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S-OIV, İnfluenza A H1N1 Pandemisi Finans Bank Tarih : 04 Kasım 2009, Çarşamba Saat : 18.00 Yer : Finansbank Genel Müdürlüğü B1 Konferans Salonu Dr.Yahya Laleli

İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

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Page 1: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

S-OIV,

İnfluenza A H1N1

Pandemisi

Finans Bank

Tarih : 04 Kasım 2009, ÇarşambaSaat : 18.00Yer : Finansbank Genel Müdürlüğü

B1 Konferans Salonu

Dr.Yahya Laleli

Page 2: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Kapsam

• Influenza A H1N1 geçmişi, geleceği

• Epidemiyolojik seminoloji,

• Tanı yöntemleri, antijenler, genetik materyalin moleküler değerlendirmesi,

• Aşı

• Bildiklerimiz …

Page 3: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Grip A/Grip A, H1N1

Mevsimsel grip nedeniyle Dünya da sene 250.000 ila500.000 kişi öldüğüne göre aynı düzeyde öldürücüolmasa da daha bulaşıcı S-OIV (pandemik H1N1) DOMUZGRİBİNİN belirli coğrafi bölgeler için daha etkin olmaküzere yeteri kadar lethal seyredeceği aşikardır. Bu gripetkeni genetik değişikliğe uğrayıp süper lethal halegelmeden hastalığı aktif geçirmek, ama riskli/hassaskişileri aşılama dahil koruma altına almak, toplumunsağlıklı yaşam ve hijyenik uygulamalara bağlı kalmasınısağlamak hepimizin görevidir.

Page 4: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

The Persistent Legacy of the 1918 Influenza VirusDavid M. Morens, M.D., Jeffery K. Taubenberger, M.D., Ph.D., and Anthony S. Fauci, M.D.

N.Eng.J Med.,July 16, 2009

Page 5: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

20. yy’ın pandemileriyle ilgili bazı “bilinen bilinmeyenler”

• Üç pandemi (1918, 1957, 1968)

• Her biri şekil ve dalga olarak birbirinden farklı

• Efektif reprodüktif sayıda bazı değişiklikler

• Değişik gruplar etkilendi

• Vaka ölüm oranı bakımından da hastalık seyrinin değişik ağırlıkta oluşu

• Hafifletmek için değişik yaklaşımlar gerektiriyor

Page 6: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Beklenmedik enfeksiyonlar!

THE FIRST TURNING POINTA different virus was the world's wake-up call. SARS (severe acute respiratory syndrome) started in China, and once it broke out of the mainland in early 2003, it took just weeks to infect more than 8,000 people from 37 countries. The virus killed more than 770 people before it disappeared.Governments started scrambling to put together plans to handle the next global disease threat. Soon after, bird flu hit Asia, reinforcing the need.

Page 7: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Avrupa’nın pandemi için gözden geçirilmiş planlama varsayımları-2009’daki ilk dalga pandemi (H1N1)

Clinical attack rate

(klinik olarak hasta vaka sayısı)

% 30

Peak clinical attack rate

(klinik olarak hastavaka sayısının en

üst oranı)

Haftada % 6,5 (% 4,5’tan % 8’e kadar

değişen oranda)

Complication rate

(komplikasyon oranı)

Klinik vakaların % 15’i

Hospitalisation rate

(hastaneye yatırılma oranı)

Klinik vakaların % 2’si

Case fatalitiy rate

(ölümle sonuşlanan vaka oranı)

Klinik vakaların % 0.1- 0.2’si (%

0.35’e kadar )

Peak absence rate

(iş gücü kaybı oranı)

İş gücünün % 12 kadarı

Page 8: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Grip ve BizlerNereden Nereye?

