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'False claims' fly as TGA works on high-dose flu vax
Posted 31 October 2017
Australian flu vaccine manufacturers are working with the TGA to expedite approval of new high-dose or adjuvant vaccines in time for the 2018 winter flu season as both the Chief Medical Officer and Seqirus hit back at media claims Australians were given a "discount flu vaccine" in 2017.
"The claim that Australians received a cheap flu vaccine is utterly false," a statement released by the Department of Health and quoting Chief Medical Officer Professor Brendan Murphy said in response to a News Limited story.
"I could not be clearer - I completely refute this false claim. The flu vaccines chosen this year were the best available in the Australian market, selected by medical experts in Australia and around the world.
"They are the same vaccines which are available and used in the UK, US and other countries and the same vaccines available on the private market in Australia."
News Limited National Health reporter Sue Dunlevy quoted Immunisation Coalition chair Professor Paul Van Buynder in an article saying Australians were given a $6 "budget" flu vaccine in 2017.
Prof Van Buynder said Sanofi's latest high-dose trivalent FluZone vaccine, which he said cost $8 per dose, was 24 per cent more effective. FluZone has been approved in the US in time for the northern hemisphere flu season and was filed with the TGA in July for approval in Australia.
RACGP president Dr Bastian Seidel was also quoted as "calling on the government to fund the stronger vaccine" and for vaccines to be made universally available on the NIP - a call supported by National Seniors Australia, which linked the 504 Australian flu deaths directly to the "cut price flu vaccine ... chosen by the government".
The claims prompted vaccine manufacturer Seqirus to reveal it was working with the TGA to have its trivalent influenza vaccine Fluad listed on the NIP for people aged 65 and older in 2018. Acquired by Seqirus from Novartis in 2015, a spokesperson for Seqirus said the vaccine was ARTG registered but had previously not been available in Australia.
She said Seqirus was working with the TGA to amend the registration and have it listed on the NIP for 2018 with Sanofi's FluZone also expected to be included in government negotiations for older Australians. The current version of Fluad includes an adjuvant that makes it more effective.
"Following this year's very severe influenza season, the Australian government has been investigating providing new, enhanced, vaccines for elderly persons," Professor Murphy said. "Seqirus and other manufacturers have not previously sought regulatory approval for sale of these vaccines in Australia and it would have been illegal and irresponsible for government to have attempted to offer them on the NIP."
Seqirus' vice president commercial operations Lorna Meldrum said the company "is working to expedite regulation of our enhanced vaccine".
"The two vaccines mentioned in the media today are not available in Australia because the companies have not had them registered for use in Australia with the Therapeutic Goods Administration," Professor Murphy said.
"They have, therefore, not submitted an application for their use on the National Immunisation Program with the Pharmaceutical Benefits Advisory Committee (PBAC). A vaccine cannot be considered by the PBAC unless a company submits an application and the vaccine has been approved for use in Australia by the Therapeutic Goods Administration.
"At the request of the Health Minister Greg Hunt, I am working on ways to strengthen the National Immunisation Program including holding talks with manufacturers on new and strengthened vaccines."
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 31 October 2017
Australian flu vaccine manufacturers are working with the TGA to expedite approval of new high-dose or adjuvant vaccines in time for the 2018 winter flu season as both the Chief Medical Officer and Seqirus hit back at media claims Australians were given a "discount flu vaccine" in 2017.
"The claim that Australians received a cheap flu vaccine is utterly false," a statement released by the Department of Health and quoting Chief Medical Officer Professor Brendan Murphy said in response to a News Limited story.
"I could not be clearer - I completely refute this false claim. The flu vaccines chosen this year were the best available in the Australian market, selected by medical experts in Australia and around the world.
"They are the same vaccines which are available and used in the UK, US and other countries and the same vaccines available on the private market in Australia."
News Limited National Health reporter Sue Dunlevy quoted Immunisation Coalition chair Professor Paul Van Buynder in an article saying Australians were given a $6 "budget" flu vaccine in 2017.
Prof Van Buynder said Sanofi's latest high-dose trivalent FluZone vaccine, which he said cost $8 per dose, was 24 per cent more effective. FluZone has been approved in the US in time for the northern hemisphere flu season and was filed with the TGA in July for approval in Australia.
RACGP president Dr Bastian Seidel was also quoted as "calling on the government to fund the stronger vaccine" and for vaccines to be made universally available on the NIP - a call supported by National Seniors Australia, which linked the 504 Australian flu deaths directly to the "cut price flu vaccine ... chosen by the government".
The claims prompted vaccine manufacturer Seqirus to reveal it was working with the TGA to have its trivalent influenza vaccine Fluad listed on the NIP for people aged 65 and older in 2018. Acquired by Seqirus from Novartis in 2015, a spokesperson for Seqirus said the vaccine was ARTG registered but had previously not been available in Australia.
She said Seqirus was working with the TGA to amend the registration and have it listed on the NIP for 2018 with Sanofi's FluZone also expected to be included in government negotiations for older Australians. The current version of Fluad includes an adjuvant that makes it more effective.
"Following this year's very severe influenza season, the Australian government has been investigating providing new, enhanced, vaccines for elderly persons," Professor Murphy said. "Seqirus and other manufacturers have not previously sought regulatory approval for sale of these vaccines in Australia and it would have been illegal and irresponsible for government to have attempted to offer them on the NIP."
Seqirus' vice president commercial operations Lorna Meldrum said the company "is working to expedite regulation of our enhanced vaccine".
"The two vaccines mentioned in the media today are not available in Australia because the companies have not had them registered for use in Australia with the Therapeutic Goods Administration," Professor Murphy said.
"They have, therefore, not submitted an application for their use on the National Immunisation Program with the Pharmaceutical Benefits Advisory Committee (PBAC). A vaccine cannot be considered by the PBAC unless a company submits an application and the vaccine has been approved for use in Australia by the Therapeutic Goods Administration.
"At the request of the Health Minister Greg Hunt, I am working on ways to strengthen the National Immunisation Program including holding talks with manufacturers on new and strengthened vaccines."
Megan Brodie
megan.brodie@lushmedia.com.au
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