July 6, 2012

Getting Shingles from a Shingles Vaccine: What’s the Risk?

(Ivanhoe Newswire) — Shingles is a painful skin rash caused by inflammation of the skin, usually after someone has had chickenpox. Shingles is more detrimental to the elderly, and can lead to further complications.

Although some have suggested that patients receiving medication for immune-mediated diseases such as rheumatoid arthritis or psoriasis may be at increased risk of herpes zoster (HZ; shingles) shortly after receipt of the vaccine, an analysis that included nearly 20,000 vaccinated Medicare beneficiaries finds that the live zoster vaccine is not associated with an increased risk of HZ shortly after vaccination in patients currently treated with biologics, and that it is associated with a significantly reduced longer-term risk of HZ in patients with an immune-mediated disease.

Jie Zhang, Ph.D., of the University of Alabama at Birmingham, and colleagues, evaluated patients with immune-mediated diseases. The retrospective cohort study included 463,541 Medicare beneficiaries 60 years and older with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis (a form of chronic inflammation of the spine), or inflammatory bowel disease using Medicare claims data from January 2006 through December 2009. The researchers measured the incidence rate of herpes zoster within 42 days after vaccination (a safety concern) and beyond 42 days.

Dr. Jeffrey R. Curtis of the University of Alabama, Birmingham, who worked with the study said, “There is almost no clinical data suggesting that it is a safety problem, and what the theoretical concern is if you are giving a live weakened virus vaccine, that if someone is immune compromised, because they are on one of these biologic drugs, that they could actually get the disease that the vaccine is trying to prevent, that´s the theoretical risk.”
The researchers found that among 633 patients exposed to biologics, including 551 patients exposed to anti-tumor necrosis factor (TNF) biologics, no cases of varicella or HZ occurred within the 42 days following vaccination. Among all patients, only 1 case of primary varicella was identified within the 42-day risk window, occurring on day 10 after vaccination.

“It is only about 600 people that we can take home these points, so I don´t believe the strength of this data allows us to recommend that we overturn the counter indication to do this, but I think it´s the first data available at least for reasonably sizeable numbers of individuals to suggest maybe this isn´t such a bad idea,” said Dr. Curtis.

"Despite the recognition that patients with immune-mediated conditions are at increased risk of HZ, this and previous studies have shown that only a small fraction of these patients received the vaccine, likely in part due to safety concerns. Our data call into question the current recommendations that HZ vaccine is contraindicated in patients receiving biologics and suggest a need for a randomized controlled trial to specifically address the safety and effectiveness of HZ vaccination among patients receiving biologics," the authors conclude.

Dr. Curtis added, “The American College of Rheumatology funded our research group to plan a randomized double placebo controlled trial to test the safety of this approach, we have now submitted to get the full trial submitted of 4,000 people.”

SOURCES: JAMA, July 2012 and Archives Journals