LONDON and PHILADELPHIA, July 26,
2021 /PRNewswire/ -- GlaxoSmithKline plc today announced
that the US Food and Drug Administration (FDA) has approved
Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the
prevention of shingles (herpes zoster) in adults aged 18 years and
older who are or who will be at increased risk of shingles due to
immunodeficiency or immunosuppression caused by known disease or
therapy. Immunocompromised individuals are at greater risk of
shingles and associated complications than immunocompetent
individuals.
Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine,
given intramuscularly in two doses, was initially approved by FDA
in 2017 for the prevention of shingles in adults 50 years of age or
older. Shingrix is not indicated for prevention of primary
varicella infection (chickenpox). The approval for this new
population expands the number of people who can be protected
against shingles by Shingrix.
"We're proud to offer Shingrix in the US for the prevention of
shingles in those who are immunocompromised, with FDA granting a
broad indication for use in adults at increased risk of this
disease," said Thomas Breuer, Chief
Medical Officer, GSK Vaccines. "Older age and being
immunocompromised are the most common risk factors for shingles
disease. GSK is committed to this important patient population at
increased risk for shingles disease and its complications by
bringing them a vaccine option that can help prevent this painful
condition."
The GSK Clinical Development Program evaluated the benefit-risk
profile of Shingrix in heterogeneous immunocompromised patient
populations.
This approval for a new population was based on clinical studies
examining the safety and efficacy of Shingrix in adults (≥18 years
of age) who had undergone an autologous hematopoietic stem cell
transplant (auHSCT) and those undergoing treatment for
hematological malignancies (post-hoc analysis). Further safety and
immunogenicity data were generated in adults who were, or were
anticipated to be, immunodeficient or immunosuppressed due to known
disease or therapy, including patients with HIV, solid tumors, and
renal transplants.1,2,3,4,5,6
"In addition to this new patient population, there are more than
100 million adults 50 years and older in the US already recommended
to receive Shingrix," said Breuer. "We know many of these
individuals missed recommended vaccines during the pandemic and we
hope this can be a reminder to them to catch up on all their
immunizations, including Shingrix."
According to recently published report from Avalere Health
and supported by GSK, more than 17 million doses of recommended
vaccines, including Shingrix, were missed by adults during the
pandemic.
Shingrix is the first shingles vaccine indicated for use in
those who are at increased risk of the disease due to being
immunodeficient or immunosuppressed due to disease or therapy. It
combines a non-live antigen, to trigger a targeted immune response,
with a specifically designed adjuvant system to generate a
Varicella Zoster Virus (VZV)-specific immune response. For
immunocompetent adults, Shingrix is intended to be administered in
two doses, 2 to 6 months apart.
However, for adults who are or will be immunodeficient or
immunosuppressed due to known disease or therapy and who would
benefit from a shorter vaccination schedule, the second dose can be
administered 1 to 2 months after the first dose.
The US Centers for Disease Control and Prevention's Advisory
Committee on Immunization Practices (ACIP) has begun discussions to
consider recommendations for use of Shingrix in immunocompromised
adults.
Shingrix was previously approved by the European Commission (EC)
for prevention of shingles and post-herpetic neuralgia (PHN) in
adults 18 years of age or older at increased risk of shingles and
granted marketing authorization on August
25, 2020.
About Shingles
Shingles is caused by the reactivation
of the varicella zoster virus (VZV), the same virus that causes
chickenpox.7 Nearly all older adults have the VZV
dormant in their nervous system, waiting to reactivate with
advancing age.8 As people age, the cells in the
immune system lose the ability to maintain a strong and effective
response to VZV reactivation.7,9
Shingles typically presents as a painful, itchy rash that
develops on one side of the body and can last for two to four
weeks.9,10 The pain associated with shingles is
often described as burning, shooting or stabbing. Even once
the rash is gone, a person can experience postherpetic neuralgia
(PHN), pain lasting from at least three months up to several
years.7 PHN is the most common complication of
shingles, occurring in 10 to 18 percent of all shingles
cases.7,11
There are an estimated 1 million cases of shingles in the US
each year.7 More than 99 percent of those
over 50 years old are infected with VZV, and one in three Americans
will develop shingles in their lifetime. The risk increases to one
in two for adults aged 85 years and older.
