Can the Shingles vaccine cause injury and/or death?

Can the Shingles vaccine cause injury and/or death?

Can the Shingles vaccine cause injury and/or death?

The following article tries to shed light on the vast world of adverse reactions, with a specific look at the one against Herpes Zoster, but we urge you to read all the focuses listed below to understand the other related issues, such as the problem of multiple vaccines, hypersensitivity to one or more compounds of the vaccine, the SIDS problem and that of adjuvants.

According to the Shingrix vaccine package insert, adverse events reported during the clinical trial included pain, swelling and redness at the injection site, headache, fever, fatigue, chills, gastrointestinal problems, gout and ischemic optic neuropathy.(1) GlaxoSmithKline has committed to conducting multiple postmarketing studies for the SHINGRIX vaccine, which it licensed in 2017. According to data presented by the U.S. Centers for Disease Control and Prevention (CDC) at its June Advisory Committee on Immunization Practices (ACIP) meeting 2018. Most reports concerned women and were not serious events; the most common reaction was pain at the injection site.(2)

At the February 2019 ACIP meeting, Dr. Tom Shimabukuro of the CDC's Immunization Safety Office (ISO) reported a potential safety signal with the SHINGRIX vaccine. An association between Guillain Barré syndrome (GBS) and the vaccine was found in the Vaccine Safety Datalink (VSD) and Vaccine Adverse Events Reporting System (VAERS). GBS is a rare neurological disease that causes inflammation of the peripheral nerves. Complications can include temporary or chronic paralysis, including complete paralysis of the body.(3)

The CDC, FDA, and the Centers for Medicare and Medicaid Services (CMS) conducted a review of data from the Medicare claims database. According to the FDA:(4) “The risk of GBS following Shingrix vaccination was assessed in analyzes of self-controlled case series using a risk window of 1 to 42 days post vaccination and a control window of 43 to 183 days post vaccination. The The primary analysis found an increased risk of GBS in the 42 days following vaccination with Shingrix, with an estimated 3 GBS excess cases per million doses given to adults 65 years of age and older. An increased risk of GBS was observed in the 42 days following the first dose of Shingrix, with an estimated 6 GBS excess cases per million doses given to adults 65 years of age and older, while no increased risk of GBS after second dose of Shingrix.These analyzes of GBS diagnoses in claims data were supported by analyzes of GBS cases confirmed by medical record review."

The FDA has established an association between Shingrix and GBS, but said current data is not available to establish a causal relationship. However, concluded that a review of the section "Warnings and Precautions" of the SHINGRIX package leaflet on the risk of GBS was justified.(5)

Additional adverse events reported after Shingrix vaccine was approved included allergic reactions, angioedema, hives and rash, and decreased mobility in the vaccine arm.(6)

Adverse events reported in clinical trials or post-marketing with Zostavax vaccine include pain, swelling and redness at the injection site, headache, zoster-like skin rash, fever, shock, joint and muscle pain, swollen glands, and respiratory symptoms. .(7) Optic neuritis following administration of the Zostavax vaccine was also reported in a published case study.(8)

The Zostavax package insert states that "Vaccine virus transmission can occur between vaccinees and susceptible contacts,"(9) that is, the vaccinated individual is infectious with chickenpox of the vaccine strain and can infect others with chickenpox if they have not previously had chickenpox.

Merck, the maker of Zostavax, is currently defending 60 lawsuits alleging the vaccine has caused serious side effects, including death. The outcome of these proceedings is pending.(10) Sales of Zostavax in the United States were discontinued in November 2020.(11)

Merck, the maker of Zostavax, is currently suing and defending against lawsuits alleging that the vaccine caused serious side effects, including death.(12) In December 2022, a Pennsylvania federal judge dismissed nearly 1.200 claims alleging shingles after the Zostavax vaccine. The claims were reportedly denied by the judge due to a lack of evidence that the shingles rash was related to the vaccine. Other lawsuits over autoimmune disorders and hearing loss are pending.(13)

This article is summarized and translated by National Vaccine Information Center.

 

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