HQ Team
June 18, 2024: The US Food and Drug Administration has given the green light to Merck’s vaccine to protect adults against the different types of bacteria that cause invasive pneumococcal disease.
Capvaxive, was approved under the FDA’s Priority Review of Merck’s application. Continued approval for the vaccine may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of Capvavive in adults above 18 years old.
The FDA approved the vaccine after end-stage clinical trials.
Single dose vaccine
The investigational study evaluated Capvaxive with the existing pneumococcal 20-valent conjugate vaccine, or PCV20, in adults 18 years of age and older who had not previously received a pneumococcal vaccine.
The main trial results were supported by data from supplementary experiments evaluating Merck’s vaccine in vaccine-naïve and vaccine-experienced adults.
Capvaxive, administered in a single dose, protects against eight serotypes of bacteria Streptococcus pneumoniae which are mainly responsible for adult invasive pneumococcal disease.
Pneumococcal pneumonia
“Complications from invasive pneumococcal disease can lead to hospitalisation, organ damage and even death,” said Dr Walter Orenstein, a member of Merck’s Scientific Advisory Committee.
“Many cases of adult disease are caused by serotypes not included in other approved pneumococcal conjugate vaccines.
“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,” he said in a statement.
Merck’s vaccine covered more serotypes of invasive pneumococcal disease in adults when compared to the existing pneumococcal 20-valent conjugate vaccine or PCV20.
Eight unique serotypes
In adults, 50 years of age and older, the vaccine covered the serotypes responsible for about 84% of invasive pneumococcal disease cases, compared to about 52% covered by PCV20, according to the Merck statement.
Capvaxive included eight unique serotypes not covered by other currently approved pneumococcal vaccines.
Those serotypes were responsible for about 27% of cases in adults 50 years of age and older and about 30% in adults 65 years of age and older.
More than 150,000 adults are hospitalised from pneumococcal pneumonia each year in the US. There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children.
Non-invasive pneumococcal illnesses include pneumonia — when pneumococcal disease is confined to the lungs — and invasive pneumococcal illnesses, which include pneumococcal bacteremia or infection in the bloodstream.
Cough or sneeze
Bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord) are also seen in patients.
The bacteria can be transmitted from one person to another through respiratory droplets when they cough, sneeze, or talk.
The exact duration of contagiousness for individuals with a Streptococcus pneumoniae infection is unknown. Individuals may remain contagious until their oral and nasal secretions no longer contain a significant number of pneumococci.