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Page 10: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Influenza A

Subtipleri vardır: • 2 yüzey antijeni vardır;

– Hemagglutinin (HA) – bilinen 16 subtipi var

– Neuraminidase (NA) – bilinen 9 subtipi var

10

This image is in the public domain in the United States

Hemagglutinin

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MutasyonAntijenik Kayma/Antijenik Degisim

Page 13: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US
Page 14: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Morens D et al. N Engl J Med 2009;361:225-229

Genetic Relationships among Human and Relevant Swine Influenza Viruses, 1918-2009

Page 15: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Morens D et al. N Engl J Med 2009;361:225-229

Mortality Associated with Influenza Pandemics and Selected Seasonal Epidemic Events, 1918-2009

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2009 İnfluenza A/ H1N1 görülen ülkeler

Konfirme İnfluenza A/ H1N1 nedeniyle ölüm vakaları

Konfirme İnfluenza A/ H1N1 vakaları

27.Ekim 2009

Page 17: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Epidemioloji

Page 18: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Low: no influenza activity or influenza activity is

at baseline level*

Medium: level of influenza activity usually seen

when influenza virus is circulating in the country

based on historical data

High: higher than usual influenza activity

compared to historical data

Very high: influenza activity is particularly severe

compared to historical data

Unknown: influenza activity is not known

* Baseline influenza activity is the level that

clinical influenza activity remains in throughout

the summer and most of the winter.

Page 19: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

ILI: influenza-like illness

ARI: acute respiratory infection

Country:countries may be made up of one or more regions

Region:

The population under surveillance in a defined geographical sub-division of a country. A region should not (generally) have a population of less than 5 million unless the country is large with geographically distinct regions

Indicator of the geographical spread of influenza: Each country defines the

geographical spread of influenza according to the definitions outlined below.

The definitions are based on those used by the WHO global influenza

surveillance system – FluNet.

Page 20: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

No report: no report received

No activity: reports indicate no evidence of influenza virus activity. Cases of ILI/ARI

may be reported in the country but the overall level of clinical activity remains at

baseline levels and influenza virus infections are not being laboratory confirmed.

Cases occurring in people recently returned from other countries are excluded

Sporadic: isolated cases of laboratory confirmed influenza infection in a region, or

an outbreak in a single institution (such as a school, nursing home or other

institutional setting), with clinical activity remaining at or below baseline levels. Cases

occurring in people recently returned from other countries are excluded

Local outbreak: increased ILI/ARI activity in local areas (such as a city, county or

district) within a region, or outbreaks in two or more institutions within a region, with

laboratory confirmed cases of influenza infection. Levels of activity in remainder of

region, and other regions of the country, remain at or below baseline levels

Regional activity*: ILI/ARI activity above baseline levels in one or more regions with

a population comprising less than 50% of the country's total population, with

laboratory confirmed influenza infections in the affected region(s). Levels of activity in

other regions of the country remain at or below baseline levels

* This term is not (generally) to be used in countries with a population of less than 5

million unless the country is large with geographically distinct regions

Widespread activity: ILI/ARI activity above baseline levels in one or more regions

with a population comprising 50% or more of the country's population, with laboratory

confirmed influenza infections

Unknown: influenza geographical spread is not known

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With interventions

Aims of community reduction of influenza transmission — mitigation

Delay and flatten epidemic peak.

Reduce peak burden on healthcare system and threat.

Somewhat reduce total number of cases.

Buy a little time.

Dailycases

Days since first case

No intervention

Animated slide: Press keyBased on an original graph developed by the US CDC, Atlanta

Page 25: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

2009 flu pandemic data

Ölüm Son 7 gündeki artış

Dünya genelinde 6,021 +686 (11%)†

Avrupa 292 +54 (18%)

Orta asya 6 +6 (100%)

Akdeniz ülkeleri 181 +31 (17%)

afrika 108 +2 (2%)

Kuzey Amerika 1,421 +474 (33%)†

Orta amerika 166 +6 (4%)

Güney Amerika 2,693 +34 (1%)

Asya 586 +54 (9%)

güneydoğu Asya 357 +25 (7%)

Avustralya 211 +0 (0%)

29Ekim, 2009[1]

†The USA introduced a new reporting system on August 30, 2009.

All lab-confirmed deaths which have occured in the U.S. since

then have been reported together by the ECDC on October 26.

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Page 30: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Tani testleri

• Tani Testleri kullanis gayeleri.

