GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the National Medical Products Administration (NMPA) has approved Shingrix for the prevention of shingles (herpes zoster) in adults aged 50 years or older.
Shingrix is a recombinant subunit adjuvanted vaccine given intramuscularly in two doses.
The approval is in response to last year's inclusion of Shingrix on a list of 48 'clinically urgently needed new medicines' in China designated for expedited review, reflecting the country's prioritization of critical new prevention and treatment options.
Shingles is caused by reactivation of the varicella zoster virus, the same virus that causes chickenpox. Nearly all adults over 50 have the shingles virus dormant in their nervous system, waiting to reactivate with advancing age[i]. Shingles affects nearly three million adults in China annually[ii].
Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: 'Today's approval of Shingrix in China is recognition of the significant scientific advance this vaccine represents. In the pivotal studies the vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a disease that affects one in three people across the Asia-Pacific region[iii]. It can result in lasting pain and other complications which can severely impact the quality of people's lives.'
'We welcome the Chinese government's progress to enable faster entry of new products into China and we look forward to working with the relevant agencies to bring the benefits of this vaccine to local communities,' he said.
Introduction of the vaccine into China will be phased, starting in 2020, to ensure consistent and reliable supply of the vaccine to all countries in which the vaccine has been launched. Over the next several years, GSK expects to increase supply of Shingrix globally and is investing in significant capacity expansion.
Shingrix is currently licensed for use in the EU, US, Canada, Japan and Australia.
Approval of Shingrix follows a comprehensive Phase III clinical trial program evaluating its efficacy, safety and immunogenicity in more than 38,000 people. In a pooled analysis of the pivotal efficacy studies, ZOE-50 and ZOE-70, Shingrix demonstrated efficacy against shingles greater than 90% across all age groups studied, as well as sustained efficacy over a follow-up period of 4 years[iv,v]. The most common local side effects reported in the clinical trials were pain, redness and swelling at the injection site. The majority were mild to moderate in intensity and transient, generally lasting less than three days [vi,vii].
Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox. Nearly all older adults have the VZV dormant in their nervous system, and it could reactivate with advancing age[viii]. As people age, the cells in the immune system lose the ability to maintain a strong and effective response to VZV reactivation[ix].
Shingles typically presents as a painful, itchy rash that develops on one side of the body and can last for two to four weeks. The pain associated with shingles is often described as burning, shooting or stabbing[x]. Even once the rash is gone, a person can experience post-herpetic neuralgia (PHN), pain lasting from at least three months up to several years. PHN is the most common complication of shingles, occurring in up to 30 percent of all shingles cases[xi].
Older adults and those with conditions that compromise the immune system have the greatest risk for developing shingles. More than 99 percent of those over 50 years old are infected with VZV and, it is estimated that around one in three people will develop shingles in their lifetime[xii].
Shingrix [Herpes Zoster vaccine (recombinant, AS01B[xiii]i adjuvanted)] is a non-live, recombinant subunit vaccine to help prevent shingles (herpes zoster) in adults 50 years of age and older. The 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 that occurs as people age[xiv].
Shingrix is to be given intramuscularly in two doses.
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