Anyone who has had the chickenpox virus is at risk for shingles, a viral infection that causes a painful, localized skin rash. People with shingles are at risk for complications including severe and debilitating pain called postherpetic neuralgia (PHN), vision loss or blindness, pneumonia, hearing problems, brain inflammation (meningitis, encephalitis), or death. In 2006, Merck & Co. introduced the shingles vaccine Zostavax, essentially a larger-than-normal dose of the chickenpox vaccine, designed to protect people age 60 and older from getting shingles.

In March 2011, the Food and Drug Administration (FDA) approved Zostavax for adults age 50 and older as well. Merck is using this clearance to market the vaccine to adults in their 50s, which brought their sales as high as $749 million in 2015.

But according to a lawsuit brought by dozens of people, Zostavax can cause otherwise healthy people to develop the painful rash or even worse, suffer serious complications including death.

Both chickenpox and shingles are caused by the varicella-zoster virus. When someone develops chickenpox, the varicella-zoster virus lies dormant. But for some, the virus can reawaken and produce shingles. Zostavax was shown to be 51% effective and lasts only about four to five years. In other words, about half of the people who get the vaccine will still get shingles.

The Centers for Disease Control and Prevention (CDC) no longer recommends Zostavax for the prevention of shingles and the long-term pain from PHN. The reason is that the vaccine only lasts a few years, and people in their 60s are at greater risk for the rash and its complications. Instead, the CDC recommends healthy adults age 50 and older get two doses of GlaxoSmithKline’s vaccine called Shingrix, which was approved by the FDA in 2017.

But, Zostavax’s efficacy is largely unknown. According to a Ring of Fire report by Farron Cousins, CDC states Zostavax “reduced the risk of shingles by 51%” based on a clinical trial of 38,000 adults age 60 and older. Reuters, however, reported Zostavax had an effectiveness that wavered between 18% and 70%, with its efficacy waning noticeably the older a patient gets.

According to Cousins, some patients who have gotten the shingles vaccine never got shingles, but the virus attacked their central nervous system, putting them at risk for shingles-associated complications like meningitis or encephalitis.

According to the nonprofit National Vaccine Information Center, as of Aug. 31, 2018, there have been 46,561 shingles vaccine-related adverse events reported to the federal vaccine Adverse Events Reporting System (VAERS) including 142 deaths, 1,023 hospitalizations, and 766 related disabilities.

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