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F I S C A L I M P A C T R E P O R T

SPONSOR King

ORIGINAL DATE

LAST UPDATED

1-28-06

HB 271

SHORT TITLE Influenza Vaccine Supply and Contents

SB

ANALYST Collard

APPROPRIATION (dollars in thousands)

Appropriation

Recurring

or Non-Rec

Fund

Affected

FY06

FY07

NFI

(Parenthesis ( ) Indicate Expenditure Decreases)

Duplicates HJM 5

ESTIMATED ADDITIONAL OPERATING BUDGET IMPACT (dollars in thousands)

FY06

FY07

FY08 3 Year

Total Cost

Recurring

or Non-Rec

Fund

Affected

Total

N/A $ 223,170.0 $0.1 223,170.0 Recurring General Fund

(Parenthesis ( ) Indicate Expenditure Decreases)

See Narrative

SOURCES OF INFORMATION

LFC Files

Responses Received From

Department of Health (DOH)

Health Policy Commission (HPC)

Public Education Department (PED)

SUMMARY

Synopsis of Bill

House Bill 271 requires that children under age 8 and pregnant women only receive influenza

vaccine that contains no more than a trace of mercury. The bill allows for exemptions when, in

the judgment of the health care provider, the vaccine is medically indicated and mercury-free or

trace vaccine is unavailable. DOH can authorize an exemption from the provisions if necessary

to ensure that an adequate supply of vaccine is available to protect the public’s health. DOH is

also directed to implement a plan to increase immunizations among school children and children

in daycare.

House Bill 271 – Page

2

FISCAL IMPLICATIONS

Although the bill does not contain an appropriation, DOH indicates an additional cost is associ-

ated with providing preservative-free vaccine. Preservative-free vaccine is packaged in single

doses and costs $3.46 more per dose than multi-dose vaccines containing preservatives. DOH

estimates that approximately 6,000 doses of preservative-containing influenza vaccine were

given to high risk children and pregnant women in the 2005-2006 season. Vaccine prices have

not been set for FY07; using current costs, the increased cost to purchase the same amount of

preservative-free vaccine would be $20,760 (equivalent to approximately 10,000 doses of vac-

cine). The cost of increasing influenza vaccinations among schoolchildren and children attend-

ing day care will depend on the plan and has not yet been determined.

DOH does not explain the additional $202,410 it claims is needed for preservative-free vaccines

in the ESTIMATED ADDITIONAL OPERATING BUDGET IMPACT table above.

SIGNIFICANT ISSUES

DOH indicates childhood immunizations are one of the most cost-effective public health inter-

ventions, resulting in the almost entire elimination of polio, diphtheria, measles, mumps, rubella

and tetanus among children in the United States.

Current guidelines for mercury exposure are based on methylmercury, contained in fish. Ethyl-

mercury is contained in thimerosal, used as a preservative in vaccines to prevent bacterial/fungal

growth. Ethylmercury has not been as well studied and specific exposure guidelines have not

been developed. Although no specific safety problems have occurred, in 1999 the US Public

Health Service and the American Academy of Pediatrics urged the removal of thimerosal from

childhood vaccines to reduce the overall exposure of infants to mercury as a precautionary meas-

ure.

There has been significant media attention recently regarding these exposures that has increased

the awareness and concerns of the public. Concerns have been raised about potential mercury

exposures from vaccines containing thimerosal.

The conclusions of the Institute of Medicine (IOM) Report, Immunization Safety Review: Vac-

cines and Autism (May 2004) concluded that: thimerosal-containing vaccines are not associated

with autism and that the hypotheses regarding a link between autism and thimerosal-containing

vaccines lack supporting evidence and are only theoretical.

(

http://www.iom.edu/CMS/3793/4705/20155.aspx

). In addition, the IOM report expressed con-

cern that “Using an unsubstantiated hypothesis to question the safety of vaccination . . . could

lead to widespread rejection of vaccines and inevitable increases in incidences of serious infec-

tious diseases like measles, whooping cough, and Hib bacterial meningitis.”

A few remaining vaccines using thimerosal as a preservative include some tetanus-diphtheria

(for over age 6 years), injectable influenza vaccines for persons over the age of 3 years, and a

special vaccine for travelers to prevent Japanese encephalitis. Since mid-2001, vaccines rou-

tinely recommended for infants in the US have been manufactured either without or with only

trace amounts of thimerosal thus already providing a substantial reduction in the total mercury

exposure from vaccines for children.

House Bill 271 – Page

3

Seven states have enacted legislation that restricts thimerosal content in vaccines; four set an age

limit of three years of age.

