Australia’s Therapeutic Goods Administration (TGA) released a safety advisory on Monday stating that people with immunodeficiency should not use Zostavax.
The advisory states that people with compromised immune function shouldn’t use Zostavax, a shingles vaccine, because of an association with a risk of mild to serious complications, including death, from being infected by the virus used to make the vaccine.
The advisory mentions a new case of this happening in a patient who was taking low doses of an immunosuppressive medicine. The patient died three weeks after receiving the vaccine.
The TGA had an expert panel review Zostavax’s role in the death. The panel found the vaccine was “administered consistent with existing recommendations” and the findings were “consistent with a causal association between Zostavax and fatal (vaccine-related) varicella-zoster virus infection,” according to the advisory.
Zostavax is contraindicated in patients with immunodeficiency in Australia. The low doses of immunosuppressive medicine the patient was taking were not large enough to make the patient ineligible for Zostavax, though.
Zostavax contains a live, attenuated varicella-zoster virus.
“This case draws attention to the potential for the rare event of disseminated vaccine-related varicella-zoster virus infection in patients on low doses of immunosuppressive medication, occurring typically 2 to 4 weeks after Zostavax vaccination,” the advisory states. “Disseminated varicella-zoster virus infection is potentially life-threatening and suspicion should prompt appropriate diagnostic testing, initiation of empirical aciclovir treatment while awaiting test results and, where possible, cessation of immunosuppression.”
The advisory states that people who receive Zostavax should seek immediate medical attention if they:
• Get a chickenpox-like rash two to four weeks after receiving Zostavax
• Feel sick
• Have a fever
An advisory panel for the United States’ Centers for Disease Control and Prevention (CDC) recommended in 2017 that Shingrix should be preferentially used over Zostavax. Shingrix has been shown in clinical trials to be about 98% effective in year one and 85% effective over three years. Zostavax has been shown to reduce shingles by 51%. Shingrix has been shown by studies to be 91% effective against post-herpetic neuralgia, which Zostavax has been shown to be 67% effective against.
Serious side effects have been reported in users of Zostavax, including hearing loss, vision loss, shingles (which the vaccine is intended to prevent), acute retinal necrosis, seizures, limb paralysis, brain damage, fatal liver failure and death.