ACIP Recommends Herpes Zoster Subunit Vaccine

In a narrow 8-7 vote, the Advisory Committee on Immunization Practices (ACIP) endorsed the use of the newly FDA approved zoster vaccine recombinant, adjuvanted (Shingrix, GlaxoSmithKline) over the established zoster vaccine live (Zostavax, Merck).

This endorsement may be “likely to prevent…more disease compared to a nonpreferential recommendation,” said Kathleen Dooling, MD, MPH, medical epidemiologist in the Division of Viral Diseases at the CDC. “A preference would promote access to the more efficacious vaccine whereas health systems or providers may choose to carry only the less expensive vaccine if no preference is stated.”

The panel agreed that Shingrix has some superior outcome data; however, some members said it was too early to make the preferential recommendation.

“There’s a lot we have to learn over the next couple of years,” Cynthia Pelligrini, senior vice president, public policy and government affairs at the March of Dimes. “I’m more comfortable starting with a straight recommendation and giving ourselves the ability to go to the preferential in a couple of years when we know more, but to me to start out with a preferential recommendation, with as great as this vaccine sounds, is really hard.”

Once more real-world data are obtained, the panel should reconsider their recommendation, according to ACIP panel member Grace Lee. “Our decision making should be dynamic and as more data come in and as the uncertainty resolves, we should reconsider the decision at a future date.”

In another vote, the ACIP panel recommended Shingrix, a non-live, recombinant subunit vaccine for the prevention of herpes zoster and related complications in immunocompetent adults age 50 years and older. Shingrix, which just received FDA approval on Friday, is administered in 2 doses.

The ACIP also recommended the use of Shingrix in patients who have previously been vaccinated with zoster vaccine live.

There were some concerns raised about safety or side effects associated with revaccination. “[Zostavax] a live vaccine, and this is an adjuvanted, subunit vaccine,” said Edward Belongia, MD, director of the Center for Clinical Epidemiology and Population Health at the Marshfield Clinic Research Foundation in Marshfield, Wisc. “There’s no biological reason that I’m aware of to expect any interaction of those that might be harmful. The data are limited; it’s a relatively small study but there are some data on that.”

Officials with the ACIP make recommendations to the Centers for Disease Control and Prevention (CDC).