GSK presents new data backing shingles vaccine
The firm says data show that when Shingrix was given to patients aged 50 years or over at the same time as an unadjuvanted seasonal flu vaccine, both vaccines were well tolerated and the immune response to each vaccine was similar whether it was administered at the same time or separately.
On the dosing front, the Phase III clinical trial programme also showed that the second shot of the vaccine can be administered during a window of two to six months following the first dose, with a similar level of immune response and comparable safety profile.
Using an established standard health survey, GSK said it also determined that the small number of patients who developed shingles despite being administered Shingrix reported reduced levels of pain versus those who did not.
Shingrix is a non-live, recombinant vaccine to help prevent shingles and its complications, given intramuscularly in two shots.
The jab has been filed in the US, while regulatory submissions in the European Union and Canada are also on the cards for this year and in Japan in 2017. GSK says the data, presented at infectious Disease Week scientific conference in New Orleans, Louisiana, USA, is included in the drug’s applications.
“GSK’s shingles candidate vaccine has consistently shown high efficacy in older people in its Phase III development programme. This underscores the potential impact of this novel vaccine candidate to help prevent shingles, and to help overcome the challenge of decreasing immunity that comes with age,” said Dr Thomas Breuer, chief medical officer, GSK Vaccines.
The new data “further support the vaccine candidate’s profile in helping to prevent shingles and improve quality of life, and provide new evidence to support flexible dosing options,” he added.
Around 224,000 people in the UK get shingles every year, 60,000 of which are affected by post herpetic neuralgia (PHN), which causes a burning pain that persists even after the rash and blisters of shingles has disappeared.