Shingles Vaccine Shingrix Gets FDA Panel Backing


An expert advisory board voted 11-0 in confidence of the vaccine's safety and efficacy trial data Wednesday.

A US Food and Drug Administration (FDA) expert advisory panel voted unanimously Wednesday to back the safety and efficacy trial data of herpes zoster (shingles) vaccine HZ/su (Shingrix) for older patients.

The advisory panel's 11-0 vote of support for GlaxoSmithKline's (GSK) Shingrix comes over a month before the treatment's October 24 FDA biologics license application (BLA) decision date. The vaccine's potential for approval jumps with the panel's backing — and could address a major gap in treatment.

Simon Murray, MD, Clinical Assistant Professor of Medicine at Rutgers Medical School, told MD Magazine that about 50% of patients to receive the current form of shingles vaccine (Zostavax) still inherit the rash.

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

Shingrix is a non-live, recombinant vaccine for patients aged 50 years and older. It is an intramuscular injection of 2 doses, the second coming 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 rate efficacy in patients.

However, panelists also considered the vaccine's risks. A majority of patients in the trial given Shingrix experienced local or general short-duration reactogenicity, according to the FDA.

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

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 series of 2 shots, not just one, but the current shingles vaccine we have now is not adequate," Murray said.

Shingrix supplementally reduced neuropathy associated with shingles, Murray said. He predicted, prior to the advisory panel's vote of confidence, that the vaccination would well-received. However, Murray wondered whether patients to 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," Murray said. "I think it will definitely be approved."

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