Page 31: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Description of the system According to the nationally defined sampling strategy, sentinel physicians take nasal or pharyngeal swabs from patients with influenza-like illness (ILI), acute respiratory infection (ARI) or both and send the specimens to influenza-specific reference laboratories for

a. virus detection,

b.(sub-)typing,c. antigenic or genetic characterisation and

d. antiviral susceptibility testing. For details on the current virus strains recommended by WHO

Page 32: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

B.Stoneetal./JournalofVirologicalMethods117(2004)103–112

Page 33: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

B.Stoneetal./JournalofVirologicalMethods117(2004)103–112

Fig.2.Quantification curves relating cycle number(a) or melting temperature curves(b) and hybridization probe fluorescence signals obtained in the Light Cycler during real time PCR amplification of influenza A matrix gene with H1N1,H3N2, an equal mix of H1N1 and H3N2, un infected MDCK cells and sterile water.

Page 34: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

B.Stoneetal./JournalofVirologicalMethods117(2004)103–112

Fig.2.Quantification curves relating cycle number(a) or melting temperature curves(b) and hybridization probe fluorescence signals obtained in the Light Cycler during real time PCR amplification of influenza A matrix gene with H1N1,H3N2, an equal mix of H1N1 and H3N2, un infected MDCK cells and sterile water.

Page 35: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Table 2: Weekly and cumulative influenza virus detections by type, subtype and surveillance system, weeks 40/2009–43/2009

Note: A(pandemic H1N1, A(H3) and A(H1) includes both N-subtyped and not N-subtyped viruses

Page 36: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Table 3: Antiviral resistance by influenza virus type and subtype, weeks 40/2009–43/2009

ECDC Surveillance Report, Weekly influenza surveillance overview, 30 October 2009

Page 37: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

China starts batch production of A/H1N1 vaccine www.chinaview.cn 2009-06-09 20:36:09

A researcher with Sinovac Biotech Company begins preparation work for producing A/H1N1 influenza vaccine for human use with the seed lot of flu virus "NYMCX-179A". China received on Monday, June 8, 2009 the flu strain samples shipped from the United States, for the mass production of A/H1N1 influenza vaccine. Chinese drug companies are expected to have the vaccine produced by July.(Xinhua Photo)

Page 38: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

1917 ve 1976 Domuz Gribi

Another H1N1 flu jumped from pigs to people in 1976,

and killed an army recruit in New Jersey. The US went

on high alert and vaccinated thousands of people – but

the virus did not spread readily enough to maintain an

epidemic, and fizzled out

The 1918 flu pandemic, caused by another H1N1 virus,

started with a mild, early wave in spring and early

summer. The flu lab at the Los Alamos National

Laboratory in the US estimates that the R0 of the 1918

virus in spring was only 1.45. That shot up, they

estimate, to 3.75 when the virus began its lethal second

wave the following autumn.

Page 39: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

The FDA has approved 4 vaccine preparations.

• All influenza vaccine preparations in the United States for the 2009-2010 season contain residual egg protein and none contain adjuvant;

• Children 6 months to 9 years of age who are given influenza A (H1N1) monovalent vaccine should receive 2 doses separated by about 4 weeks; persons ≥ 10 years of age should receive 1 dose;

• The influenza A (H1N1) monovalent vaccines were made according to standards used for seasonal and influenza vaccines and have the same age group indications, precautions, and contraindications as vaccines that are FDA-approved for seasonal flu; preliminary data indicate that the safety and efficacy of the 2009 Influenza A (H1N1) monoclonal vaccine is the same as for seasonal flu vaccines;

• Side effects, including local pain at the injection site, were reported in 46% of recipients, and systemic reactions (headache, malaise or myalgias) were reported in 45%; the safety profile is consistent with the experience with seasonal flu vaccine;

• Influenza activity due to influenza A (H1N1) increased in September 2009 and is expected to continue through fall and winter;

• There is minimal evidence of significant antigenic change since the first characterization of the virus in April 2009, indicating that the virus continues to be well matched with the vaccine strain; and

• The vaccines of the 4 suppliers have some differences that are important to recognize

MMWR Morb Mortal Wkly Rep. 2009;58:1100-1101.)

Page 40: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

The FDA has approved 4 vaccine preparations.

