Optimising Flu Recommendations the European View

Angus Nicoll CBE - Head of Influenza Programme

European Society of Clinical Microbiology & Infectious Diseases –Conference on the Impact of Vaccine on Public Health Prague Czech Republic – April 1st-3rd 2011

Aim and Structure of Talk

To take a forward look on flu immunisation in Europe for the next four years

Identifying general issues that apply for all vaccines but relate especially for seasonal influenza vaccination and more specific seasonal influenza issues

What can we learn from the pandemic experience that is relevant to seasonal influenza and immunisation in general?

Acknowledgements - European Influenza Surveillance NetworkGabriela El Belazi, Hubert Hrabcik, Peter Lachner, Reinhild Strauss, Robert Muchl, Theresia Popow – Kraupp,

Françoise Wuillaume, Leen Meulenbergs, Sophie Quoilin, Mira Kojouharova, Rositsa Kotseva, Teodora Georgieva, Avraam Elia, Chryso Gregoriadou, Chrystalla Hadjianastassiou, Despo Pieridou Bagatzouni, Olga Kalakouta, Jan Kyncl, Jitka Castkova, Martina Havlickova, Andreas Gilsdorf, Brunhilde Schweiger, Gabriele Poggensee, Gerard Krause, Silke Buda, Tim Eckmanns, Anne Mazick, Annette HartvigChristiansen, Kåre Mølbak, Lars Nielsen, Steffen Glismann, Inna Sarv, Irina Dontsenko, JelenaHololejenko, Natalia Kerbo, Olga Sadikova, Tiiu Aro, Amparo Larrauri, Gloria Hernandez – Pezzi, PilarPerez – Brena, Rosa Cano – Portero, Markku Kuusi, Petri Ruutu, Thedi Ziegler, Sophie Vaux, Isabelle Bonmarin, Daniel Lévy-Bruhl, Bruno Lina, Martine Valette, Sylvie Van Der Werf, Vincent Enouf, Ian Fisher, John Watson, Joy Kean, Maria Zambon, Mike Catchpole, Peter Coyle, William F Carman, Stefanos Bonovas, Takis Panagiotopoulos, Sotirios Tsiodras Ágnes Csohán, Istvan Jankovics, KatalinKaszas, Márta Melles, Monika Rozsa, Zsuzsanna Molnár, Darina O'flanagan, Derval Igoe, Joan O’donnell, John Brazil, Margaret Fitzgerald, Peter Hanrahan, Sarah Jackson, Suzie Coughlan, Arthur Löve, Gudrun Sigmundsdottir, Isabella Donatelli, Maria Grazia Pompa, Stefania D'amato, Stefania Iannazzo, Sabine Erne, Algirdas Griskevicius, Nerija Kupreviciene, Rasa Liausediene, Danielle Hansen – Koenig, Joel Mossong, Mathias Opp, Patrick Hau, Pierre Weicherding, Antra Bormane, Irina Lucenko, NatalijaZamjatina, Raina Nikiforova, Charmaine Gauci, Christopher Barbara, Gianfranco Spiteri, Tanya Melillo, Adam Meijer, Frederika Dijkstra, Ge Donker, Guus Rimmelzwaan, Paul Bijkerk, Simone Van Der Plas,Wim Van Der Hoek, Katerine Borgen, Susanne Dudman, Siri Helene Hauge, Olav Hungnes, AnetteKilander, Preben Aavitsland, Andrzej Zielinski, Lidia Brydak, Magdalena Romanowska, MalgorzataSadkowska – Todys, Maria Sulik, Carlos Manuel Orta Gomes, Jose Marinho Falcao, Raquel Guiomar, Teresa Maria Alves Fernandes, Adriana Pistol, Emilia Lupulescu, Florin Popovici, Viorel Alexandrescu, Annika Linde, Asa Wiman, Helena Dahl, Malin Arneborn, Mia Brytting, Eva Grilc, Irena Klavs, Katarina Prosenc, Maja Socan, Hana Blaskovicova, Margareta Slacikova, Mária Avdicová, Martina Molcanová, Šárka Kovácsová

ECDC: Ammon A, Amato Gauci AJ, Zucs P, Snacken R, Ciancio B, Plata F, Broberg E, Nicoll A.

