GSK shingles vaccine now available in Malaysia

A vaccine for the prevention of shingles in adults aged 50 and over and those aged 18 and over at increased risk

KUALA LUMPUR, Malaysia, Sept. 13, 2024 /PRNewswire/ -- GlaxoSmithKline Pharmaceutical Sdn Bhd (GSK) today announced the launch of its Herpes Zoster vaccine, Shingrix (MAL24056002ARZ), also known as Recombinant Zoster Vaccine, Adjuvanted (RZV) in Malaysia for the prevention of shingles (herpes zoster, HZ) and post-herpetic neuralgia (PHN) in adults aged 50 years and over.ⁱ RZV is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses.

RZV will initially be available in Malaysia to adults aged 50 and over and those aged 18 and over who are at increased risk of HZ.

Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox.ⁱⁱ As people age, the cells in the immune system lose the ability to mount a strong and effective response to infection, increasing the risk of developing shingles.ⁱⁱⁱ The disease can cause unbearable pain and, in some cases, people can also develop post-herpetic neuralgia (PHN) a long-lasting nerve pain following shingles.^iv

RZV is a vaccine designed to prevent shingles in adults aged 50 years and over and 18 years and over who are at increased risk in countries where the indication for this population has been approved.ⁱ  RZV is also approved for adults aged 18 and over who are at increased risk of HZ.ⁱ  Immunocompromised individuals are at greater risk of shingles and associated complications and RZV is a shingles vaccine approved for this at-risk patient population.

In an analysis of the pivotal efficacy studies, ZOE-50, RZV demonstrated vaccine efficacy of up to 97%ⁱ in adults 50 years and above, over a follow-up period of approximately three years.ⁱ Recent interim data demonstrated overall vaccine efficacy of RZV of greater than 80% over the primary follow-up period approximately six to 10 years after initial vaccination in people 50 years and over.^v

Dr. Alap Gandhi, Country Medical Director of GlaxoSmithKline Pharmaceutical Sdn Bhd (GSK) Malaysia said: "Shingles is a disease that can cause excruciating pain and is caused by the reactivation of the varicella zoster virus. RZV has been designed to boost the immune response to the virus in people aged 50 and over or in those with immunocompromised conditions." He concluded, "We are pleased that people in Malaysia will now have access to the RZV vaccine to help reduce the burden of this painful disease."

RZV is an approved shingles vaccine to combine a non-live antigen with GSK's adjuvant and may help overcome the natural age-related decline in immunity that contributes to the challenge of protecting adults aged 50 and over from this disease.^vi,vii

RZV has resulted in positive vaccination recommendations. In Malaysia, RZV is recommended by Guideline for Adult Immunization by Malaysia Society of Infectious Diseases and Chemotherapy for persons who are 50 years and above and for immunosuppressed patients 18 years and above.^xi

With the launch of RZV in Malaysia, GSK hopes to continue to play a part in the betterment of public health in Malaysia.

PM-MY-SGX-COCO-240003 09/24                                                 Date of Approval: Sept 2024
KKLIU 2560 / EXP 29.01.2025

Trademarks are owned by or licensed by GSK.

Notes to editors

About Shingles
Shingles is caused by varicella zoster virus (VZV), the same virus that causes chickenpox. Adults aged 50 and over may have the VZV dormant in their nervous system, that may reactivate with advancing age.^viii As people age, the cells in the immune system lose the ability to mount a strong and effective response to infection, increasing the risk of developing shingles.ⁱⁱⁱ

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face.^ix The pain is often described as aching, burning, stabbing or shock-like. Following the rash, a person can also 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 10-20 percent of all shingles cases depending on their age.

About Shingrix

Shingrix [Herpes Zoster vaccine (recombinant, AS01_B^ix adjuvanted)] is a non-live, recombinant subunit vaccine indicated for the prevention of shingles (herpes zoster) and, in some markets, for post-herpetic neuralgia (PHN), in adults 50 years of age and over.

Approval of RZV follows a comprehensive Phase III clinical trial program evaluating its efficacy, safety, and immunogenicity in more than 30,000 people. 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.   

The indication for RZV also includes the prevention of HZ in adults aged 18 and over who are or will be at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy.^x

RZV, given intramuscularly in two doses, was designed to enhance the immune response of a declining or compromised immune system.ⁱ

Important Safety Information

The following is based on the Malaysia Prescribing Information for Recombinant Zoster Vaccine (RZV). Please consult the full Prescribing Information for all the labelled safety information.

About GSK
GSK is a global biopharma company with the ambition and purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people over the next 10 years. Our bold ambitions for patients are reflected in new commitments to growth and a step-change in performance. We have been operating in Malaysia for over 65 years, since starting our first operations in October 1958. In the last six decades, GSK Malaysia has grown substantially both in its infrastructure, business operations as well as talent base. Currently operating with over 400 employees spread across our two business entities – Pharmaceuticals & Vaccines and Business Service Centre. Find out more at Malaysia | GSK.