• All influenza vaccine preparations in the United States for the 2009-2010 season contain residual egg protein and none contain adjuvant;

• Children 6 months to 9 years of age who are given influenza A (H1N1) monovalent vaccine should receive 2 doses separated by about 4 weeks; persons ≥ 10 years of age should receive 1 dose;

• The influenza A (H1N1) monovalent vaccines were made according to standards used for seasonal and influenza vaccines and have the same age group indications, precautions, and contraindications as vaccines that are FDA-approved for seasonal flu; preliminary data indicate that the safety and efficacy of the 2009 Influenza A (H1N1) monoclonal vaccine is the same as for seasonal flu vaccines;

• Side effects, including local pain at the injection site, were reported in 46% of recipients, and systemic reactions (headache, malaise or myalgias) were reported in 45%; the safety profile is consistent with the experience with seasonal flu vaccine;

• Influenza activity due to influenza A (H1N1) increased in September 2009 and is expected to continue through fall and winter;

• There is minimal evidence of significant antigenic change since the first characterization of the virus in April 2009, indicating that the virus continues to be well matched with the vaccine strain; and

• The vaccines of the 4 suppliers have some differences that are important to recognize

MMWR Morb Mortal Wkly Rep. 2009;58:1100-1101.)

Page 41: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Table 1 Results of haemagglutination inhibition tests of influenza A(H1N1) viruses with post‐infection ferret seraA

Page 42: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Table 1. FDA-Approved Influenza A (H1N1) Vaccines

Supplier Vaccine Form Mercury µg/0.5 mL

Age

MedImmune(nasal spray)

Live virus 0.2 mL(nasal spray sprayer)

0 2-49 yrsb

Sanofi (IM)a Inactivated0.25 mL prefilled syringe0.5 mL prefilled syringe

5 mL multidose vial

00

25

6-35 mosb

> 36 mosb

> 6 mosb

Novartis (IM)a 5 mL multidose vial0.5 mL prefilled syringe

25< 1.0

≥ 4 yrsb

> 4 yrsb

CSL Biotherapies, Inc(IM)a

0.5 mL prefilled syringe5.0 mL multidose vial

024.5

> 18 yrs> 18 yrs

a0.5 mL doses contain 15 µg hemagglutinin of the vaccine strain A/California/7/2009 (H1N1)bTwo doses separated by 4 weeks for children 2-9 years (CDC. Update on influenza A (H1N1) monovalent vaccines.

MMWR Morb Mortal Wkly Rep. 2009;58:1100-1101.)

Page 43: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

FDA/ Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients

Influenza A (H1N1) 2009 monovalan aşılar 6 ekim, 2009

Aşı Üretici Tanıtım Civa içeriği

(μg Hg/0.5 mL

dose)

Yaş grubu Doz Enjeksiyon

yeri

İnaktive Sanofi Pasteur 0.25 mL 0 6--35 2† Kas içine

0.5 mL 0 ≥36 1 veya 2† Kas içine

5.0 mL 25.0 ≥6 1 veya 2† Kas içine

İnaktive Novartis Vaccines

and Diagnostics

Limited

5.0 mL 25.0 ≥4 yaş 1 veya 2† Kas içine

0.5 mL <1.0 ≥4 yaş 1 veya 2† Kas içine

İnaktive CSL Limited 0.5 mL 0 ≥18 yaş 1 Kas içine

5.0 mL 24.5 ≥18 yaş 1 Kas içine

LAIV (Canlı aşı)¶ MedImmune LLC 0.2--mL 0 2--49 yaş 1 veya 2†† İntranasal

Page 44: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

The FDA has approved 4 vaccine preparations.

• All influenza vaccine preparations in the United States for the 2009-2010 season contain residual egg protein and none contain adjuvant;

• Children 6 months to 9 years of age who are given influenza A (H1N1) monovalent vaccine should receive 2 doses separated by about 4 weeks; persons ≥ 10 years of age should receive 1 dose;

• The influenza A (H1N1) monovalent vaccines were made according to standards used for seasonal and influenza vaccines and have the same age group indications, precautions, and contraindications as vaccines that are FDA-approved for seasonal flu; preliminary data indicate that the safety and efficacy of the 2009 Influenza A (H1N1) monoclonal vaccine is the same as for seasonal flu vaccines;

• Side effects, including local pain at the injection site, were reported in 46% of recipients, and systemic reactions (headache, malaise or myalgias) were reported in 45%; the safety profile is consistent with the experience with seasonal flu vaccine;

• Influenza activity due to influenza A (H1N1) increased in September 2009 and is expected to continue through fall and winter;

• There is minimal evidence of significant antigenic change since the first characterization of the virus in April 2009, indicating that the virus continues to be well matched with the vaccine strain; and

• The vaccines of the 4 suppliers have some differences that are important to recognize

MMWR Morb Mortal Wkly Rep. 2009;58:1100-1101.)

