GlaxoSmithKline’s Shingrix has been approved in the US for protection against shingles in adults aged 50 years or older.
The decision follows recent unanimous backing from an FDA advisory panel, on the back of data from clinical trials showing that the jab not only reduced incidence of shingles but also the overall incidence of postherpetic neuralgia (PHN), a form of chronic pain linked with the disease, even in those who went on to develop the condition.
Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox. The disease typically presents as a painful, itchy rash that develops on one side of the body and can last for two to four weeks.
The probability of developing shingles rises with age as the immune system loses the ability to fight the infection, and it is estimated that up to one in every three people will develop shingles during their lifetime.
Shingrix is a non-live, recombinant vaccine which, according to Thomas Breuer, chief medical officer of GSK Vaccines, represents “a significant scientific advancement” in vaccinology. “The vaccine has shown over 90 percent efficacy across all age groups in the prevention of shingles,” he noted.
There are an estimated one million cases of shingles in the US each year.
Shingrix won its first regulatory approval in Canada last week, decisions are still being awaited in Europe, Japan and Australia.