Zoster vaccine

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Zoster vaccine
Shingles vaccines.jpg
Vaccine description
Target Herpes zoster, postherpetic neuralgia, Ramsay Hunt syndrome type II
Vaccine type
  • Zostavax: attenuated
  • Shingrix: recombinant protein subunit
Clinical data
Trade names Zostavax, Shingrix
License data
Pregnancy
category
Routes of
administration
ATC code
Legal status
Legal status
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A zoster vaccine is a vaccine that reduces the incidence of herpes zoster (shingles), a disease caused by reactivation of the varicella zoster virus, which is also responsible for chickenpox. [7] Shingles provokes a painful rash with blisters, and can be followed by chronic pain (postherpetic neuralgia), as well as other complications. Older people are more often affected, as are people with weakened immune systems (immunosuppression). Both shingles and postherpetic neuralgia can be prevented by vaccination. [8]

Contents

Two zoster vaccines have been approved for use in people over 50 years old. [8] Shingrix (GSK) is a recombinant subunit vaccine which has been used in many countries since 2017. [9] Zostavax (Merck), in use since 2006, [10] is an attenuated vaccine which consists of a larger-than-normal dose of chickenpox vaccine. [7] Unlike Shingrix, Zostavax is not suitable for people with immunosuppression or diseases that affect the immune system. [8] Zostavax was discontinued in the United States in November 2020. [11]

Shingrix appears to prevent more cases of shingles than Zostavax, although side effects seem to be more frequent. [9] [12]

Another vaccine, known as varicella vaccine, is used to prevent diseases caused by the same virus. [13]

Medical uses

Zoster vaccination is used to prevent shingles and its complications, including postherpetic neuralgia. [7] [8] It can be considered a therapeutic vaccine, given that it is used to treat a latent virus that has remained dormant in cells since chicken pox infection earlier in life. [7] The two available zoster vaccines are intended for use in people over the age of 50. [8] As of 2021 it remained to be confirmed whether a booster dose was required, [14] [9] but the Advisory Committee on Immunization Practices (ACIP) in the United States recommends Shingrix for adults over the age of 50, including those who have already received Zostavax. [15]

Shingrix

Shingrix Shingrix.jpg
Shingrix

The ACIP voted that Shingrix is preferred over Zostavax for the prevention of zoster and related complications because data showed vaccine efficacy of more than 90% against shingles across all age groups. Unlike Zostavax, which is given as a single shot, Shingrix is given as two identical intramuscular doses, two to six months apart. [15] [10] [16] [ better source needed ] Shingrix provides high levels of immunity for at least 7 years after vaccination, but it is possible the vaccine may provide protection for much longer. [17] [18]

A large randomized clinical trial[ which? ] showed Shingrix reduced the incidence of shingles 96.6% (relative risk reduction, RRR) in the 50–59 age group, and 91.3% (relative risk reduction, RRR) in those over age 70.[ citation needed ] The absolute decrease in risk (absolute risk reduction, ARR) of herpes zoster following immunization over three and a half years is 3.3% (3.54% down to 0.28%) while the decrease in the risk of postherpetic neuralgia is 0.3% (0.34% down to 0.06%). [19] [20] [21]

Zostavax

Zostavax vaccine ZOSTAVAX (shingles (herpes zoster) vaccine (live)) (United Kingdom).jpg
Zostavax vaccine

The Zostavax vaccine (both single dose and two-dose regime) is likely effective at protecting people from herpes zoster disease for a duration of up to three years. [22] The degree of longer term protection (beyond 4 years from the initial vaccination) is not clear. The need for re-vaccination after the first full vaccine schedule is complete remains to be confirmed. [22]

Zostavax was shown to reduce the incidence of shingles by 51% in a study of 38,000 adults aged 60 and older who received the vaccine. The vaccine also reduced by 67% the number of cases of postherpetic neuralgia (PHN) and reduced the severity and duration of pain and discomfort associated with shingles, by 61%. [23] [24] [3] The FDA originally recommended it for individuals 60 years of age or older who are not severely allergic to any of its components and who meet the following requirements: [25] [26]

In 2006, the US Advisory Committee on Immunization Practices (ACIP) recommended that the live vaccine be given to all adults age 60 and over, including those who have had a previous episode of shingles, [27] and those who do not recall having had chickenpox, since more than 99% of Americans ages 40 and older have had chickenpox. [17]

