What Is Zostavax?
Zostavax is a shingles vaccine. It was intended for use in adults who are 60 years old or older. It was a one-shot vaccine and could be given at a doctor’s office or pharmacy. Zostavax was only effective at producing shingles immunity for about half of the people who received it and provided protection against shingles for about 5 years.
What Is Shingles?
Shingles is an outbreak of painful blisters which usually occurs in a band on one side of the torso, head, neck, or other areas of the body. It most commonly affects older people who have previously been exposed to chickenpox.
Shingles is caused by the same virus that causes chickenpox, the herpes zoster virus which is also called varicella zoster. It occurs when the chickenpox virus goes dormant to hide in the nervous system and is reactivated at a later time.
The Zostavax shingles vaccine is a live, attenuated virus that is a weakened form of the Herpes zoster virus. Receiving this vaccine should induce the body to create antibodies against shingles. This is different from other types of vaccines which use portions of viruses or non-viable, killed organisms to produce an immune response.
Zostavax was manufactured by Merck. Merck is one of the biggest pharmaceutical companies involved in the vaccine industry in the U.S. and the world.
Is Zostavax FDA-Approved?
Zostavax received FDA approval in 2006. As of November 18, 2020, Zostavax is no longer available for use in the United States. Zostavax was discontinued because Shingrix, another shingles vaccine, seems to prevent more instances of shingles. Shingrix is now the only shingles vaccine to have FDA approval.
What Are the Side Effects of Zostavax?
Like all vaccinations, Zostavax had the potential to cause side effects in some people. Most side effects were mild to moderate and would go away on their own over time. The Zostavax vaccine was intended to protect people from shingles but may have caused some who took the vaccine to get the virus or to experience serious or life-threatening complications. Because Zostavax uses a live virus, rather than becoming immune, some patients contracted shingles from the virus intended to protect them. Some of these patients may have developed other complications as well.
Zostavax may cause a number of side effects that are common to many types of vaccinations. In other cases, reactions may be more severe including those who contract the illness because their immune systems are weakened and cannot fight the live, attenuated virus.
Common side effects of the vaccine include:
- Pain at the injection site
- Mild fever
- Muscle pain
- Joint pain
Some people who get the vaccine may have side effects that are more severe or even life-threatening.
Serious side effects may include:
- Shingles illness
- Chickenpox infection
- Rash or hives
- Necrotizing retinitis or other eye disorder
- Blindness or vision loss
- Hearing loss
- Brain damage
- Spinal cord damage
- Liver failure
- Herpetic or postherpetic neuralgia
- An autoimmune disorder such as Gillian-Barre Syndrome
- Cardiovascular event
The company has faced lawsuits for issues relating to their vaccines in addition to the injury lawsuits they face for Zostavax.
A 1986 National Childhood Vaccine Injury Act protects pharmaceutical companies against lawsuits for vaccine injuries. The act requires that injury claims for childhood vaccines be filed with the U.S. government and not through the court system. A National Vaccine Injury Compensation Program was established to provide compensation to injured patients. It has paid out over $3 billion for a number of vaccine injuries caused by childhood immunizations.
Merck is facing at least 50 Zostavax lawsuits and more may be expected.
Merck is facing lawsuits related to its MMR Vaccine. Two former Merck scientists have claimed that the company manipulated clinical test results to ensure that their MMR vaccine would not face commercial competition. Those scientists said that mumps outbreaks show that the vaccine has fallen below the 95% efficacy rate required to maintain its market standing and that the vaccines are no longer as effective.
Merck is also facing lawsuits for its Gardasil vaccine. 49 patients experienced complications or injury after receiving Merck’s HPV vaccine, Gardasil. The claims included episodes of Gillian-Barre Syndrome (GBS), blindness, seizures, and other complications including death.
Merck has been accused of failing to inform the public about the possibility of shingles infections until it was added to the prescribing information in December 2014. The vaccine had been on the market since 2006, but the warning was not initially listed. Zostavax lawsuits have claimed that the omission was intended to conceal the risks of the vaccine.
Because Zostavax is intended for patients over the age of 50, Zostavax is not listed under the childhood vaccine act. Merck is not protected against Zostavax lawsuits and is responsible for any wrongdoing or negligence that may have contributed to the injury.
Multiple Zostavax lawsuits have already been filed in federal, state, and local courts. Federal lawsuits were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania in August 2018, but other lawsuits may be pending in local courts as well.
Zostavax lawsuits have claimed that the vaccine is dangerous and can cause serious complications or may lead to death. The lawsuits also claim that Merck purposefully and intentionally hid the information about the risks of the vaccine and failed to inform the public or medical profession about the potential for complications.
Because the Zostavax lawsuits are still rather recent, it is difficult to know what the cases may settle for. Compensation in past medical injury lawsuits has included payment for medical costs, lost wages, pain and suffering, or wrongful death when the patient has died.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.