Page 45: İnfluenza A H1N1 Pandemisi - Düzen Laboratuvarlar …1917 ve 1976 Domuz Gribi Another H1N1 flu jumped from pigs to people in 1976, and killed an army recruit in New Jersey. The US

Influenza A (H1N1) 2009 Monovalan aşı

• İnfluenza A (H1N1) 2009 Monovalan aşılar tek bir influenza suşu (İnfluenza /California/7/09-like virus) içermektedir.

• Enjektable olan aşılar inaktivedir.

• İntranasal kullanılacak olan aşı ise canlı attenue virüs aşısıdır.

Information on the Influenza A (H1N1)2009 Monovalent Vaccine approvals.

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FDA kullanılabilirliğine nasıl karar verdi ?

• Tüm aşıların ABD de kullanılabilmesi için FDA onayı gereklidir. • FDA her sene farklı firmalarca üretilen farklı suşlardan oluşan

mevsimsel grip aşısı onayını verir. • Her üreticinin yaptığı monovolan Influenza A (H1N1) 2009 aşısı da

mevsimsel grip aşısında olduğu gibi yerleşik yumurta-temelli üretim proçesi kullanılarak verilmiştir.

• Mevsimsel influenza aşı üretimi ve geliştirilmesi , aşının güvenirliği ile ilgili çalışmalar konusunda birçok deneyim vardır.

• Güvenlik ve etkinlik için mevsimsel grip aşısında yapılan çalışmalar Influenza A (H1N1) 2009 Monovalan aşısı içinde başarılı bir şekilde yapılmıştır.

• Influenza A (H1N1) 2009 Monovalan aşısının klinik çalışmaları devam etmektedir. Bu çalışmaların verilerini de immunojenite oluşumu için gereken uygun dozun kararı FDA tarafından takip edilecektir.

• Influenza A (H1N1) 2009 Monovalan aşıları mevsimsel grip aşısı için yapılan prosedürlerin aynısından geçmiştir.

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Influenza A (H1N1) 2009 Monovalan aşının güvenliği nasıl takip edilecek?

• FDA ve CDC çok yakından takip ediyorlar ,• FDA, CDC, HHS laboratuvarları ile beraber

çalışarak, influenza A/H1N1 2009 aşılama programını takip edecektir.

• Laboratuvarlar arası bilgiler bir internet ağı ile takip edilecektir.

• Ayrıca FDA belirlediği uluslararası partnerlerle daha geniş bir ağ oluşturarak aşı güvenliğini takip edecektir.

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Zhu F et al. N Engl J Med 2009;10.1056/NEJMoa0908535

Geometric Mean Titer of Hemagglutination-Inhibition Antibodies among Subjects Receiving Nonadjuvanted Vaccine, According to Age Group

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GlaxoSmithKline PLC (GSK), H1N1 aşısının H5N1 aşısı ile benzer toleribilite göstermiş olduğunu açıkladı. TEMEL NOKTALAR : -Geçen hafta 150,000 den fazla insan H1N1 aşısı ile aşılanmış,

-Ek olarak 2,000 den fazla kişiyle ilgili klinik çalışma devam etmektedir.

-İspanya da 200 çocuk üzerinde yapılan İlk pediatrik (devam etmekte olan) klinik çalışma sonuçlarına göre aşının ilk dozundan sonra kuvvetli yanıt alınmış. H1N5 aşısına karşı alınan tolaribilitesi benzer bulunmuş.

-Çalışmada kullanılan aşı yarım doz H1N1 antijeni (1.9 μg) ve yarım doz adjuvant içeriyor, yetişkin aşısı ile karşılaştırılmış.

