On 20 October, the US Food and Drug Administration (FDA) gave the greenlight for GlaxoSmithKline’s (GSK) shingles vaccine, Shingrix. This makes Shingrix the second shingles vaccine approved by the FDA, the first being Merck’s Zostavax. Aside from approval of sale in the United States, Shingrix has similarly been approved for sale in Canada. Regulatory filings are currently underway to seek approval for sales in the European Union, Australia and Japan.

Getting to know Shingrix

Developed by leading global healthcare company, GSK, Shingrix is currently poised to be the sole competitor to the only other shingles vaccine on the market, Merck’s Zostavax. More than just competition, Shingrix promises stronger protection against shingles with a 98% protection in the first year and a continued protection of 85% or higher three years after the vaccination. By comparison, Zostavax offers only a 51% protection rate in the first year with protection that wanes relatively quickly with the effects becoming null within seven to nine years after vaccination.

“We are absolutely thrilled to get to this point because the science behind this vaccine offers tremendous potential for helping patients, protecting them against getting shingles and its complications,” said Dr Leonard Friedland, vice president for scientific affairs and public health for GSK’s North American vaccines unit.

Shingrix is expected to be available in the consumer market before the end of the year. The targeted patient groups include individuals above the age of 50 or those who have an impaired immunity system. Shingrix will be administered as a two-dose injection catered for adults.

Treating shingles

Shingles is a delayed complication of chickenpox which stems from the varicella zoster virus, which remains dormant in the body after the initial infection. In most healthy individuals, the dormant virus presents no problem as the immunity system keeps the virus at bay. For the elderly or immune system suppressed patients, shingles may manifest as an extremely painful, itchy rash on one side of the torso and face.

Shingles manifests as an extremely painful rash on one side of the torso or face.
Shingles manifests as an extremely painful rash on one side of the torso or face.

More serious cases of shingles lead to complications such as strokes, vision and hearing loss, and post-herpetic neuralgia. Post herpetic-neuralgia is the most predominant complication of shingles as it can lead to a lifetime of debilitating pain resulting in decreased quality of life. It is estimated that, one in five shingles patients will develop post-herpetic neuralgia.

Hence, the necessity for an effective shingles vaccine especially in the elderly population.

Market analysis

With an estimated market value of one billion dollars in sales by the year 2022, it is no surprise that GSK is very excited to bring the new vaccine to the market. Despite costing more, Shingrix is still expected to take a big bite out of Merck’s existing monopoly over the market share. If deployed appropriately, Shingrix is projected to cause domestic sales of Zostavax to drop by nearly 31% in the next five years.

While Shingrix may have been approved by the FDA, even more critical to the success of the vaccine lies in the coming meeting of the Advisory Committee on Immunization Practices (ACIP). The ACIP – an expert panel that advises the Centres for Disease Control and Prevention (CDC) on vaccine issues – is expected to cast their votes on the recommendation of the use of Shingrix in adults. The vote is expected to take place on Wednesday and will determine the recommended routine vaccination age.

GSK’s latest shingles vaccine, Shingrix, received FDA approval late last week – making it the second shingles vaccine to be approved for market sales. Aside from some much-needed competition in the shingles vaccine space, Shingrix also brings with it a greater rate of protection albeit at a higher cost. International approval is still underway but, GSK already has plans to make their vaccine available to the market before the end of the year. MIMS

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Sources:
https://www.statnews.com/2017/10/20/shingles-vaccine-approval/
https://www.statnews.com/2017/06/22/shingles-vaccine-preferred/
https://www.gsk.com/en-gb/media/press-releases/gsk-announces-first-approval-of-shingrix-in-canada/
https://www.reuters.com/article/us-usa-fda-gsk/gsk-wins-u-s-shingles-vaccine-approval-uk-nod-for-gene-therapy-idUSKBN1CS0TU