Correspondence
Varicella–Zoster Vaccine
N Engl J Med 2007; 357:88-90July 5, 2007
- Article
To the Editor:
In their article about the varicella–zoster virus (VZV) vaccine for the prevention of herpes zoster, Kimberlin and Whitley (March 29 issue)1 mention that the frequency and type of serious adverse events were similar for the vaccinees and placebo recipients. However, in the Adverse Event Monitoring Substudy, which involved a closely followed subgroup of 3345 recipients of the VZV vaccine (Zostavax, Merck) and 3271 placebo recipients, the rate of serious adverse events was higher among the vaccine recipients than among the placebo recipients (1.9% vs. 1.3%; relative risk, 1.53; 95% confidence interval, 1.04 to 2.25).2 To assess further the rates of serious adverse events after vaccination with Zostavax, Merck has agreed to conduct a postlicensure randomized, placebo-controlled clinical trial involving 6000 vaccine recipients and 6000 placebo recipients.3
3 ReferencesEmily Jane Woo, M.D., M.P.H.
Robert Ball, M.D., M.P.H.
M. Miles Braun, M.D., M.P.H.
Food and Drug Administration, Rockville, MD 208521
Kimberlin DW ,Whitley RJ . Varicella-zoster vaccine for the prevention of herpes zoster. N Engl J Med 2007;356:1338-1343
Full Text | Web of Science | Medline2
Zostavax [zoster vaccine live (Oka/Merck)]. Whitehouse Station, NJ: Merck, May 2006 (package insert). (Accessed June 14, 2007, at http://www.fda.gov/cber/label/zosmer052506LB.pdf.)
3
Center for Biologics Evaluation and Research. Product approval information licensing action. May 25, 2006. (Accessed June 14, 2007, at http://www.fda.gov/cber/approvltr/zosmer052506L.htm.)
To the Editor:
Kimberlin and Whitley recommend universal immunization with the VZV vaccine for all immunocompetent persons 60 years of age or older. The authors reference an unpublished study estimating that 17 people would need to be vaccinated in order to prevent one case of herpes zoster and approximately 31 would need to be vaccinated in order to prevent one case of postherpetic neuralgia. However, in the Shingles Prevention Study,1 the number needed to treat in order to prevent one case of herpes zoster was 59. Furthermore, the number needed to treat in order to prevent one case of persistent pain (pain score, >2 on a scale of 1 to 10) at 6 months was 802. Finally, in the substudy specifically designed to evaluate adverse events, there was a significant increase in the number of serious adverse events seen in the vaccine group of the trial.
Until further information about the safety of this vaccine is available, prudence would dictate that patients should be permitted to decide individually whether they wish to receive it. Important to the information they should be given is the very modest (at best) benefit combined with the real possibility that unknown health risks will be found with post-marketing surveillance.
Chester B. Good, M.D., M.P.H.
VA Pittsburgh Healthcare System, Pittsburgh, PA 15240Dr. Good reports serving as the chairperson of the Veterans Affairs Medical Advisory Panel for Pharmacy Benefits Management. No other potential conflict of interest relevant to this letter was reported.
1 References1
Oxman MN ,Levin MJ ,Johnson GR , et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005;352:2271-2284
Full Text | Web of Science | Medline
To the Editor:
Kimberlin and Whitley state that “the zoster vaccine is not licensed for use in immunocompromised people. However, this population is at especially high risk for the development of herpes zoster. This group includes people who are mildly immunosuppressed, such as people with diabetes. . . .” These statements pose a dilemma. What is the recommendation of the authors regarding the administration of the zoster vaccine to patients with diabetes and well-controlled glycemia? The official product-information sheet for Zostavax does not list diabetes as a formal contraindication to its use.1
1 ReferencesDavid L. Keller, M.D.
Medical Institute of Little Company of Mary, Torrance, CA 90503To the Editor:
Kimberlin and Whitley recommend herpes zoster immunization on the basis of efficacy trials and epidemiologic data obtained from community-dwelling elderly persons who visited their general practitioners because of pain.1,2 Little is known about hospitalized elderly patients who may be at particularly high risk for herpes zoster infection. We studied 25,477 hospitalized older patients (mean [±SD] age, 83.0±8.4 years). Among these patients, we identified 112 patients (mean age, 85.5±8.0 years) with herpes zoster. Women represented 67% of these older hospitalized patients and 75% of the patients with herpes zoster. The incidence rate was 4.88 cases per 1000 admissions among women and 3.01 cases per 1000 admissions among men (P=0.03).
Postherpetic neuralgia (more than 3 months after the eruption) was the reason for hospitalization in 12% of the patients with herpes zoster; an acute rash was present in 55%. Symptoms of herpes zoster appeared during the hospital stay in 33% of the patients; 92% of the patients reported pain. All patients were treated with either acyclovir (39% of the patients) or valacyclovir (61%), and when pain was present, patients received analgesics. These results indicate the strong need for prevention of herpes zoster infection in the elderly and reinforce the recommendations of Kimberlin and Whitley.
2 ReferencesPierre-Olivier Lang, M.D., M.P.H.
François Herrmann, M.D., M.P.H.
Jean-Pierre Michel, M.D.
University Hospitals of Geneva, CH-1226 Geneva, Switzerland
pierre.o. lang@hcuge. ch 1
Chidiac C ,Bruxelle J ,Daures JP , et al. Characteristics of patients with herpes zoster on presentation to practitioners in France. Clin Infect Dis 2001;33:62-69
CrossRef | Web of Science | Medline2
de Melker H ,Berbers G ,Hahne S , et al. The epidemiology of varicella and herpes zoster in the Netherlands: implications for varicella zoster virus vaccination. Vaccine 2006;24:3946-3945
CrossRef | Web of Science | Medline
To the Editor:
Kimberlin and Whitley note that a VZV vaccine with a higher titer of virus than that of current vaccines was required to prevent herpes zoster in older adults. The vaccine seemed to induce a new peak in memory T cells that was well above the threshold for zoster. Surely the use of a VZV vaccine with higher viral titers in children will also lead to a higher peak of memory T-cell levels as compared with current vaccines. It would then take longer for the memory T cells to fall below the threshold for varicella, providing longer protection from varicella for children.
The limitations of this hypothesis are the assumption that there is an immunologic threshold for varicella (as there is for zoster) and the potential for the increased risk of toxicity from the higher-titer vaccine. A recent recommendation was made for all children to receive a second dose of VZV vaccine after breakthrough cases of varicella occurred among children immunized with only one dose.1 The use of a higher-titer vaccine might prevent the need for a second dose.
1 ReferencesSanjaya N. Senanayake, F.R.A.C.P., M.B., B.S.
Canberra Hospital, Woden, ACT 2606, Australia
sanjaya.senanayake@act. gov. au 1
Chaves SS ,Gargiullo P ,Zhang JX , et al. Loss of vaccine-induced immunity to varicella over time. N Engl J Med 2007;356:1121-1129
Full Text | Web of Science | Medline
- Citing Articles (1)
Citing Articles
1
M. Amparo Torrecilla Rojas, Fermín García Rodríguez, Manuel Rodríguez Rodríguez, Josefa Ruiz Fernández. (2009) La vacunación frente a herpes zóster. Atención Primaria 41:7, 424-425
CrossRef