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1. ÜRETİCİ: GlaxoSmithKline

2. İÇERİK:

3.75 micrograms**İnaktive, A/California/7/2009 (H1N1)v-like strain (X-179A)(WHO ve EU decision for the pandemic ).10.69 milligrams AS03 adjuvant squalene11.86 milligrams DL-α-tocopherol4.86 milligrams polysorbate 805 micrograms thiomersal

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Posology18-60 yaş :0.5 ml ilk doz 2. doz; en az 3 hafta sonra 60 yaş üstü : 0.5 ml ilk doz 2. doz; en az 3 hafta sonra

10-17 yaş: Aşının gerekli olduğu düşünülüyorsa 0.5 ml ilk doz2. doz; en az 3 hafta sonra

If vaccination is considered to be necessary, consideration may be given to dosing in accordance with the recommendations for adults. However, the choice of dose for this age group should take into account the available data on safety and immunogenicity in adults and in children aged from 3-9 years.

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3-9 yaş:Eğer gerek duyulursa,İlk doz 0.25 ml ,2. doz 3 hafta sonra

If vaccination is considered to be necessary, the available data suggest that administration of 0.25 ml of vaccine (i.e. half of the adult dose) at an elected date and a second dose administered at least three weeks later may be sufficient. There are very limited safety and immunogenicity data available on the administration of AS03- adjuvanted vaccine containing 3.75 μg HA derived from A/Vietnam/1194/2004 (H5N1) and on administration of half a dose of the same vaccine (i.e. 1.875 μg HA and half the amount of AS03 adjuvant in 0.25 ml ) at 0 and 21 days in this age group.

6 ay – 3 yaş If vaccination is considered to be necessary, consideration may be given to dosing in accordance withthe recommendation in children aged 3-9 years. See sections 4.8 and 5.1.Children aged less than 6 monthsVaccination is not currently recommended in this age group.

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Genetic and phylogenetic characterization

• Mutations previously identified to confer resistance to oseltamivir or zanamivir have not been observed in the NA gene of the viruses characterized to date. The novel influenza A(H1N1) viruses tested so far in functional assays were sensitive to both these antiviral drugs.

• An asparagine at position 31 of the M2 protein, associated with resistance to amantadine and rimantadine, has been observed in all the viruses analysed to date.

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Studies with inactivated seasonal influenza virus vaccinesAlthough cross‐immunogenicity studies with seasonal influenza vaccines are still ongoing,

preliminary data indicate that immunization with seasonal vaccines induces little or no crossreactiveantibody to the novel influenza A (H1N1) viruses.Recommended virus for novel influenza A (H1N1) vaccinesThe majority of the novel influenza A (H1N1) isolates are antigenically and geneticallyrelated to the A/California/7/2009 (H1N1)v virus. Should vaccines be prepared against thenovel influenza A (H1N1) virus, it is therefore recommended that vaccines contain thefollowing:An A/California/7/2009 (H1N1)v ‐like virusWHO

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FDA

• Elde edilen veriler 6 aydan 9 yaşa kadar olan çocuklarda influenza A/ H1N1 2009 monovalan aşı ile antikor oluşumunun çok az veya hiç olmadığını göstermiştir.

• 9 yaş ve altındaki çocuklarda monovalan influenzaA /H1N1 2009 aşısının 2 doz yapılması gerekmektedir.

• Erişkinlerde ve 10 yaş üstündeki çocuklarda ise tek doz aşı yeterlidir. Klinik çalışmalar tamamlandığında optimal doz için ek bilgiler edinilecektir.

(MMWR 2009; 58(19) 521-524, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a1.htm).

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Aşıda koruyucu

• Mevsimsel grip aşısı gibi, Influenza A (H1N1) 2009 Monovalan aşıları thimerosal, civa koruyucuları eklendiğinde de en az koruyucu olmayan formları kadar etkindir.

• 2001 yılından beri, FDA thimersol içeren yeni aşılara izin vermiyor. Eskiden üretilmiş olup izin almış aşılarda ise CDC çocuklarda hiç thimersol içermeyen veya eser düzeyde thimersol içeren aşıları öneriyorlar.

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Weekly Influenza Surveillance Report Published for the EU/EEA Countries Week 43/2009 October 30th

• The number of countries with medium to very high intensity influenza activity continues to increase.

