RNS Number : 3750Q
28 June 2022
Issued: 28 June 2022, London UK
Japan's Ministry of Health, Labour and Welfare accepts Shingrix
regulatory submission to prevent shingles in at-risk adults aged 18
years and older
-- Regulatory submission aims to expand the number of people who
can be protected against shingles, including those with
immunodeficiency or immunosuppression
-- Shingrix is already approved in Japan for adults aged 50 years and above
GSK plc (LSE/NYSE: GSK) today announced the submission of a
regulatory application to the Japanese Ministry of Health, Labour
and Welfare (MHLW) for Shingrix (Zoster Vaccine Recombinant,
Adjuvanted) for the prevention of shingles (herpes zoster) in
adults aged 18 years and older who are at increased risk. This
includes individuals with immunodeficiency or immunosuppression
caused by known disease or therapy. Immunocompromised individuals
are at greater risk of shingles and associated complications than
immunocompetent individuals. [i]
Shingrix , a non-live, recombinant sub-unit adjuvanted vaccine
given intramuscularly in two doses, was initially approved in 2018
by the Japanese MHLW to prevent shingles in adults aged 50 years or
The MHLW regulatory submission is based on six clinical trials
in patients aged 18 years and older who had undergone recent
blood-forming cells (stem cell) transplantation, kidney transplant,
or have blood cancer, solid tumour or HIV. [ii](, [iii] , [iv] ,
[v] , [vi] , [vii])
In Japan, adults aged 18 years and older who are
immunocompromised or have chronic medical conditions have a higher
incidence of shingles, including a higher risk of developing
associated complications such as post-herpetic neuralgia (PHN), a
severe intermittent or continuous long-term nerve pain that occurs
in areas of skin previously affected by shingles. In a
retrospective cohort study using data from Japanese adults aged 18
years and older, the risk of shingles was higher in women,
irrespective of age and increased with age. [viii]
Shingles, also known as herpes zoster, is caused by a
reactivation of the varicella-zoster virus (VZV) - the same virus
that causes chickenpox - which lays dormant in the body after the
initial infection. Natural age-related decline of the immune system
can allow VZV to resurface, causing shingles. People with a
suppressed or compromised immune system are also at increased risk
of developing shingles. (i) Globally, over 90% of adults aged 50
years and older are infected with VZV and are at risk of developing
shingles. [ix] Approximately 600,000 new cases of shingles are
reported in Japan each year. [x]
Shingrix is a non-live, recombinant sub-unit vaccine approved by
the Japanese MHLW on 23 March 2018 to prevent shingles in adults 50
years and older.
It combines an antigen, glycoprotein E, and an adjuvant system,
AS01B, to generate a VZV-specific immune response that can help
overcome the decline in VZV immunity as people age. The recombinant
shingles vaccine is not indicated to prevent primary varicella
In adults 50 years and older, the vaccine is intended to be
administered in two doses, two to six months apart. However, for
adults 18 years and older who are immunodeficient, immunosuppressed
or likely to become immunosuppressed due to known disease or
therapy and who would benefit from a shorter vaccination schedule,
the second dose can be administered one to two months after the
first dose in countries where the indication for this population
has been approved.
The European Commission and the United Kingdom approved Shingrix
on 25 August 2020 to prevent shingles and PHN in adults aged 18 or
older at increased risk of shingles. On 26 July 2021, the US Food
and Drug Administration approved the vaccine to prevent shingles in
adults aged 18 years or older at increased risk of shingles due to
immunodeficiency or immunosuppression caused by known disease or
therapy. The extended indication for preventing shingles and PHN in
adults aged 18 years or older at increased risk of developing
shingles has also recently been approved in Australia.
Shingrix is also recommended in the US by the US Centers for
Disease Control and Prevention's Advisory Committee on Immunization
Practices as the preferred vaccine for the prevention of shingles
and related complications for immunocompetent adults aged 50 years
and older. [xi]
GSK is a science-led global healthcare company. For further
information, please visit www.gsk.com/about-us .
Media enquiries: Tim Foley +44 (0) 20 8047 (London)
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Jeff McLaughlin +1 215 751 7002 (Philadelphia)
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 in the Company's
Annual Report on Form 20-F for 2021, GSK's Q1 Results for 2022 and
any impacts of the COVID-19 pandemic.
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[i] Mueller, NH et al. Varicella Zoster Virus Infection:
Clinical Features, Molecular Pathogenesis of Disease and Latency.
Neurologic Clinics, 2008; 26;675-697.
[ii] Bastidas A, et al. JAMA 2019;132:123-133.
[iii] Berkowitz EM, et al. J Infect Dis 2015;211:1279-1287.
[iv] Vink P, et al. Cancer 2019;125:1301-1312.
[v] Dagnew AF, et al. Lancet Infect Dis 2019;19:988-1000.
[vi] Vink P, et al. Cancer 2019;125:1301-1312.
[vii] Stadtmauer E, et al. Blood. 2014;124(19):2921-2929
[viii] Imafuku S et al. Risk of herpes zoster in the Japanese
immunocompromising and chronic disease conditions: Results from
a claims database cohort study, from 2005 to 2014. Journal of
Dermatology. 2020. ; 47: 236-244.
[ix] Bricout H et al. "Herpes zoster-associated mortality in
Europe: a systematic review." BMC Public Health 15:466 (2015).
Available at: https://doi.org/10.1186/s12889-015-1753-y Last
accessed: June 2022.
[x] Gnann et al. Clinical practice. Herpes zoster. N Eng J Med.
[xi] Dooling KL et al. Recommendations of the Advisory Committee
on Immunization Practices for Use of Herpes Zoster Vaccines. CDC.
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June 28, 2022 02:00 ET (06:00 GMT)
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