FDA Approves Pneumococcal Disease Vaccine with Broader Protection

The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

Prevnar 13 is approved for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae. It also is approved for the prevention of otitis media caused by the seven serotypes shared with Prevnar. The bacterium can cause infections of the blood, middle ear, and the covering of the brain and spinal cord, as well as pneumonia.

“Although the rates of invasive pneumococcal disease have declined dramatically, there are still children in the United States who are suffering with this serious illness,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “The availability of Prevnar 13 will help prevent pneumococcal disease caused by the six additional serotypes.”

The seven Streptococcus pneumoniae serotypes against which Prevnar is directed accounted for about 80 percent of IPD in young children in North America at the time that the vaccine was licensed. With the use of Prevnar, by 2007 the overall rate of IPD caused by these seven serotypes in children less than 5 years old was reduced by 99 percent. However, at that time, it was also shown that of the remaining invasive pneumococcal disease in this age group, 62 percent are caused by the six additional serotypes that will be included in Prevnar 13.

Safety was evaluated in 5,084 infants and young children who received Prevnar 13, compared with 2,760 who received Prevnar, the control vaccine. Common adverse reactions reported after administration of Prevnar 13 were pain, redness and swelling at the injection site, irritability, decreased appetite and fever. These reactions were similar to what has been observed with Prevnar, which has a good safety record in the United States.

Vaccine effectiveness was assessed in a randomized U.S. multi-center immunogenicity study. Prevnar 13 post-vaccination antibody response comparisons to Prevnar were evaluated by several immunological measures. An evaluation of all these measures showed that Prevnar 13 induced antibodies that were comparable to those shown to be protective in Prevnar.

Post marketing studies will include continued monitoring for reduction in IPD and otitis media, as well as continued evaluation of safety.

The vaccine is administered in a four-dose schedule given at 2, 4, 6 and 12-15 months of age. The vaccine is available in single-dose, pre-filled syringes.

Prevnar 13 is manufactured by Wyeth Pharmaceuticals Inc. of Collegeville, Pa., a wholly owned subsidiary of Pfizer Inc.

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Mayo Clinic Study Finds Increased Risk of Pneumococcal Disease in Asthma Patients

/PRNewswire-USNewswire/ -- Mayo Clinic research shows adults with asthma are at increased risk of serious pneumococcal disease caused by Streptococcus pneumoniae, the most common bacteria causing middle ear infections and community acquired pneumonia. It also causes blood stream infections and brain infections. According to the Centers for Disease Control, pneumococcal infection is one of the leading causes of death from a vaccine-preventable disease. The researchers recommend including asthma as an indication for pneumococcal vaccination in adults. The results of the study were recently published in the October edition of the Journal of Allergy and Clinical Immunology.

"We found that adults with invasive pneumococcal disease, a serious, potentially fatal disease, are seven times more likely to be asthmatics. Our study also showed that 17 percent of the burden of invasive pneumococcal disease can be attributable to asthma at a population level. This is quite a significant impact on the burden of invasive pneumococcal disease," says Young Juhn, M.D., a pediatric and adolescent medicine physician-scientist at Mayo Clinic and lead author of the study. "Invasive pneumococcal disease is a vaccine-preventable disease. The implication is that we have the ability to significantly reduce instances of this potentially fatal disease by expanding the indication for the pneumococcal vaccine to include adults with asthma."

Researchers used a population-based, retrospective case-control study of 3,941 records from the Rochester, Minn. population to see if there was a higher incidence of pneumococcal disease among people with asthma. Adults diagnosed with asthma were almost seven times more likely to develop invasive pneumococcal diseases than adults who were not diagnosed with asthma. In children the sample size for was not large enough to draw a definitive conclusion.

"The Advisory Committee on Immunization Practices (ACIP), which is the governing body for immunization practices in the United States, voted unanimously to include asthma as a pneumococcal vaccine condition at the recent ACIP meeting in October, 2008. Adults with asthma should receive the pneumococcal vaccine," says Dr. Juhn.

Further research implications include finding out why a connection exists between instances of pneumococcal disease and asthma, determining whether the connection between asthma and this particular bacterial infection also exists with other bacterial infections, such as pertussis (whooping cough), and the connection between asthma and other non-infectious diseases, such as inflammatory bowel disease, juvenile diabetes, and rheumatoid arthritis. Dr. Juhn does not believe all asthmatic patients react the same way. He is looking for a subset of asthmatic patients who have an increased susceptibility to microbial infection.

Study authors, in addition to Dr. Juhn, include Hirohito Kita, M.D., Department of Allergic Diseases Research, Mayo Clinic; Barbara Yawn, M.D., Department of Epidemiology, Mayo Clinic; Thomas Boyce, M.D., Department of Pediatric Infectious Diseases, Mayo Clinic; Kwang Yoo, M.D., Ph.D., Department of Internal Medicine, Kunkook University, Republic of Korea; Michaela McGree, Department of Biostatistics, Mayo Clinic; Amy Weaver, Department of Biostatistics, Mayo Clinic; Peter Wollan, Ph.D., Department of Epidemiology, Mayo Clinic; and Robert Jacobson, M.D., Department of Pediatric and Adolescent Medicine, Mayo Clinic.

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