Overall, the safety of Prevnar® was evaluated in a total of five clinical studies in the US in which 18,168 infants and children received a total of 58,699 doses of vaccine at 2, 4, 6, and 12-15 months of age. In addition, the safety of Prevnar® was evaluated in 831 Finnish infants using the same schedule, and the overall safety profile was similar to that in US infants. The safety of Prevnar® was also evaluated in 560 children from 4 ancillary studies in the US who started immunization at 7 months to 9 years of age. Tables 12 and 13 summarize systemic reactogenicity data within 2 or 3 days across 4,748 subjects in US studies (3,848 infant doses and 997 toddler doses) for whom these data were collected and according to the pertussis vaccine administered concurrently.
There are those that say that not all middle ear infections really need antibiotics. Before there were doctors and antibiotics, most middle ear infections did ultimately improve on their own. But a significant percentage of those untreated ear infections did not "go away on their own" and led to serious complications such as progression of the infection to the neighboring mastoid bone (mastoiditis), ruptured ear drums, deafness, and even spread of the infection to the spinal fluid surrounding the brain ( meningitis ). Given the safety and experience we have with antibiotics today, I think that antibiotics are important tools in treating ear infections, along with the "feel better" medications.
My research interests include the study of vaccine-preventable diseases and viral respiratory diseases in young children and immunocompromised hosts, including transplant recipients, as well as the evaluation of antiviral therapy for the prevention and treatment of viral diseases.
As a Clinical Associate of Fred Hutchinson Cancer Research Center, I am active in many transplant-related protocols in the prevention and treatment of disease in the immunocompromised host. As a member of the NIH-sponsored Seattle Vaccine Treatment and Evaluation Unit, I am involved in research with new vaccines and maternal immunization with Tdap and influenza vaccines.
My research group is active in studying influenza virus vaccines in diverse populations, including infants, school-age children in the schools, and pregnant women.