Members of the Advisory Committee on Immunization Practices, or ACIP, voted 8-7 today to recommend the recently approved herpes zoster vaccine, Shingrix, over the only other FDA-approved vaccine, Zostavax.
Shingrix (GlaxoSmithKline) — a subunit adjuvanted vaccine that requires two doses — is now recommended for the prevention of herpes zoster, or shingles, in immunocompetent adults aged 50 years and older. ACIP members also voted 12-3 to recommend Shingrix for adults who previously received Zostavax (Merck), which is administered in a single dose.
The FDA approved Shingrix on Oct. 20. The approval was based on data from a phase 3 clinical trial program that showed the vaccine was more than 90% effective at preventing shingles in more than 38,000 participants. Shingrix also reduced the incidence of postherpetic neuralgia, the most common complication of shingles.
At today’s ACIP meeting, Kathleen Dooling, MD, MPH, a medical epidemiologist at the CDC’s Division of Viral Diseases, presented findings from the ACIP Herpes Zoster Work Group, which evaluated data on the safety and efficacy of Shingrix. She reported that the work group found “strong evidence” that Shingrix is safe, effective and durable, with minimal waning immunity in the first 4 years of vaccination. They also determined that Shingrix is cost-effective for all age groups, including individuals aged 50 to 59 years — a population that is not currently recommended to receive the Zoster vaccine because of concerns with waning immunity with age.
According to data presented by Angela Guo, MPH, a fellow at U.S. Department of Energy’s Oak Ridge Institute for Science and Education and a researcher at the CDC’s Division of Viral Diseases, Shingrix maintained at least 85% efficacy against shingles 4 years after vaccination. In contrast, Zostavax was estimated to be 40% or less effective 4 years after vaccination.
Because of a lack of vaccine efficacy and waning immunity with Zostavax, the ACIP Herpes Zoster Work Group recommended administering Shingrix to patients who had previously received Zostavax. ACIP members set a minimum interval of 8 weeks between the administration of Shingrix following Zostavax. However, guidance for determining an optimal interval for patients will be published by CDC at a later date.
Despite the observed benefits of Shingrix, members expressed concern over the lack of long-term safety data, potential adherence issues with the two-dose regimen and the possibility of vaccine supply issues.
“It has never been given outside of a research setting, and that’s what I’m really struggling with,” Cynthia Pellegrini, senior vice president of public policy and government affairs for the March of Dimes, said during the meeting. “We know there are a lot of unknowns and there is a lot we need to learn over the next few years. To start out with a preferential recommendation, as great as this vaccine sounds, is really hard.”
The majority, however, believed that the advantages of Shingrix outweighed those concerns.
“It is the role of the ACIP to address the evidence available to us and to make changes to our recommendations if the evidence changes,” said Kelly Moore, MD, MPH, director of the Tennessee Department of Health’s immunization program and assistant clinical professor in the department of health policy at Vanderbilt University School of Medicine. “The evidence before us is this vaccine performs in a very superior fashion and will prevent much more disease than the other product that’s available. It’s up to us to figure out how to make sure that the public gets the two doses that they need.” – by Stephanie Viguers
Gou, Moore and Pellegrini report no relevant financial disclosures.