The FDA approved the use of Shingrix, a recombinant inactivated vaccine, for protection against shingles in patients aged 50 and older on October 20, 2017. The American Committee on Immunization Practices (ACIP), recommended that Shingrix be given instead of Zostavax, the currently available live, attenuated vaccine which has been on the market since 2006. Shingles is a disease caused by reactivation of the chicken pox virus (varicella zoster virus), which resides quiescently in the spinal cord for years. The chicken pox virus can become active again and cause a painful rash that comes out in the distribution of a nerve on one side of the body. Even after the rash resolves, the virus can cause post herpetic neuralgia (PHN) that can last weeks to years after the acute illness. Post herpetic neuralgia is described as a burning, chronic pain in the distribution of the nerve that is affected by shingles. Patients can suffer with serious pain which is quite debilitating.
The good news about the new vaccine is that the efficacy rate for prevention of shingles is much higher than that of the old vaccine. In 2 large clinical trials, Shingrix had an efficacy rate of 97% prevention of shingles, and in patients over 70, the rate was 91% effective. Looking at the first trial, out of 7344 patients who received the vaccine, 6 patients developed shingles. In contrast, out of 7415 patients who got the placebo, 210 patients got shingles. In comparison, the established vaccine, Zostavax, reduced the rate of shingles by 51% overall, with 37.5% efficacy in patients over 70. Therefore Shingrix appears to be much more effective in older patients than Zostavax and it is approved for patients 50 and older, whereas Zostavax was approved for 60 and older.
It is important to note that the new vaccine is given in 2 doses about 2-6 months apart. The ACIP also recommended that all patients who already received the old vaccine be given the new vaccine, with the interval between vaccines at least 8 weeks apart. Shingrix can be given at the same time as the flu vaccine without problems. The main side effects of Shingrix are pain, redness and swelling at the injection site, which is given intramuscularly. Since it is not a live vaccine, the new vaccine is also approved for patients with immunosuppression, but there is no data on its effectiveness in such cases.
The vaccine is expected to be available at the end of this year. Please speak with your medical team about whether this vaccine is right for you.