March 11, 2022 Print
Pharma News: GSK Australia confirmed the availability of its shingles vaccine, Shingrix, as a private script for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in people aged 18 years and over who are at increased risk of shingles.
Until now, GSK and MSD’s zoster vaccines have only been licensed in Australia for use in adults 50 years and older.
People with a recent immunosuppressive condition may have a 50% higher risk of shingles than the general population. For people who are severely immunocompromised, the risk can be up to four times higher than the general population.
The TGA approval of Shingrix was supported by a range of clinical trials in highly immunocompromised populations aged 18 years and older, including patients with solid tumours, haematological malignancies, HIV infection, autologous hematopoietic stem cell transplant recipients, and renal transplant patients on chronic immunosuppressive treatment.
In these trials, Shingrix demonstrated a robust immune response and reported adverse reactions were consistent with those reported in adults aged 50 years and over.
This new indication builds on
Shingrix’s existing approval for Australian adults aged 50 years and over for the prevention of shingles and PHN.
The availability of vaccines to help prevent shingles and PHN in people at increased risk is an important milestone, according to Professor Tony Cunningham, infectious disease physician, clinical virologist and Co-Director of the Centre for Virus Research at the Westmead Institute for Medical Research.
“Shingles can be very painful and is often described as burning, shooting or stabbing pain. This acute pain can last for two to four weeks, with some people potentially experiencing complications and chronic pain for months,” said Professor Cunningham.
“People who are at increased risk of shingles, due to underlying conditions or treatments, are significantly more likely to experience severe disease and hospitalisation than the general population. For these patients, vaccines can play an important role in helping reduce the impact of the infection.”
“Doctors never like to see their patients in pain, so today’s announcement is welcome news for healthcare professionals and their patients.”
Co Luu, Vaccines Medical Director at GSK Australia, said bringing innovative medicines and vaccines to Australia is a core focus.
“GSK Australia is very proud to make this shingles vaccine available to include the indication of Australians aged 18 years and over who are at increased risk of herpes zoster. The burden of shingles is significant, so we’re thrilled that with this approval we will be able to help protect more Australians from shingles,” said Mr Luu.
“We are committed to bringing innovative medicines and vaccines to the people who need them most, and today’s announcement is evidence of that.”
Shingrix is a non-live, recombinant Varicella Zoster Virus adjuvanted vaccine given intramuscularly in two doses.