The FDA has approved Prevnar 13, for use on people over 50. Prevnar 13 is a pneumococcal 13-valent conjugate vaccine, that can prevent pneumonia and disease caused by the bacterium, Streptococcus pneumoniae.
The bacterium most commonly infects the lungs, (Pneumococcal pneumonia), causing congestion and a potentially fatal build up of fluid and mucus. However it can become more invasive entering the spinal fluid, and even the blood.
Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research said :
“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.”
Prevnar or Prevnar 13 is made by Pfizer while GlaxoSmithKline market a similar product under the name of Synflorix. They were approved in Feb. 2010 for use in children ages 6 weeks through 5 years for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae and for the prevention of otitis media caused by seven of the serotypes of the bacterium.
In the more recent randomized, multi-center studies in the United States and Europe, people 50 and older received either Prevnar 13 or Pneumovax 23, a licensed pneumococcal vaccine also approved for use in this age group. The trials showed Prevnar 13 inducing antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23. Therefore the FDA used their new accelerated approval pathway, that allows for earlier treatment for serious and life threatening illnesses. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.
To assure the safety of the product, 6000 people aged 50 who had not received the Prenumovax23 were given Prevnar 13 as an alternative. Common adverse reactions reported with Prevnar 13 were pain, redness, and swelling at the injection site, limitation of movement of the injected arm, fatigue, headache, chills, decreased appetite, generalized muscle pain, and joint pain. Similar reactions were observed in those who received Pneumovax 23.
The accelerated approval means that the product can be more widely used whilst full clinical trials are being conducted. In addition, another research is being conducted on 85,000 patients 65 and over, who have not previously received Pneumovax 23, to assess the effectiveness and clinical benefit of Prevnar 13 in preventing pneumococcal pneumonia.
Written by Rupert Shepherd