Vaccine Innovation: Vaccine Innovation: Challenges and Challenges and

Opportunities to Protect Opportunities to Protect HealthHealth

Julie Louise Gerberding, M.D., M.P.HJulie Louise Gerberding, M.D., M.P.HPresident, Merck VaccinesPresident, Merck Vaccines

Protecting Health with VaccinesProtecting Health with Vaccines

Unmet Health Needs

Evidence-based Value

Population Impact

Research& Development Safety Efficacy Cost-

effectiveness

Guidelines for Use Advocacy Access Consumer

Engagement

HEALTH IMPROVEMENT

“Developing just one new vaccine involves numerous discoveries in microbiology, chemistry, biochemistry,

immunology and molecular biology, an average of 15 to 20 years of development, and extraordinary finances that can

exceed the $800 million mark.” IFPMA, 2010

Vaccine Pipeline: PreventionVaccine Pipeline: Prevention

IFPMA , July 2009

Vaccine Pipeline: NonVaccine Pipeline: Non--infectious infectious DiseasesDiseases

IFPMA , July 2009

Protecting Health with VaccinesProtecting Health with Vaccines

Unmet Health Needs

Evidence-based Value

Research& Development Safety Efficacy Cost-

effectiveness

Guidelines for Use

1985 (7) 1995 (10) 2010 (16)

PolioDiphtheriaPertussisTetanusMeaslesRubellaMumpsHib (infant)HepBHepAVaricellaPneumococcalInfluenzaMeningococcalRotavirusHPV

PolioDiphtheriaPertussisTetanusMeaslesRubellaMumpsHib (infant)HepBVaricella

PolioDiphtheriaPertussisTetanusMeaslesRubellaMumps

1964 (6)

SmallpoxPolioDiphtheriaPertussisTetanusMeasles

U.S Recommended Childhood U.S Recommended Childhood ImmunizationsImmunizations

Protecting Health with VaccinesProtecting Health with Vaccines

Unmet Health Needs

Evidence-based Value

Research& Development Safety Efficacy Cost-

effectiveness

Guidelines for Use Advocacy

Estimated Vaccine Coverage among Children Estimated Vaccine Coverage among Children 1919--35 Months of Age, United States, 196735 Months of Age, United States, 1967--20082008

DTP / DTaP(3+)

MMR(1+)

Hib (3+)

2010 Target

Hep B (3+)

Polio (3+)

Varicella (1+)

PCV 7 (3+)

Source: USIS (1967-1985), NHIS (1991-1993) CDC, NCHS, and NIS (1994-December 2008), CDC, NIP, NCIRD and NCHS; No data from 1986-1990 due to cancellation of USIS because of budget reductions.

Protecting Health with VaccinesProtecting Health with Vaccines

Unmet Health Needs

Evidence-based Value

Research& Development Safety Efficacy Cost-

effectiveness

Guidelines for Use Advocacy Access

Vaccines for Children

Program (VFC)43%

Other including Private Sector

47%

Section 317 Program

7%

State Purchases3%

U.S. Pediatric Vaccines Recommended for Children 0U.S. Pediatric Vaccines Recommended for Children 0--6 6 Years of Age: Doses Distributed by Funding SourceYears of Age: Doses Distributed by Funding Source

Calendar Year 2007Calendar Year 2007

Source: Biologics Surveillance Data 2007. Represents a national summary of self-reported distribution data by the vaccine manufacturers. The data are an estimate of the annual national distribution and does not equal administration. Reported data may be incomplete and include possible over-reporting or under-reporting of distribution data and may not reflect all vaccines or manufacturers.“Other” represents all purchases not on CDC contracts, including private, health insurance, and government purchases through other mechanisms. Data do not include influenza vaccine doses.Updated July 17, 2008

“We organized our numerous diverse insights about such barriers…• Identifying, registering and locating children for immunization• Immunization session planning and management• Immunization session execution and logistics• Tracking children and work activities• Accountability and training• Awareness and demand”

Protecting Health with VaccinesProtecting Health with Vaccines

Unmet Health Needs

Evidence-based Value

Research& Development Safety Efficacy Cost-

effectiveness

Guidelines for Use Advocacy Access Consumer

Engagement

““Which concerns, if any, do you have Which concerns, if any, do you have about childhood vaccines?about childhood vaccines?””

2009 2009 Weighted %Weighted %

It is painful for children to receive It is painful for children to receive so many shots during one so many shots during one doctordoctor’’s visit.s visit.

4444

My child getting too many My child getting too many vaccines in one doctorvaccines in one doctor’’s visit.s visit.

3434

Vaccines causing fevers in my Vaccines causing fevers in my child.child.

2828

Children get too many vaccines Children get too many vaccines in the first two years of life.in the first two years of life.

2828

Talking with Parents About Talking with Parents About VaccinesVaccines

Audience: Healthcare providersDuring the Office Visit• Take time to listen• Solicit and welcome questions• Keep the conversation going• Use a mix of science and personal

anecdotes• Acknowledge benefits and risks• Respect parents’ authority

After the Office Visit• Document parents’ questions/concerns• Follow up a few days after the visit

Protecting Health with VaccinesProtecting Health with Vaccines

Unmet Health Needs

Evidence-based Value

Research& Development Safety Efficacy Cost-

effectiveness

Guidelines for Use Advocacy Access Consumer

Engagement

Population Coverage

HEALTH IMPROVEMENT