New Approval for SHINGRIX Vaccine

New Approval for SHINGRIX Vaccine
Hanna Friedrich, PharmD, Cub Pharmacy

On July 26, 2021 the Food and Drug Administration (FDA) announced a new and exciting approval for the SHINGRIX vaccine. The new approval is for adults 18 years and older with qualifying immunocompromised conditions. GlaxoSmithKline’s SHINGRIX vaccine was approved in 2017 as a two dose series for adults 50 years of age and older for the prevention of Herpes Zoster, also known as shingles. Of note, the vaccine is not indicated for the prevention of primary varicella infection, or chickenpox. SHINGRIX is an inactive adjuvant, recombinant vaccine which is safe to co-administer with other vaccines, irrespective of the timing of any live vaccines previously administered. According to the Centers for Disease Control and Prevention (CDC), SHINGRIX is 97% effective in preventing shingles in adults 50-69 years old who receive both doses. The current approval is for two separate doses to be administered intramuscularly two to six months apart. The FDA has now approved the administration of the second dose in immunosuppressed patients in as little as one month after the first dose. This will allow immunocompromised patients to reach immunity faster. This expanded indication will have a positive impact on the pharmacy profession, as well as improve patient outcomes. Access to the vaccine for high-risk patients will help prevent complications and worsening of their chronic conditions. Pharmacists are the most accessible health care provider. With this unique position, pharmacists will have an opportunity to help many patients improve their overall health. At the time of this publication, the Advisory Committee on Immunization Practices (ACIP) had not published updated recommendations. It is imperative to wait for ACIP to define qualifying immunodeficiency immunosuppressed disease states, and immunosuppressive drug therapy before implementation of this new indication.

For further information and updates on qualifying conditions, check the ACIP meeting agendas found at: https://www.cdc.gov/vaccines/acip/meetings/agenda-archive.html.

For meeting minutes use the following link for more information: https://www.cdc.gov/vaccines/acip/meetings/minutes-archive.html

 

Reference:

  1. GlaxoSmithKline plc. Shingrix approved in the US for prevention of shingles in immunocompromised adults. Available at: https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-the-.... Published 26 July 2021. Accessed 4 August 2021.
  2. Centers for Disease Control and Prevention. Shingrix Shingles Vaccination: What Everyone Should Know. Available at: https://www.cdc.gov/vaccines/vpd/shingles/public/shingrix/index.html. Published January 25, 2018. Accessed August 24, 2021.