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 2019.

PM-MY-SGX-COCO-240003 09/24                                                                 Date of Approval: Sept 24
Trademarks are owned by or licensed by GSK.

References

ⁱ Herpes zoester (HZ, or shingles) vaccine (non-live recombinant, AS01_B adjuvanted). https://assets.gskinternet.com/pharma/GSKpro/Malaysia/Shingrix/shingrix_v01_28_mar_2024_clean.pdf

ⁱⁱ 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 Bowsher D. Acute Herpes Zoster and Postherpetic Neuralgia: effects of acyclovir and outcome of treatment with amitriptyline. British Journal of General Practice; 1992; 42; 244-246.

^iv 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: February 2023.

^v Strezova A et al. Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination. Open Forum Infectious Diseases. 2022;9:10.

^vi 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.

^vii 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.

^viii 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.

^ix Mueller, NH et al. Varicella Zoster Virus Infection: Clinical Features, Molecular Pathogenesis of Disease and Latency. Neurologic Clinics, 2008; 26;675-697.
^x Lecrenier et al.  EXPERT REVIEW OF VACCINES 2018, VOL. 17, NO. 7, 619–634.

^xi Guideline for Adult Immunization – 3rd Edition, Malaysia Society of Infectious Diseases and Chemotherapy (Published in October 2020, Revised in November 2023), Page 187

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

GSK shingles vaccine now available in Malaysia

Global Hit Streaming Series Reaches Top Spot on Netflix and Earns International Acclaim

LOS ANGELES, Sept. 18, 2024 /PRNewswire/ -- The groundbreaking Netflix series "3 Body Problem," produced in collaboration with The Three-Body Universe, has garnered six nominations at the 76th Primetime Emmy Awards, including the prestigious Outstanding Drama Series prize. This recognition highlights the series' extraordinary production and global success.

According to official Netflix data, "3 Body Problem" topped Netflix's viewership charts, amassing over 46.6 million views within seven weeks of its release in March. With its broad appeal, the series drew a substantial international audience and ranked in the top ten across 93 countries and territories.

"The Three-Body Problem" trilogy stands as the leading Chinese novel series on the global stage. Translated into 35 languages, the trilogy has surpassed 30 million copies in sales and received over ten major international literary awards. The English version alone has sold more than 2.56 million copies, with a renewal fee of $1.25 million, setting a new benchmark for the export of Chinese literary rights overseas.

The Three-Body Universe (TBU), the exclusive global rightsholder for content development and commercial operations of "The Three-Body Problem" trilogy, continues to lead the IP industry with its innovative and captivating storytelling. The company's diverse portfolio spans film and television, pan-entertainment, interactive, and immersive experiences, with plans to release one to two major projects every year.

In addition to "3 Body Problem," TBU is also widely recognized for producing the hit Mandarin-language TV series "Three-Body." Beloved by Chinese audiences, the show has been broadcast on over 11 international television networks and streaming platforms, with Peacock distributing it in the U.S. The series has reached viewers across Asia, the Americas, Europe, and Oceania. "Three-Body" is also available on Tencent Video's international platform, WeTV, further extending its reach to ASEAN countries, as well as Arabic-, Spanish-, and Portuguese-speaking regions.

"The Three-Body Problem" IP has also expanded into a diverse range of cultural products. Its graphic novels have been commissioned for publication in 11 languages. Other successful adaptations include animated series, variety shows, VR/AR experiences, and immersive live events.

At the 2024 Shanghai International Film Festival, The Three-Body Universe CEO, Jilong (Cedric) Zhao spoke about the highly anticipated film adaptation of "The Three-Body Problem," set to be directed by Zhang Yimou. "We will bring together China's top creative talents and production expertise, working with industry-leading partners around the world to bring this film to the international stage." A veteran of IP development and operations, Zhao also shared his vision for the IP market. "2024 has seen the sensational debut of "3 Body Problem," marking the first year for the internationalization of the Three-Body franchise. The series achieved groundbreaking success in North American, Japanese, and Middle Eastern markets, which also drove a surge in book sales and Three-Body-themed merchandise. This triumph demonstrates the vast potential and promising future for the Three-Body IP and other Chinese intellectual properties on the global landscape."

Building on its current success, The Three-Body Universe is gearing up to develop its first animated feature film and video game for the global market. Through collaborating with world-class talents and business partners, The Three-Body Universe seeks to create groundbreaking, premium content that resonates with both domestic and international audiences, further expanding the reach and impact of the Three-Body IP worldwide.

For more information, please contact:

Emma NG, PR Dept., TBU
emma.ng@3body.com
WhatsApp: +86 15611739029

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

"3 Body Problem" Nominated for Outstanding Drama Series at the 76th Primetime Emmy Awards