Shingrix Approved For Prevention of Shingles in Adults aged 50+

The US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older.

But, Shingrix has not been approved for the prevention of chickenpox.

The approval of Shingrix is based on a comprehensive Phase III clinical trial in more than 38,000 people. In a pooled analysis of these studies, Shingrix demonstrated efficacy against shingles greater than 90% across all age groups.

Also, a sustained efficacy was found over a follow-up period of 4 years.

Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses. It combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age.

By preventing shingles, Shingrix reduces the overall incidence of postherpetic neuralgia (PHN), a form of chronic nerve pain and the most common complication associated with shingles.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for the use of Shingrix at its meeting on 25 October 2017.

Following this FDA approval, and pending a recommendation from ACIP, Shingrix will be available shortly.

On October 13, 2017, Shingrix was approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older. Regulatory filings in the European Union, Australia and Japan are underway.

Shingrix Important Safety Information:

• You should not receive SHINGRIX if you are allergic to any of its ingredients or had an allergic reaction to a previous dose of SHINGRIX.
• The most common side effects are pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach.
• Vaccination with SHINGRIX may not protect all individuals.
• Ask your healthcare provider about the risks and benefits of SHINGRIX. Only a healthcare provider can decide if SHINGRIX is right for you.

Shingles is a painful rash that usually develops on one side of the body, often the face or torso. The rash forms blisters that typically scab over in 7 to 10 days and clears up within 2 to 4 weeks.

For some people the pain can last for months or even years after the rash goes away. This long-lasting pain is called post-herpetic neuralgia (PHN), and it is the most common complication of shingles. Your risk of shingles and PHN increases as you get older.

ZostaVax, approved in 2006 by the FDA, is the only shingles vaccine currently approved for use in the United States. This vaccine reduces the risk of developing shingles by 51% and PHN by 67%.

ZostaVax is given in one dose as a shot, and can be given in a doctor’s office or pharmacy.

Most pharmacies offer ZostaVax. The retail price of this vaccine varies based upon insurance coverage and location.

Vaccine discounts can be found here.

For further information please visit GSK.