Shingrix shingles vaccine approved by FDA

[Hindags]

I just read this article published in the New York Times, April 10, 2018.

nytimes.com/2018/04/09/well...

The next to the last paragraph is probably most pertinent to us. I'm sure it hasn't been tested on people with PMR yet but perhaps with other AI disorders or on immunosuppressant medications.

This is an article from last November that talks more about people in immunosuppressed states. nytimes.com/2017/11/10/heal...

This article out of Canada has more details comparing people who took Shingrix vs Placebo under the Clinical Trials section.

ca.gsk.com/media/1350788/sh...

I found the discussion of adverse events most germaine.

Potential Immune-Mediated DiseasesIn studies ZOE-50 and ZOE-70, new onset of potential immune-mediated diseases (pIMDs) or exacerbation of existing pIMDs were reported for 1.2% of subjects who received SHINGRIX and 1.4% of subjects who received placebo during the entire follow-up period (median 4.4 years, range: 0 to 5.0 years). Approximately half of pIMDs occurred with time to onset longer than one year after the last vaccination. The most frequently reported pIMDs in the vaccine and placebo groups were polymyalgia rheumatica (0.2% in each group), rheumatoid arthritis (0.1% versus 0.2%, respectively), psoriasis (0.1% in each group), and autoimmune thyroiditis (0.1% in each group).

I think it is worthwhile discussing with my Rheumy. I had chicken pox at 18 months, and Herpes Zoster at age 22 in my middle ear. So I know it is lurking.....I had the older vaccine when it came out, but I suspect I'm susceptible. Not sure I want to rock the PMR boat right now, but if I read this correctly, there was no difference between Shingrix and Placebo groups over the four years tested.

[SnazzyD]

I’d be more reassured if I knew the placebo group just had something like saline instead of the carrier, with all the adjuvants etc, minus the virus. It may be the constituents of the vaccine other than the virus that stimulate an immune response that, in some, cause an overreaction.

[PMRpro Ambassador in reply to SnazzyD]

Should be multiple groups - no virus, no carriers, vaccine.

[SnazzyD in reply to PMRpro]

Yes, should be but when I was researching vaccines for my kids, some vaccine data hadn’t be done like that. Also, another thing I found was short periods for collecting the data.

[PMRpro Ambassador in reply to SnazzyD]

Oh yes - don't I know. I trust nothing until it's been on the market for a decent interval!

[jinasc]

If its live...........................I would not touch it.

I had had shingles and then when it raised its ugly head again, the GP moved fast and I got the 'stuff' (cannot remember the name) which stopped it in its tracks. The 'stuff' has to be given within a 24 hours window from the first signs.

[HeronNS in reply to jinasc]

It's not live. And it's supposed to be much more effective in the older population than Zostavax. My husband had it last week and was knocked flat with flulike symptoms for most of a day. He had a large very red patch at vaccination site, which subsided to a bruiselike appearance after another couple of days. I wouldn't let him have Zostavax as I haven't had CP and didn't want to risk exposure to the live virus.

[jinasc in reply to HeronNS]

Great, I read it quickly, but could not find 'live' or 'dead'

Cheers HeronNS.

[HeronNS in reply to jinasc]

medsask.usask.ca/documents/...

[jinasc in reply to HeronNS]

Heron

Thank you, have bookmarked it.

[polymy in reply to jinasc]

I think the ‘stuff’ is Acyclovir. I had it too as soon as the rash appeared. It stopped more blisters appearing but I was still poorly and had nerve pain for a few weeks.

Liz.

[jinasc in reply to polymy]

Thank you it is the name of the 'stuff'. I am sorry to hear you still had pain and were poorly for a few weeks, a couple of days and I was fine. Guess I was lucky that day.

[Rimmy]

Still I feel conflicted about whether to have or not to have - even the non-live vaccine Shingrix !!!??? ---- I'll be interested to read the responses and consensus here and any reported experiences ...

Thanks for the info Hindags

Rimmy

[Grants148]

I did not have this vaccine,l know someone who became very ill after it. I am sure that it may be perfectly OK for a lot of people but the side effects can be a problem and having PMR could make it more risky. I had chicken pox as a child and also had shingles a few years ago,although it was only a small area that was affected.

[VAl4266]

I had the shingles jab,the two months later had shingles, was very painful for about. 4 weeks, then faded out, I haven't had the pain afterwards, as some people have after shingles, so maybe the vaxination was the reason it wasn't so severe

[HeronNS in reply to VAl4266]

Which vaccination did you have? Zostavax (live vaccine, fairly ineffective for older patients) or Shingrix (killed virus something like 90% effective in people over 50)?

[PMRpro Ambassador in reply to HeronNS]

The Canadian documentation claims 98%!!!!

[rbecich]

Just got the first dose last week. Be sure you are not doing anything for 3 days after getting the shot. Very sore arm for about four days and felt under the weather for a couple of days.

[tomhalil]

I'm sorry if this sounds as a dumb question but what is this vaccine supposed to accomplish for us?

[PMRpro Ambassador in reply to tomhalil]

It is claimed that it reduces the risk of developing shingles and, if you do develop shingles, reduces the risk of post-herpetic neuraligia which is probbaly the worse part of shingles.

cdc.gov/vaccines/vpd/shingl...

[VAl4266]

I don't know which one of the vaxination I had but will find out when I go to dr, on Monday, if I can of course

[HeronNS in reply to VAl4266]

If you weren't required to have a second shot it will have been Zostavax as the Shingrix requires two doses, the second within 2 to 6 months after the first.

[PMRpro Ambassador in reply to VAl4266]

It will have been the Zostavax one, Shingrix is not yet available to the public in the UK:

uknow.uky.edu/uk-healthcare...

[VAl4266]

Ok,yes was just the one, perhaps that is why I ended up with shingles then,didn't get the right one,

[HeronNS in reply to VAl4266]

Shingrix has only recently been approved, may not have been available then.

[PMRpro Ambassador in reply to HeronNS]

Still isn't as far as I know.

[HeronNS in reply to PMRpro]

In UK and/or Europe?

[PMRpro Ambassador in reply to HeronNS]

According to the link I put up it will not be until sometime this year in Europe, including the UK.

[HeronNS in reply to PMRpro]

Ha, guess I should have read further up thread. Start my day by checking my notifications.... I wonder if the second shot is typically better or worse for reaction than the first. If worse I think hubby will need to plan his schedule carefully.

[PMRpro Ambassador in reply to HeronNS]

Don't know - will be interesting to find out! He is noble to do this for us!!!