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A new vaccine to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults has been approved by the Food and Drug Administration.
The injectable drug, Capvaxive (Pneumococcal 21-valent Conjugate Vaccine), protects against 22 serotypes that cause invasive pneumococcal disease in adults, the company said in a news release. These strains account for about 84% of invasive pneumococcal disease cases among adults aged 50 years or older and about 85% of these cases in adults aged 65 years or older.
The drug company said about 150,000 adults in the United States are hospitalized annually because of pneumococcal pneumonia.
“Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines,” Walter Orenstein, MD, a professor emeritus of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta, Georgia, and a member of Merck’s Scientific Advisory Committee, said in the release.
A draft agenda shows a Centers for Disease Control and Prevention (CDC) advisory panel will meet on June 27 to discuss the vaccine. If the committee votes to approve Capvaxive, the CDC director will decide whether to make it available across the country.
Testing showed that Capvaxive was well tolerated by people it was tested on, with the main reports being pain where they got the shot, fatigue, headaches, and muscle aches, Merck said.
The eight unique serotypes included in CAPVAXIVE will protect against invasive pneumococcal disease and pneumococcal pneumonia, not just pneumonia.
According to Reuters, Merck said Capvaxive has a wholesale acquisition price of $287 per dose, but most people will probably have access to it at no cost if the drug receives a routine CDC recommendation. Capvaxive’s main competition is expected to be Pfizer’s shot, Prevnar 20, which was approved in 2021 for use in adults aged 18 years or older, Reuters reported.
A version of this article appeared on Medscape.com.
A new vaccine to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults has been approved by the Food and Drug Administration.
The injectable drug, Capvaxive (Pneumococcal 21-valent Conjugate Vaccine), protects against 22 serotypes that cause invasive pneumococcal disease in adults, the company said in a news release. These strains account for about 84% of invasive pneumococcal disease cases among adults aged 50 years or older and about 85% of these cases in adults aged 65 years or older.
The drug company said about 150,000 adults in the United States are hospitalized annually because of pneumococcal pneumonia.
“Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines,” Walter Orenstein, MD, a professor emeritus of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta, Georgia, and a member of Merck’s Scientific Advisory Committee, said in the release.
A draft agenda shows a Centers for Disease Control and Prevention (CDC) advisory panel will meet on June 27 to discuss the vaccine. If the committee votes to approve Capvaxive, the CDC director will decide whether to make it available across the country.
Testing showed that Capvaxive was well tolerated by people it was tested on, with the main reports being pain where they got the shot, fatigue, headaches, and muscle aches, Merck said.
The eight unique serotypes included in CAPVAXIVE will protect against invasive pneumococcal disease and pneumococcal pneumonia, not just pneumonia.
According to Reuters, Merck said Capvaxive has a wholesale acquisition price of $287 per dose, but most people will probably have access to it at no cost if the drug receives a routine CDC recommendation. Capvaxive’s main competition is expected to be Pfizer’s shot, Prevnar 20, which was approved in 2021 for use in adults aged 18 years or older, Reuters reported.
A version of this article appeared on Medscape.com.
A new vaccine to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults has been approved by the Food and Drug Administration.
The injectable drug, Capvaxive (Pneumococcal 21-valent Conjugate Vaccine), protects against 22 serotypes that cause invasive pneumococcal disease in adults, the company said in a news release. These strains account for about 84% of invasive pneumococcal disease cases among adults aged 50 years or older and about 85% of these cases in adults aged 65 years or older.
The drug company said about 150,000 adults in the United States are hospitalized annually because of pneumococcal pneumonia.
“Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines,” Walter Orenstein, MD, a professor emeritus of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta, Georgia, and a member of Merck’s Scientific Advisory Committee, said in the release.
A draft agenda shows a Centers for Disease Control and Prevention (CDC) advisory panel will meet on June 27 to discuss the vaccine. If the committee votes to approve Capvaxive, the CDC director will decide whether to make it available across the country.
Testing showed that Capvaxive was well tolerated by people it was tested on, with the main reports being pain where they got the shot, fatigue, headaches, and muscle aches, Merck said.
The eight unique serotypes included in CAPVAXIVE will protect against invasive pneumococcal disease and pneumococcal pneumonia, not just pneumonia.
According to Reuters, Merck said Capvaxive has a wholesale acquisition price of $287 per dose, but most people will probably have access to it at no cost if the drug receives a routine CDC recommendation. Capvaxive’s main competition is expected to be Pfizer’s shot, Prevnar 20, which was approved in 2021 for use in adults aged 18 years or older, Reuters reported.
A version of this article appeared on Medscape.com.
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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>“CAPVAXIVE is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive p</metaDescription> <articlePDF/> <teaserImage/> <teaser>Merck injectable vaccine to prevent pneumococcal pneumonia and 21 serotypes of invasive pneumococcal disease approved by the FDA.</teaser> <title>FDA Approves New Pneumococcal Vaccine</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">20</term> <term>6</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">50732</term> <term>234</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA Approves New Pneumococcal Vaccine</title> <deck/> </itemMeta> <itemContent> <p>A new <span class="Hyperlink">vaccine</span> to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults has been approved by the Food and Drug Administration. </p> <p>The injectable drug, <span class="Hyperlink"><a href="https://www.fda.gov/vaccines-blood-biologics/capvaxive">Capvaxive (Pneumococcal 21-valent Conjugate Vaccine)</a></span>, protects against 21 serotypes that cause invasive pneumococcal disease in adults, the company said in a <span class="Hyperlink"><a href="https://www.merck.com/news/u-s-fda-approves-capvaxive-pneumococcal-21-valent-conjugate-vaccine-for-prevention-of-invasive-pneumococcal-disease-and-pneumococcal-pneumonia-in-adults/">news</a></span> release. These strains account for about 84% of invasive pneumococcal disease cases among adults aged 50 years or older and about 85% of these cases in adults aged 65 years or older. <br/><br/>The drug company said about 150,000 adults in the United States are hospitalized annually because of pneumococcal pneumonia. <br/><br/>“Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines,” Walter Orenstein, MD, a professor emeritus of medicine, epidemiology, global health, and pediatrics at Emory University, Atlanta, Georgia, and a member of Merck’s Scientific Advisory Committee, said in the release. <span class="tag metaDescription">“CAPVAXIVE is designed to include the serotypes that cause the majority of invasive pneumococcal disease in adults, helping to protect adults against invasive pneumococcal disease and pneumococcal pneumonia.”</span> <br/><br/>A draft agenda shows a Centers for Disease Control and Prevention (CDC) advisory panel will meet on June 27 to discuss the vaccine. If the committee votes to approve Capvaxive, the CDC director will decide whether to make it available across the country.<br/><br/>Testing showed that Capvaxive was well tolerated by people it was tested on, with the main reports being pain where they got the shot, fatigue, headaches, and muscle aches, Merck said.<br/><br/>The vaccine can prevent pneumonia caused by serotypes 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B, which are not prevented by other pneumococcal vaccines. <br/><br/>According to Reuters, Merck said Capvaxive has a wholesale acquisition price of $287 per dose, but most people will probably have access to it at no cost if the drug receives a routine CDC recommendation. Capvaxive’s main competition is expected to be Pfizer’s shot, Prevnar 20, which was approved in 2021 for use in adults aged 18 years or older, Reuters reported.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-new-pneumococcal-vaccine-2024a1000bcm">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>