Glaxo Seeks FDA Approval for Experimental Shingles Vaccine

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On October 24th, 2016, GlaxoSmithKline Plc sought regulatory approval of its experimental shingles vaccine, known commercially as Shingrix, after the successful completion of a late-stage clinical test involving 37,000 patients. Shingrix vaccine is designed to help the body combat the Herpes varicella virus, which is primarily known for causing Chicken Pox in small children and adolescents. Herpes varicella can lay dormant within a person for years or decades, and then emerge as shingles in individuals who are elderly or immunocompromised. These recurring infections can cause serious complications or death in persons who are already in a weakened state.

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Understanding Shingles

Shingles is caused by the Herpes varicella leaving its dormant phase and infesting the skin in a manner similar to Chicken Pox. It is a highly common disease, affecting at least one in three Americans during their lifetime. Generally, it is only a very painful infection, leading to severe itching and large rashes. However, in elderly patients or those with compromised immune systems, it can result in disability or death, due to the damage of skin, muscles and nerve tissue. This is particularly the case in elderly patients, who may suffer persistent long-term pain even from a small case of Shingles.

Effectiveness Over Time

Herpes varicella vaccines have been commercially available for years. However, the problem has always been that they have limited effectiveness and known side effects. Worse still, it is very difficult to determine when the effect has worn off. For this reason, Shingrix has been developed to provide no less than four years of protection in persons above the age of fifty, a fact which has been experimentally tested and confirmed in clinical trials. GlaxoSmithKline is very concerned about the safety of this drug in elder patients, which it also hopes to make the primary market, and has engaged in rigorous testing to ensure both that it is safe and provides protection for a suitable amount of time. Testing has revealed that Shingrix provides 88% protection four years after the initial vaccination and a maximum of 91% protection during the early stages of the vaccine

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Different Approach

Historically, most Herpes varicella vaccines have been based on the “dead virus” method, whereby the virus is rendered unable to replicate through heating or chemical damage. While this does produce an effective vaccine, the usage of dead viruses is potentially dangerous for immunocompromised patients. This is particularly the case in HIV patients, transplant patients, and those with certain cancers of the blood. As such, Shingrix has been developed using the “protein coat” method. Rather than only killing the viruses with heat or chemicals, the genetic information inside them which enables replication is removed, leaving an empty shell. This shell is then used to make the vaccine, teaching the immune system to respond to its presence without any risk of the virus becoming re-activated. It is hoped that this alternative approach, combined with its apparent long-lasting results, will help prevent shingles in millions of patients per year.

Experimental Shingles Vaccine Approach

In light of the extensive clinical trials by GlaxoSmithKline, it is very likely that Shingrix will be approved for sale within the next few years, and will enter the market shortly after approval. The experimental shingles vaccine must be administered in two doses over the course of ninety days and must be re-administered every four years for maximum effectiveness. GlaxoSmithKline hopes to reach out to the elderly, especially those over the age of eighty-five, who have a greater than 50% chance of contracting Shingles during their remaining years. GlaxoSmithKline has already made plans to produce several million doses within the first few years if the vaccine is approved.

Learn more about the Shingles Vaccine.

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