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FDA Expert Advisory Panel Backs New Shingles Vaccine

SEP 13, 2017 | KEVIN KUNZMANN
Today, in a unanimous vote, a US Food and Drug Administration (FDA) expert advisory panel voted unanimously to back safety and efficacy trial data of Shingrix, a new herpes zoster (shingles) vaccine for older patients.

The advisory panel's 11-0 vote to support for this vaccine, developed by GlaxoSmithKline, comes over a month before the treatment's October 24, 2017 FDA (biologics license application) decision date.

The Centers for Disease Control and Prevention reports that in the United States, about one in every three individuals will develop shingles within their lifetime; in fact, it is estimated that 1 million cases of shingles occur annually in this country. The risk of devleoping shingles increases with age, but anyone who has recovered from chicken pox in the past could potentially develop the rash. Before the rash develops, individuals usually experience pain, itching, or tingling in the area where the rash will soon develop; the rash usually develops on one side of the face or body.

The vaccine's potential for approval jumps with the panel's backing, and has the potential to address a major gap in treatment.

Simon Murray, MD, an internist associated with the University Medical Center of Princeton, shared that about 50% of patients that receive the current shingles vaccine (Zostavax) still inherit the painful rash.

"Granted, they’re tenuated cases of shingles, but 50% of people who get that vaccine fail," Dr. Murray said. "And shingles is a big problem."

Shingrix is a non-live, recombinant vaccine for patients 50 years of age or over; it is an intramuscular injection of 2 doses, the second to be received in the second month of treatment. GSK's FDA application includes the results of 2 randomized, placebo-controlled clinical trials that showed a 97.16% and 89.79% vaccination efficacy rate in patients.

Panelists also took into account the vaccine's risks. A majority of patients in the trial who were given Shingrix experienced local or general short-duration reactogenicity, the FDA reported.

However, the rate of severe adverse effects, deaths, and immune mediated diseases in the studies were proportional between treatment and placebo groups.

Dr. Murray noted that immunity was maintained by older patients over a longer period of time with Shingrix, and that the drug is "well-tolerated, with few side effects."

"It is a killed vaccine, not a live vaccine, mixed with some immune stimulants that makes it more immunogenic," Dr. Murray said. "It is a series of 2 shots, not just one, but the current shingles vaccine we have now is not adequate."

Shingrix supplementally reduced neuropathy associated with shingles, Dr. Murray said. He predicted, prior to the advisory panel's vote of confidence, that the vaccination was well-received. However, Dr. Murray wondered whether patients who have taken Zostavax would need to be re-vaccinated with Shingrix, if it is approved next month.

"I don’t know how that’s going to play out," Dr. Murray admitted. "I think it will definitely be approved."
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