They Don t Want Them Or You t Want Them Or You They Don Don t - - PowerPoint PPT Presentation

They Don They Don’ ’t Want Them Or You t Want Them Or You Don Don’ ’t Have Them: t Have Them: Vaccine Shortages and Parents Vaccine Shortages and Parents’ ’ Changing Perceptions About Changing Perceptions About Vaccines Vaccines

Mark H. Sawyer, MD Mark H. Sawyer, MD UCSD School of Medicine UCSD School of Medicine San Diego HHSA Immunization Branch San Diego HHSA Immunization Branch

Vaccine Shortages Vaccine Shortages

Vaccine Shortages Vaccine Shortages Objectives Objectives

• List the vaccines currently in short supply in the

List the vaccines currently in short supply in the U.S. U.S.

• Describe the factors that lead to vaccine

Describe the factors that lead to vaccine shortages shortages

• Describe the things you can do in the office to

Describe the things you can do in the office to minimize the impact of vaccine shortages minimize the impact of vaccine shortages

Vaccine Shortages Vaccine Shortages Recent History Recent History

• 2001 DTaP

2001 DTaP

• 2001 Pneumococcal

2001 Pneumococcal conjugate conjugate

• 2001 MMR

2001 MMR

• 2002 Varicella

2002 Varicella

• 2004 Influenza

2004 Influenza

• 2004 Pneumococcal

2004 Pneumococcal conjugate conjugate

• 2005 Typhoid

2005 Typhoid

• 2006 MCV4

2006 MCV4

• 2007 MMRV

2007 MMRV

• 2007 Hepatitis A (Merck)

2007 Hepatitis A (Merck)

• 2008 HIB (Merck)

2008 HIB (Merck)

• ???

???

Vaccine Shortages Vaccine Shortages Status in April 2008 Status in April 2008

• Hib vaccine (

Hib vaccine (Pedvax Pedvax HIB/Comvax) HIB/Comvax)

• Concern about vaccine sterility

Concern about vaccine sterility

• Projected to last until end of 2008

Projected to last until end of 2008

• MMRV

MMRV

• Vaccine production problems (varicella vaccine and zoster

Vaccine production problems (varicella vaccine and zoster vaccine not affected) vaccine not affected)

• Projected to last until 2009

Projected to last until 2009

• Hepatitis A (VAQTA)

Hepatitis A (VAQTA)

• Vaccine manufacturing

Vaccine manufacturing

• Projected to last until end of 2008

Projected to last until end of 2008

Vaccine Shortages Vaccine Shortages Why do we have them? Why do we have them?

• Decrease in number of vaccine manufacturers:

Decrease in number of vaccine manufacturers: 25 in 1970 25 in 1970’ ’s > 5 in early 2000 s > 5 in early 2000’ ’s s

• Need to be absolutely sure about safety

Need to be absolutely sure about safety

• Increased scrutiny by FDA

Increased scrutiny by FDA

• Increasingly complex vaccines and combination

Increasingly complex vaccines and combination vaccines vaccines

Vaccine Shortages Vaccine Shortages Consequences Consequences

• Missed opportunities to immunize

Missed opportunities to immunize

• Failed immunization and drop in coverage rates

Failed immunization and drop in coverage rates

• Disease in susceptible children

Disease in susceptible children-

• Will

Will Haemophilus make a comeback? Haemophilus make a comeback?

• Loss of public confidence

Loss of public confidence

• Loss of public interest

Loss of public interest

Vaccine Shortages Vaccine Shortages Actions for Your Practice Actions for Your Practice

• Prioritize your existing vaccine supply

Prioritize your existing vaccine supply

• Keep track of your inventory

Keep track of your inventory-

• Immunization

Immunization Information Systems (Immunization Registries) Information Systems (Immunization Registries) can help can help

• Track children who have missed vaccines

Track children who have missed vaccines

• Provide recall notices/phone calls when vaccine

Provide recall notices/phone calls when vaccine becomes available becomes available

Vaccine Shortages Vaccine Shortages What can you do to prevent them? What can you do to prevent them?

• Order from more than one manufacturer when possible

Order from more than one manufacturer when possible

• Use vaccines as they are recommended by

Use vaccines as they are recommended by CDC/AAP/AAFP CDC/AAP/AAFP

• Order influenza vaccine early each year

Order influenza vaccine early each year

• Advocate for a strengthened immunization

Advocate for a strengthened immunization infrastructure in the U.S. infrastructure in the U.S.

