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FDA approves herpes zoster vaccine Shingrix
GlaxoSmithKline recently announced that the FDA has approved the company’s herpes zoster vaccine, Shingrix, for adults aged 50 years and older.
The approval is based on data from a phase 3 clinical trial program that assessed the safety, efficacy and immunogenicity of the nonlive vaccine in more than 38,000 participants. In a pooled analysis, Shingrix was more than 90% effective at preventing herpes zoster, or shingles, the release said. It also reduced the incidence of postherpetic neuralgia, the most common complication of shingles. The efficacy of the vaccine was sustained over a 4-year follow-up period.
Shingrix is administered in two doses intramuscularly, according to the release. It combines glycoprotein E with an adjuvant system that enhances immunologic response.
“Shingrix represents a significant scientific advancement in the field of vaccinology,” Thomas Breuer, MD, MSc, senior vice president and chief medical officer of GlaxoSmithKline Vaccines, said in the release. “The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects one in three people in the United States. The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome the age-related decline in immunity.”
GlaxoSmithKline expects Shingrix will be available in the United States soon. On Oct. 25, members of the Advisory Committee on Immunization Practices, or ACIP, voted 8-7 to recommend Shingrix over the only other FDA-approved shingles vaccine, Zostavax (Merck). ACIP members also voted 12-3 to recommend Shingrix for adults who previously received Zostavax, which is administered in a single dose.
In addition to its recent approval in the U.S. Shingrix was approved for use in Canada on Oct. 13. It is also currently undergoing regulatory review in the European Union, Australia and Japan.
Disclosure: Breuer is an employee of Glaxo-SmithKline
Perspective
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Shingrix is a substantial advance over Zostavax. The Merck vaccine is an attenuated vaccine given in one dose. Shingrix is a subunit vaccine that is adjuvanted and requires two doses. Shingrix appears to be advantageous in that it provides an immune response and protection against shingles for people of even advanced age. The protection rates are higher than with the Merck vaccine. Even people aged 70 and 80 years seem to have protection rates of 90%, or even a little higher.
The data are still being analyzed. There are 4-year data concerning persistence of protection, and that seems to be improved above the Merck vaccine. Seven years after immunization with Zostavax, patients immunity levels appear to be down to baseline again. So, the availability of Shingrix will be a great improvement over the protection that was afforded by the Merck vaccine.
There are a few questions rheumatologists should have regarding the new Shingrix vaccine for patients with autoimmune and autoinflammatory diseases. The new vaccine, recently approved by the FDA, is a nonlive recombinant subunit vaccine combined with a potent adjuvant system intended to generate long-lasting immunity. There appears to be no doubt of the potent efficacy of this vaccine across all age groups. The fact that it is not a live vaccine offers the hope that it will be safe in patients who are heavily immunosuppressed.
I, for one, have some significant concerns regarding this vaccine and what the potential effects of this adjuvant system may portend to patients with pre-existing autoimmune and autoinflammatory diseases. Although there is no firm link between adjuvants and autoimmunity, there are numerous anecdotes of exacerbation or the development of autoimmune symptoms that linger in the literature. Although the safety profile of Shingrix, in general, in nonimmunosuppressed patients appears acceptable, the package submitted to the regulatory agency revealed there were numerous disorders reported in patients who received the vaccine. These included inflammatory arthritis, psoriasis, reactive arthritis, optic neuritis and others. There was no firm link in a causal manner, and some of these types of problems were seen in the placebo group as well. As always with a new agent, caution is warranted. I look to the manufacturers to perform detailed safety analysis in representative patient populations that reflect the types of patients we see in our practice.