New shingles vaccine approved, recommended highly by ACIP

Clinicians now have a new way to fight shingles, and the vaccine has been listed as the preferred choice over its predecessor by at least one federal agency.
The U.S. Food and Drug Administration (FDA) approved Shingrix for adults aged 50 and older in October 2017, and Advisory Committee on Immunization Practices (ACIP) voted days later to recommend preferential use of Shingrix over Zostavax, which was the only shingles vaccine available until now. FDA's approval and ACIP's recommendation were based on a Phase III clinical trial program evaluating the vaccine's safety and efficacy in a cohort of more than 38,000 individuals. The trials showed 90% efficacy across all age groups, according to the vaccine's manufacturer GSK.

Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox. Most adults have the virus in their system, but it lies dormant until reactivated--usually as an individual ages and their immune system declines. The reactivated virus presents with a painful, itchy rash that can last for weeks with pain continuing for months in more extreme cases. 

Len Friedland, MD, vice president of Scientific Affairs and Public Health at GSK, said there are more than 1 million new cases of shingles every year, and all adults have a 1 in 3 chance of developing the infection. In individuals aged 85 and older, that risk increases to 1 in 2, he said.

Len Friedland, MD

"Shingles can be really impactful and change people's lives," Friedland told Medical Economics. “Its clinical presentation is a very severe type of pain that can really stop people in their tracks. People refer to the pain as the type of pain they experience when they deliver a child or have a kidney stone.”

In addition to the pain of shingles infection, patients can experience acute complications including postherpetic neuralgia (PHN), a form of chronic nerve pain and the most common complication associated with shingles.

Zostavax was approved by the FDA in 2006 and has been the only vaccine for shingles until now. It is a live vaccine and licensed for patients 60 and older, according to the FDA.

Shingrix is a non-live vaccine using recombinant antigens and adjuvants to enhance immune response. Friedland said testing of the vaccine showed 90% efficacy in preventing the development of shingles over a four-year period.

“The results have proven that this approach has generated a high level of protection for people regardless of age,” Friedland said.

Next: Differences versus Zostavax

Differences vs. Zostavax

Friedland said Shingrix's approval for age 50 and older can offer protection to an additional 42 million at-risk patients. GSK is also investigating the use of Shingrix in immunocompromised patients over the age of 18--a group that cannot receive a live vaccine like Zostavax.

"It is well recognized that these patients are at a much higher risk of getting shingles and its complications," said Friedland. “There is tremendous interest in the development of a shingles vaccine for immunocompromised patients."

Friedland said additional data on the use of Shingrix in this population will be published as research is completed.

Aside from functionality, there are other differences between the two vaccines. Unlike Zostavax which is administered in one subcutaneous injection, Shingrix is administered over two intramuscular doses given two to six months apart. Patients must complete the full series for maximum protection, Friedland said.

“The reason it’s a two-dose vaccine is the early data clearly illustrated that giving two doses was going to give the type of strong immune response we were looking for to give this high level of protection," Friedland said. There also are storage and handling differences between the two vaccines. Zostavax must be frozen, and Shingrix is refrigerated, according to GSK. 
The most common side effects of Shingrix are pain, redness or muscle pain at the injection site, as well as fatigue, headache, shivering, fever and upset stomach.

Shingrix can be ordered now, but insurance coverage for the vaccine may be spotty at first. GSK expects payer coverage of the vaccine to become widespread by the first quarter of 2018. For patients opting to self-pay for the vaccine, the cost for the entire series is $280--$140 for the first shot and $140 for the second.