• California Immunization Coalition (

California Immunization Coalition (http://immunizeca.org/ http://immunizeca.org/) )

• AAP (

AAP (http:// http://www.aap.org www.aap.org/ /) )

• AAFP (

AAFP (http:// http://www.aafp.org www.aafp.org/ /) )

Vaccine Safety Concerns Vaccine Safety Concerns

Objectives Objectives

• List the major concerns voiced by the

List the major concerns voiced by the community about vaccines community about vaccines

• List tips in communicating about vaccine safety

List tips in communicating about vaccine safety with patients/parents with patients/parents

• Identify talking points to address each of the

Identify talking points to address each of the major concerns in the community major concerns in the community

• Identify useful resources on vaccine safety for

Identify useful resources on vaccine safety for providers, parents, and patients providers, parents, and patients

The Issue The Issue

• A growing number of people have vaccine safety

A growing number of people have vaccine safety concerns concerns

• Personal belief exemptions (PBE) rates are increasing

Personal belief exemptions (PBE) rates are increasing

• Several recent events have put this issue in the spotlight

Several recent events have put this issue in the spotlight

• f national media attention
• f national media attention
• Jenny McCarthy book tour

Jenny McCarthy book tour

• Hannah Poling Vaccine Injury Compensation Program ruling

Hannah Poling Vaccine Injury Compensation Program ruling

• Measles outbreaks in U.S.

Measles outbreaks in U.S.

The Controversies The Controversies

• Vaccines and autism

Vaccines and autism

• Thimerosal

Thimerosal

• Other vaccine ingredients

Other vaccine ingredients

• Vaccines in general

Vaccines in general

• Too many vaccines overwhelm the immune

Too many vaccines overwhelm the immune system system

• Diseases no longer exist

Diseases no longer exist— —or aren

• r aren’

’t that t that dangerous dangerous

• Individual rights vs. public health needs

Individual rights vs. public health needs

General Talking Points General Talking Points

• The diseases are here now and remain dangerous

The diseases are here now and remain dangerous

• Vaccines are safe

Vaccines are safe

• “

“Natural immunity is not better Natural immunity is not better” ”

• Adverse events do occur following immunization

Adverse events do occur following immunization

• Protection through immunization is both an individual

Protection through immunization is both an individual and a community endeavor and a community endeavor

• A choice not to immunize leaves you/your child at risk

A choice not to immunize leaves you/your child at risk and also places others at risk and also places others at risk

• Know the source of the information you are receiving

Know the source of the information you are receiving

The Diseases are Here The Diseases are Here Talking Points Talking Points

• 15,600 cases of pertussis in U.S. in 2006

15,600 cases of pertussis in U.S. in 2006

• 1194 cases of meningococcal disease in 2006

1194 cases of meningococcal disease in 2006

• 3308 cases of drug

3308 cases of drug-

• resistant pneumococcal

resistant pneumococcal disease in 2006 disease in 2006

• 3000 deaths from cervical cancer in U.S. in 2007

3000 deaths from cervical cancer in U.S. in 2007

• Measles outbreak in San Diego affected 12

Measles outbreak in San Diego affected 12 children, 3 families who were not avoiding children, 3 families who were not avoiding vaccines, and impacted many more vaccines, and impacted many more

Vaccine Vaccine-

• Preventable Disease Are Dangerous

Preventable Disease Are Dangerous Talking Points Talking Points

• 1 hospitalization out of 12 measles cases in San

1 hospitalization out of 12 measles cases in San Diego (February 2008) Diego (February 2008)

• Several deaths every year from pertussis in

Several deaths every year from pertussis in California California

• At least 10% of people with meningococcal

At least 10% of people with meningococcal disease die disease die

• Influenza kills thousands every year

Influenza kills thousands every year

Vaccines are Safe Vaccines are Safe Talking Points Talking Points

• Hundreds of millions of doses of vaccine given every

Hundreds of millions of doses of vaccine given every year in U.S. with no problem year in U.S. with no problem

• Billions of vaccines are given in the world every year

Billions of vaccines are given in the world every year with no problem with no problem

• Vaccine safety infrastructure is large

Vaccine safety infrastructure is large

• VAERS

VAERS

• VSD

VSD

• CISA

CISA

• FDA

FDA

• CDC

CDC

“ “Natural Immunity is Better Natural Immunity is Better” ” Talking Points Talking Points

• Natural immunity is only better if you survive

Natural immunity is only better if you survive the illness without serious consequences the illness without serious consequences

• Natural immunity comes with a price:

Natural immunity comes with a price:

deafness, paralysis, pneumonia, blood stream deafness, paralysis, pneumonia, blood stream infection, joint infections, brain infections, liver infection, joint infections, brain infections, liver transplantation, liver cancer, infant deaths, transplantation, liver cancer, infant deaths, dehydration, dehydration,…… ……. .

