Shingles (herpes zoster) is a disease characterized by a painful skin rash and is caused by a virus. About one in three adults in the United States develop shingles, but the rash usually goes away in a few weeks. Shingles is typically found in the elderly and studies have revealed that one out of every five people diagnosed with shingles suffer nerve pain that may last for years.
Zostavax Shingles Vaccine
The pharmaceutical giant, Merck, has developed Zostavax, a vaccine and is only approved for people age 50 and over. Zostavax, FDA approved in 2006, is the only live virus shingle vaccine currently available, according to the National Vaccine Information Center (NVIC).
The vaccine contains live varicella zoster virus, which is the chicken pox virus that also causes shingles. The virus remains dormant in the body after a person has had chicken pox. If the immune system becomes weakened, which happens usually later in life, the virus may reactivate to cause the shingles virus. Zostavax has a weakened form of the virus and is designed to stimulate the immune system in an effort to keep the virus dormant and prevent the outbreak of shingles, according to Merck.
Personal injury attorneys at Parker Waichman are actively reviewing potential lawsuits regarding pharmaceuticals, including Zostavax.
Zostavax Serious Side Effects and Lawsuits
A lawsuit was filed in February 2017 by a woman who developed headache, dizziness, and blurry vision within a 24-hour period of receiving the vaccine. The result was permanent vision loss.
“From contracting shingles as a result of the vaccine all the way to serious personal injuries such as blindness in one eye, individuals who have serious paralysis in their extremities, brain damage, all the way to death.” Lawyers say Merck has minimized the risk of side effects and death involving Zostavax, a drug that generated $749 million in 2016. The majority of lawsuits have been filed in Pennsylvania, with Judge Denis Cohen presiding over the state court litigation and Judge Harvey Bartle III overseeing Zostavax lawsuits in federal court.
Zostavax is not a routine childhood immunization, so people who are injured do not have to go through the Vaccine Injury Compensation Program (VICP) to seek compensation. Rather, they are allowed to file civil lawsuits against vaccine manufacturers under the normal laws associated with defective pharmaceutical medicines.
Zostavax has about 14-times more virus than the Varivax chicken pox vaccine given to children. The virus is weakened or “attenuated,” but it sometimes causes severe infections or shingles. This is particularly likely to occur if the virus is not weakened enough.
Complications from shingles may include scarring, skin infections, chronic pain, nerve damage, pneumonia, encephalitis, visual loss, hearing loss, paralysis, and even death.
Specific People Advised to Not Take the Shingles Vaccine
People who should not take the vaccine because they may be immune deficient include individuals with a history of leukemia, lymphoma, disorders affecting the bone marrow or lymphatic system, AIDS (acquired immunodeficiency syndrome), or those on immunosuppressive therapy.
Regarding the vaccine’s association to fatalities, NCIV analysis indicates that there were more than 1,100 serious adverse events reports made to the Vaccine Adverse Events Reporting System from 1990 until September 2015 associated with shingles-containing vaccinations. Of these reported events, 90 were for deaths linked to the shingles vaccine.
Potential Competition from GlaxoSmithKline
A Biologics License Application has been filed with the U.S. Food and Drug Administration (FDA) for a vaccine called Shingrix, that analysts have said may reel in more than $1 billion by 2021, according to a Thomson Reuters consensus.
GlaxoSmithKline (GSK) cited data from two Phase III trials, testing the vaccine in more than 37,00 people. The shot represents a “major” market disruptor, GSK vaccines head Moncef Slaoui previously told FiercePharma, if it is approved by the FDA.
Though the two vaccines have not yet been tested head-to-head, Zostavax posted lower efficacy numbers in its clinical trials, and its effectiveness wanes within the first five years in people 60 and over. In its own studies, Zostavax showed a 64 percent reduction of herpes zoster in people aged 60 to 69, a number that fell to 41 percent in the 70 to 79 age range and 18 percent for those 80 and older.