• Seventeen out of 27 countries report a rising trend.

• In sentinel samples, the proportion of influenza-like illness that tested positive for influenza has risen to 40%—a remarkably high percentage.

• Among positive sentinel isolates, influenza A(H1N1)v accounts for 82%.

• In 18–59 year-old patients with severe acute respiratory infection (SARI), females were overrepresented.

• In almost 40% of reported SARI cases, no underlying condition was identified.

http://www.ecdc.europa.eu/en/activities/surveillance/EISN/Newsletter/091030_EISN_Weekly_Influenza_Surveillance_Overview.pdf

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HASTALIK BULGULARI NELERDİR?

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Semptom Sayı (%)

Ateş * 249 (93%)

Öksürük 223 (83%)

Nefes darlığı 145 (54%)

Uyuşukluk 108 (40%)

Titreme 99 (37%)

Myalji 96 (36%)

Rinore 96 (36%)

Boğaz ağrısı 84 (31%)

Başağrısı 83 (31%)

Kusma 78 (29%)

Wheezing 64 (24%)

Diare 64 (24%)

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Durum Avrupa için daha kötü olabilirdi!Ne olabilirdi ve hala neler olabilir-bir karşılaştırma!

• Amerika’da ortaya çıkan pandemik bir suş Güneydoğu Asya’da ortaya çıkan bir pandemi

• Virüsle ilgili acil veri paylaşımı, çok hızlı tanı ve aşılar gecikmiş veri paylaşımı

• Pandemi (H1N1) henüz çok patojen değil daha patojen olan A(H5N1) suşuna kıyasla

• Majör risk grubunda (yaşlılar) görünüşte rezidüel immünite rezidüel immünite yok

• Bilinen patojenizite belirteçleri yok artmış patojenizite• Başlangıçta oseltamivire duyarlı virüsün geliştirdiği antiviral direnç• Kuzey Amerika’dan iyi veri ve bilgi gelişi Avrupa’ya gelene kadar minimal

düzeyde veri• Avrupa’ya yazın ulaşacak Geç sonbahar ve kışın ulaşacak• Çoğu vakada hafifi seyirli hemen ağır seyirli

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KENDİMİ VE ÇEVREMİ NASIL KORURUM ? KORUMALIYIM?

TEK KULLANIMLIK MENDIL KULLANDIĞINI ÇÖPE AT ELLERİNİ YIKA

BELİRTİLERDE DOKTORA GİT İNSANLARA BULAŞTIRMA KALABALIKTAN UZAK DUR

YAKIN TEMASTAN KAÇINELLERİNİ YIKA! BURUN AĞIZ VE GÖZLERİNE

SÜRME

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KORUNMA

El yıkamanın etkin yöntemini öğrenin, uygulayın ve

bilhassa çocuklarınıza öğretin.

Sosyal kontaklardan (el sıkma, öpüşme gibi) sakının.

Kalabalık ortamlardan kaçının, yaşam alanınızı sıkça

havalandırın.

Immun sisteminizi ayakta tutmak için; yeteri kadar uyuyun,

dengeli ve etkin (antioksida yönünden güçlü) beslenin ve

egzersiz yapın, egzersiz düzeyini ve vücut temizliğinizi

daha etkin sürdürün.

Riskli şahıslar (hamileler, kronik hastalığı olanlar, hizmet

üretiminde yoğun insan teması olanlar) aşılanmalıdır.

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Bir kac ay icinde ne olacak?

Will it sweep through impoverished Southern Hemisphere countries in the next few months? Will it roar back in the rest of the world in the fall? And who will be vaccinated if it does?In the weeks since swine flu grabbed international attention, and even years before that, some important actions have helped shape the course of this outbreak and the ways the world will handle future epidemics. The big worry is that the virus will mutate, becoming more severe.

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Ne kadar gucluyuz?

