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Characterizing of Biological Characterizing of Biological Threats to SecurityThreats to Security

Sam A Bozzette, MD, PhDSam A Bozzette, MD, PhDUC Institute on Global Conflict and CollaborationUC Institute on Global Conflict and Collaboration

& RAND Health& RAND Health

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Public Policy and Biological Threats

2-3 week residential “bootcamp” at UCSD

– Intent to enroll up to 18 fellows

– Primary target UC system grad stds /post-docs

– also sought are UC Jr faculty, PRGS Students, Professionals from US and abroad

Immersion into policy aspects of biothreats

Utilize many topical expert speakers (1-3 per session)

Arrange out of session contacts as feasible

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Broad Range of Threats

• Intentional threats a small element in the total picture

– Nature is scarier than nations or terrorists (think SARS, West Nile, Hantavirus, Ebola, HIV).

– New Diseases

– New variants of old diseases

– New territories for old diseases

– Human, animal, plants vulnerabilities all considerations

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Emerging and Reemerging IDs

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Global HIV

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Intentional threats

• Familiar (Salmonella in salad bars)

• Ancient (Smallpox)

• Arcane (Wool sorters disease, aka inhalation anthrax)

• Exotic (Meliodosis, hemorrhagic fevers)

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Select Agents and Toxins

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Intentional Threat Complexity Varies

• Materials:

– Easily obtainable (lab techs)

– High Tech (milled anthrax spores)

• Delivery systems:

– Simple (direct contamination)

– Advanced (aerosolization)

• Operations

– Isolated

– Coordinated

• Attacks are unlikely to be obvious

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Key Prevention and Response Technologies

• “Primary” prevention

• Treaties / Control Regimes

• Information / technology control

• Environmental monitoring

• Surveillance / Monitoring

• Public health responses

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Response Technologies

Heavily dependent on:

• Dual use systems & facilities

• Poorly configured public sector

– Public health infrastructure badly decayed• Personnel• Diagnostic, isolation, other facilities

– Little tradition of directed public research

• Reluctant Private sector activities/investments

– Actions / decisions of providers & health care systems

– Regulatory concerns

– Pharmaceutical industry incentives

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The Case of Smallpox Vaccination

• Infectious, contagious, disfiguring viral disease of humans

• Vaccine = live vaccinia virus

– Successful vaccination >95% protected ~5yrs

– Complications: ~50/million; Deaths: 1-3/million

• U.S. extremely vunerable

– Universal vaccination stopped in 1971

– Heath system unprepared for vaccination or care

– Health care workers at high risk

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Generating A Recommendation for National Security Policy on Smallpox

• Develop plausible attack/response scenarios

• Identified Policy options

• Perform systematic literature review

• Model outcomes based on scenarios

• Relate outcomes to policy options

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Deaths: 3 Attacks and 3 Policies

110022002700Airport—low success

Prior Prior vaccination vaccination of HCW and of HCW and

publicpublic

Prior Prior vaccination vaccination

of HCWof HCW

NoNopriorprior

actionactionDeaths

500 25 0Hoax

540 200 300Building

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Should We Vaccinate Now?

• Expected gains should exceed expected losses

– Probability(gains) losses (losses gains)

– Probability (outbreak) (lives lost if no outbreak) [(lives lost if no outbreak) (lives saved if outbreak)]

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Should We Vaccinate Now?

• Example: vaccination prior to building attack

– Vaccination of health workers causes 25 deaths but can avert 100

– Policy is favored when risk of attack [25 (25 100)] ~20%

• Expected gains should exceed expected losses

– Probability(gains) losses (losses gains)

– Probability (outbreak) (lives lost if no outbreak) [(lives lost if no outbreak) (lives saved if outbreak)]

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Threshold Probabilities: When Should We Vaccinate?

