FDA Panel Backs New Zoster Subunit Vaccine Save
GlaxoSmithKline has announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously in support of the efficacy, safety and approval of its herpes zoster subunit (HZ/su) vaccine (called Shingrix) for the prevention of herpes zoster (shingles) in adults ages 50 and over.
This would be the first worldwide approval of HZ/su, should the FDA follow the advisory committees recommendation.
The candidate vaccine is a non-live, recombinant subunit vaccine to help prevent herpes zoster (shingles) and its complications, such as postherpetic neuralgia, in adults 50 years of age and older. The candidate vaccine combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age.
The advantage of this agent is that it is a nonlive virus vaccine, that has >90% protection against HZ infection and post-herpetic neuralgia and that efficay does not wane with increasing recipient age.
The name “Shingrix” has not yet been approved for use by any regulatory authority.
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