Vaccines do have side effects Vaccines do have side effects Talking Points Talking Points

• MMR

MMR

• Rash

Rash-

• 1 in 20 recipients

1 in 20 recipients

• febrile seizures

febrile seizures-

• RR 5.68

RR 5.681

1

• MMRV and febrile seizures

MMRV and febrile seizures-

• 2.3 fold increase

2.3 fold increase2

2

• DTaP

DTaP3

3

• 4

4th

th or 5

• r 5th

th dose DTaP and arm swelling

dose DTaP and arm swelling-

• 1 in 30

1 in 30 recipients recipients

• Seizures

Seizures-

• 1 in 14,000 recipients

1 in 14,000 recipients

• LAIV and nasal congestion/fever

LAIV and nasal congestion/fever

• 1. Ward KN et al. Pediatrics 2007; 120:315 2. MMWR March 2008 3: CDC web site

Vaccines are a Community Endeavor Vaccines are a Community Endeavor Talking Points Talking Points

• Herd immunity is very

Herd immunity is very important important

• Elimination of H. flu disease

Elimination of H. flu disease

• Decrease in influenza and

Decrease in influenza and pneumococcal disease in pneumococcal disease in elderly because of pediatric elderly because of pediatric immunization immunization

• Drop in Hepatitis A disease in

Drop in Hepatitis A disease in California California

• Outbreaks involve immunized

Outbreaks involve immunized as well as unimmunized as well as unimmunized

Being Unimmunized Leaves You at Risk Being Unimmunized Leaves You at Risk Talking Points Talking Points

• The unimmunized are at increased risk to

The unimmunized are at increased risk to develop disease and expose others develop disease and expose others

• All of the measles cases in San Diego in 2008 were

All of the measles cases in San Diego in 2008 were unimmunized unimmunized

• 3 of them were too young to be immunized and

3 of them were too young to be immunized and were exposed in a doctor were exposed in a doctor’ ’s office s office

• Unimmunized children are at increased risk for

Unimmunized children are at increased risk for pertussis, mumps, chickenpox in schools pertussis, mumps, chickenpox in schools

Individual Risk of Exemption Individual Risk of Exemption -

• Pertussis

Pertussis

Age Group Rate per 100,000 exemptors Rate per 100,000 vaccinated Relative Risk (95% CI) 3-5 191 11 17 (9 - 31) 6-10 142 9.4 15 (9 - 25) 11-14 35 19 1.9 (0.8 -5) 15 -18 13 0 (0 - 2) 3 -18 80 13 5.9 (4 - 8)

Feikin, JAMA, 2001;284:3145

Know Your Source Know Your Source

Know Your Source Know Your Source Talking Points Talking Points

• Majority of sites found on an Internet search of

Majority of sites found on an Internet search of “ “Vaccines Vaccines” ” are anti are anti-

• vaccine sites

vaccine sites

• NNII site provides tips on how to evaluate the

NNII site provides tips on how to evaluate the credibility of Web sites credibility of Web sites http://www.immunizationinfo.org http://www.immunizationinfo.org

• How to identify a credible web site

How to identify a credible web site

• Scientific studies cited and are current

Scientific studies cited and are current

• Lack of financial conflict of interest (selling a book)

Lack of financial conflict of interest (selling a book)

• Experience in field

Experience in field

• Lack of anecdotes

Lack of anecdotes

The Controversies The Controversies

• Vaccines and autism

Vaccines and autism

• Thimerosal

Thimerosal

• Other vaccine ingredients

Other vaccine ingredients

• Vaccines in general

Vaccines in general

• Too many vaccines overwhelm the immune

Too many vaccines overwhelm the immune system system

• Diseases no longer exist

Diseases no longer exist— —or aren

• r aren’

’t that t that dangerous dangerous

• Individual rights vs. public health needs

Individual rights vs. public health needs

Thimerosal Causes Autism Thimerosal Causes Autism Talking Points Talking Points

• Numerous studies have failed to show a link between

Numerous studies have failed to show a link between vaccines and autism vaccines and autism

