New Merck Vaccine, Capvaxive, Secures FDA Approval for Adult Protection Against Pneumococcal Diseases: 85% Effectiveness and Fewer Side Effects Than Pfizer's Prevnar

New Jersey, United States United States of America
85% effectiveness in preventing invasive pneumococcal disease in adults aged 65 and above compared to Pfizer's Prevnar's 51%
Fewer side effects reported for older adults, common side effects include pain at injection site, fatigue, headache, muscle aches and redness/swelling
Merck's Capvaxive secures FDA approval for adults
No reports of Guillain-Barré syndrome among Capvaxive recipients
Protects against 21 strains of bacteria causing pneumonia and meningitis
New Merck Vaccine, Capvaxive, Secures FDA Approval for Adult Protection Against Pneumococcal Diseases: 85% Effectiveness and Fewer Side Effects Than Pfizer's Prevnar

Merck & Co. has secured US approval for its new pneumococcal vaccine, Capvaxive, which aims to rival Pfizer Inc.'s Prevnar in protecting adults from bacterial infections leading to pneumonia and meningitis.

Capvaxive is approved for preventing bacterial infections behind pneumonia and meningitis for adults aged 18 and above. According to the Centers for Disease Control and Prevention (CDC), approximately 150,000 US adults are hospitalized with pneumococcal pneumonia each year.

The Food and Drug Administration (FDA) approval comes as Capvaxive specifically protects against 21 strains of the bacteria that cause these severe illnesses. This coverage is expected to have rapid uptake due to its ability to prevent around 85% of invasive pneumococcal disease cases in adults aged 65 and above, compared to Pfizer's Prevnar which covers only around 51%.

The vaccine was well-tolerated among people who received it, with older adults reporting fewer side effects. Common after-effects for those over age 50 included pain at the injection site, fatigue, and headache. Adults aged 18 to 49 years old reported these complaints as well as muscle aches and redness and swelling at the site of the injection.

There were no reports of Guillain-Barré syndrome among people who received Capvaxive. This rare form of paralysis is a known side effect associated with some vaccines.

Before Capvaxive can be put into use, it must receive a recommendation from the CDC's Advisory Committee on Immunization Practices (ACIP). The committee meets next week for one of its regularly scheduled meetings to discuss and vote on the vaccine.



Confidence

91%

Doubts
  • Are there any long-term side effects associated with Capvaxive that have not yet been reported?
  • Is the reported effectiveness rate of Capvaxive compared to Prevnar based on clinical trials or real-world data?

Sources

100%

  • Unique Points
    • FDA approves Merck’s new vaccine designed to protect adults from pneumococcus bacteria, which can cause serious illnesses including pneumonia.
    • , The vaccine, called Capvaxive, specifically protects against 21 strains of the bacteria to prevent severe forms of pneumococcal disease that can spread and lead to invasive infections like meningitis or bacteremia.
    • , Approximately 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year.
    • , Capvaxive is expected to have rapid uptake due to its coverage of 85% of invasive pneumococcal disease cases in adults 65 and above, compared to Pfizer’s Prevnar which covers only around 51%.
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (100%)
    None Found At Time Of Publication
  • Bias (100%)
    None Found At Time Of Publication
  • Site Conflicts Of Interest (100%)
    None Found At Time Of Publication
  • Author Conflicts Of Interest (100%)
    None Found At Time Of Publication

100%

  • Unique Points
    • Capvaxive protects against pneumococcal pneumonia, which hospitalizes about 150,000 adults in the US annually and kills about 1 in 20 who develop it
    • Capvaxive also protects against invasive pneumococcal disease that can take the form of bloodstream infections or meningitis and kills roughly 1 in 6 older adults who develop it, resulting in about 3,000 deaths annually
    • Capvaxive covers 21 different serotypes of Streptococcus pneumoniae bacteria, including eight not targeted by other vaccines
    • Serotypes targeted by Capvaxive were responsible for roughly 85% of invasive pneumococcal disease cases diagnosed during 2018 to 2021
    • No reports of Guillain-Barr syndrome among people who received Capvaxive
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (100%)
    None Found At Time Of Publication
  • Bias (100%)
    None Found At Time Of Publication
  • Site Conflicts Of Interest (100%)
    None Found At Time Of Publication
  • Author Conflicts Of Interest (100%)
    None Found At Time Of Publication

100%

  • Unique Points
    • Merck & Co. received US approval for a pneumococcal vaccine called Capvaxive
    • Capvaxive is approved to prevent bacterial infections behind pneumonia and meningitis for adults over 18
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (100%)
    None Found At Time Of Publication
  • Bias (100%)
    None Found At Time Of Publication
  • Site Conflicts Of Interest (100%)
    None Found At Time Of Publication
  • Author Conflicts Of Interest (100%)
    None Found At Time Of Publication

93%

  • Unique Points
    • The FDA has approved Merck’s Capvaxive (V116) as the world’s first pneumococcal disease vaccine designed for adults.
    • ,
    • Capvaxive specifically adapts for patients age 50 and older, covering 84% of pneumococcal disease in this age group according to CDC data.
    • Capvaxive covers eight serotypes not found in any currently licensed vaccine, responsible for 30% of invasive pneumococcal disease in adults 65 years and older.
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (70%)
    The article does not explicitly state any falsehoods or outright lies. However, it heavily emphasizes the novelty and importance of Merck's new vaccine without adequately contextualizing it in relation to existing vaccines. The article repeatedly mentions that Capvaxive is the first pneumococcal vaccine designed for adults, implying that this is a groundbreaking innovation when in fact, while it is indeed the first to be specifically designed for adults, other vaccines like Pfizer's Prevnar 20 are also used in adults. This emphasis on novelty could mislead readers into thinking that Capvaxive is a significantly more advanced or effective vaccine than its competitors when the actual differences have not been fully spelled out. Additionally, while the article does mention that there have not been any studies comparing the efficacy of Capvaxive and Prevnar 20, it doesn't highlight that Capvaxive's approval is contingent upon verification of its clinical benefits in a confirmatory study. This could give readers an overly positive impression of the vaccine's proven effectiveness.
    • The FDA has approved the world’s first pneumococcal disease vaccine designed for adults...
    • The approval of Capvaxive is backed by four phase 3 trials...
    • Capvaxive is specifically adapted for patients age 50 and older as the 21 serotypes it covers account for 84% of the pneumococcal disease of people in the age group...
    • Merck took the lead in developing a pneumococcal vaccine for adults and now stands to benefit as other companies developing shots for adults in the indication lag behind.
  • Fallacies (95%)
    The article contains an appeal to authority with the statement 'The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116)'. However, this is not a fallacy as it is reporting a fact. The article also contains an informal fallacy of hasty generalization with the statement 'There have not been any studies conducted to compare the efficacy between Capvaxive and Prevnar 20'. This statement is based on limited information and does not take into account that there has been a study showing non-inferiority in common serotypes and superiority in unique serotypes. The article also contains an inflammatory rhetorical device with the statement 'Merck took the lead in developing a pneumococcal vaccine for adults and now stands to benefit as other companies developing shots for adults in the indication lag behind'. This statement is not a fallacy but it does contain inflammatory language.
    • ]The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116)[
    • There have not been any studies conducted to compare the efficacy between Capvaxive and Prevnar 20
  • Bias (100%)
    None Found At Time Of Publication
  • Site Conflicts Of Interest (100%)
    None Found At Time Of Publication
  • Author Conflicts Of Interest (0%)
    None Found At Time Of Publication