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GSK to file shingles vax in Aust
Posted 1 November 2016
GSK will file its Shingrix shingles vaccine for approval in Australia and, if successful, consider seeking listing on the National Immunisation Program (NIP), a company spokesperson has said.
GSK filed its Shingrix herpes zoster virus vaccine in the US last week for people aged 50 years and older at risk of contracting shingles. The company confirmed filing in Europe and Canada would follow with further filings to occur in Japan and other jurisdictions in 2017.
A GSK spokesperson said Australia would be included with plans to file with the TGA. While it would not comment on timing, it is expected filing in Australia will occur next year.
"GSK's herpes zoster sub unit candidate vaccine is currently not registered for use in Australia, however GSK is committed to seeking registration," the spokesperson said. "Regulatory approvals in Australia (under current processes) can take 12 to 14 months.
"Assuming regulatory approval, GSK will consider applying for NIP scheduling."
Shingrix's competitor, Seqirus' Zostavax shingles vaccine, is listed on the NIP from today, making it available free to Australians aged 70 and older. Zostavax was recommended for listing at the November 2014 PBAC meeting and listed in November last year.
However, although trials showed Zostavax reduced the incidence of herpes zoster by 70 per cent in the 50 to 59 year old age group, Shingrix provided 97 per cent protection, according to data published in the New England Journal of Medicine.
Furthermore, Shingrix demonstrated 90 per cent efficacy in adults aged 70 years and older that was maintained for at least four years and cut the incidence of postherpetic neuralgia, a form of chronic pain associated with the condition.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 1 November 2016
GSK will file its Shingrix shingles vaccine for approval in Australia and, if successful, consider seeking listing on the National Immunisation Program (NIP), a company spokesperson has said.
GSK filed its Shingrix herpes zoster virus vaccine in the US last week for people aged 50 years and older at risk of contracting shingles. The company confirmed filing in Europe and Canada would follow with further filings to occur in Japan and other jurisdictions in 2017.
A GSK spokesperson said Australia would be included with plans to file with the TGA. While it would not comment on timing, it is expected filing in Australia will occur next year.
"GSK's herpes zoster sub unit candidate vaccine is currently not registered for use in Australia, however GSK is committed to seeking registration," the spokesperson said. "Regulatory approvals in Australia (under current processes) can take 12 to 14 months.
"Assuming regulatory approval, GSK will consider applying for NIP scheduling."
Shingrix's competitor, Seqirus' Zostavax shingles vaccine, is listed on the NIP from today, making it available free to Australians aged 70 and older. Zostavax was recommended for listing at the November 2014 PBAC meeting and listed in November last year.
However, although trials showed Zostavax reduced the incidence of herpes zoster by 70 per cent in the 50 to 59 year old age group, Shingrix provided 97 per cent protection, according to data published in the New England Journal of Medicine.
Furthermore, Shingrix demonstrated 90 per cent efficacy in adults aged 70 years and older that was maintained for at least four years and cut the incidence of postherpetic neuralgia, a form of chronic pain associated with the condition.
Megan Brodie
megan.brodie@lushmedia.com.au
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