As only a slightly immunocompromised smoldering patient, I've been debating getting the current Merck shingles vaccine (which is a live vaccine and is therefore technically contraindicated for immunocompromised patients). If you are immunocompromised and have a bad reaction to the current shingles vaccine, you can develop "disseminating disease", which is not at all pleasant and may even be worse than getting shingles itself - at least according to my doctor.
The good news is that I met with my oncologist today and he thought that there may be a new shingles vaccine on the horizon that may be used by immunocompromised patients such as myself. After the appointment, I did a little research and he was indeed spot on. The vaccine is known as Shingrix and it may receive FDA approval as soon as late October this year. Unlike Merck's current shingles vaccine, Shingrix is not a live vaccine, and it appears to be more efficacious in preventing shingles than the current Merck vaccine. This may be great news for us myeloma patients who don't want to prophylaptically take acyclovir every day to fend off shingles, or who are simply on a fearful watch for any signs of developing shingles.
Here's an article with more information:
http://www.fiercepharma.com/vaccines/eager-for-marketing-approval-gsk-s-shingrix-passes-revaccination-test
Forums
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: New shingles (Varicella zoster) vaccine: Shingrix
Thanks. That's great news.
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Arizonan - Name: Arizonan
- Who do you know with myeloma?: Self
- When were you/they diagnosed?: April 2010
- Age at diagnosis: 54
Re: New shingles (Varicella zoster) vaccine: Shingrix
A quick update on this:
A U.S. Food and Drug Administration advisory committee has unanimously recommended that Shingrix be approved by the FDA for marketing as a new shingles vaccine:
"'Impressed' FDA panel unanimously recommends GSK shingles vaccine," Reuters, Sep 13, 2017 (link to full text of article)
A few excerpts from the article:
"A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline’s Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over.
Panel members said they were “very impressed” by efficacy data from Shingrix clinical trials, and that it represents an improvement over Zostavax, the only marketed shingles prevention vaccine from Merck & Co.
While the FDA is not required to follow recommendations of its advisory panels, the enthusiasm expressed would seem to indicate that approval is a virtual certainty in coming weeks ...
In clinical trials, Shingrix has shown greater protection against shingles among older recipients than that demonstrated by Zostavax. Four years after injection, the GSK vaccine remained about 90 percent effective in people over age 70, while the efficacy of Zostavax declines noticeably over time ...
Shingrix, given in two doses two months apart, also reduces incidence of nerve pain following a shingles outbreak known as postherpetic neuralgia.
In two pivotal Phase III studies involving more than 29,000 subjects, serious side effects were similar for Shingrix and a placebo. Panelists had questions about a small but greater incidence of certain reported adverse health issues among Shingrix recipients, including gout and stroke."
Cheers!
A U.S. Food and Drug Administration advisory committee has unanimously recommended that Shingrix be approved by the FDA for marketing as a new shingles vaccine:
"'Impressed' FDA panel unanimously recommends GSK shingles vaccine," Reuters, Sep 13, 2017 (link to full text of article)
A few excerpts from the article:
"A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline’s Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over.
Panel members said they were “very impressed” by efficacy data from Shingrix clinical trials, and that it represents an improvement over Zostavax, the only marketed shingles prevention vaccine from Merck & Co.
While the FDA is not required to follow recommendations of its advisory panels, the enthusiasm expressed would seem to indicate that approval is a virtual certainty in coming weeks ...
In clinical trials, Shingrix has shown greater protection against shingles among older recipients than that demonstrated by Zostavax. Four years after injection, the GSK vaccine remained about 90 percent effective in people over age 70, while the efficacy of Zostavax declines noticeably over time ...
Shingrix, given in two doses two months apart, also reduces incidence of nerve pain following a shingles outbreak known as postherpetic neuralgia.
In two pivotal Phase III studies involving more than 29,000 subjects, serious side effects were similar for Shingrix and a placebo. Panelists had questions about a small but greater incidence of certain reported adverse health issues among Shingrix recipients, including gout and stroke."
Cheers!
Re: New shingles (Varicella zoster) vaccine: Shingrix
This is fantastic news Ian! Many thanks for posting the update. I wonder how long it will take for the vaccine to make it into the doctor's offices in the US and elsewhere, once officially approved by the FDA and other regulatory bodies throughout the world?
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: New shingles (Varicella zoster) vaccine: Shingrix
This is still a live vaccine. So I would ask your oncologist / myeloma specialist if it's ok for you to have the shingles vaccine. Even a little immune compromised can be the difference between being protected and getting a very bad reaction to the shot.
Nancy in Phila
Nancy in Phila
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NStewart - Name: Nancy Stewart
- Who do you know with myeloma?: self
- When were you/they diagnosed?: 3/08
- Age at diagnosis: 60
Re: New shingles (Varicella zoster) vaccine: Shingrix
I wonder if acyclovir would be needed still on top of this? Hopefully not.
