If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  FDA Advisory Panel Recommends First Pneumococcal Conjugate Vaccine For Children MADISON, N.J. -- November 5, 1999 -- The FDA’s Vaccines and Related Biological Products Advisory Committee today recommended for licensure the first conjugate vaccine intended for the prevention of invasive pneumococcal disease in infants and young children. The Committee’s opinion is provided to the FDA, but is not binding. If licensed by the FDA, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) will be marketed as Prevenar by Wyeth Lederle Vaccines, a unit of Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation. Streptococcus pneumoniae, also known as pneumococcus, causes invasive diseases, including serious illnesses such as bacteremia (bloodstream infection) and a potentially fatal or crippling form of meningitis (brain or spinal cord infection). Worldwide, more than 1.2 million children die each year as a result of pneumococcal disease. In the U.S. there are approximately 16,000 cases of invasive pneumococcal disease each year among children under age 5. Pneumococcal disease in children costs the U.S. health care system an estimated $1.5 billion annually. The vaccine is currently under going "priority review" by the FDA, an accelerated review process reserved for products that provide a significant improvement in the prevention, diagnosis, or treatment of a serious or life-threatening disease. Last month the CDC’s Advisory Committee on Immunization Practices voted to recommend the vaccine for routine use in all children up to age five. This recommendation is subject to FDA licensure of the vaccine and an additional review if any new safety or efficacy data become available prior to such approval. "The positive endorsement from the FDA’s Advisory Committee is great news for children," says Kevin Reilly, President of Wyeth Vaccines and Nutrition. "This is a breakthrough vaccine that has the potential to reduce serious life-threatening pneumococcal disease in children, and, if it is licensed by the FDA, we intend to move quickly to make it available." In making its decision, the FDA Advisory Committee reviewed safety and efficacy data from numerous clinical trials including a major trial, involving approximately 38,000 children. Children in the trial were monitored for up to three years after receiving the vaccine. In clinical trials, the most frequently reported adverse events included injection site reactions, fever (38.oC), irritability, drowsiness, restless sleep, and decreased appetite. Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) targets the seven serotypes (strains) of pneumococcal bacteria most prevalent in the U.S., which are also among the most resistant to antibiotics.
Related Link: Wyeth-Ayerst Laboratories.
|
