ACIP Declines to Recommend Zoster Vaccine for Under-60s

Yael Waknine

November 10, 2011

November 10, 2011 — Although herpes zoster vaccine (Zostavax, Merck & Co, Inc.) is approved by the US Food and Drug Administration (FDA) for use in adults aged 50 through 59 years, the Advisory Committee on Immunization Practices (ACIP) has declined to make a recommendation in this regard because of production issues and supply shortages.

According to an article published by the US Centers for Disease Control and Prevention (CDC) in the November 11 issue of Morbidity and Mortality Weekly Report, ACIP may reconsider this issue when a stable supply of vaccine is assured.

The herpes zoster vaccine was licensed by the FDA in 2006 for the prevention of shingles among adults aged 60 years and older, with a population expansion approved in March 2011 to include those aged 50 through 59 years.

The action was based on data from a randomized study of about 22,000 adults aged 50 to 59 years living in the United States and 4 other countries. Results at 1 year showed that the vaccine reduced the risk of developing shingles by 69.8% relative to placebo (95% confidence interval, 54.1% - 80.6%).

ACIP based its decision on published and unpublished data presented at the February and June 2011 meetings that included information on the epidemiology of herpes zoster and its complications, as well as vaccine safety, efficacy, long-term protection, cost-effectiveness, and supply. Limited data were available on the vaccine’s ability to provide long-term protection in either age group.

Merck is the only supplier of varicella zoster virus–containing vaccines, which also include varicella vaccine (Varivax), and the combined measles, mumps, rubella and varicella vaccine (ProQuad). Production shortfalls have led to prioritized production of Varivax over Zostavax since 2008. As a result, filling of orders for the shingles vaccine has been delayed intermittently.

Planned improvements by the company in its production processes and the addition of new manufacturing facilities are expected to increase the supply of the vaccine over the next several years.

Herpes zoster vaccine is indicated for the prevention of shingles in adults aged 50 years and older. Contraindications remain unchanged, including its use in pregnant women; individuals with a primary or acquired immunodeficiency; and those with a history of anaphylactic reaction to gelatin, neomycin, or any other component of the vaccine.

Clinicians who choose to use the vaccine among certain patients aged 50 through 59 years despite the absence of an ACIP recommendation are advised to consider the particularly poor anticipated tolerance of herpes zoster or postherpetic neuralgia symptoms, such as those attributable to preexisting chronic pain, severe depression, or other comorbid conditions; a potential inability to tolerate treatment medications because of hypersensitivity or interactions with long-term therapy with other medications; and occupational considerations.

Efficacy in patients who develop immunodeficiency after immunization is not guaranteed.

Additional information regarding vaccine supply may be obtained by contacting the company’s customer center at 877-829-6372.

MMWR Morb Mortal Wkly Rep. 2011;60:1513-1545. Full text

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