prevnar 13®. Only a healthcare provider can decide if Prevnar 13® is right for youPlease see full prescribing information for PREVNAR 13®.About Pfizer: Breakthroughs That Change Patients’ LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[{"id":180879140,"gmtCreate":1623199993280,"gmtModify":1704198128311,"author":{"id":"3585109808495850","authorId":"3585109808495850","name":"CYLiew","avatar":"https://static.tigerbbs.com/a99a6d5d4a17c0d959b0793804d401eb","vip":1,"crmLevel":1,"crmLevelSwitch":0,"idStr":"3585109808495850","authorIdStr":"3585109808495850"},"htmlText":"Wow good news","listText":"Wow good news","text":"Wow good 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