Shingles (Herpes Zoster) Vaccines
Herpes Zoster, known as shingles, is a vaccine-preventable disease caused by the varicella-zoster virus (VZV), which also causes chickenpox, says the U.S. Centers for Disease Control and Prevention (CDC). The U.S. Food and Drug Administration (FDA) approved shingles vaccines for use according to updated schedules published for 2024. The European Medicines Agency (EMA) approves various shingles vaccines in over 30 countries. As of 2024, the shingles vaccination market exceeds $2 billion annually.
Shingles Vaccines Approved
Shingrix - GSK's Shingrix is a non-live, adjuvanted recombinant shingles vaccine (zoster) consisting of the varicella-zoster virus glycoprotein E antigen and the AS01B adjuvant system, a proprietary adjuvant containing QS-21 and MPL with liposomes.
Zostavax - Merck's Zostavax is a live, attenuated varicella-zoster virus (weakened chickenpox virus) vaccine. According to the U.S. CDC, the zoster vaccine can be administered concurrently with all other live and inactivated vaccines, including those routinely recommended for people 60 or older.
SK bioscience's SKYZoster™ is a live vaccine that attenuates the varicella-zoster virus. SKYZoster was approved in South Korea by the Ministry of Food and Drug Safety in September 2017.
SINOVAC's live attenuated varicella vaccine, a WHO-prequalified Chinese varicella vaccine, was successfully delivered to the Republic of Türkiye in 2023 and is registered in Lebanon and Kenya.
Shingles Vaccine Candidates 2024
Curevo Vaccine's Amezosvatein (CRV-101) is an adjuvanted subunit shingles vaccine candidate designed to maximize CMI protection by combining the gE protein antigen with our proprietary adjuvant. On January 7, 2024, Curevo announced positive data from a Phase 2 trial of Amezosvatein head-to-head versus Shingrix in participants 50 and older. There were zero confirmed cases of herpes zoster (shingles) in the amezosvatein arm of participants. On October 16, 2024, the Company announced that Amezosvatein met all primary endpoints in the randomized, active-controlled, and observer-blind Phase 2 trial. Based upon these results, Curevo will advance amezosvatein into global Phase 3 trials in 2025.
BioNTech SE initiated a randomized, controlled, dose-selection Phase 1/2 clinical trial of BNT167 in February 2023. The trial evaluates mRNA vaccine candidates' safety, tolerability, and immunogenicity against shingles. The last Update was Posted on March 24, 2023, and a data update is expected in 2023. The estimated Primary Completion Date is July 5, 2025.
Jiangsu Recbio Technology Co., Ltd. announced on December 29, 2023, that REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+T cells and antibodies. On December 19, 2022, it received approval from the Philippines FDA to conduct a randomized, observer-blinded, phase I clinical trial. The Interim Analysis results published on December 29, 2023, showed that REC610 demonstrated an overall favorable safety and tolerability profile in healthy participants aged 40 and above after two vaccination doses. REC610 induced strong gE-specific humoral and cellular immune responses, evident after the first vaccination and peaked 30 days after the second vaccination.
Immorna announced on January 9. 2023, that the U.S. FDA cleared its investigational new drug application to conduct a Phase 1 multi-center study of JCXH-105, a self-replicating RNA vaccine against Shingles. In addition, on May 30, 2023, it announced that the first subject had been dosed in the Company's First-In-Human (FIH) Phase 1 multi-center study of JCXH-105.
Dynavax's Z-1018 is an investigational vaccine candidate being developed to prevent shingles in adults aged 50 and older. As of June 2024, the first participant was dosed in a Phase 1/2 clinical trial, evaluating the safety, tolerability, and immunogenicity of Z-1018.
Shingles Vaccination and Dementia
The journal BMC Public Health published on October 2, 2023, results from a study that concluded both the zoster vaccine for the prevention of shingles/herpes zoster and the influenza vaccine to prevent influenza was associated with diminished risk of dementia, with the zoster association appearing more pronounced. A non-peer-reviewed study published on May 25, 2023, reported that shingles vaccinations were associated with a 19.9% lower risk of dementia.
Shingles Vaccine Price
Most patients pay an out-of-pocket cost of about $50 per dose with insurance. The U.S. CDC Vaccine Price List was last updated in July 2022. As of January 2023, vaccinations covered under MedicaPartart D, approved and recommended by the CDC, will be covered without a co-pay. Vaccine prices and discount information are posted at InstantRx™.