About Shingrix
Shingrix is a non-live, recombinant
subunit vaccine approved in the US, Canada, EU, UK, China, Japan,
Hong Kong, Australia, New
Zealand, and Singapore to
help prevent shingles (herpes zoster) in people aged 50 years or
older. It combines an antigen, glycoprotein E, and an adjuvant
system, AS01B, intended to generate a Varicella Zoster
Virus (VZV)-specific immune response immune response that can help
overcome the decline in immunity as people age.
Shingrix was previously approved by the European Commission (EC)
and in the UK for prevention of shingles and post-herpetic
neuralgia (PHN) in adults 18 years of age or older at increased
risk of shingles and granted marketing authorization on
August 25, 2020.
The updated US Prescribing Information will be available soon at
www.gskpro.com.
Important Safety Information for Shingrix
The
following is based on the US Prescribing Information for Shingrix.
Please consult the full Prescribing information for all the labeled
safety information.
- Shingrix is contraindicated in anyone with a history of a
severe allergic reaction (e.g., anaphylaxis) to any component of
the vaccine or after a previous dose of Shingrix.
- Review immunization history for possible vaccine sensitivity
and previous vaccination-related adverse reactions. Appropriate
medical treatment and supervision must be available to manage
possible anaphylactic reactions following administration of
Shingrix.
- In a postmarketing observational study, an increased risk of
Guillain-Barré syndrome was observed during the 42 days following
vaccination with Shingrix.
- Syncope (fainting) can be associated with the administration of
vaccines, including Shingrix. Procedures should be in place to
avoid falling injury and to restore cerebral perfusion following
syncope.
- In individuals aged 50 years and older: Solicited local adverse
reactions were pain, redness, and swelling. Solicited general
adverse reactions were myalgia, fatigue, headache, shivering,
fever, and gastrointestinal symptoms.
- In autologous hematopoietic stem cell transplant recipients
(aged 18 to 49 and >50 years of age): Solicited local adverse
reactions were pain, redness, and swelling. Solicited general
adverse reactions were fatigue, myalgia, headache, gastrointestinal
symptoms, shivering, and fever.
- The data are insufficient to establish if there is
vaccine-associated risk with Shingrix in pregnant women.
- It is not known whether Shingrix is excreted in human milk.
Data are not available to assess the effects of Shingrix on the
breastfed infant or on milk production/excretion.
- Vaccination with Shingrix may not result in protection of all
vaccine recipients.
About GSK
GSK is a science-led global healthcare
company with a special purpose: to help people do more, feel
better, live longer. For further information please visit
www.gsk.com/about-us.
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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 2020 and any impacts of
the COVID-19 pandemic.
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1 Bastidas A, et al. JAMA 2019;132:123–133.
2 Berkowitz EM, et al. J Infect Dis
2015;211:1279–1287.
3 Vink P, et al. Cancer 2019;125:1301–1312.
4 Dagnew AF, et al. Lancet Infect Dis
2019;19:988–1000.
5 Vink P, et al. Clin Infect Dis 2019. doi:
10.1093/cid/ciz177.
6 Stadtmauer E, et al. Blood.
2014;124(19):2921-2929.
7 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.
8 Gnann et al. Clinical practice. Herpes zoster. N
Eng J Med. 2002;347(5):340-6.
9 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.
10 Lal H et al. Efficacy of an Adjuvanted Herpes
Zoster Subunit Vaccine in Older Adults. N Engl J Med.
2015;372:2087-96.
11 Yawn et al. Health care utilization and cost
burden of herpes zoster in a community population. Mayo Clin Proc. 2009;84(9):787-94.
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SOURCE GlaxoSmithKline plc