An invasive disease called Pneumococcal pneumonia is known to afflict the lungs and is a common form of bacterial infection seen in adults. On this front, the US Food and Drug Administration (FDA) has approved of the Prevnar 13 injection which is a pneumococcal 13-valent conjugate vaccine, for the prevention of pneumonia and Pneumococcal pneumonia in individuals aged 50 and above.
Pneumococcal pneumonia is caused by a bacterium namely Streptococcus pneumonia which apparently affects the lungs and then spreads to other body parts. It targets portions of the body that are devoid of germs such as blood or spinal fluid. It is therefore regarded as invasive.
“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia. Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group,†commented Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research.
In this randomized trial, individuals aged 50 or above were exposed to Prevnar 13 or Pneumovax 23, the latter being approved previously for use in adults. As per the outcomes, Prevnar 13 introduced antibody levels that appeared to be relative to or higher than the proportions delivered by Pneumovax 23.
The safety of the vaccine was tested in a set of 6,000 people in the age-group 50 and above who were administered Prevnar 13. While some of them had previously experienced the Pneumovax 23 vaccine, a few others had not encountered the same.
The side-effects reported via use of Prevnar 13 were inclusive of pain, swelling, redness at the injection site, less mobility of the injected arm, tiredness, headache, muscle pain, low appetite, chills and joint pain. Prevnar 13 is already approved for use in children aged between 6 weeks to 5 years for treating the aforesaid disease and a condition called otitis media. Another trial to gauge the clinical benefit of the vaccine is underway.
Collegeville, Pa.-based Wyeth Pharmaceuticals which is now a part of Pfizer manufactured Prevnar 13.