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Sunday, January 7, 2018

Thousands Sue Merck for Shingles Vaccine “Causing What It's ...
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Zoster vaccines includes a number of vaccines that have been shown to reduce the incidence of herpes zoster (also known as shingles). One type of zoster vaccine is, essentially, a larger-than-normal dose of the chickenpox vaccine, as both shingles and chickenpox are caused by the same virus, the varicella zoster virus (VZV). A recombinant version was approved in the United States in 2017.


Video Zoster vaccine



Medical uses

A Cochrane review of Zostavax concluded that "Herpes zoster vaccine is effective in preventing herpes zoster disease and this protection can last three years". The duration of protection beyond four years after vaccination with the zoster vaccine is unknown. The need for re-vaccination has not been defined.

United States

Two forms of zoster vaccines are available in the United States.

Zostavax is the zoster vaccine which was developed by Merck & Co. and approved and licensed by the U.S. Food and Drug Administration (FDA) in May 2006. The FDA originally recommended it only for individuals 60 years of age or older who are not severely allergic to any of its components and who meet the following requirements:

  • does not have a weakened immune system due to HIV/AIDS or another disease or medications (such as steroids, radiation and chemotherapy) that affect the immune system.
  • does not have a history of cancer affecting the bone marrow or lymphatic system, such as leukemia or lymphoma.
  • does not have active, untreated tuberculosis.

In 2006, the U.S. Centers for Disease Control and Prevention's (CDC) 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, and those who do not recall having had chickenpox, since more than 99 percent of Americans ages 40 and older have had chickenpox.

In 2011, the FDA approved the live vaccine for use in individuals 50 to 59 years of age.

Shingrix is a zoster vaccine developed by GlaxoSmithKline which was approved in the United States by the FDA in October 2017. The Advisory Committee on Immunization Practices (ACIP) recommended Shingrix for adults over the age of 50, and for those who had already received Zostavax. The Committee voted that Shingrix is preferred over Zostavax for the prevention of zoster and related complications because phase 3 clinical data showed vaccine efficacy of >90% against shingles across all age groups, as well as sustained efficacy over a 4-year follow-up. Unlike Zostavax, which is given as a single shot, Shingrix is given as two intramuscular doses, two to six months apart.

European Union

In 2006, the European Medicines Agency (EMEA) issued a marketing authorisation for the zoster vaccine to Sanofi Pasteur for routine vaccination in individuals aged 60 and over. In 2007, the EMEA updated the marketing authorisation for routine vaccination in individuals aged 50 and over.

United Kingdom

From 2013 the UK National Health Service 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. The original intention was for people aged between 70 and 79 to be vaccinated, but the NHS later said that the vaccination programme was being staggered as it would be impractical to vaccinate everyone in their 70s in a single year.


Maps Zoster vaccine



Side effects

The live vaccine 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.

In one study 64 percent of the Zostavax group and 14 percent of the controls had some adverse reaction. However, the rates of serious adverse events were comparable between the Zostavax group (0.6 percent) and those receiving the placebo (0.5 percent).

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.


Expert panel recommends more effective shingles vaccine | The ...
src: media.spokesman.com


Composition

The live Zostavax vaccine contains a minimum of 19,400 plaque-forming units (PFU) of the Oka/Merck strain of live, attenuated varicella-zoster virus. It is sterile and does not contain any preservatives. It is injected subcutaneously (under the skin) in the upper arm. The live vaccine was developed using the MRC-5 line of fetal stem cells. This has raised religious and ethical concerns for some potential users, since that cell line was derived from an aborted fetus.

Shingrix is a suspension for intramuscular injection consisting of a lyophilized recombinant varicella zoster virus (VZV) glycoprotein E (gE) antigen that is reconstituted at the time of use with AS01B adjuvant suspension. The antigen is a purified truncated form of the VZV gE expressed in Chinese Hamster Ovary cells. The AS01B adjuvant suspension is composed of 3-O-desacyl-4'- monophosphoryl lipid A (MPL) from Salmonella minnesota and a saponin molecule (QS-21) purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation consisting of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate-buffered saline solution.


Famicare Bedok Clinic
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Cost effectiveness

A 2007 study found that the live vaccine is likely to be cost-effective in the U.S., projecting an annual savings of $82 to $103 million in healthcare costs with cost-effectiveness ratios ranging from $16,229 to $27,609 per quality-adjusted life year gained. In 2007, the live vaccine was officially recommended in the U.S. for healthy adults aged 60 and over.


Thousands Sue Merck for Shingles Vaccine
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References


What you need to know about the new shingles vaccine | The ...
src: media.spokesman.com


External links

  • Zostavax Product Page U.S. Food and Drug Administration (FDA)
  • Shingrix Product Page Food and Drug Administration (FDA)
  • Vaccine Information Statement U.S. Centers for Disease Control and Prevention (CDC)

Source of article : Wikipedia