Herpes Zoster Vaccination - "Shingrex" versus "Zostavax"
Canuck said
Mar 11, 2018
From "Medscape":
Perspective > Medscape Infectious Diseases > Offit on Vaccines
COMMENTARY
Shingrix: Is the Hype Justified?
Paul A. Offit, MD - DISCLOSURES -
February 13, 2018
Hi. My name is Paul Offit. I'm talking to you from the Vaccine Education Center at Children's Hospital of Philadelphia. I want to talk about a newly licensed and recommended shingles vaccine.
Shingles, as you know, is a reactivation of an original chickenpox infection that travels down a dermatome and causes rash and pain. It's a common infection - roughly 1 in every 1000 people every year in the United States will suffer shingles, and about 1 in 3 people in the United States will suffer shingles in their lifetime. Usually, shingles occurs in those > 65 years of age.
The pain of shingles is one of the worst pains in medicine. It's right up there with corneal abrasions, labor and delivery, and kidney stones (which is like labor and delivery for men) - an incredibly painful experience.
The first shingles vaccine was licensed and recommended in 2006. It's called Zostavax® and is a live, weakened form of the chickenpox (varicella) virus. In fact, Zostavax is the varicella vaccine; it's just 14 times the dose. The efficacy of Zostavax against rash was about 51%; the efficacy against postherpetic neuralgia (the pain associated with shingles) was about 67%, and the duration wasn't great. After about 4 years, the protective effect for postherpetic neuralgia went from about 67% down to about 30%.
Recently, in October 2017, another shingles vaccine was licensed and recommended. It's called Shingrix, and it's made in quite a biologically different manner. Instead of being a whole weakened form of the virus, it's just one protein that sits on the surface of the virus - the so-called glycoprotein E - and then two adjuvants are used. One adjuvant is called monophosphoryl lipid A (which is just a detoxified lipid A), the same adjuvant that was used in Cervarix®. The other is a novel adjuvant, one that we haven't used in this country before. It's called QS-21. It's a glycoside (specifically, saponin). The "QS" stands for the name of the tree (Quillaja saponaria) from which this product was purified. It's a soap tree indigenous to Chile. The "21" stands for the 21st chromatographic peak from which this saponin was isolated.
If you look at the efficacy of Shingrix against rash, it's not 51% (as was the case with Zostavax); it's in the mid- to high 90% range, for all age groups - even for those over 70 years of age.[1,2] Similarly, if you look at the protective efficacy against postherpetic neuralgia, it's in the high 80% to low-mid 90% range, and the duration is much greater - 4 years later, the protective efficacy is still about 85%.[1,2]
How should this vaccine be used? This was the question faced by the Advisory Committee on Immunization Practices (ACIP) in October. They made the following recommendations[3]:
This vaccine can be given starting at 50 years of age;
It's a two-dose vaccine, with the second dose being given 2-6 months after the first;
It is the preferred vaccine - those who have not yet received a shingles vaccine should receive Shingrix rather than Zostavax; and
Even if you've already had Zostavax, it is still recommended that you receive two doses of the Shingrix vaccine.
It's pretty remarkable. Typically, the gold standard for inducing long-lived, highly effective protective immune responses is much better defined for live attenuated viruses than for purified protein (so-called "subunit vaccines"), but this is one of those rare examples - in fact, the only example I can think of - where the purified protein (the glycoprotein A) vaccine induces a better and longer lasting response than the live attenuated viral vaccine.
The side effect profile for systemic side effects (fever, myalgia, chills) is somewhat worse for Shingrix than for Zostavax, but that said, fewer than 5% of people who received Shingrix said that it interfered in any sense with their daily lives. So, it certainly looks like the better vaccine.
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this article: Paul A. Offit. Shingrix: Is the Hype Justified? - Medscape - Feb 13, 2018.
Canuck said
Mar 6, 2018
Tig wrote:
Sometimes I barely have time to read a synopsis! Ill do better Back on diaper duty...
Hey! Nice - you are babysitting! Send pics. C.
Tig said
Mar 5, 2018
Sometimes I barely have time to read a synopsis! I’ll do better Back on diaper duty...
Canuck said
Mar 4, 2018
I believe (if you "read between the lines" of their announcement of "changes" below) - that IS what they seem to be trying to say or are striving for, a "change" over to the Shingrex and away form the "live" Zostavax. Even for Shingrex there still exist caveats for certain "immunocompromized" and contra-indications (when to delay use) that have yet to firmed up it seems (pending).
Tig said
Mar 4, 2018
Just my opinion, but until additional investigation is complete, I would give the Zostavax vaccine a pass. There have been some questions regarding its use and safety.
”For patients who are immunocompromised, their bodies may not be able to fight off the small dose of the virus.”