Side effects

Shingrix

Temporary side effects from the Shingrix shots are likely and can be severe enough in one out of six people to affect normal daily activities for up to three days. [17] Mild to moderate pain at the injection site is common, and some may have redness or swelling. [17] Side effects include fatigue, muscle pain, headache, shivering, fever, and nausea. [17] Symptoms usually resolve in two to three days. [17] Side effects with Shingrix are greater than those with Zostavax and occur more frequently in individuals aged 50 to 69 years compared with those 70 years and older. [9] [4]

Zostavax

The live vaccine (Zostavax) is very safe; one to a few percent of people develop a mild form of chickenpox, often with about five or six blisters around the injection site, and without fever. The blisters are harmless and temporary. [28] [29] In one study 64% of the Zostavax group and 14% of the controls had some adverse reaction. However, the rates of serious adverse events were comparable between the Zostavax group (0.6%) and those receiving the placebo (0.5%). [30] A study including children with leukaemia found that the risk of getting shingles after vaccination is much lower than the risk of getting shingles for children with natural chicken pox in their history. Data from healthy children and adults point in the same direction. [28]

Zostavax is not used in people with compromised immune function. [31] [32]

Composition

Shingrix

Shingrix is a suspension for intramuscular injection consisting of a lyophilized recombinant varicella zoster virus glycoprotein E antigen that is reconstituted at the time of use with AS01B suspension as an immunological adjuvant. The antigen is a purified truncated form of the glycoprotein, expressed in Chinese hamster ovary cells. The AS01B adjuvant suspension is composed of 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella (Minnesota strain) and a saponin molecule (QS-21) purified from Quillaja saponaria (soap bark tree) extract, combined in a liposomal formulation consisting of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate-buffered saline solution. [33]

Zostavax

Zostavax contains live attenuated varicella-zoster virus. [28] [11] It is injected subcutaneously (under the skin) in the upper arm. [34] The live vaccine is produced using the MRC-5 line of fetal cells. [3] This has raised religious and ethical concerns for some potential users, since that cell line was derived from an aborted fetus. [35]

Cost effectiveness

A 2007 study found that the live vaccine is likely to be cost-effective in the US, projecting an annual savings of US$82 to US$103 million in healthcare costs with cost-effectiveness ratios ranging from US$16,229 to US$27,609 per quality-adjusted life year gained. [36] In 2007, the live vaccine was officially recommended in the US for healthy adults aged 60 and over, but is no longer given out in the United States as of 2020, given the superiority of Shingrix. [37] [38] [39]

In Canada the cost of Shingrix is about CA$300 for the two doses. [19] This likely represents a more cost effective intervention than the live vaccine given its lower cost and increased effectiveness. [40]

History

European Union

In 2006, the European Medicines Agency (EMA) issued a marketing authorization for the zoster vaccine to Sanofi Pasteur for routine vaccination in individuals aged 60 and over. [41] [5] In 2007, the EMA updated the marketing authorization for routine vaccination in individuals aged 50 and over. [42] [5]

Shingrix was approved for medical use in the European Union in March 2018, with an indication for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults 50 years of age or older. [6]

United Kingdom

From 2013, the UK National Health Service (NHS) started offering shingles vaccination to elderly people. People aged either 70 or 79 on 1 September 2013, were offered the vaccine. People aged 71 to 78 on that date would only have an opportunity to have the shingles vaccine after reaching the age of 79. [43] The original intention was for people aged between 70 and 79 to be vaccinated, but the NHS later said that the vaccination program was being staggered as it would be impractical to vaccinate everyone in their 70s in a single year. [44]

In 2021, vaccination against shingles is available on the NHS to people aged 70 to 79. [45] Vaccination is with single-dose Zostavax, except for people for whom Zostavax is deemed unsuitable, for example, with a condition that affects the immune system, for whom two-dose Shingrix vaccine is recommended. [45] The NHS stated "The shingles vaccine is not available on the NHS to anyone aged 80 or over because it seems to be less effective in this age group". [45]

United States

Zostavax was developed by Merck & Co. and approved and licensed by the US Food and Drug Administration (FDA) in May 2006, [23] In 2011, the FDA approved the live vaccine for use in individuals 50 to 59 years of age. [3] [46] Shingrix is a zoster vaccine developed by GlaxoSmithKline that was approved in the United States in October 2017. [47] Shingrix, which provides strong protection against shingles and PHN, was preferred over Zostavax before Zostavax was discontinued. [48]

