Issued: 17 April 2024, London
UK
New
long-term data show Shingrix continues to provide high
protection against shingles in adults aged 50 and over for more
than a decade
· End-of-trial data show 79.7% efficacy in participants aged 50
years and over, six to 11 years after
vaccination1
· Vaccine efficacy remains high at 82.0% at year 11 after
initial vaccination[1]
· No new safety concerns were identified during the follow-up
period1
GSK plc (LSE/NYSE: GSK) today
announced positive data from the ZOSTER-049 long-term follow-up
phase III trial which followed participants for up to approximately
11 years following initial vaccination with Shingrix (Recombinant Zoster Vaccine
or RZV). The final trial data demonstrate that RZV maintains
efficacy against shingles for more than a decade in adults over 50.
The data will be presented at ESCMID Global (European Society of
Clinical Microbiology and Infectious Diseases) 2024, formerly known
as ECCMID in Barcelona, Spain (27-30 April
2024).1
The results from ZOSTER-049, an
extension from two phase III clinical trials in adults aged 50 and
over (ZOE-50 and ZOE-70), include:1
· 79.7%
vaccine efficacy (VE) in adults aged ≥50 cumulatively within the
period from year six to year 11 after vaccination (95% CI
73.7-84.6)
· 82.0%
VE in adults ≥50 at year 11 (95% CI 63.0-92.2), showing VE remains high in each year after
vaccination
· 73.1%
VE in adults aged ≥70 cumulatively from six to 11 years after
vaccination (95% CI 62.9-80.9) showing high VE rates across all age
groups
Dr
Javier Díez-Domingo, Principal Investigator, FISABIO (Foundation
for the Promotion of Health and Biomedical Research of the
Valencian Community, Spain) said: "These final data demonstrate continued protection over more
than a decade with high efficacy maintained in both the 50+ and 70+
age groups. Infectious diseases like
shingles pose a significant risk to adults due to the natural
decline in our immune system, and these
data represent a remarkable advancement in our understanding
of what can be achieved long-term for effective protection against
shingles."
Phil Dormitzer, Senior Vice President, Head of Vaccines
R&D, said: "These data go far beyond the typical
long-term follow-up period for a trial,
tracking the efficacy of vaccination for some
participants as they aged into their 70s, 80s and
90s. With the vaccine now included
in many national immunisation programmes around the world, these
data add to the body of evidence on the extended
long-term protection against shingles and provide further
confidence to inform public immunisation
strategies."
Globally, shingles will affect up to
1 in 3 people in their lifetimes.[2],[3],[4],[5]
A variety of factors can increase the risk of
developing shingles, including advancing age and immunodeficiency
or immunosuppression,[6] as well as other
chronic conditions such as COPD, diabetes mellitus, and
asthma.[7]
Shingles typically presents as a rash, with
painful blisters across the chest, abdomen or face,[8] with the pain often described as aching, burning,
stabbing or shock-like.2 Following the rash, up to 30%
of people experience post-herpetic
neuralgia (PHN),[9] a long-lasting nerve pain that can last weeks or months and
can occasionally persist for several years.2
Shingles is also associated with significant
healthcare and human cost, with 57% of people with
shingles reported missing
work for an average of 9.1 days.[10]
We will continue to evaluate
long-term data and conduct real-world evidence studies related to
vaccine efficacy, immunogenicity, and safety across indicated
populations, including those at highest risk of shingles to assess
a potential need for revaccination in future.
About ZOSTER-0491
ZOSTER-049 is a phase III open-label,
long-term follow-up trial
from two pivotal phase III randomised clinical
trials (ZOE-50, ZOE-70). The trial
evaluated the efficacy, safety, and immunogenicity
in adults 50 years and over at time of vaccination, for six
additional years after completion of the ZOE-50 and ZOE-70 trials,
up to approximately 11 years of follow-up.
ZOSTER-049 included over 7,000
participants from 18 countries across five continents, with vaccine
recipients compared to historical controls.
No new safety concerns were
identified during the follow-up period in ZOSTER-049.
No serious adverse events were considered causally
related to RZV vaccination by the investigators. In adults aged 50
years and over, the most frequently reported adverse reactions with
RZV are pain at the injection site, myalgia, fatigue and headache.
Most of these reactions were mild to moderate in intensity and
generally lasted less than three days.[11]
About shingles
Shingles is caused by the
reactivation of the varicella-zoster virus (VZV), the same virus
that causes chickenpox.2 By age 50, VZV is present in
most adults[12] and may reactivate with
advancing age.8 As
people age, the strength of the immune system response to infection
wanes, increasing the risk of developing
shingles.2
About Shingrix
Shingrix (Recombinant Zoster
Vaccine or RZV) is a non-live, recombinant subunit vaccine
indicated for the prevention of shingles in adults 50 and over. It
combines an antigen, glycoprotein E, with an adjuvant system,
AS01B, and may help overcome the natural age-related decline in
responses to immunisation that contributes to the challenge of
protecting adults aged 50 and over from shingles.[13],[14] RZV is not
indicated to prevent primary varicella infection (chickenpox). In
several countries, RZV is also approved for adults aged 18 years or
over at increased risk for shingles. The use of RZV should be in
accordance with official recommendations and local product
label.
Please refer to the Product
Information (PI) for important dosage, administration, and safety
information in Europe available at this link:
https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix
About GSK
GSK is a global biopharma company
with a purpose to unite science, technology, and talent to get
ahead of disease together. Find out more at gsk.com.
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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 under Item 3.D "Risk factors" in the
company's Annual Report on Form 20-F for 2023.
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References