There was a fair bit of "talk" in the Journals, about safety profiles, and "Shingrex" getting approved for use over the "live" Zostavax in 2018. Between 2015 and as late as 2017 studies were still being completed about the effectiveness of Hep B and Zostavax immunizations in folk in association with co-infections such a Hep C - (see also these older Zostavax trial studies - Trials - Hep B or Shingles Immunization - (if never immunized for these) and if you have HCV .
From Medscape:
Morbidity & Mortality Weekly Report - Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older - United States, 2018
David K. Kim, MD; Laura E. Riley, MD; Paul Hunter, MD
Morbidity and Mortality Weekly Report. 2018;67(5):158-160.
Changes in the 2018 Adult Immunization Schedule
Zoster Vaccination[2]
On October 20, 2017, the Food and Drug Administration approved the use of RZV (SHINGRIX, GlaxoSmithKline [GSK]) for adults aged 50 years or older for the prevention of herpes zoster (shingles) and its complications.
On October 25, ACIP recommended the use of:
1) RZV among immunocompetent adults aged 50 years or older for the prevention of herpes zoster and related complications,
2) RZV among adults aged 50 years or older who previously received the zoster vaccine live (ZVL) (ZOSTAVAX, Merck and Co.),and
3) either RZV or ZVL for adults aged 60 years or older (RZV is preferred).
On October 26, 2017, ACIP recommended the following in the 2018 adult immunization schedule:
·Administer 2 doses of RZV 2-6 months apart to adults aged 50 years or older regardless of past episode of herpes zoster or receipt of ZVL.
·Administer 2 doses of RZV 2-6 months apart to adults who previously received ZVL at least 2 months after ZVL.
·For adults aged 60 years or older, administer either RZV or ZVL (RZV is preferred).
The clinical trials for RZV excluded pregnancy and confirmed or suspected immunocompromising conditions that can result from disease (e.g., malignancy, HIV infection) or therapy (e.g., cancer chemotherapy, treatment for autoimmune disorders).[3-6] Therefore, no ACIP recommendation currently exists for use of RZV among pregnant women (health care providers should consider delaying administration of RZV for pregnant women) or adults with immunocompromising conditions, including HIV infection (additional discussions and recommendations by ACIP on the use of RZV in adults with immunocompromising conditions are pending).
Consistent with the existing recommended use of ZVL, ACIP recommended RZV for adults who are receiving low-dose (<20 mg/day of prednisone or equivalent) or short-term (<14 days of corticosteroids) immunosuppressive therapy, are anticipating immunosuppression, or have recovered from an immunocompromising illness.[7] The clinical trials for RZV did not exclude adults with non-immunocompromising chronic health conditions.[3-6]
Therefore, given the safety and effectiveness profiles of other conjugate vaccines recommended for adults (e.g., hepatitis B and pneumococcal vaccines), ACIP recommended that RZV should routinely be used for age-eligible adults with diabetes mellitus; chronic heart, lung, liver, or kidney disease; functional or anatomical asplenia; or complement deficiencies ...
From "Medscape":
COMMENTARY
Shingrix: Is the Hype Justified?
Paul A. Offit, MD - DISCLOSURES -
February 13, 2018
Hi. My name is Paul Offit. I'm talking to you from the Vaccine Education Center at Children's Hospital of Philadelphia. I want to talk about a newly licensed and recommended shingles vaccine.
Shingles, as you know, is a reactivation of an original chickenpox infection that travels down a dermatome and causes rash and pain. It's a common infection - roughly 1 in every 1000 people every year in the United States will suffer shingles, and about 1 in 3 people in the United States will suffer shingles in their lifetime. Usually, shingles occurs in those > 65 years of age.
The pain of shingles is one of the worst pains in medicine. It's right up there with corneal abrasions, labor and delivery, and kidney stones (which is like labor and delivery for men) - an incredibly painful experience.
The first shingles vaccine was licensed and recommended in 2006. It's called Zostavax® and is a live, weakened form of the chickenpox (varicella) virus. In fact, Zostavax is the varicella vaccine; it's just 14 times the dose. The efficacy of Zostavax against rash was about 51%; the efficacy against postherpetic neuralgia (the pain associated with shingles) was about 67%, and the duration wasn't great. After about 4 years, the protective effect for postherpetic neuralgia went from about 67% down to about 30%.
Recently, in October 2017, another shingles vaccine was licensed and recommended. It's called Shingrix, and it's made in quite a biologically different manner. Instead of being a whole weakened form of the virus, it's just one protein that sits on the surface of the virus - the so-called glycoprotein E - and then two adjuvants are used. One adjuvant is called monophosphoryl lipid A (which is just a detoxified lipid A), the same adjuvant that was used in Cervarix®. The other is a novel adjuvant, one that we haven't used in this country before. It's called QS-21. It's a glycoside (specifically, saponin). The "QS" stands for the name of the tree (Quillaja saponaria) from which this product was purified. It's a soap tree indigenous to Chile. The "21" stands for the 21st chromatographic peak from which this saponin was isolated.
