{"id":8466,"date":"2017-09-17T16:27:07","date_gmt":"2017-09-17T20:27:07","guid":{"rendered":"https:\/\/blogs.nejm.org\/hiv-id-observations\/?p=8466"},"modified":"2017-10-26T18:53:12","modified_gmt":"2017-10-26T22:53:12","slug":"inactivated-zoster-vaccine-soon-to-be-approved-should-patients-wait","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/inactivated-zoster-vaccine-soon-to-be-approved-should-patients-wait\/2017\/09\/17\/","title":{"rendered":"Subunit Zoster Vaccine Soon to Be Approved — Should Patients Wait for It?"},"content":{"rendered":"
\"\"<\/a>

Man with herpes zoster, 1893. National Library of Medicine.<\/p><\/div>\n

For the last year or so, conversations with patients about getting the zoster vaccine have gone something like this:<\/p>\n

Patient:<\/em> So should I get the shingles vaccine? I saw an ad for it on TV<\/a>.
\nMe:<\/em> \u00a0Well, yes … and no.
\nPatient (confused — he\/she has never heard me say anything but an enthusiastic “Yes!” to vaccines):<\/em> \u00a0What does that mean?
\nMe:<\/em> \u00a0There’s a better shingles vaccine coming soon, likely within a year. So I’d wait.<\/p>\n

Now it looks like that wait is almost over.<\/p>\n

This past week, an FDA advisory panel voted unanimously that the investigational subunit zoster vaccine is safe and effective for adults older than 50.\u00a0The materials the panel reviewed are here<\/a>.<\/p>\n

FDA approval should follow soon — potentially next month — along with the critical review and recommendations from the Advisory Committee on Immunization Practices (ACIP).<\/p>\n

The expert advisory panel based their decision on two pivotal randomized trials, ZOE-50<\/a> and ZOE-70<\/a>, which compared the vaccine (administered as two doses) to placebo in people aged 50 and older or 70 and older, respectively. The studies enrolled nearly 30,000 subjects.<\/p>\n

Vaccine efficacy was 97% in the first study, 89% in the second. The incidence of post-herpetic neuralgia was also reduced.<\/p>\n

Importantly, adverse events were more common in vaccine recipients, but most were of mild severity. There was no significant difference in the incidence of severe side effects, deaths, or autoimmune processes.<\/p>\n

Though these studies were not a direct comparison with the currently available live-attenuated zoster vaccine (Zostavax), remember that the efficacy of that vaccine is only around 50%<\/a>.<\/p>\n

Plus,\u00a0it has been around long enough that we now know its efficacy wanes substantially over time<\/a>.<\/p>\n

That Zostavax is a live-virus vaccine creates additional difficulties. There is understandable concern — and confusion<\/a> — about giving it to people with defects in cell-mediated immunity, for whom it’s contraindicated, and their household contacts, for whom it isn’t.<\/p>\n

Finally, there are the practical difficulties of storing it before administration. Even clinics that do lots of immunizations — ours, for example — don’t have the required stand-alone freezer for storage of this vaccine. Many patients currently need to go to a pharmacy to get it, which adds an additional required step.<\/p>\n

So this inactivated zoster vaccine won’t be just a “me-too” approval, but a real advance in prevention of what can be a truly debilitating condition. With the caveat that we lack safety data in very large patient populations — that should come after licensing — I’m not surprised the advisory panel voted the way they did.<\/p>\n

It was exciting enough that I felt inspired to relay the following:<\/p>\n

\n

Big news because
1) Highly effective
2) Safe
3) Not live attenuated
5) Shingles can be BAD
5) Have been telling my pts about it for months! https:\/\/t.co\/4HJrK0wNAo<\/a><\/p>\n

— Paul Sax (@PaulSaxMD) September 13, 2017<\/a><\/p><\/blockquote>\n