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No re-try for Bexsero anytime soon
Posted 1 June 2017
GSK will not be re-applying to have meningococcal B vaccine Bexsero added to the National Immunisation Program (NIP) anytime soon a Senate estimates hearing has heard.
Answering questions on vaccination posed by Tasmanian Labor Senator Lisa Singh, Commonwealth Chief Medical Officer Professor Brendan Murphy said the company had indicated during recent talks it wouldn't be reapply until it had more data.
"We had a meeting with them (GSK) several weeks ago and they said that they didn't feel they were in a position in the near future to submit another application because they wanted to gather more evidence of efficacy in carriage," he said.
GSK has applied three times to have Bexsero added to the program and been knocked back each time because it didn't meet the effectiveness criteria, he said.
But, he added, the company was now funding a carriage study currently running in South Australia. Adding some details that suggested Bexsero may forever struggle for program inclusion, he said meningococcal B cases in 2016 were at their lowest point into 20 years with only 92 cases being reported, against a high of 300.
"There is...a cost-effectiveness consideration which the PBAC puts over any vaccine application and that reflects the number of cases and the cost of the vaccine and the likely impact in terms of reducing cases," he added, noting that although five to 25 per cent of the population carried "the bugs" only a very small number of people were ever infected.
"It's unlike almost any other vaccine-preventable disease in that the vast majority of people who carry the bacterium never get the disease," he added.
And there was now more concern from authorities about meningococcal W "which has been increasing in recent times".
During the session TGA's deputy secretary health products regulation group Professor John Skerritt interjected with news "from as recently as four or five hours ago" on the easing of the recurring Bexsero shortage.
He said following GSK's announcement earlier this month that Australia would receive an additional 200,000 doses of the vaccine, two of those lots had arrived on May 16, another on May 25 "and another literally today".
Batch release had already been carried out on the doses which arrived on May 16 and, all going well, the other batch releases were likely to happen within days, he said.
David Rowley
david.rowley@lushmedia.com.au
Posted 1 June 2017
GSK will not be re-applying to have meningococcal B vaccine Bexsero added to the National Immunisation Program (NIP) anytime soon a Senate estimates hearing has heard.
Answering questions on vaccination posed by Tasmanian Labor Senator Lisa Singh, Commonwealth Chief Medical Officer Professor Brendan Murphy said the company had indicated during recent talks it wouldn't be reapply until it had more data.
"We had a meeting with them (GSK) several weeks ago and they said that they didn't feel they were in a position in the near future to submit another application because they wanted to gather more evidence of efficacy in carriage," he said.
GSK has applied three times to have Bexsero added to the program and been knocked back each time because it didn't meet the effectiveness criteria, he said.
But, he added, the company was now funding a carriage study currently running in South Australia. Adding some details that suggested Bexsero may forever struggle for program inclusion, he said meningococcal B cases in 2016 were at their lowest point into 20 years with only 92 cases being reported, against a high of 300.
"There is...a cost-effectiveness consideration which the PBAC puts over any vaccine application and that reflects the number of cases and the cost of the vaccine and the likely impact in terms of reducing cases," he added, noting that although five to 25 per cent of the population carried "the bugs" only a very small number of people were ever infected.
"It's unlike almost any other vaccine-preventable disease in that the vast majority of people who carry the bacterium never get the disease," he added.
And there was now more concern from authorities about meningococcal W "which has been increasing in recent times".
During the session TGA's deputy secretary health products regulation group Professor John Skerritt interjected with news "from as recently as four or five hours ago" on the easing of the recurring Bexsero shortage.
He said following GSK's announcement earlier this month that Australia would receive an additional 200,000 doses of the vaccine, two of those lots had arrived on May 16, another on May 25 "and another literally today".
Batch release had already been carried out on the doses which arrived on May 16 and, all going well, the other batch releases were likely to happen within days, he said.
David Rowley
david.rowley@lushmedia.com.au
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