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Sanofi bringing high-dose flu vax to Aust
Posted 12 July 2017
Sanofi has applied to bring what would be the first high-dose influenza vaccine to Australia while further expanding its vaccines portfolio with an acquisition which will give it the only FDA-approved recombinant protein-based flu jab.
Sanofi announced the acquisition of US vaccines biotech Protein Sciences in a deal worth up to US$750 million, demonstrating its commitment to the continued growth of its flu vaccines business.
The world's top vaccines provider also confirmed it had filed its high-dose trivalent flu vax, branded FluZone in the US, for ARTG registration with a green light likely to provide elderly Australians with a more effective flu preventative in time for the 2018 flu season.
Sanofi's FluQuadri, currently listed on the NIP, is one of a number of standard-dose quadrivalent influenza vaccines available in Australia. The high-dose trivalent vaccine contains four times the amount of antigen as a standard vaccine, although the standard quadrivalent vax has an additional B strain not present in the trivalent vaccines.
"Sanofi has applied to register the high-dose influenza vaccine in Australia but at this stage we cannot speculate on timing for registration or about its potential availability on the NIP," a Sanofi spokesperson said.
"The Department of Health can make a vaccine available on the NIP once the vaccine has been approved by the TGA and has gone through the rigorous process of ATAGI and PBAC evaluation."
Recent trial results for FluZone showed the risk of contracting laboratory-confirmed influenza in the recipients of the high dose influenza vaccine was 24 per cent lower than that of participants who were given the standard dose trivalent vaccine.
Sanofi Australia's Head of Medical Dr Christian Felter said the company was "very, very excited" to bring the high-dosage vax to Australia, particularly people aged 65 and older who are most at risk from influenza due to failing immune systems and other complications which create a "perfect storm" for this age group.
"Our hope is to make this available as an alternative to those Australians over 65 who are most at risk from other complications," Dr Felter said.
If successful in achieving ARTG registration, Sanofi will seek NIP-listing in the hope of having the vaccine available for the 2018 flu season.
Sanofi's purchase of Protein Sciences, a privately held vaccines biotech, will add the FDA-approved Flublok Quadrivalent to Sanofi's expanding stable of flu jabs and consolidate its position as the biggest flu vax provider globally. Australia's CSL-owned flu unit Seqirus is currently a distant second.
As the only recombinant protein-based flu vax approved by the FDA, Flublok provides particular advantages over the current egg-based vaccines which may not elicit as strong an immune response as cell-culture derived antigens, and cannot be taken by patients with egg allergies. Some reports say vaxes like Flublok are the future of flu vaccines, with the company already working on a US national pandemic influenza preparedness campaign.
Megan Brodie
megan.brodie@lushmedia.com.a
Posted 12 July 2017
Sanofi has applied to bring what would be the first high-dose influenza vaccine to Australia while further expanding its vaccines portfolio with an acquisition which will give it the only FDA-approved recombinant protein-based flu jab.
Sanofi announced the acquisition of US vaccines biotech Protein Sciences in a deal worth up to US$750 million, demonstrating its commitment to the continued growth of its flu vaccines business.
The world's top vaccines provider also confirmed it had filed its high-dose trivalent flu vax, branded FluZone in the US, for ARTG registration with a green light likely to provide elderly Australians with a more effective flu preventative in time for the 2018 flu season.
Sanofi's FluQuadri, currently listed on the NIP, is one of a number of standard-dose quadrivalent influenza vaccines available in Australia. The high-dose trivalent vaccine contains four times the amount of antigen as a standard vaccine, although the standard quadrivalent vax has an additional B strain not present in the trivalent vaccines.
"Sanofi has applied to register the high-dose influenza vaccine in Australia but at this stage we cannot speculate on timing for registration or about its potential availability on the NIP," a Sanofi spokesperson said.
"The Department of Health can make a vaccine available on the NIP once the vaccine has been approved by the TGA and has gone through the rigorous process of ATAGI and PBAC evaluation."
Recent trial results for FluZone showed the risk of contracting laboratory-confirmed influenza in the recipients of the high dose influenza vaccine was 24 per cent lower than that of participants who were given the standard dose trivalent vaccine.
Sanofi Australia's Head of Medical Dr Christian Felter said the company was "very, very excited" to bring the high-dosage vax to Australia, particularly people aged 65 and older who are most at risk from influenza due to failing immune systems and other complications which create a "perfect storm" for this age group.
"Our hope is to make this available as an alternative to those Australians over 65 who are most at risk from other complications," Dr Felter said.
If successful in achieving ARTG registration, Sanofi will seek NIP-listing in the hope of having the vaccine available for the 2018 flu season.
Sanofi's purchase of Protein Sciences, a privately held vaccines biotech, will add the FDA-approved Flublok Quadrivalent to Sanofi's expanding stable of flu jabs and consolidate its position as the biggest flu vax provider globally. Australia's CSL-owned flu unit Seqirus is currently a distant second.
As the only recombinant protein-based flu vax approved by the FDA, Flublok provides particular advantages over the current egg-based vaccines which may not elicit as strong an immune response as cell-culture derived antigens, and cannot be taken by patients with egg allergies. Some reports say vaxes like Flublok are the future of flu vaccines, with the company already working on a US national pandemic influenza preparedness campaign.
Megan Brodie
megan.brodie@lushmedia.com.a
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