• Thimerosal out of vaccines and no change in rates of

Thimerosal out of vaccines and no change in rates of autism autism

• Poling case

Poling case-

• National Vaccine Compensation Program

National Vaccine Compensation Program

• No new scientific information

No new scientific information

• Not a scientific determination

Not a scientific determination

• Not a normal child

Not a normal child

• Minimal standard to rule in favor of patients

Minimal standard to rule in favor of patients

• Spending more money on thimerosal and autism is

Spending more money on thimerosal and autism is taking it away from research on the real cause of autism taking it away from research on the real cause of autism

Other Vaccine Components and Autism Other Vaccine Components and Autism

It It ain ain’ ’t t over until the fat lady sings

• ver until the fat lady sings…

…

• Aluminum

Aluminum

• Bovine serum albumen

Bovine serum albumen

• Adjuvants

Adjuvants

• Yeast proteins

Yeast proteins

• Human cell line derivatives

Human cell line derivatives

• …………………

………………….. ..

Vaccines Cause Autism Vaccines Cause Autism Talking Points Talking Points

• Genetic factors related to autism

Genetic factors related to autism

• Symptoms of autism present before many

Symptoms of autism present before many vaccines are given vaccines are given

• Ongoing studies specifically looking at risk:

Ongoing studies specifically looking at risk: none identified none identified

Vaccines Overwhelm the Immune System Vaccines Overwhelm the Immune System Talking Points Talking Points

• Number of antigens in vaccines has decreased

Number of antigens in vaccines has decreased even though we are giving more vaccines even though we are giving more vaccines1

1

• Your immune system responds to hundreds of

Your immune system responds to hundreds of antigens every day. antigens every day.

• Studies do not show increase in infections in

Studies do not show increase in infections in general following immunization general following immunization

1 Offit P, Pediatrics 2002

Diseases no longer exist Diseases no longer exist Talking Points Talking Points

• Measles in San Diego

Measles in San Diego

• Pertussis outbreaks occur regularly in San Diego

Pertussis outbreaks occur regularly in San Diego

• School

School-

• based varicella outbreaks common

based varicella outbreaks common

• Polio, measles, diphtheria

Polio, measles, diphtheria… ….are just a plane ride .are just a plane ride away away

Why Should I Put My Child At Risk For The Why Should I Put My Child At Risk For The Greater Good? Greater Good? Talking Points Talking Points

• Because you are actually putting your child at

Because you are actually putting your child at risk by not having them immunized. risk by not having them immunized.

• Measles

Measles exemptors exemptors: 35x increased risk : 35x increased risk

• Pertussis

Pertussis exemptors exemptors: 5.9x increased risk : 5.9x increased risk

• When you or your child are not immunized, they

When you or your child are not immunized, they put others at risk: measles in San Diego put others at risk: measles in San Diego

• None of us want to see a resurgence of the

None of us want to see a resurgence of the diseases we have largely eliminated diseases we have largely eliminated

Measles in San Diego Measles in San Diego Lessons Learned Lessons Learned

• Measles is very contagious

Measles is very contagious-

• a problem in

a problem in populations with high rates of PBE populations with high rates of PBE’ ’s s

• Infection control in offices and community labs

Infection control in offices and community labs important to prevent transmission important to prevent transmission

• Many physicians in 2008 are not familiar with

Many physicians in 2008 are not familiar with measles measles

• Coordination of laboratory testing can speed

Coordination of laboratory testing can speed diagnosis and control of outbreak diagnosis and control of outbreak

Information for Health Information for Health-

• Care

Care Professionals Professionals

NNII (www.immunizationinfo.org) NNII (www.immunizationinfo.org) VEC (www.vaccine.chop.edu) VEC (www.vaccine.chop.edu) IAC (www.immunize.org) IAC (www.immunize.org) CDC/NIP (www.cdc.gov/nip) CDC/NIP (www.cdc.gov/nip) AAP ( AAP (www.aap.org www.aap.org) ) AAFP ( AAFP (www.aafp.org www.aafp.org/) /) IVS (www.vaccinesafety.edu) IVS (www.vaccinesafety.edu) Vaccine Page (www.vaccines.org) Vaccine Page (www.vaccines.org)

Summary

• The diseases are here now and remain dangerous

The diseases are here now and remain dangerous

• Vaccines are safe

Vaccines are safe

• Adverse events do occur following immunization

Adverse events do occur following immunization

• Vaccines do not cause autism

Vaccines do not cause autism

• Protection through immunization is both an individual

Protection through immunization is both an individual and a community endeavor and a community endeavor

• A choice not to immunize leaves you/your child at risk

A choice not to immunize leaves you/your child at risk and also places others at risk and also places others at risk

• Know the source of the information you are receiving

Know the source of the information you are receiving