In June 2020, Merck discontinued the sale of Zostavax in the US. Vaccine doses already held by practitioners could still be administered up to the expiration date (none expired later than November 2020). [49] [11]

The US Centers for Disease Control and Prevention (CDC) recommends that healthy adults 50 years and older get two doses of Shingrix, at least two months apart. Initial clinical trials only tested a gap of less than six months between doses, but unexpected popularity and resulting shortages caused further testing to validate wider spacing of the two doses. [50] [51] Adults 19 years and older who are immunocompromised because of disease or therapy are also recommended to receive two doses of Shingrix. [17]

The zoster vaccine is covered by Medicare Part D. In 2019, more than 90% of Medicare Part D vaccine spending was for the zoster vaccine. 5.8 million vaccine doses were administered to Part D beneficiaries that year at a cost of $857 million. [52]

Related Research Articles

<span class="mw-page-title-main">Ramsay Hunt syndrome type 2</span> Presentation of shingles in the geniculate ganglion

Ramsay Hunt syndrome type 2, commonly referred to simply as Ramsay Hunt syndrome (RHS) and also known as herpes zoster oticus, is inflammation of the geniculate ganglion of the facial nerve as a late consequence of varicella zoster virus (VZV). In regard to the frequency, less than 1% of varicella zoster infections involve the facial nerve and result in RHS. It is traditionally defined as a triad of ipsilateral facial paralysis, otalgia, and vesicles close to the ear and auditory canal. Due to its proximity to the vestibulocochlear nerve, the virus can spread and cause hearing loss, tinnitus, and vertigo. It is common for diagnoses to be overlooked or delayed, which can raise the likelihood of long-term consequences. It is more complicated than Bell's palsy. Therapy aims to shorten its overall length, while also providing pain relief and averting any consequences.

<span class="mw-page-title-main">MMR vaccine</span> Any of several combined vaccines against measles, mumps, and rubella

The MMR vaccine is a vaccine against measles, mumps, and rubella, abbreviated as MMR. The first dose is generally given to children around 9 months to 15 months of age, with a second dose at 15 months to 6 years of age, with at least four weeks between the doses. After two doses, 97% of people are protected against measles, 88% against mumps, and at least 97% against rubella. The vaccine is also recommended for those who do not have evidence of immunity, those with well-controlled HIV/AIDS, and within 72 hours of exposure to measles among those who are incompletely immunized. It is given by injection.

<span class="mw-page-title-main">Varicella zoster virus</span> Herpes virus that causes chickenpox and shingles

Varicella zoster virus (VZV), also known as human herpesvirus 3 or Human alphaherpesvirus 3 (taxonomically), is one of nine known herpes viruses that can infect humans. It causes chickenpox (varicella) commonly affecting children and young adults, and shingles in adults but rarely in children. VZV infections are species-specific to humans. The virus can survive in external environments for a few hours.

<span class="mw-page-title-main">Shingles</span> Viral disease caused by the varicella zoster virus

Shingles, also known as herpes zoster, is a viral disease characterized by a painful skin rash with blisters in a localized area. Typically the rash occurs in a single, wide mark either on the left or right side of the body or face. Two to four days before the rash occurs there may be tingling or local pain in the area. Other common symptoms are fever, headache, and tiredness. The rash usually heals within two to four weeks; however, some people develop ongoing nerve pain which can last for months or years, a condition called postherpetic neuralgia (PHN). In those with poor immune function the rash may occur widely. If the rash involves the eye, vision loss may occur.

<span class="mw-page-title-main">DPT vaccine</span> Combination vaccine

The DPT vaccine or DTP vaccine is a class of combination vaccines against three infectious diseases in humans: diphtheria, pertussis, and tetanus (lockjaw). The vaccine components include diphtheria and tetanus toxoids, and either killed whole cells of the bacterium that causes pertussis or pertussis antigens. The term toxoid refers to vaccines which use an inactivated toxin produced by the pathogen which they are targeted against to generate an immune response. In this way, the toxoid vaccine generates an immune response which is targeted against the toxin which is produced by the pathogen and causes disease, rather than a vaccine which is targeted against the pathogen itself. The whole cells or antigens will be depicted as either "DTwP" or "DTaP", where the lower-case "w" indicates whole-cell inactivated pertussis and the lower-case "a" stands for "acellular". In comparison to alternative vaccine types, such as live attenuated vaccines, the DTP vaccine does not contain any live pathogen, but rather uses inactivated toxoid to generate an immune response; therefore, there is not a risk of use in populations that are immune compromised since there is not any known risk of causing the disease itself. As a result, the DTP vaccine is considered a safe vaccine to use in anyone and it generates a much more targeted immune response specific for the pathogen of interest.

