GSK announces approval of Shingrix in China for prevention of shingles in adults aged 50 and over
Issued: London, UK
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.
Important Safety Information for Shingrix
- You should not receive Shingrix if you are allergic to any of its ingredients or had an allergic reaction to a previous dose of Shingrix.
- The most common side effects are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.
- Vaccination with Shingrix may not protect all individuals.
- Ask your healthcare professional about the risks and benefits of Shingrix. Only a healthcare professional can decide if Shingrix is right for you.
Shingrix is not indicated for the prevention of chickenpox.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com/about-us/.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.
[i] Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008 Jun;57(RR-5):1-30
[iii] Chen LK, et al. 2017, Looking back to move forward: a twenty-year audit of herpes zoster in Asia-Pacific. BMC Infect Dis. 2017 Mar 15;17(1):213.
[iv] Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med. 2015;372:2087-96.
[v] Cunningham et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375:1019-32.
[vi] GlaxoSmithKline. Data on File. 2017.
[vii] Lal H, et al., 2015.
[viii] Harpaz et al. 2008
[ix] Harpaz et al. 2008; Johnson RW et al. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Therapeutic Advances in Vaccines. 2015;3(4):109-120.
[x] Harpaz et al. 2008; Robert W Johnson & Tessa L Whitton (2005) Management of herpes zoster (shingles) and postherpetic neuralgia, Expert Opinion on Pharmacotherapy, 5:3, 551-559.
[xi] Kawei K et al., BMJ Open 2014;4(6):e004833
[xii] Harpaz et al. 2008; Brissson et al. Epidemiology of varicella zoster virus infection in Canada and the United Kingdom. Epidemiol. Infect. (2001), 127, 305±314.
[xiii]i The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.
[xiv] Lal H, et al., 2015.; Garçon N, et al. Understanding modern vaccines. 2011.