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Merck & Co., maker of the vaccine, Zostavax, is facing mounting concerns over the efficacy of the drug. Allegations have surfaced that not only does the vaccine protect against shingles as advertised, but may in fact cause a more aggressive version of the strain of infection in addition to serious unwarned for side effects and significant increase risk associated with auto-immune disorders.


Shingles are caused by the same virus, varicella-zoster virus (VZV), which causes chickenpox. Later in life, the virus can be reactivated and cause shingles, which is a painful rash that usually appears as a stripe of blisters on the body. Pain can continue even after the rash is gone. This condition is known as postherpetic neuralgia. To prevent shingles, adults can get a chickenpox or shingles vaccine. Zostavax was approved by the FDA in May 2006, for the prevention of shingles among individuals ages 60 or older. It is a more potent version of the Merck chickenpox vaccine, Varivax.


A significant point of concern has been the growing number of adverse event reports (Vaccine Adverse Event Reporting System or “VAERS”) that have been submitted to the FDA. As of September 2015, there had been more than 1,100 submissions reporting conditions such as autoimmune disorders like meningitis, paralysis, acute disseminated encephalomyelitis (ADEM), Bell’s Palsey, traverse myelitis, chronic inflammatory demyelinating polyneuropathy (CIPD), myalgia, arthralgia, lymphadenopathy, actinic keratosis, severe cutaneous disease, cellulitis in addition to vision loss, tinnitus or hearing loss, encephalitis, meningitis, Ramsey Hunt Syndrome, skin discoloration or rash and at least 36 deaths.


According to lawsuits filed, “A risk of using a live virus vaccine is that it is not weakened enough or ‘under-attenuated.’ Under-attenuated live virus creates an increased risk of developing the disease the vaccine was to prevent,” the lawsuit states. “Once injected, the attenuated live virus has been shown to recombine into more virulent strains causing disease.” This theory is supported by a study published in The Pediatric Infectious Disease Journal in 2000.

Potential Risk of a Viral Infection

One particular issue of note is that as of 2012 the label, patient information sheet, and prescribing information for Zostovax contain no reference to the potential risk of a viral infection. As this drug is designed for a patient population over 60, the fact that there is no warning regarding individuals with compromised immune systems is concerning. Instances of VZV activation occur at a rate 20 times higher in immunocompromised patients.


The instructions and information published by Merck indicate that only one inoculation is recommended. However, in 2009, the CDC published a report wherein it found that the Zostavax vaccine wanes in its efficacy within five years, and has almost no remailing preventative effects after seven years. This information is found nowhere in the packaging literature for the vaccine.


In August of 2018 Zostavax claims were centralized (MDL #2848) in the Eastern District of Pennsylvania. There are currently nearly 2,000 product liability suits filed. Coordinated pre-trial proceedings are being overseen by Judge Harvey Battle III. The first round of Bellwether trials is scheduled to being in January of 2022. Additionally, claims have also been centralized in New Jersey State Court via a Multi-County Litigation (MCL) under the watch of State Superior Court Judge James. F. Hyland.


In December 2020 Judge Battle ruled that Merck & Co must turnover internal emails about potential label changes, stating that they were not shielded by the attorney-client privilege.


MDL Links:

  1. https://www.paed.uscourts.gov/documents2/mdl