Nancy, great news in that it seems this is not a live vaccine:
"Furthermore, Shingrix is a recombinant sub-unit vaccine rather than a live, attenuated virus like Zostavax. Live virus vaccines can't be used in immune-compromised patients, whereas Shingrix should have no problem getting approval for those situations." (source)
Also:
"Shingrix is a non-live, recombinant vaccine that combines glycoprotein E, a protein found on the varicella zoster virus (VZV), with an adjuvant system, AS01B, which is intended to enhance the immunological response to the antigen. " (source)
Nancy, great news in that it seems this is not a live vaccine:
"Furthermore, Shingrix is a recombinant sub-unit vaccine rather than a live, attenuated virus like Zostavax. Live virus vaccines can't be used in immune-compromised patients, whereas Shingrix should have no problem getting approval for those situations." (source)
Also:
"Shingrix is a non-live, recombinant vaccine that combines glycoprotein E, a protein found on the varicella zoster virus (VZV), with an adjuvant system, AS01B, which is intended to enhance the immunological response to the antigen. " (source)
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moonscape - Who do you know with myeloma?: me
- When were you/they diagnosed?: 11/2015
Re: New shingles (Varicella zoster) vaccine: Shingrix
The U.S. Food and Drug Administration went along with its advisory committee recommendation and has approved Shingrix, the new "non-live" shingles vaccine. Here is a Reuters article about the approval:
"GlaxoSmithKline adult shingles vaccine wins U.S. approval," Reuters, Oct 20, 2017 (full text of article)
Some key points:
The press release says that "the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses."
Interestingly, the FDA approval of the vaccine was not the first. About a week earlier, Singrix was approved in Canada. Here's a link to the GSK press release announcing the Canadian approval. It says that Shingrix "has been approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older." It goes on to say that Shingrix "is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses and is expected to be available through physicians’ offices and pharmacies in early 2018."
The press release about the Canadian approval also explains how Shingrix works. It says that the vaccine combines "a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to enhance this response and help address the natural age-related decline of the immune system."
Cheers!
"GlaxoSmithKline adult shingles vaccine wins U.S. approval," Reuters, Oct 20, 2017 (full text of article)
Some key points:
- The company said it expects Shingrix 'will be available shortly.'"
- "Shingrix has shown greater protection against shingles among older recipients than Zostavax. Four years after injection, the Glaxo vaccine remained about 90 percent effective in people over age 70, while the efficacy of Zostavax declines noticeably over time."
- "Given in two doses two months apart, Shingrix also reduces incidence of nerve pain following a shingles outbreak."
The press release says that "the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses."
Interestingly, the FDA approval of the vaccine was not the first. About a week earlier, Singrix was approved in Canada. Here's a link to the GSK press release announcing the Canadian approval. It says that Shingrix "has been approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older." It goes on to say that Shingrix "is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses and is expected to be available through physicians’ offices and pharmacies in early 2018."
The press release about the Canadian approval also explains how Shingrix works. It says that the vaccine combines "a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to enhance this response and help address the natural age-related decline of the immune system."
Cheers!
Re: New shingles (Varicella zoster) vaccine: Shingrix
This is very good news! Thanks again Ian. I will be asking my GP's office to place an order for the vaccine.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: New shingles (Varicella zoster) vaccine: Shingrix
Good news about this being a non-live vaccine. I'll ask my oncologist about it when I see him next week. The center where I am treated participated in a clinical trial for a non-live vaccine. I don't know if Shingrix is the vaccine that was being tested in the trial that they were part of.
Nancy in Phila
Nancy in Phila
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NStewart - Name: Nancy Stewart
- Who do you know with myeloma?: self
- When were you/they diagnosed?: 3/08
- Age at diagnosis: 60
Re: New shingles (Varicella zoster) vaccine: Shingrix
I echo the above comments about a non-live shingles vaccine being a good development! I hope to get it next year also.
Just had the flu shot and also the pneumococcal vaccine. Here in Alberta the pneumococcal vaccine is just given free once to healthy people over age 65, but for me this was a five year repeat of the vaccine, since I had all my (childhood and other) vaccines again after my stem cell transplant. I also had that vaccine before my stem cell transplant, when I was initially diagnosed and going through induction chemotherapy, due to being immune-compromised.
I understood at the time of all my childhood re-vaccinations that the varicella vaccine (for chickenpox) can help to prevent shingles, since the two viruses are in the same family. It will be nice to get a vaccine meant just for shingles though, hopefully!
Just had the flu shot and also the pneumococcal vaccine. Here in Alberta the pneumococcal vaccine is just given free once to healthy people over age 65, but for me this was a five year repeat of the vaccine, since I had all my (childhood and other) vaccines again after my stem cell transplant. I also had that vaccine before my stem cell transplant, when I was initially diagnosed and going through induction chemotherapy, due to being immune-compromised.
I understood at the time of all my childhood re-vaccinations that the varicella vaccine (for chickenpox) can help to prevent shingles, since the two viruses are in the same family. It will be nice to get a vaccine meant just for shingles though, hopefully!
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Nancy Shamanna - Name: Nancy Shamanna
- Who do you know with myeloma?: Self and others too
- When were you/they diagnosed?: July 2009
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