GlaxoSmithKline announced on Friday that Canadian health officials have approved their promising new shingles vaccine for public distribution. The recombinant zoster vaccine, now available to senior Canadians as Shingrix, has been approved to prevent herpes zoster (shingles). The drug is recommended for shingles sufferers aged 50 and older.
Shingrix Soon To Be Available In The United States
The vaccine incorporates an antigen with glycoprotein E and an adjuvant system, AS01B, to boost immunity. The vaccine generates a stronger and more durable response in patients in their senior years, when immune system response begins to weaken, according to a press release announcing the news of the approval.
Delivered intramuscularly, the vaccine is administered in two separate doses, which are separated by a two to six month waiting period. GlaxoSmithKline claims their new vaccine is 90% effective in the prevention of shingles in adults 50 and over.
Shingrix differs from Zostavax, Merk’s current live virus shingles vaccine, because it does not contain any live virus. Zostavax, on the other hand, has been known to cause shingles itself and other shingles-related injuries.
Currently, Shingrix is only available to Canadian patients, but the vaccine may soon be available worldwide. The drug is currently under review by the United States, the European Union, Australia, and Japan. The U.S. may be the next country to approve the GlaxoSmithKline drug. In September, the U.S. Food and Drug Administration voted unanimously to approve the drug, so it may not be long before Shingrix hits the market south of the Canadian border.
A Clinical Trial Supports Canada’s Early Approval of Shingles Vaccine
Even though Canada is the first country to approve the drug for shingles patients, that decision wasn’t made lightly. To the contrary, the decision to approve the GlaxoSmithKline vaccine was based on a phase 3 clinical trial that tested Shingrix’s effectiveness, safety, and immunogenicity. 37,000 patients made up the test group and, among them, the vaccine demonstrated a 90% efficacy rate. A four-year follow-up study revealed that the clinical trial subjects had still not contracted shingles, reinforcing the findings that Shingrix has a high efficacy rate.
Like most vaccines, Shingrix was not without side effects. The most common side effect was a swollen and painful redness near the injection site. The swelling and redness dissipated within three days and less in some cases.
Thomas Breuer, M.D., senior vice president and chief medical officer of GSK Vaccines, says the company was faced with the challenge of creating a shingles vaccine that would be effective in older adults. The company took on that task, because older adults are at a higher risk of contracting some diseases, such as shingles, so that age group has a greater need for preventions and treatments.
“Shingrix was developed specifically to overcome the age-related decline in immunity against the varicella zoster virus,” Dr. Breuer added.
In Canada alone, shingles affects 130,000 adults every year. The rest of North America, Europe, and Asia-Pacific regions all see similar numbers, making a vaccine important in almost every part of the world. In addition to adults over 50 years of age, anyone with a condition that compromises the immune system is at a greater risk of contracting shingles. 90% of adults 50 and older get infected with the varicella zoster virus every year. One in three individuals develop shingles at some point in their lifetime, but that risk increases to a 50% chance of contracting shingles past the age of 85.
Common symptoms of shingles are a pain, burning, or numbness and tingling of the skin; a sensitivity to touch; a red rash in affected areas of the skin; fluid-filled blisters that may burst, and frequent itching. Currently, there is no cure for shingles.