Prevnar 13, a pneumonia vaccine, is approved for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.
Pneumococcal pneumonia, caused when the bacterium Streptococcus pneumoniae infects the lungs, is the most common disease caused by this bacterium in adults. When the bacterium invades parts of the body that are normally free from germs, such as the blood or spinal fluid, the disease is considered “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,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “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.”
The new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments 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.
In 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 studies showed that for the 12 common serotypes, Prevnar 13 induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23.
The safety of Prevnar 13 was evaluated in about 6,000 people ages 50 and older who received Prevnar 13 and who had and had not previously received Pneumovax 23. 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.
Accelerated approval is granted on the condition that a clinical trial is conducted during the post-approval marketing of the vaccine to verify the anticipated clinical benefit. An additional trial in 85,000 people ages 65 and older, with no previous history of receiving Pneumovax 23, is underway to confirm the clinical benefit of Prevnar 13 in the prevention of pneumococcal pneumonia.
Prevnar 13 is already approved 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.
The approval of Prevnar 13 for adults 50 years and older supports the Department of Health and Human Services’ Healthy People 2020 objectives.
Prevnar 13 is manufactured by Collegeville, Pa.-based Wyeth Pharmaceuticals.
Prevenar 13 Vaccine is used to prevent pneumonia, meningitis, blood and, ear infections. The vaccine helps the body make its own antibodies which protects you against these diseases. It only protects against disease caused by the thirteen strains of Streptococcus pneumoniae bacteria included in the vaccine.
Prevenar 13 Vaccine is given as an injection into a muscle by your doctor or nurse. It should not be self-administered. It is important that you receive all the doses of this vaccine to make it effective.
Some common side effects of this vaccine include injection site reactions (such as pain, swelling, redness), irritability, loss of appetite, and sleepiness. If these side effects persist or get worse, let your doctor know. The doctor may help with ways to reduce or prevent these symptoms.
To ensure safety, before receiving the vaccine, it is important to let the doctor know if you have any other illnesses. You should also tell the doctor about all the medicines you are taking. Pregnant and breastfeeding mothers should consult and seek advice from their doctor before receiving the vaccine.
Source: U.S. Food and Drug Administration, USA