Acknowledgements

Thomas Abraham – China & WHO adviser

Centers for Disease Prevention and Control - USA

Department of Health (London) & the Health Protection Agency

John Spika and Public Health Agency of Canada

Darina O’Flanagan, Jolita Merecikene & VENICE

Yuelong Shu and China CDC – newest WHO Flu Collaborating Centre

WHO–HQ Tony Mounts, Sylvie Briand, Keiji Fukuda

WHO-Copenhagen Caroline Brown, Josh Mott

ECDC Influenza and Vaccine Preventable Disease Teams: Andrew Amato, Eeva Broberg, Bruno Ciancio, Johan Geiseke, Piotr Kramarz, Pierluigi Lopalco, Kari Johansen, Vicente Lopez, Giovanni Mancarella, Ulla-Karin Nurm, Pasi Penttinen, Flaviu Plata, Rene Snacken, J Todd Weber, Philip Zucs.

But Angus Nicoll takes responsibility for the comments

Declaration of Interest

I have no conflict of interest I am aware of – see ECDC Transparencyfor ECDC’s influenza programme team

Janusthe god of gates, doors, doorways, endings & beginnings

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Pandemics of influenza

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1889RussianinfluenzaH2N2

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1968Hong KonginfluenzaH3N2

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1900Old Hong Kong influenzaH3N8

1918SpanishinfluenzaH1N1

1915 1925 1955 1965 1975 1985 1995 20051895 1905 2010 2015

2009PandemicinfluenzaH1N1

Recorded human pandemic influenza(early sub-types inferred)

Reproduced and adapted (2009) with permission of Dr Masato Tashiro, Director, Center for Influenza Virus Research, National Institute of Infectious Diseases (NIID), Japan. Animated slide: Press space bar

H1N1Pandemic

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Human Flu B viruses: not subject to pandemics - drift not shift

Consequences of this: • Most influenza morbidity/mortality between pandemics

• Historically there has usually been a single group of A viruses plus B viruses in the interpandemic periods1

• Then an A(H1N1) remerged in 1977 and so there were two groups of influenza A viruses 1977 to 2008.

• A pandemic changes the seasonal influenza A viruses – often with significant consequences

• Between pandemics the viruses do not stand still - for examples emergence of the Fujian strain of A(H3N2) in 2003/4 and oseltamivir resistant A(H1N1) in Europe 2007/82,3

1. Kilbourne ED. Influenza pandemics of the 20th century. Emerg Infect Dis. 2006 Jan. Available from http://www.cdc.gov/ncidod/EID/vol12no01/05-1254.htm

2. CDC Update: Influenza Activity United States and Worldwide, 2003--04 Season, and Composition of the 2004--05 Influenza Vaccine MMWR July 2, 2004 / 53(25);547-552 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5325a1.htm

3. Meijer A, et al. Oseltamivir-resistant influenza A (H1N1) virus, Europe, 2007–08 season. Emerg Infect Dis. 2009 April; http://www.cdc.gov/eid/content/15/4/552.htm

2010 onwards - a most exciting time – the first ‘new’ seasonal influenza since 1970

What is it going to be like?

• Will it be like old seasonal influenza?

• Who will be at risk of severe disease?

– those with chronic conditions? Older people? Children? Pregnant women?

• The social, and political impact of the 2009 pandemic – which varies by country

We just don’t know yet!

Well so far in this inter-pandemic period?

What has it been like (2010-2011)?

It has been different from before the pandemic!

Source: WHO/GIP, data in HQ as of 22 March 2011.Data used are from FluNet (www.who.int/flunet), 9:42 am snapshot, from WHO regional offices and/or ministry of health websites.

