Pandemic Influenza Vaccine Pandemic Influenza Vaccine Manufacture PreparednessManufacture Preparedness

Lin Su

Sinovac Biotech Co., Ltd

Vaccine R&D Supported by GovernmentVaccine R&D Supported by Government

• Pandemic influenza vaccine R&D program– National Key Technologic R&D Program, supported by China

MOST, MOH, SFDA

– Financially supported by National and local government

Collaboration with China CDCCollaboration with China CDC

• Pandemic influenza vaccine development was taken as an important part in Chinese National Pandemic Preparedness Plan– Sinovac signed a collaboration agreement with China CDC collaborate o

n vaccine development, in 2004

• China CDC provided supports on basic R&D– Surveillance

– Virus isolation

– Constructing rg prototype strain using Chinese strain

• Antigen sparing strategy– Antigen: whole virion– Adjuvant： Al– Lower dose

The fast the better The more the better

• Technology– Reverse genetics

• Pre-registration vaccine– Clinical evaluation

• Safety/immunogenicity

– Production process– China SFDA fast track approval

procedure

Strategy for Pandemic VaccineStrategy for Pandemic Vaccine

0

10

20

30

40

50

60

70

80

90

100

Pla

cebo

1.25

µg

2.5µ

g

5µg

10µ

g

Pla

cebo

1.25

µg

2.5µ

g

5µg

10µ

g

Pla

cebo

1.25

µg

2.5µ

g

5µg

10µ

g

Pla

cebo

1.25

µg

2.5µ

g

5µg

10µ

g

Pla

cebo

1.25

µg

2.5µ

g

5µg

10µ

g

Pla

cebo

1.25

µg

2.5µ

g

5µg

10µ

g

Pla

cebo

1.25

µg

2.5µ

g

5µg

10µ

g

Pla

cebo

1.25

µg

2.5µ

g

5µg

10µ

g

Pla

cebo

1.25

µg

2.5µ

g

5µg

10µ

g

Pain Ery thema Induration Sw ellness Fev er Headache Fatigue My algia Nausea

Per

cen

t

Mild

Moderate

Sev ere

0

10

20

30

40

50

60

70

80

90

100

Pla

ce

bo

1.2

5µ

g

2.5

µg

5µ

g

10

µg

Pla

ce

bo

1.2

5µ

g

2.5

µg

5µ

g

10

µg

Pla

ce

bo

1.2

5µ

g

2.5

µg

5µ

g

10

µg

Pla

ce

bo

1.2

5µ

g

2.5

µg

5µ

g

10

µg

Pla

ce

bo

1.2

5µ

g

2.5

µg

5µ

g

10

µg

Pla

ce

bo

1.2

5µ

g

2.5

µg

5µ

g

10

µg

Pla

ce

bo

1.2

5µ

g

2.5

µg

5µ

g

10

µg

Pla

ce

bo

1.2

5µ

g

2.5

µg

5µ

g

10

µg

Pla

ce

bo

1.2

5µ

g

2.5

µg

5µ

g

10

µg

Pain Ery thema Induration Sw ellness Fev er Headache Fatigue My algia Nausea

Perc

en

t

Mild

Moderate

Sev ere

1st dose

2nd dose

Pandemic Vaccine Clinical Results (1)Pandemic Vaccine Clinical Results (1)

• Safety results

– No SAE reported

– Most reported local and systemic reactions were graded as mild and transient

– The frequencies of local and systemic reactions after the second dose are

significant lower than after the first dose

Pandemic Vaccine Clinical Results (2)Pandemic Vaccine Clinical Results (2)

0

10

20

30

40

50

60

70

80

90

100

0 14 28 42 56

10.00μg

5.00μg

2.50μg

1.25μg

Placebo

％HI Seropositive (％ )

Day

• Immunogenicity results

– Antibody responses were detected in 1.25/2.5/5/10 ug groups 14 days after 1st dose

– Antibody responses showed a clear dose-related effect

– Highest antibody responses after 2 doses were recorded in the 10 ug group: 78%

Manufacturing Capacity Expansion PlanManufacturing Capacity Expansion Plan

• Expand to 20 million doses per year

• Supported by national government

• Well established process

• Finished by the end of 2007

Epidemic vs. CapacityEpidemic vs. Capacity

Situation in ChinaSituation in China

• 22 cases, 14 death

• Numbers of outbreaks in poultry

16 billion population

20 million do

ses

Things need to doThings need to do

• Enhance R&D

• Expand capacity

• Government supports

• Encourage public use of seasonal influenza vaccines produced in China

Thank You!Thank You!