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CDC's Advisory Committee recommends approval of Shingrix with QS-21 Stimulon as preferred vaccine for prevention of shingles

Lexington, Massachusetts
Friday, October 27, 2017, 12:00 Hrs  [IST]

Agenus, an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of three recommendations for the use of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) containing QS-21 Stimulon for the prevention of shingles (herpes zoster): Herpes Zoster subunit vaccine (Shingrix) is recommended for the prevention of herpes zoster and related complications for immunocompetent adults age 50 year and older.

Herpes Zoster subunit vaccine (Shingrix) is recommended for the prevention of herpes zoster and related complication for immunocompetent adults who previously received Zoster Vaccine Live (Zostavax). Herpes Zoster subunit vaccine (Shingrix) is preferred over Zoster Vaccine Live (Zostavax) for the prevention of herpes zoster and related complications.

"The Advisory Committee's vote to recommend Shingrix enhanced with QS-21 Stimulon on three different counts further confirms our belief in the vaccine's efficacy and its potential to extend immunization for up to 62 million adults in the United States," remarked Garo Armen, Ph.D., chairman and chief executive officer, Agenus. "The vote confirms the importance of ensuring that millions of at-risk adults are protected against shingles with Shingrix."

QS-21 Stimulon is an immune-potent adjuvant designed to boost the immune system by helping the body generate antibodies and T cells that guard against infection. The addition of QS-21 Stimulon enhances the immunogenicity of Shingrix by boosting immune response, which is critically important for older adults, the population most vulnerable to shingles and the painful and often debilitating consequences of the virus.

Shingrix was approved by the US Food and Drug Administration (FDA) on October 20, 2017 for use in adults aged 50 years and older. Data from studies of people vaccinated with Shingrix, who were previously vaccinated with Zostavax, have been presented previously to the ACIP and have been published in peer-reviewed journals, but have not yet been reviewed by the FDA.

The most common side effects of Shingrix are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach, which are related to the immune system responding to the vaccine. Based on available data, the majority of reactions to the vaccine were transient and mild to moderate in intensity, lasting less than three days.

Shingles is a major public health issue in the US, impacting as many as 1 in 3 older adults over the age of 50 years. Shingles is caused by a virus called varicella zoster, which is also known as the chicken pox virus. Nearly all older adults have the varicella zoster virus dormant in their nervous system waiting to reactivate with advancing age and weakened immune systems.

The ACIP recommendations will be forwarded to the director of the CDC and the US Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future Morbidity and Mortality Weekly Report (MMWR).


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