0-1011-20

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Influenza transmission zonesInternational boundaries

A(H1N1) 2009A(H1N1)A(H3N2)

A (not subtyped)B

* when total number of samples tested >10

** when influenza positive samples >20

Virus subtype **

Map_data_zone_global.PercAH1N1

Map_data_zone_global.PercAH1

Map_data_zone_global.PercAH3

Map_data_zone_global.PercANOTSUBTYPED

Map_data_zone_global.PercB

Global Overview of FluNet Data

The Viral Mix has changed

In Europe 2010-2011

• The old seasonal A(H1N1) viruses have gone – and with them most of the oseltamivir resistance

• The B Viruses are still there – both Victoria and Yagamata

• But what about the ‘nasty’ A(H3N2) ?

• …. and A(H1N1)2009 - the pandemic virus?

Proportion of influenza-positive sentinel samples in Europe by type, subtype, & week of report, from week 40/2010 to 4/2011

no old A(H1N1), very little A(H3N2) , A(H1N1) 2009 dominatingSource: European Influenza Surveillance Network – ECDC

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Rates of influenza-positive sentinel samples in Europe by type and

subtype, and by week of reporting, from week 40/2010 to week 04/2011.

Steadily Rising B Viruses – dominating by week 11/2011

Source: European Influenza Surveillance Network – ECDC

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So for the new seasonal influenza circulating Viruses – the mix has changed in Europe

1970 to 2008 in Globally 2010-2011 in Europe

‘old’ seasonal A(H1N1) - latterlyacquired resistance to oseltamivir

Eclipsed by the new A(H1N1)2009

Of course the pandemic virus (called A(H1N1)2009 or A(H1N1)pdm) was not there before

A(H1N1) 2009 - the predominant A viruses

A(H3N2) – most pathogenic in older people (over 65 years)

A(H3N2) – minimal amounts

B viruses latterly – two distinct clusters – Victoria & Yagamata

B viruses still – two distinct clusters – Victoria & Yagamata

Has the change in the viral mix mattered?

Yes – because there has been a change in the clinical and epidemiological pattern

What has happened as a result? By Week 12 in Europe cf before

• Severe disease and deaths in young adults (under 65 years)

• Mostly but not entirely in the risk groups around 20% in previously healthy adults).

• Acute respiratory distress syndrome seen as in the pandemic

Intensive care units - Considerable pressures in Ireland, Greece & the UK – point peak prevalencesof severe flu cases needing ICU care of 1-2 per 105

population but less intense (Denmark, France, Netherlands, Norway).

Example – Influenza Deaths - UK to the end of March

To the end of March - 565 fatal influenza cases reported. Based on over 500 cases with further information

Virus type:

Associated with H1N1 (2009) - 92%

Associated with influenza B - 7%

Age:

< 5 years 4%

5 to 14 years 4%;

15 to 64 years 70%

> 64 years 22%

Cf: Previous estimates of 80-90% of deaths in persons over age 64years Source: HPA Seasonal Influenza Report March 31st 2011

UK - Risk Factors for Severe Disease

UK: 69% of 480 fatal cases with available information had one clinical risk for vaccination – conversely 31% healthy.

– 23% with respiratory disease including asthma

– 19% with immunosuppression

– 8 (2%) cases were pregnant

Vaccination: 72% of 178 has not been vaccinated with seasonal vaccine this season (would have expected about 50% by chance alone)

Sources: HPA Seasonal Influenza Report March 31st 2011

Department of Health - London (Winterwatch) March 3rd 2011

What has the vaccine effectiveness been in the 2010-2011 Season?

2010/11 influenza vaccine effectiveness ranged between 43% and 65% in preventing mild laboratory confirmed influenza infections.

Preliminary results come from an ECDC-funded network of European studies.

The Influenza Monitoring Vaccine Effectiveness in Europe (I-MOVE) is a network funded by the ECDC and coordinated by EpiConcept to monitor seasonal and pandemic influenza vaccine effectiveness

These estimates are somewhat less than for the adjuvanted pandemic vaccines in 2009-2010 season

See Puig-Barberà J. 2010-2011 influenza seasonal vaccine, preliminary mid-season effectiveness estimates: reason for concern, confounding or are we following the right track?. Euro Surveill. 2011;16(11):pii=19821. Available online: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19821

Sources: http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19821http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19820 http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19818http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19799 http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19791

