Zostavax Lawsuit

Overview

Merck’s Zostavax vaccine contains live varicella zoster virus – the chickenpox virus that also causes shingles. Once a person has chickenpox, the virus remains dormant in their body for the rest of their life. However, as people age and their immune systems become weaker, the virus can reactivate and cause shingles. Zostavax contains a “weakened” or “attenuated” form of the varicella zoster virus, which is designed to stimulate the immune system, keep the virus dormant and prevent shingles.

What’s the Problem with the Shingles Vaccine?

For starters, the Zostavax vaccine is only effective in about half of patients (according to Merck; other studies have found it to be far less effective), and it may also cause the very disease its meant to prevent — shingles — as well as chickenpox. There is also some indication that Zostavax may increase the risk of death.

According to the National Vaccine Information Center (NVIC), there were over 1,100 reports made to the Vaccine Adverse Events Reporting System (VAERS) from 1990 until September 2015 related to shingles vaccines. Of these, at least 90 reports involved the death of a patient who had received the vaccination.

Zostavax Side Effects

Shingles
Chickenpox
Injection site reactions (pain, redness, itching, swelling, warmth, bruising)
Allergic reactions
Vision damage / keratitis
Headache
Diarrhea
Joint and/or muscle pain
Skin rash
Death
And more

Studies

In January 2016, Health Sciences Institute (HSI) researchers published an article which reported that “UCLA researchers found that only one in 175 people who get the vaccine will be able to dodge a shingles flare-up.” However, Merck claims that the Zostavax vaccine is at least 51% effective.

According to the authors, Merck arrived at this percentage as follows: In the placebo group, 3.3% of test subjects developed shingles, compared to 1.6% in the vaccine group. Though this does constitute a 50% difference, it also means the real, absolute risk reduction is only 1.7%. Is that worth it, considering the significant health risks associated with the Zostavax vaccination?

Mass Vaccination Triggers Shingles Outbreak

Widespread use of the chickenpox vaccine in children over the past 20 years in the U.S. has limited natural boosting of Varicella Zoster immunity in the adult population, according to NVIC. As a result, a significant increase in cases of Herpes zoster has been reported among adults. Merck’s response was to repackage its chickenpox vaccine as Zostavax and make it about 14 times stronger.

Symptoms of Shingles

When the varicella zoster virus reactivates, it causes shingles. Early symptoms include headache, sensitivity to light and flu-like symptoms without a fever. As the illness progresses, patients may experience itching, tingling, or pain where a band or strip of rash may appear several days or weeks later. The rash may appear anywhere but will be on only one side of the body. The rash will first form blisters, then scab over, and finally clear up over a few weeks. The band of pain and rash are the most prominent symptoms of shingles.

Complications of Chickenpox in Adults

Adults are more likely than children to die from chickenpox and suffer adverse health complications resulting from varicella infection, according to the National Foundation for Infectious Diseases (NFID). Complications may include:

Dehydration
Joint infections
Toxic shock syndrome
Pneumonia
Blood stream infections (sepsis)
Bleeding problems
Infection or inflammation of the brain (encephalitis, cerebellar ataxia)
Bone infections

Zostavax Timeline

May 2006 – Approved by the FDA

May 26, 2006 – Zostavax approved by the FDA for the prevention of shingles in patients aged 60 and over.

March 2011 – Approved to treat shingles

March 24, 2011 – FDA approves Zostavax to prevent shingles in patients ages 50 to 59.

August 2014 – Side effect labeling changed

August 18, 2014 – Shingles added as a possible side effect to the labeling of Zostavax.

January 2016 – Health Sciences Institute article published

January 21, 2016 – Article published by the Health Sciences Institute (HSI) finds that only 1 in 175 people who receive the Zostavax vaccination will be able to dodge a shingles flare-up.

February 2016 – FDA approves label change

February 17, 2016 – FDA approves Zostavax label change indicating that the vaccination can cause “Eye disorders: necrotizing retinitis.”