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What is the history of Shingles vaccine use in America?


In 2006 the first shingles (herpes zoster) vaccine approved by the FDA for use in the U.S. was Zostavax by Merck.1 2  Zostavax is a single dose live attenuated virus vaccine licensed for use in healthy Americans age 60 and older that do not have weakened immune systems. Zostavax is a much more potent version of Varivax chicken pox vaccine. In 2011 the FDA expanded Zostavax use to include Americans age 50 to 59.

In 2017 Shingrix, a new genetically engineered, adjuvanted, recombinant vaccine, was approved by the FDA for use in healthy adults age 50 and older. In October 2017 the CDC gave preference to the use of Shingrix over Zostavax, except in cases where individuals had an allergic reaction to Shingrix.3

Shingles vaccine is one of the few vaccines not covered by the National Childhood Vaccine Injury Act of 1986, which means individual may sue the vaccine manufacturer directly for vaccine injuries associated with the vaccine. Currently Merck, the manufacturer for Zostavax is defending itself against 60 lawsuits that allege the vaccine caused serious side-effects, including death. The outcome of these proceedings is pending.4

IMPORTANT NOTE: NVIC encourages you to become fully informed about Shingles and the Shingles vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

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References

1 FDA. Zostavax (Frozen). Product Information Sheet. Mar. 21, 2018

2 FDA. Zostavax (Refrigerator Stable). Product Information Sheet. Mar. 21, 2018

3 CDC. Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. MMWR 67(3);103-108. Jan. 26, 2018.

4 Luhana, R. Merck Files Motion to Consolidate Zostavax Lawsuits in Florida. The Legal Examiner. May 30, 2018.


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