One of the lessons of the pandemic

Severe end (hospital) and mortality influenza surveillance is weak in many EU countries - Europe does not have good data on this routinely

What has happened? By Week 5 UK and Ireland

• The impact was first on higher level (intensive) care services (UK). They coped - but pressures were well above the pandemic peak. In the UK 1.4/105

prevalent ITU flu cases cases, in Ireland 1.1/105

• Community consultations rose above autumn 2009 pandemic levels

• Young adults (under 65 years) dying from flu -mostly in clinical risk groups but also some healthy individuals (20%)

• In UK an increase in two invasive bacterial infections and all cause all age mortality – again not seen in the pandemic – but unclear if either related to flu

Rise in invasive bacterial infections in the UKSeen in UK only so far where

Coincided with the rise in severe influenza cases and similar age groups

Confined to invasive Group A Strep (iGAS) and Pneumococci

Not seen for Staph, Haemophilus. Invasive Meningococci has risen but just returning to baseline after a very low year in 2009

Group A Strep are mostly emm1 one of the commoner types

A limited number of proven dual infections (iGAS and influenza) – but unclear if higher risk

Anecdotal but persuasive reports from ITU physicians of severe cases of influenza deteriorating very quickly with invasive bacerial disease

Medical authorities issued an alert to all doctors http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_123647.pdf

ECDC has looked elsewhere in Europe - contact Aftab Jasir aftab.jasir@ecdc.europa.eu – has not found evidence of the same – but has more found a weakness of surveillance for these invasive bacterial diseases and the capability of integrating bacterial surveillance with data on influenza

HPA - Health Protection Report. Volume 5 Number 3 Published

21 January 2011 Weekly count of invasive Group A Streptococcal

infection routine laboratory reports: England, Wales and

Northern Ireland http://www.hpa.org.uk/hpr/archives/2011/hpr0311.pdf

Well that is it for Europe – what about elsewhere in the world

It has been different!

Guidelines | 27 July 2006|

Influenza Hospitalizations and Deaths

Canada 2010/11 519 lab confirmed pediatric hospitalizations

– 82% influenza A; of subtyped A's 83% H3N2, 17% H1N1

– 18% were 0-5 month olds; 29% were 6-23 month olds

849 adult hospitalized cases reported:

– 97% were flu A. Of A's subtyped: 84% were H3N2

– 69% were aged 65 years or older;.

191 fatal cases

– 96% flu A; of A's subtyped: 91% H3N2

– 79% 65 years of age or older; another 12% were 45 - 64 years old

The mix is different in N. America

1970 to 2008 Globally 2010-2011 in Europe 2010-2011 in NorthAmerica

Seasonal A(H1N1) -latterly acquired resistance to oseltamivir

Eclipsed by the newA(H1N1)2009

Eclipsed by the newA(H1N1)2009

Of course the pandemic virus (called A(H1N1)2009 or

A(H1N1)pdm) was not there before

A(H1N1) 2009 - the predominant A viruses

Small amounts of A(H1N1) 2009

A(H3N2) – most pathogenic in older people (over 65 years)

A(H3N2) – minimal amounts

A(H3N2) – predominates

B viruses latterly – two distinct clusters – Victoria & Yagamata

B viruses still – two distinct clusters – Victoria & Yagamata

B viruses still – two distinct clusters – Victoria & Yagamata

And somewhere in between in N. Asia (Northern China) in 2010-20112010-2011 in Europe 2010-2011 in North

America 2010-2011 in North Asia (N. China)

Old A(H1N1) Eclipsed by the new A(H1N1)2009

Old A(H1N1) Eclipsed by the new A(H1N1)2009

Old A(H1N1) Eclipsed by the new A(H1N1)2009

A(H1N1) 2009 - the predominant A viruses

Small amount of A(H1N1)2009

Late appearance and then rise in A(H1N1)2009

A(H3N2) – minimal amounts

A(H3N2) – predominates A(H3N2) predominated initially but as it subsided A(H1N1)2009 rose

B viruses continue to be important still – two distinct clusters – Victoria & Yagamata

B viruses still – two distinct clusters – Victoria & Yagamata

B viruses still – two distinct clusters – Victoria & Yagamata

Influenza Surveillance in Northern China 2009-2011

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Characteristics of pandemic influenza H1N1 2009 deaths and severe disease

Mainland China 2011 to end March 2011

Influenza Deaths: 66 fatal influenza cases reported

Mainly in middle-aged and younger adults. 51/66 (77.3%) aged 15 to 64 years .

