GlaxoSmithKline’s Shingles Vaccine “Shingrix”- Highly Impactful with 90% Efficacy
UPDATE: US FDA approved the GlaxoSmithKline‘s Shingrix™ for the prevention of shingles in adult patients aged 50 years and over in October 2017.
“Shingrix represents a significant scientific advancement in the field of vaccinology. The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects 1 in 3 people in the United States.1 The risk and severity of shingles increase with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome the age-related decline in immunity,” said Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines.
Shingrix received its first approval in Canada. It is the only shingles vaccine to achieve more than 90 percent efficacy in adults aged 50 years and above.
After filing for FDA regulatory approval in October, GlaxoSmithKline (GSK) sought European approval for Shingrix™- a non-live, adjuvanted shingles vaccine candidate.
The company submitted the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the approval of Shingrix for Herpes zoster prevention in patients aged 50 years or more. Moreover, GSK filed a regulatory approval application for the vaccine candidate in Japan in April.
The vaccine is administered intramuscularly in two doses with an interval of two-to-six months between the doses.
The MAA is based on the Phase III clinical trial programmes, ZOE-50 and ZOE-70 conducted in more than 37,000 patients to evaluate the safety, efficacy and immunogenicity of Shingrix vaccine. In ZOE-50, two doses of the vaccine candidate reduced the risk of herpes zoster by 97.2 percent in the individuals aged 50 or more in comparison to placebo.
Similarly, results from ZOE-70 demonstrated 90 percent efficacy against shingles in the vaccine-administered individuals aged 70 years or more compared to placebo of the same age group. Additionally, Shingrix was also found effective against postherpetic neuralgia (PHN), a type of chronic pain associated with shingles. It decreased the overall incidence of PHN.
The data from both the trials were published in the New England Journal of Medicine.
GSK is also conducting a study to evaluate the vaccine candidate in individuals who were previously vaccinated with the presently available live-attenuated vaccine. It is also being assessed in immuno-compromised individuals with high risk for shingles including hematopoietic stem cell and renal transplant patients, solid and hematological cancer patients and HIV-infected individuals.
The company is expecting that the ongoing clinical trials will provide further information about the safety profile, efficacy of the vaccine in individuals with high risk of the disease.
According to the analysts, the drug has a potential to be a blockbuster drug with $1 billion per year sales in future and can give strong competition to Merck‘s rival shot, Zostavax which earned $749 million in 2015. Although the head-to-head study of the two vaccines has not been performed but in the individual studies, Zostavax showed a 64% reduction of herpes zoster in people of 60 to 69 age group and the efficiency decreased in older age group people.The trial results of Shingrix has demonstrated greater protection among older recipients, though Shingrix is required in two doses compared to one dose of Merck’s Zostavax.
Dr. Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D, GSK said, “Shingles is a common but serious condition that results from the reactivation of the virus that causes chicken pox and can cause lasting pain and other complications.”
Editor’s Note: The article was originally published on 30, November 2016 and has been updated for comprehensiveness.