Postherpetic neuralgia (PHN) is neuropathic pain that occurs due to damage to a peripheral nerve caused by the reactivation of the varicella zoster virus. PHN is defined as pain in a dermatomal distribution that lasts for at least 90 days after an outbreak of herpes zoster. Several types of pain may occur with PHN including continuous burning pain, episodes of severe shooting or electric-like pain, and a heightened sensitivity to gentle touch which would not otherwise cause pain or to painful stimuli. Abnormal sensations and itching may also occur.

<span class="mw-page-title-main">Influenza vaccine</span> Vaccine against influenza

Influenza vaccines, colloquially known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies from year to year, most provide modest to high protection against influenza. Vaccination against influenza began in the 1930s, with large-scale availability in the United States beginning in 1945.

<span class="mw-page-title-main">Vaccination schedule</span> Series of vaccinations

A vaccination schedule is a series of vaccinations, including the timing of all doses, which may be either recommended or compulsory, depending on the country of residence. A vaccine is an antigenic preparation used to produce active immunity to a disease, in order to prevent or reduce the effects of infection by any natural or "wild" pathogen. Vaccines go through multiple phases of trials to ensure safety and effectiveness.

The MMRV vaccine combines the attenuated virus MMR vaccine with the addition of the varicella (chickenpox) vaccine. The MMRV vaccine is typically given to children between one and two years of age.

<span class="mw-page-title-main">Pneumococcal conjugate vaccine</span> Vaccine against Strep pneumoniae

Pneumococcal conjugate vaccine is a pneumococcal vaccine made with the conjugate vaccine method and used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine. The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children.

<span class="mw-page-title-main">Gardasil</span> Human papillomavirus vaccine

Gardasil is an HPV vaccine for use in the prevention of certain strains of human papillomavirus (HPV). It was developed by Merck & Co. High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women. The HPV strains that Gardasil protects against are sexually transmitted, specifically HPV types 6, 11, 16 and 18. HPV types 16 and 18 cause an estimated 70% of cervical cancers, and are responsible for most HPV-induced anal, vulvar, vaginal, and penile cancer cases. HPV types 6 and 11 cause an estimated 90% of genital warts cases. HPV type 16 is responsible for almost 90% of HPV-positive oropharyngeal cancers, and the prevalence is higher in males than females. Though Gardasil does not treat existing infection, vaccination is still recommended for HPV-positive individuals, as it may protect against one or more different strains of the disease.

<span class="mw-page-title-main">Varicella vaccine</span> Vaccine to prevent chickenpox

Varicella vaccine, also known as chickenpox vaccine, is a vaccine that protects against chickenpox. One dose of vaccine prevents 95% of moderate disease and 100% of severe disease. Two doses of vaccine are more effective than one. If given to those who are not immune within five days of exposure to chickenpox it prevents most cases of disease. Vaccinating a large portion of the population also protects those who are not vaccinated. It is given by injection just under the skin. Another vaccine, known as zoster vaccine, is used to prevent diseases caused by the same virus – the varicella zoster virus.

<span class="mw-page-title-main">Hepatitis B vaccine</span> Vaccine against hepatitis B

Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people, routine immunization results in more than 95% of people being protected.

<span class="mw-page-title-main">Hepatitis A vaccine</span> Vaccine to prevent hepatitis A

Hepatitis A vaccine is a vaccine that prevents hepatitis A. It is effective in around 95% of cases and lasts for at least twenty years and possibly a person's entire life. If given, two doses are recommended beginning after the age of one. It is given by injection into a muscle. The first hepatitis A vaccine was approved in Europe in 1991, and the United States in 1995. It is on the World Health Organization's List of Essential Medicines.

<span class="mw-page-title-main">Chickenpox</span> Human viral disease

Chickenpox, or chicken pox, also known as varicella, is a highly contagious, vaccine-preventable disease caused by the initial infection with varicella zoster virus (VZV), a member of the herpesvirus family. The disease results in a characteristic skin rash that forms small, itchy blisters, which eventually scab over. It usually starts on the chest, back, and face. It then spreads to the rest of the body. The rash and other symptoms, such as fever, tiredness, and headaches, usually last five to seven days. Complications may occasionally include pneumonia, inflammation of the brain, and bacterial skin infections. The disease is usually more severe in adults than in children.

