Zostavax Vaccine to Prevent Shingles - FDA Approval

Author: U.S. Food and Drug Administration
Published: 2011/03/25
Topic: FDA News and Approvals - Publications List

Page Content: Synopsis - Introduction - Main

Synopsis: FDA approves Zostavax a live attenuated virus vaccine for the prevention of shingles in individuals 50 to 59 years of age.

Introduction

FDA Approves Zostavax Vaccine to Prevent Shingles in Individuals 50 to 59 Years of Age.

Focus

The Food and Drug Administration (FDA) today approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older.

In the United States shingles affects approximately 200,000 healthy people between the ages of 50 and 59, per year. It is a disease caused by the varicella-zoster virus, which is a virus in the herpes family and the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerves in the body. For reasons that are not fully understood, the virus can reappear in the form of shingles, more commonly in people with weakened immune systems and with aging.

"The likelihood of shingles increases with age. The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

Shingles is characterized by a rash of blisters, which generally develop in a band on one side of the body and can cause severe pain that may last for weeks, and in some people, for months or years after the episode.

Approval was based on a multi-center study conducted in the United States and four other countries in approximately 22,000 people who were 50-59 years of age. Half received Zostavax and half received a placebo. Study participants were then monitored for at least one year to see if they developed shingles. Compared with placebo, Zostavax reduced the risk of developing shingles by approximately 70 percent.

The most common side effects observed in the study were redness, pain and swelling at the site of injection, and headache.

Zostavax was originally approved on May 26, 2006, for the prevention of shingles in individuals 60 years of age and older.

Zostavax is manufactured by Merck & Co. Inc., of Whitehouse Station, New Jersey.

Zostavax Product Page - www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm136941.htm

Explore Similar Topics

• : Cognoa ASD Diagnosis Aid is an aid for diagnosis of ASD in patients 18 months - 5 years of age who are at risk of developmental delay based on concerns of a parent, caregiver, or health care provider.

• : U.S. FDA authorizes marketing of Neurolutions IpsiHand Upper Extremity Rehabilitation System to facilitate muscle rehabilitation in stroke patients.

Citing and References

Founded in 2004, Disabled World (DW) is a leading resource on disabilities, assistive technologies, and accessibility, supporting the disability community. Learn more on our About Us page.

Cite This Page: U.S. Food and Drug Administration. (2011, March 25). Zostavax Vaccine to Prevent Shingles - FDA Approval. Disabled World (DW). Retrieved May 19, 2025 from www.disabled-world.com/medical/pharmaceutical/fda/zostavax.php

Permalink: <a href="https://www.disabled-world.com/medical/pharmaceutical/fda/zostavax.php">Zostavax Vaccine to Prevent Shingles - FDA Approval</a>: FDA approves Zostavax a live attenuated virus vaccine for the prevention of shingles in individuals 50 to 59 years of age.

While we strive to provide accurate and up-to-date information, it's important to note that our content is for general informational purposes only. We always recommend consulting qualified healthcare professionals for personalized medical advice. Any 3rd party offering or advertising does not constitute an endorsement.