GSK seeks to extend shingles vaccine Shingrix to younger at-risk adults in China

GSK plc (LSE/NYSE: GSK) has reached a pivotal milestone in the prevention of shingles (herpes zoster) in China, with the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) now reviewing the regulatory application for Shingrix (Recombinant Zoster Vaccine or RZV) for adults aged 18 years and over at increased risk. This review could significantly broaden the eligible population for shingles prevention beyond the current approval for adults aged 50 and over, addressing a crucial healthcare need.

Originally approved by the NMPA in 2019, Shingrix is a non-live, recombinant subunit adjuvanted vaccine designed to prevent shingles in adults. Administered intramuscularly in two doses, Shingrix combines an antigen, glycoprotein E, with an adjuvant system, AS01B, to enhance the immune response, particularly vital for adults whose natural immune response may decline due to age or health conditions.

Globally, up to one in three people will experience shingles in their lifetime, with the disease caused by the reactivation of the varicella-zoster virus (VZV), the same virus responsible for chickenpox. Factors such as advancing age, immunodeficiency or immunosuppression, and chronic conditions like COPD, diabetes, and asthma can significantly increase the risk of developing shingles.

GSK’s Shingrix Vaccine Application for Younger Adults Under Review by China’s NMPA

In China alone, it’s estimated there are around six million cases of shingles annually, with individuals at increased risk, including those who are immunocompromised, facing over three times the incidence rate compared to the general population.

The NMPA’s consideration of Shingrix for younger, at-risk adults is informed by six clinical trials encompassing patients aged 18 and over who have undergone stem cell transplantation, kidney transplant, or have conditions such as blood cancer, solid tumor, or HIV.

Shingles typically manifests as a painful rash with blisters, affecting the chest, abdomen, or face. The pain can vary from aching to shock-like sensations. A significant complication of shingles is post-herpetic neuralgia (PHN), a long-lasting nerve pain that can persist for months or even years, occurring in 5-30% of all shingles cases.

The review of GSK’s application for Shingrix by the NMPA marks a critical step forward in expanding access to preventive measures against shingles for a broader demographic in China. By potentially including adults aged 18 and over at increased risk, Shingrix could play a pivotal role in reducing the incidence and severity of shingles, offering protection to those most vulnerable due to immunodeficiency or chronic conditions.

This development not only underscores GSK’s commitment to public health but also highlights the importance of innovative vaccine technology in addressing global health challenges. The approval of this application could significantly impact shingles prevention strategies, offering hope and protection to millions of at-risk individuals in China.