<span class="mw-page-title-main">Measles vaccine</span> Vaccine used to prevent measles

Measles vaccine protects against becoming infected with measles. Nearly all of those who do not develop immunity after a single dose develop it after a second dose. When the rate of vaccination within a population is greater than 92%, outbreaks of measles typically no longer occur; however, they may occur again if the rate of vaccination decreases. The vaccine's effectiveness lasts many years. It is unclear if it becomes less effective over time. The vaccine may also protect against measles if given within a couple of days after exposure to measles.

<span class="mw-page-title-main">Rubella vaccine</span> Vaccine used to prevent rubella

Rubella vaccine is a vaccine used to prevent rubella. Effectiveness begins about two weeks after a single dose and around 95% of people become immune. Countries with high rates of immunization no longer see cases of rubella or congenital rubella syndrome. When there is a low level of childhood immunization in a population it is possible for rates of congenital rubella to increase as more women make it to child-bearing age without either vaccination or exposure to the disease. Therefore, it is important for more than 80% of people to be vaccinated. By introducing rubella containing vaccines, rubella has been eradicated in 81 nations, as of mid-2020.

In medicine, varicella zoster virus globulin, VZV antibodies, zoster immunoglobulin (ZIG), varicella zoster immune globulin, is an immune system medication that is used mostly for immunosuppressed patients who have been or may be exposed to the varicella zoster virus (VZV).

<span class="mw-page-title-main">Tetanus vaccine</span> Vaccines used to prevent tetanus

Tetanus vaccine, also known as tetanus toxoid (TT), is a toxoid vaccine used to prevent tetanus. During childhood, five doses are recommended, with a sixth given during adolescence.

Live recombinant vaccines are biological preparations that stimulate immune responses to a pathogen through the use of genetically modified live bacteria or viruses. These live pathogens are biologically engineered to express exogenous antigens in the cytoplasm of target cells, thereby triggering immune responses. This form of vaccine combines the beneficial features of attenuated and recombinant vaccines, providing the long-lasting immunity of attenuated vaccines’ with recombinant vaccines’ genetically engineered precision and safety.

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  41. ↑ "Zostavax EPAR" (PDF). European Medicines Agency (EMA). July 2006. Archived (PDF) from the original on 5 July 2019. Retrieved 27 March 2011.
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  43. ↑ "Shingles Vaccination (16 July 2013, archived)". NHS UK. Archived from the original on 2 June 2014.
  44. ↑ "Who can have the shingles vaccine? (16 July 2013, archived)". NHS UK. Archived from the original on 10 April 2014.
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  47. ↑ "BBL approval" (PDF). U.S. Food and Drug Administration (FDA). 20 October 2017. Archived (PDF) from the original on 1 November 2017. Retrieved 29 April 2018.
  48. ↑ "Shingles (Herpes Zoster) Vaccination". U.S. Centers for Disease Control and Prevention (CDC). Archived from the original on 7 December 2018.
  49. ↑ "Product Discontinuation Notice: Zostavax (Zoster Vaccine Live)" (PDF). Archived from the original (PDF) on 18 August 2020.
  50. ↑ Cimons M (29 July 2018). "Don't panic if you're put on a waiting list for the new shingles vaccine". The Washington Post. Archived from the original on 5 August 2019. Retrieved 24 January 2020. The Centers for Disease Control and Prevention, which issues vaccine recommendations, says patients who wait longer than six months needn't worry, but they should get that second dose as soon as possible. Be sure not to skip it, because two doses convey the maximum immunity, more than 90%.
  51. ↑ "Frequently Asked Questions About Shingrix". U.S. Centers for Disease Control and Prevention (CDC). 26 March 2018. Archived from the original on 1 May 2021. Retrieved 23 January 2020. You and patients should make every effort to ensure that two doses are administered within the recommended 2–6 month interval. If more than 6 months have elapsed since the first dose, administer the second dose as soon as possible. Do not restart the vaccine series...
  52. ↑ Report to the Congress: Medicare and the Health Care Delivery System. Medicare Payment Advisory Commission. June 2021. p. 254. Archived from the original on 24 May 2022. Retrieved 15 June 2022.

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