Zostavax's monopoly position is not guaranteed: the key phase III of GSK herpes zoster vaccine Hz / Su is a great success

Source: Biovalley, Dec 19, 2014: GSK herpes zoster vaccine Hz / Su achieved great success in key phase III Research (zoe-50) The vaccine is expected to increase the annual revenue of GSK's expanding vaccine unit by US $1 billion Meanwhile, Zostavax, a listed herpes zoster vaccine in MSD, will be launched Form a serious challenge Currently, Zostavax is the only shingles vaccine on the market The expected listing of Hz / Su also means that the monopoly position of MSD in the field of herpes zoster will not be guaranteed According to data released by GlaxoSmithKline, Hz / Su reduced the risk of herpes zoster infection by 97.2% in the critical phase III clinical group compared with placebo However, the efficacy data of Zostavax in the 50-59-year-old group is only 69.8%, which is lower in the 60-year-old group However, different clinical trial designs mean that a direct comparison of the two may be tricky Zostavax works differently from HA / Su Zostavax is a live attenuated virus vaccine, and Hz / Su combines herpes zoster virus gE protein with adjuvant system AS01B, which aims to enhance immune response GlaxoSmithKline has yet to disclose the listing schedule of Hz / Su A spokesman for the company said more clinical data would be collected in 2015 At present, GlaxoSmithKline is also carrying out additional research to assess the ability of Hz / Su to prevent herpes zoster in the elderly aged 70 and over and in the immunocompromised population The company also said it would release overall safety data for the phase III study in the coming months Zostavax of MSD, which was approved by FDA in 2006, is the only shingles vaccine on the market, with sales of $758 million in 2013, and will maintain a strong growth, because so far only a few elderly people have been vaccinated According to Thomson Reuters, the industry forecasts that Zostavax's sales will reach $1.1 billion in 2019 However, in view of the excellent efficacy data, UBS forecasts that the annual sales of GlaxoSmithKline vaccine Hz / Su will exceed US $1 billion Phase III project of Hz / Su: the clinical project of Hz / Su phase III involves more than 37000 people The efficacy, safety and immunogenicity of Hz / Su were evaluated In addition to the elderly population, GlaxoSmithKline is currently investigating HA/su in immunocompromised groups, including solid tumors and hematological malignancies, hematopoietic stem cells, kidney transplant recipients and HIV infected patients Zoe-50 is a randomized, double-blind, placebo-controlled, multicenter, multinational phase III study involving 1616000 subjects aged 50 years and over The herpes zoster vaccine Hz / Su was inoculated according to the two-point immunization procedure (0 and 2 months) The primary end point was the overall vaccine efficacy (VE) of Hz / Su to reduce the risk of herpes zoster infection across all age groups In this study, the age groups were divided into 50-59, 60-69, 70-79, and over 80 About herpes zoster: shingles is an acute infectious skin disease caused by varicella zoster virus (VZV), typically a rash Because the virus is neurophilic, it can lurk in the neurons of the dorsal root ganglia of the spinal cord for a long time after infection When the resistance is low or tired, infected or cold, the virus can grow and reproduce again, and move to the skin along the nerve fibers, causing strong inflammation of the involved nerves and skin The rash is generally unilateral and distributed according to the ganglion segment It is composed of clustered herpes with pain The older the rash is, the more severe the neuralgia is The incidence of this disease is high in adults The incidence rate increases significantly with age Complications include scarring, visual complications, secondary infection, nerve paralysis and postherpetic neuralgia (PHN) Data from many countries show that more than 90% of adults are at risk of herpes zoster, and the risk of herpes zoster infection is significantly higher in people over 50 years old.