Monday, February 19, 2018

Australian DOH Announces Adjuvanted & High-Dose Flu Vaccines For 2018


Australia, whose `down under' flu season generally begins to ramp up in June and peaks in August, saw a particularly nasty H3N2 flu season last year (see Australia's Flu Epidemic Worsens); one that saw hospitals overrun with patients, and which raised alarms over the effectiveness of last year's flu vaccine.
In September, the Australian CMO Issued A Statement On Flu Vaccine Effectiveness citing a lower than usual VE against H3N2 - particularly among the elderly - as a contributing factor to last summer's high flu-related mortality rate.
By October, the the first estimates of Australia's VE were published (see Eurosurveillance: Low H3N2 Vaccine Effectiveness In Australia's 2017 Flu Season), where we learned that while the flu vaccine performed reasonably well against H1N1 (50%) and the Influenza B (57%) - it's VE against seasonal H3N2 averaged only 10%.

Of course, Australia hasn't been alone.  Last summer Hong Kong, Taiwan and Southern China all reported unusually severe H3N2 epidemics where concerns were raised (particularly in Hong Kong) over the effectiveness of their vaccine.
And this winter, interim estimates of the flu vaccine's effectiveness against H3N2 have ranged from 17% (in Canada) to 25% (in the United States).
Although their DOH had already embraced the use of quadrivalent (4 strain) flu vaccines - unlike in North America and parts of Europe -  High Dose and Adjuvanted  vaccines for the elderly were not licensed, and therefore unavailable last year in Australia.

Hoping to avoid a repeat of last year's devastating flu season, the DOH has announced the licensing of both the Fluzone High Dose® and adjuvanted (Fluad®) flu vaccines for those over 65 for the upcoming 2018 flu season.
Ground-breaking flu vaccines to protect millions of Aussies

The Australian Government will provide two new ground-breaking flu vaccines to over three million Australians aged 65 years and over - free of charge.

Page last updated: 19 February 2018

PDF printable version of Ground-breaking flu vaccines to protect millions of Aussies - PDF 357 KB

Joint Media Release
The Hon. Malcolm Turnbull MP
Prime Minister

The Hon. Greg Hunt MP
Minister for Health
Sunday, 18 February 2018

The Turnbull Government will provide two new ground-breaking flu vaccines to over three million Australians aged 65 years and over - free of charge.

This is a direct response to last year’s horrific flu season, which had a devastating impact around the world, and aimed squarely at saving lives.

More than 90 per cent of the 1,100 flu related deaths in 2017 were by people aged over 65 years of age.

The Turnbull Government and the Chief Medical Officer, Professor Brendan Murphy, have worked behind the scenes for many months to bring two new flu vaccines to Australia for the first time.

The vaccines have been fast-tracked to ensure lives are saved and that older Australians receive greater protection.

These new vaccines – Fluad® and Fluzone High Dose® – were registered in Australia to specifically provide increased protection for people aged 65 years and older.

From April 2018, both vaccines will be available through the National Immunisation Program following a recommendation from the Pharmaceutical Benefits Advisory Committee.

These new trivalent (three strain) vaccines work in over 65s by generating a strong immune response and are more effective for this age group in protecting against influenza.

These vaccines have been specifically made for the elderly, as their immune systems respond less effectively to vaccines.

Professor Murphy is continuing to investigate ways to improve protection from seasonal influenza, particularly for the elderly.

This includes mandating a requirement for residential aged care providers to provide a seasonal influenza vaccination program to all staff.

Additionally the Aged Care Quality Agency is continuing a review of the infection control practices of aged care services across the country.

The outcomes will inform new guidelines around the areas of the greatest risk to the safety, health and wellbeing of care recipients.

We must continue to do all we can to protect those Australians who are most at risk.

Under the National Immunisation Program, those eligible for a free flu shot include people aged 65 years and over, pregnant women, most Aboriginal and Torres Strait Islander people, and those who suffer from chronic conditions.

Last year more than 4.5 million doses of the influenza vaccine were provided at no cost to Australians who were most at risk from the flu.

Vaccination saves lives and they are fundamental to our health system.

It can save the life of the person receiving the vaccine, but importantly it also protects those who are unable to vaccinate due to health reasons.

Annual vaccination is the most important measure for preventing influenza and its complications and we encourage all Australians to get vaccinated.

We encourage all Australians aged over six months old to get a flu vaccination this year before the peak season starts in June.

Today we can also announce the following the four strains which will be contained within this year’s Southern Hemisphere vaccines:

  • A(H1N1): an A/Michigan/45/2015(H1N1) pdm09 like virus
  • A(H3N2): an A/Singapore/INFIMH-16-0019/2016(H3N2) like virus
  • B: a B/Phuket/3073/2013 like virus
  • B: a B/Brisbane/60/2008 like virus
The composition of the Australian vaccine is decided by the Australian Influenza Vaccine Committee in consultation with the World Health Organization.
          (Continue . . . )

How much of a difference these two vaccines would  have made in last summer's epidemic is unknown. While more studies are underway, early research suggests they both may help enhance the flu vaccine's effectiveness in those over 65.  The CDC explains:
Does the higher dose vaccine produce a better immune response in adults 65 years and older?

Data from clinical trials comparing Fluzone to Fluzone High-Dose among persons aged 65 years or older indicate that a stronger immune response (i.e., higher antibody levels) occurs after vaccination with Fluzone High-Dose. Whether or not the improved immune response leads to greater protection has been the topic on ongoing research. A study published in the New England Journal of Medicine indicated that the high-dose vaccine was 24.2% more effective in preventing flu in adults 65 years of age and older relative to a standard-dose vaccine. The confidence interval for this result was 9.7% to 36.5%. A separate study published in The Lancet Respiratory Medicine reported that Fluzone High-dose was associated with a lower risk of hospital admissions compared with standard-dose Fluzone for people aged 65 years or older, especially those living in long-term care facilities. The study compared hospitalization rates among more than 38,000 residents of 823 nursing homes in 38 states during the 2013-14 flu season.
Are there increased benefits of FLUAD™ compared to unadjuvanted seasonal flu vaccines for this age group?

Studies that have tested Fluad’s ability to generate an immune response against an influenza virus (immunogenicity) have found that antibody levels were comparable to levels induced by unadjuvanted trivalent seasonal flu vaccines (e.g., Agriflu). However, an observational study conducted in Canada among adults 65 years of age and older during the 2011-2012 flu season found that FLUAD™ was significantly more effective in preventing laboratory-confirmed influenza compared with an unadjuvanted standard-dose inactivated influenza vaccine.

After the disappointing  VE numbers reported in last week's MMWR: Interim Estimates of 2017–18 Seasonal Influenza Vaccine Effectiveness (VE) — US Feb. 2018 - particularly for those over 50 -  there is going to be a lot of interest in just how well these vaccines performed this winter compared to the regular vaccine in the elderly.

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