No prior vaccination Prior vaccination of health care workers Prior vaccination of health care workers and public

60%

0%

20%

40%

Lab release

Human vectors

Building

Probabilityof attack

Airport—low

Airport—high

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• December 2002 Presidential announcement:

– Vaccination of health workers to resume

– Vaccination of public may be allowed later

• Phased program

– 50,000 initial responders

– 500,000 addition health care worker

– up to 10M health and safety workers

The Policy

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The Outcome

• Only 50% of hospitals participated

• Less than 50,000 vaccinated

– Known complications low

– Possible cardiac complications dominated news

• Emphasis shifted to preparation for public health emergency

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A National Security Program

• Goal: protect public by raising population immunity

• Decisionmaking based on aggregate issues

• Losses expected and accepted

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A Public Health/Clinical Program

• Goal: optimize public health by preparing the system

• Decisonmaking based on clinical/individual considerations

• Losses unacceptable (“do not harm”)

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Comparison of Best Strategy from Each Investment Portfolio

GP Current

GP MVA-1 dose

GP MVA-2 dose

GP LC16 & MVA-2 doseGP LC16 & MVA-

1 Dose

0

500

1,000

1,500

2,000

2,500

3,000

260 265 270 275 280

Th

ou

san

ds

MillionsNumber of people protected

Nu

mb

er

of

pe

op

le w

ith

mo

rbid

ity

(i

nc

lud

ing

de

ath

)

BAD

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Large Airport Attack – Prob of Attack = .05Target Investmt RegimenPo-HCW Current NNN0Po-HCW MVA1 NNNMPo-HCW MVA1 NNMMPo-HCW MVA NNMMPo-HCW MVA1 NMMMPo-HCW MVA NMMMPo-HCW MVA1 MMMMPr-HCW Current NNN0Pr-HCW MVA1 NNNMPr-HCW MVA1 NNMMPr-HCW MVA NNMMPr-HCW MVA1 NMMMPr-HCW MVA1 NMMMPr-HCW MVA, LC LMMMPr-HCW MVA M+pN-ringPr-HCW MVA MMMMPr-H Po-G MVA1 NMMMPr-H Po-G MVA1, LC LMMMPr-H Po-G MVA, LC, M/L NMlMMPr-H Po-G MVA NMMMPr-H Po-G MVA, LC LMMMPr-H Po-G MVA MMMMPr-GP MVA1 NNMMPr-GP MVA1 NMMMPr-GP MVA1, LC LMMMPr-GP MVA1 MMMMPr-GP MVA MMMM

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

$0 $20 $40 $60 $80Billions

total government costs

QA

LY

s lo

st

preGP

preHCW

postGP

postHCW

preHCWpostGP

Ring only

dominating

extended

47,000

48,000

49,000

50,000

51,000

52,000

53,000

54,000

55,000

56,000

57,000

$0 $1 $2 $3 $4 $5Billions

total government costs

QA

LYs

lost

preHCW

postHCW

Ring only

dominating

extended

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Large Airport Attack: Best Options For Costliness and Probability

Regimens (Current Prohibited)89 - MVA1 Pre-HCW: NYCBH : NYCBH : NYCBH : MVA1 90 – MVA1 Pre-HCW: NYCBH : NYCBH : MVA1 : MVA1206- MVA1 Post-HCW: NYCBH : NYCBH : NYCBH : MVA1207- MVA1 Post-HCW: NYCBH : NYCBH : MVA1 : MVA1

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Recommendations

NIAID: Complete development of MVA, including explorations of single dose MVA

HHS: Purchase approximately 10M courses of MVA to cover:

• All immunocompromized in mass vaccination (100% acceptance)

OR

• All immunocompromized (and possibly those with relative contraindications) in ring vaccination response plus health care workers in mass response

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Expected Per-Person Costs - USD

170

250

25

170

17

50

50

10

1017

3

3

0.26

0.015

0.13

0.03

0.13

0.015

0

50

100

150

200

250

300

350

NYCBH -100%

NYCBH 10% MVA 100% MVA 10% LC16 100% LC16 10%

StoragePurchaseAdmin

Administration costs are absolutely and relatively higher in mass (100%) compared to smaller (10%) vaccination campaign, where fixed costs dominate