If you look at the efficacy of Shingrix against rash, it's not 51% (as was the case with Zostavax); it's in the mid- to high 90% range, for all age groups - even for those over 70 years of age.[1,2] Similarly, if you look at the protective efficacy against postherpetic neuralgia, it's in the high 80% to low-mid 90% range, and the duration is much greater - 4 years later, the protective efficacy is still about 85%.[1,2]
How should this vaccine be used? This was the question faced by the Advisory Committee on Immunization Practices (ACIP) in October. They made the following recommendations[3]:
This vaccine can be given starting at 50 years of age;
It's a two-dose vaccine, with the second dose being given 2-6 months after the first;
It is the preferred vaccine - those who have not yet received a shingles vaccine should receive Shingrix rather than Zostavax; and
Even if you've already had Zostavax, it is still recommended that you receive two doses of the Shingrix vaccine.
The side effect profile for systemic side effects (fever, myalgia, chills) is somewhat worse for Shingrix than for Zostavax, but that said, fewer than 5% of people who received Shingrix said that it interfered in any sense with their daily lives. So, it certainly looks like the better vaccine.
Thank you very much for your attention.
Medscape Infectious Diseases © 2018 WebMD, LLC
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this article: Paul A. Offit. Shingrix: Is the Hype Justified? - Medscape - Feb 13, 2018.
Hey! Nice - you are babysitting! Send pics.
C.
Sometimes I barely have time to read a synopsis! I’ll do better
Back on diaper duty...
I believe (if you "read between the lines" of their announcement of "changes" below) - that IS what they seem to be trying to say or are striving for, a "change" over to the Shingrex and away form the "live" Zostavax. Even for Shingrex there still exist caveats for certain "immunocompromized" and contra-indications (when to delay use) that have yet to firmed up it seems (pending).
Just my opinion, but until additional investigation is complete, I would give the Zostavax vaccine a pass. There have been some questions regarding its use and safety.
”For patients who are immunocompromised, their bodies may not be able to fight off the small dose of the virus.”
Litigation: Zostavax
There was a fair bit of "talk" in the Journals, about safety profiles, and "Shingrex" getting approved for use over the "live" Zostavax in 2018. Between 2015 and as late as 2017 studies were still being completed about the effectiveness of Hep B and Zostavax immunizations in folk in association with co-infections such a Hep C - (see also these older Zostavax trial studies - Trials - Hep B or Shingles Immunization - (if never immunized for these) and if you have HCV .
From Medscape:
Morbidity & Mortality Weekly Report - Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older - United States, 2018
David K. Kim, MD; Laura E. Riley, MD; Paul Hunter, MD
Morbidity and Mortality Weekly Report. 2018;67(5):158-160.
Changes in the 2018 Adult Immunization Schedule
Zoster Vaccination[2]
On October 20, 2017, the Food and Drug Administration approved the use of RZV (SHINGRIX, GlaxoSmithKline [GSK]) for adults aged 50 years or older for the prevention of herpes zoster (shingles) and its complications.
On October 25, ACIP recommended the use of:
1) RZV among immunocompetent adults aged 50 years or older for the prevention of herpes zoster and related complications,
2) RZV among adults aged 50 years or older who previously received the zoster vaccine live (ZVL) (ZOSTAVAX, Merck and Co.),and
3) either RZV or ZVL for adults aged 60 years or older (RZV is preferred).
On October 26, 2017, ACIP recommended the following in the 2018 adult immunization schedule:
· Administer 2 doses of RZV 2-6 months apart to adults aged 50 years or older regardless of past episode of herpes zoster or receipt of ZVL.
· Administer 2 doses of RZV 2-6 months apart to adults who previously received ZVL at least 2 months after ZVL.
· For adults aged 60 years or older, administer either RZV or ZVL (RZV is preferred).
The clinical trials for RZV excluded pregnancy and confirmed or suspected immunocompromising conditions that can result from disease (e.g., malignancy, HIV infection) or therapy (e.g., cancer chemotherapy, treatment for autoimmune disorders).[3-6] Therefore, no ACIP recommendation currently exists for use of RZV among pregnant women (health care providers should consider delaying administration of RZV for pregnant women) or adults with immunocompromising conditions, including HIV infection (additional discussions and recommendations by ACIP on the use of RZV in adults with immunocompromising conditions are pending).
Consistent with the existing recommended use of ZVL, ACIP recommended RZV for adults who are receiving low-dose (<20 mg/day of prednisone or equivalent) or short-term (<14 days of corticosteroids) immunosuppressive therapy, are anticipating immunosuppression, or have recovered from an immunocompromising illness.[7] The clinical trials for RZV did not exclude adults with non-immunocompromising chronic health conditions.[3-6]
Therefore, given the safety and effectiveness profiles of other conjugate vaccines recommended for adults (e.g., hepatitis B and pneumococcal vaccines), ACIP recommended that RZV should routinely be used for age-eligible adults with diabetes mellitus; chronic heart, lung, liver, or kidney disease; functional or anatomical asplenia; or complement deficiencies ...