FDA Approves and ACIP Recommends Shingrix Shingles Vaccine

Posted on November 06, 2017

Source: U.S. Food & Drug Administration
FDA approves and ACIP recommends Shingrix for adults aged 50 years and older to prevent shingles.

Almost 1 out of 3 people in the US will develop shingles during their lifetime, and there are approximately 1 million cases a year. Most people who get shingles will have it only once. However, it is possible to get it a second or even third time. The risk of getting shingles increases with age, especially after age 50. The most common complication of shingles is postherpetic neuralgia (PHN). About 1 out of 5 people with shingles will get PHN, and the risk also increases with age. Even children can get shingles, but it is not common.

Approximately 1-4 percent of people who get shingles are hospitalized for complications. Older adults and people with weakened or suppressed immune systems are more likely to be hospitalized. Each year, about 100 shingles-related deaths occur in the US, almost all in elderly people or those with a weakened/suppressed immune system.

On October 20, the FDA licensed Shingrix for adults aged 50 years and older to prevent shingles. On October 25, the Advisory Committee on Immunization Practices (ACIP) voted that Shingrix is:

  1. Recommended for healthy adults aged 50 years and older to prevent shingles and related complications.
  2. Recommended for adults who previously received the current shingles vaccine (Zostavax) to prevent shingles and related complications.
  3. The preferred vaccine for preventing shingles and related complications.

Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in a two-dose series, with the second dose given 2-6 months after the first. Clinical trials have shown that the 2-dose Shingrix vaccine is more effective and provided longer-lasting protection than the 1-dose Zostavax vaccine.

Zostavax was previously recommended for healthy adults age 60 and older, even though it was approved for those 50 and older. Estimated efficacy comparing Shingrix and Zostavax includes for:

  • ages 60-69 (97% vs. 64%)
  • ages 70-79 (91% vs 41%)
  • ages > 80 (91% vs 18%)

Drawbacks of Shingrix is that:

  • It requires 2 doses (and the efficacy of only 1 dose is unknown)
  • It will be more expensive than Zostavax ($280 for entire series vs. $230)
  • There are more injection-site and generalized reactions

Studies showed 80 percent of individuals had some type of vaccine reaction, compared to 30 percent of people who got a placebo. Most symptoms were mild or moderate, most commonly a sore arm and pain after injection. About half the people also developed more general side effects, such as:

  • muscle ache
  • fatigue
  • fevere
  • headaches that resolved in 2-3 days

***Note the vaccine is not yet available, and the ACIP recommendations won’t be officially approved until the CDC Director signs off on it, which will likely be later this year or in January 2018. Once approved, these ACIP recommendations will be published in the Morbidity and Mortality Weekly Report. At that time, the recommendations will become official policy. Unknown insurance coverage.