GSK's Shingrix Receives Key FDA Approval for Expanded Use in Immunocompromised Adults

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GlaxoSmithKline’s (GSK) shingles vaccine Shingrix received marketing approval in October 2017, nearly achieving blockbuster status ($999 million in sales) in its first full year on the market. However, sales of the vaccine slowed sharply during the COVID-19 pandemic. In response to the pandemic dethroning Shingrix, GSK plans to “relaunch” the vaccine to restore its upward growth trajectory.

On Monday, the U.S. FDA approved an expanded indication for Shingrix, authorizing its use for the prevention of herpes zoster in immunocompromised adults aged 18 years and older. Herpes zoster is a viral infection that causes a painful rash and blisters. Compared with immunocompetent individuals, immunocompromised individuals are at a higher risk of developing herpes zoster and its associated complications.

This FDA approval opens a new target population for Shingrix. Previously, Shingrix was initially approved for use in adults aged 50 years and older.

This recent approval is based on the results of a study evaluating the safety and efficacy of Shingrix in adult patients who have undergone stem cell transplantation and in adult patients receiving treatment for hematologic malignancies. Additionally, vaccination data were collected from adult patients with immunodeficiency or immunosuppression due to disease or treatment, including those with HIV/AIDS, solid tumors, and kidney transplant recipients.

According to a press release issued by GSK, Shingrix is the first herpes zoster vaccine approved for use in immunocompromised individuals. In the European Union, Shingrix was approved in August 2020 for adults aged 18 years and older at increased risk of herpes zoster, 11 months ahead of U.S. FDA approval; however, the COVID-19 pandemic disrupted the launch plans.

This FDA approval comes as GSK attempts to get Shingrix back on track. In 2020, Shingrix sales grew by only 10%, reaching $2.8 billion. In 2019, however, Shingrix sales doubled compared to the previous year.

Early in the COVID-19 pandemic, the U.S. Centers for Disease Control and Prevention (CDC) recommended that other vaccines should not be administered within 2 weeks after receiving a COVID-19 vaccine. Researchers found that during the pandemic, over 17 million doses of recommended vaccines were missed, including Shingrix.

Source: As GlaxoSmithKline works to get Shingrix back on track, an FDA approval increases the key vaccine's reach