Of 62 with relevant information, 10 were pregnant and another 31 had underlying condition (such as hypertension, diabetes, cirrhosis, etc.). Of the 62 one had received seasonal influenza vaccination, 1 had received pandemic influenza H1N1 2009 vaccination,

Other severe cases: 172 cases : 105 (62.%) were in age-group 15 to 64 years .

Of 115 with relevant information, 16 were pregnant, 35 had other underlying condition (such as hypertension, diabetes, Chronicbronchitis, etc.). 6 had received seasonal influenza vaccineation, 1 had received pandemic influenza H1N1 2009 vaccine,

An advantage for Europe … most years

Predominant West to East Progression of Seasonal Influenza Paget J, Marquet R, Meijer A, van d V. Influenza activity in Europe during eight seasons (1999-2007): an evaluation of the indicators used to measure activity and an assessment of the timing, length and course of peak activity (aspreada) across Europe. BMC Infect Dis. 2007;7(1):141. http://www.biomedcentral.com/1471-2334/7/141

Influenza Geographic Spread Week 02 2011 from EISN or Euroflu – updates at EU / EEA Influenza

Activity Maps

Consequence - can look at each seasons influenza in the West to inform the rest

This was done in 2010-2011

• Initial ECDC Risk Assessment

• WHO-UK-HPA-ECDC Clinicians Teleconferences

• Communication via ESCMID / ERS / ESPID / European Intensivists

• An approach later recommended by the Fineberg Committee!

Fineberg Preview of the Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza A (H1N1) 2009 March 2011 http://www.who.int/ihr/preview_report_review_committee_mar2011_en.pdf

ECDC Interim Risk Assessment – January 2011

http://wwwU.ecdc.europa.eu/en/publications/Publications/110125_RA_Seasonal_Influenza_EU-EEA_2010-2011.pdf

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Antiviral Resistance 2010-2011

Background – little use of antivirals in Europe overall

In the UK there was more use this year following the severe cases and encouragement from the authorities

Some freely transmitting oseltamivir resistant A(H1N1)2009 cases. Three out of the 27 observed so far in the UK had no known exposure to oseltamivir and were community acquired – see Lazenby et al Eurosurveillance 2011 http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19784

All A(H1N1)2009-H275Y mutation

Needs careful watching

Well if that is the virology, clinical picture and epidemiology

What about the response?

European Council Recommendation on seasonal influenza vaccination 2009 a major step forward

Council Recommendation – an EU Commitment by all the Health Ministers December 2009

Council of the European Union. Council Recommendation of 22 December 2009 on seasonal influenza vaccination (Text with EEA relevance)(2009/1019/EU). Official Journal of the European Union. 2009. L 348/71. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:348:0071:0072:EN:PDF

European Commission and the Swedish EU Presidency Played major roles to get this through

The EU Council Recommendation on Seasonal Influenza Vaccination – Dec 2009

Some Content Link Here

• Reach a target of 75 % vaccination coverage of the older age groups recommended by the WHO as early as possible and preferably by the 2014-2015 winter season.

• This target of 75 % should, if possible, be extended to the risk group of people with chronic conditions,

• Also improve immunisation in health care workers

• Take into account guidance issued by the European Centre for Disease Prevention and Control

For the Council

A CARLGREN (President)

Official Journal of the European Union

December 29th 2009 L 348/71

3

So how is Europe (EU/EEA) doing?