You may only have one chance to get out ahead of it," Dr. Richard Besser, acting chief of the Centers for Disease Control and Prevention, told The Associated Press. "It's important for people to understand that all of these decisions will need to be made with incomplete science.“

The last mass vaccination against a different swine flu, in the U.S. in 1976, was marred by reports of a paralyzing side effect — and that time the flu didn't return.___

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20. Yüzyıl pandemileri ve mevsimsel grip

Pandemi Yıl Influenza

virus

İnfekte insan

sayısı

Ölü sayısı Ölüm

oranı

İspanyol

gribi

1918

–19

A/H1N1 33% (500

milyon)

20 to 100

million[23][24][25]

>2.5%

Asya gribi 1956

–58

A/H2N2 2 million[25]

<0.1%

Hong

Kong gribi

1968

–69

A/H3N2 1 million[25]

<0.1%

Mevsimsel

grip

Her

yıl

A/H3N2,

A/H1N1,

ve B

5–15% (340

milyon – 1

milyar)

250,000–

500,000/ yıl

<0.1%

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KORUNMA

• avoid touching your mouth and nose;

• clean hands thoroughly with soap and water, or cleanse them with an alcohol-based hand rub on a regular basis (especially if touching the mouth and nose, or surfaces that are potentially contaminated);

• avoid close contact with people who might be ill;

• reduce the time spent in crowded settings if possible;

• improve airflow in your living space by opening windows;

• practise good health habits including adequate sleep, eating nutritious food, and keeping physically active.

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The levels of influenza activity in European countriesreported by EISN members during the influenza seasonare based on two assessments of influenza activity:

1. An indicator of the overall intensity of influenzaactivity in the country;

2. An indicator of the geographical spread of influenzain the country.

Each of these assessments is described below.

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Low: no influenza activity or influenza activity is

at baseline level*

Medium: level of influenza activity usually seen

when influenza virus is circulating in the country

based on historical data

High: higher than usual influenza activity

compared to historical data

Very high: influenza activity is particularly severe

compared to historical data

Unknown: influenza activity is not known

* Baseline influenza activity is the level that

clinical influenza activity remains in throughout

the summer and most of the winter.

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Influenza A/H1N1 dahil tüm grip olguları için;

― Mutlaka evde istirahat ediniz, dengeli besleniniz bol su içiniz

― Ağız burun ifrazatınızı çevreye bulaşmayacak şekilde kapalı hacimlere depolayın

― Diğer şahıslar ve bilhassa çocuklar ile temasınızı kısıtlayınız

― Sosyal ziyaretlere müsaade etmeyin

― Bulunduğunuz mekanların sık ve etkin havalandırılmasını sağlayın

― Bir doktor ile görüşmeden herhangi bir ilaç almayınız (İnfluenza A/H1 N1 gribinde genelde hafif seyrettiği için altta yatan bir sebep yoksa tedavi önerilmemektedir.)

― Eğer, ateşiniz 38 oC üzerine çıkarsa, solunum güçlüğü, nefes darlığı gibi belirtiler varsa vakit geçirmeden doktorunuzu bilgilendirin.

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For the treatment of pandemic (H1N1) 2009, how many antiviral drugs are there?

There are two approved antiviral drugs for influenza that

are available for treatment of pandemic influenza. These

are the neuraminidase inhibitors oseltamivir and

zanamivir, more commonly known by their trade names

Tamiflu and Relenza.

Another class of approved antiviral drugs known as M2

inhibitors (amantadine and rimantadine) can be effective

for treating seasonal influenza. However, the pandemic

(H1N1) 2009 virus has been shown to be resistant to

these particular antiviral drugs

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• Çinde uygulanan aşı onaylama süreci ‘’The State Food and Drug Administration’’ (SFDA)

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Tanı

Belde hastaneleri veya

Özel laboratuvarlar

“mevsimsel influenza hızlı tarama “ testini kullanabilirler.

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DOMUZ GRİBİ (İnfluenza A/H1 N1) nedir?

İnsandan insana geçen yeni tip bir virüse bağlı oluşan griptir.

İnsandan insana öksürük, aksırık sırasında damlacık yoluyla bulaşır.

Virüs bulaştığı yüzeyde 48 saat canlı kalabilir.

İnkübasyon süresi 5-10 gündür.

Bilinen insan gribine göre daha hızlı yayılır, hastalık seyri ve riski farklı değildir.

(İnfluenza A/H1 N1 gribine bağlı ölüm mevsimsel griptende azdır.)