In the Journal - Archive
Paul A. Offit, MD, Director, Vaccine Education Center at The Children’s Hospital of Philadelphia
- The role of cost-effectiveness in U.S. vaccine policy Nov. 2011
- Oil-in-water emulsion adjuvant with influenza vaccine in young children Oct. 2011
- “Near Elimination of Varicella Deaths in the US after Implementation of the Vaccination Program” Aug. 2011
- Benefits and limitations of the placebo response Jul. 2011
The role of cost-effectiveness in U.S. vaccine policy
The November 10, 2011, issue of the New England Journal of Medicine contains an editorial by Jane Kim titled "The Role of Cost-Effectiveness in U. S. Vaccination Policy" (N Engl J Med. 2011 Nov 10;365(19):1760-1). Kim describes how health advisory bodies rarely consider cost-effectiveness when making recommendations about prevention and treatment. One notable exception, however, is the Advisory Committee for Immunization Practices (ACIP) to the Centers for Disease Control and Prevention (CDC), which routinely uses cost-effectiveness analyses to determine recommendations for new vaccines.
Kim focuses on two issues faced recently by the ACIP: The routine recommendation of Human Papillomavirus (HPV) vaccine for boys and conjugate meningococcal vaccines for infants. Kim doesn’t reach any specific conclusions, only to say that "identification of high value health interventions through comparative effectiveness analysis" is important. She tips her hand by stating that the public sector cost of fully vaccinating boys is currently $1,450 and for girls is $1,800, stating that this is "expensive" and "more than double the number in 1980." However, it would be of value to compare vaccines with other prevention modalities to determine where Americans are most likely to get bang for their healthcare buck. This is a much tougher analysis to make, but certainly worthwhile.
Oil-in-water emulsion adjuvant with influenza vaccine in young children
The trivalent influenza vaccine (TIV) administered as a shot is poorly immunogenic in young children. To address this problem, researchers at the University of Tampere in Finland tested a new preparation of TIV that included MF59 adjuvant, an oil-in-water emulsion made from squalene. Studies were performed in children between 6 and 72 months of age (T. Vesikari, et al., "Oil-In-Water Emulsion Adjuvant with Influenza Vaccine in Young Children," N Engl J Med. 2011 Oct 13;365(15):1406-16). Vesikari and coworkers found that the efficacy of MF59-adjuvanted TIV was 79 percent in children 6 to 36 months of age and 92 percent in those 36 to 72 months of age. For non-adjuvanted TIV, protective efficacy in those two groups was 40 percent and 45 percent, respectively. The rate of serious side effects was no different between the groups.
These results are exciting, offering a clear path for effective immunization of young children. The biggest hurdle will likely be how the FDA views this novel adjuvant, which received negative press in Europe during the swine flu pandemic. It should be noted, however, that squalene is a normal product of cholesterol metabolism; and that MF59-containing vaccines in Europe have not had a greater incidence of serious side effects than non-adjuvanted vaccines.
“Near Elimination of Varicella Deaths in the US after Implementation of the Vaccination Program
On July 25, 2011, Mona Marin, John Zhang and Jane Seward from the CDC published a paper titled "Near Elimination of Varicella Deaths in the US After Implementation of the Vaccination Program" (Pediatrics. 2011 Aug;128(2):214-20).
The 1-dose varicella vaccine program was first implemented in the United States in 1995 with a second dose recommended in 2006. The authors examined the effect of a mostly 1-dose program by comparing the rates of varicella infection from 1990 to 1994 with those between 2005 and 2007. They found that the incidence of varicella declined from 0.41 per million in the population to 0.05 per million, an 88 percent decline. The decline was seen not only in those less than 20 years of age, but also in those less than 50, suggesting the impact of herd immunity. Further, in the six-year period between 2002 and 2007, three children were reported as having died from varicella as compared with 13 to 16 deaths reported per year in the pre-vaccine era.
The authors concluded, "The impressive decline in varicella deaths can be directly attributed to successful implementation of the 1-dose vaccination program. With the current 2-dose program, there is potential that these most severe outcomes of a vaccine-preventable disease could be eliminated."
Paul A. Offit, MD, offers comments on the latest research. Watch the video» (Medscape Infectious Diseases, August 2011)
Benefits and limitations of the placebo response
In the July 14, 2011 issue of the New England Journal of Medicine, Michael Wechsler and co-workers from Harvard Medical School and Brigham and Women’s Hospital published a paper titled "Active or Placebo, Sham Acupuncture, or No Intervention in Asthma," (N Engl J Med. 2011 Jul 14;365(2):119-26). This is one of many papers showing the benefit of the placebo response — in this case, in the treatment of asthma.
Wechsler found that while a bronchodilator (albuterol) increased lung function by 20 percent, sham acupuncture and sham bronchodilators each increased lung function by 7 percent; no intervention had no effect. In other words, participants benefited from receiving something they thought might work. Of interest, although placebos have been shown to affect a variety of allergic and immunological diseases, study after study has shown that they don’t induce adaptive immune responses. The only way to get a viral- or bacterial-specific response is to be immunized or naturally infected. Although the placebo effect is a powerful one, it has its limits.
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