Vaccine Coverage – this relies on the VENICE collaboration

Vaccination coverage for seasonal influenza vaccine in older people (65 years and above) in EU and EEA countries

Latest seasonal available in spring 2009 - For Season 2007/8

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Recommended 75% EU Target for 2014/15 Health Council 2009

Data available in spring 2008. Not available from: Austria, Cyprus, Czech Republic, Greece, Latvia

Data from VENICE survey and other sources, version November 2010. Available from http://venice.cineca.org/Final_2009_Seasonal_Influenza_Vaccination_Survey_in_Europe_1.0.pdf and http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19700

Some key points

The likelihood of older persons being immunised in EU/EEA countries varies forty-fold! - a major inequality

Reveals differing approaches to immunisation – for some countries it is seen as a public health commitment while for others they just determine policy and it is left to individuals

Note there were at least five countries that cannot report vaccine coverage

A number of previous lower performance countries have shown improvements since 2006-7

Vaccination coverage for seasonal influenza vaccine in the older people (65 years & older) in EU and EEA countries

Latest seasonal data available in spring 2008 For season 2006/7

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Data not available for: Bulgaria,Cyprus, Estonia, Greece, Iceland, Latvia, Malta

Data from VENICE survey and other sources, version 18 March 2008. Available from:http://venice.cineca.org/Influenza_Study_Report_v1.0.pdf http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19017

Developments from the Pandemic Experience

Important points about the pandemic experience

A schizophrenic virus – usually mild or no illness. But occasionally lethal even in healthy young people – a real challenge for those doing risk communication

In some countries the unexpected experience of deaths in healthy young people was a tipping point for the acceptance of vaccine. The Meningococcal Experience

There was an expectation that it would be worse and so many people feel they were misled (what Thomas Abraham refers to as Risk Advocacy)

In other countries perceived that the need for influenza vaccination was over-sold and risks underemphasised

Whatever the experience was in your country remember it was probably different elsewhere

Antivirals were generally under-used – but where they were used they worked well

Some countries immunised higher proportion of health care workers or entire populations than for seasonal flu

Estimated Pandemic vaccine coverage in entire populations 2009-10 (n=21)

Preliminary results: http://ecdc.europa.eu/en/ESCAIDE/ESCAIDE%20Presentations%20library/ESCAIDE2010_Late_Breakers_Mereckiene.pdf

Scientific UncertaintiesThese are legion but they include:-

• What are the risk groups for the new seasonal flu – do they include pregnant women and children?

• What is the effectiveness of antivirals against the new seasonal influenza?

• What is the effectiveness of the seasonal vaccines for severe disease?

• What is the impact of repeated immunisation against seasonal flu on long-term immunity?

• What will be the source of the next pandemic an A(H2 virus or an novel animal influenza; A(H5, H7 or H9?

• What is the pathogenesis mechanism of the Acute Respiratory Distress Syndrome caused by A(H1N1)2009?

• Why do some people suffer so severely from ARDS following flu and are there any specific treatments?

• What is the level of premature mortality due to the new seasonal influenza in Europe?

Some Needed Developments• Updating of risk groups initially annually

• Model for annual risk assessments of seasonal influenza in Europe

• Hospital surveillance for influenza

• Intensive care unit networks for severe respiratory disease

• Sustainable annual influenza vaccine effectiveness based on I-Move model

• Routine safety assessments for seasonal vaccines: through signal detection, assessment and hypothesis testing-VAESCO

• Sustainable annual reporting of vaccine policies, practises and performance of vaccination – based on VENICE

• Annual estimates of premature mortality attributable to

• Health economic tools for the new influenza

Conclusions on this season’s influenza

Not like the previous seasonal influenza

A mix of A(H1N1)2009 & B viruses – very little A(H3N2). No old A(H1N1)

Severe pathology associated with the influenza A(H1N1)2009

Clinical risk groups experiencing most of the disease

Some young healthy adults and children also affected

Some severe disease and deaths in older people

Considerable vulnerability in the community – immunisation gaps

Hence considerable potential health gain from continuing immunisation

Evidence that A(H1N1)2009 containing vaccines work well, and quickly –2010-2011 vaccine also works but less effective and having had both is best

Antivirals also of value though need to watch for oseltamivir resistance

Worth considering if higher level care services are ready for a surge

ITU networks have been invaluable where they exist

Thank you - contact

influenza@ecdc.europa.eu