Many physicians and immunization advocates fear that passing this type of legislation may give

the misleading message that vaccines containing thimerosal-based preservatives are not safe.

This may result in people not getting influenza and other vaccines that could protect their health.

Current influenza vaccines that are thimerosal-free cost more, which could reduce the number of

vaccines that the state and private providers can buy and administer. Uncertainty regarding ex-

ceptions may cause medical or legal concerns, potentially resulting in lower immunization rates.

DOH cautions that any barriers that lead to a reduction in influenza immunization could lead to

increased illness, hospitalization and death.

ADMINISTRATIVE IMPLICATIONS

PED indicates it would be required to collaborate with the DOH, but PED currently has a health

services consultant that can fill this role.

RELATIONSHIP

House Joint Memorial 5 establishes a task force to determine other ways to reduce exposures to

mercury in New Mexico.

TECHNICAL ISSUES

HPC suggests, for clarity, “or” could be changed to “and,” and “persons” could be changed to

“women” in subsection B of the bill to read as follows:

Children under the age of eight or and persons women who are known to be pregnant shall not

receive any influenza vaccine containing more than trace amounts of mercury as defined by the

United States food and drug administration unless, in the judgment of the health care provider,

administering the vaccine is medically indicated and mercury free or trace vaccine is unavailable

and the patient or guardian is notified that the vaccine to be administered contains mercury.

OTHER SUBSTANTIVE ISSUES

HPC research indicates the following:

Thimerosal Toxicity

According to the US Food & Drug Administration (FDA):

·

Allergic responses to thimerosal are described in clinical literature, with these responses

manifesting themselves primarily in the form of delayed-type local hypersensitivity reac-

tions, including redness and swelling at the injection site. Such reactions are usually mild

and last only a few days.

·

At the initial National Vaccine Advisory Committee-sponsored meeting on thimerosal in

1999, concerns were expressed that infants may lack the ability to eliminate mercury. More

recent NIAID-supported studies at the University of Rochester and National Naval Medical

Center in Bethesda, MD examined levels of mercury in blood and other samples from infants

who had received routine immunizations with thimerosal-containing vaccines.

House Bill 271 – Page

4

o

Blood levels of mercury did not exceed safety guidelines for methyl mercury for all

infants in these studies. Further, mercury was cleared from the blood in infants ex-

posed to thimerosal faster than would be predicted for methyl mercury; infants ex-

creted significant amounts of mercury in stool after thimerosal exposure, thus re-

moving mercury from their bodies.

o

These results suggest that there are differences in the way that thimerosal and

methyl mercury are distributed, metabolized, and excreted. Thimerosal appears to

be removed from the blood and body more rapidly than methyl mercury. NIAID is

sponsoring a follow-up study with larger numbers of infants in Buenos Aires where

thimerosal-containing vaccines are still administered to children.

Should Children Receive Influenza Vaccine Containing Thimerosal.

According to the Centers for Disease Control and Prevention (CDC) there is no convincing

evidence of harm caused by the small amount of thimerosal in vaccines, except for minor effects

like swelling and redness at the injection site due to sensitivity to thimerosal. Further, since 1999,

newly formulated thimerosal preservative-free childhood vaccines (Hepatitis B, Hib, and DTaP)

have been licensed. With the newly formulated childhood vaccines, the maximum total exposure

during the first six months of life will now be less than three micrograms of mercury. Based on

guidelines established by the FDA, the Environmental Protection Agency (EPA) and the Agency

for Toxic Substances and Disease Registry (ATSDR), no child will receive excessive mercury

from childhood vaccines regardless of whether or not their flu shot contains thimerosal as a

preservative.

Recent research suggests that healthy children under the age of 2 are more likely than older

children and as likely as people over the age of 65 to be hospitalized with flu complications.

Therefore, vaccination with reduced or standard thimerosal-content flu vaccine is encouraged

when feasible in children, including those that are 6-23 months of age.

Should Pregnant Women Receive Influenza Vaccine Containing Thimerosol.

According to the CDC, a study of influenza vaccination examining over 2,000 pregnant women

demonstrated no adverse fetal effects associated with influenza vaccine. Case reports and limited

studies indicate that pregnancy can increase the risk for serious medical complications of

influenza. One study found that out of every 10,000 women in their third trimester of pregnancy

during an average flu season, 25 will be hospitalized for flu related complications.

Additionally, the CDC states that influenza-associated excess deaths among pregnant women

have been documented during influenza pandemics. Because pregnant women are at increased

risk for influenza-related complications and because a substantial safety margin has been

incorporated into the health guidance values for organic mercury exposure, the benefits of

influenza vaccine with reduced or standard thimerosal content outweighs the theoretical risk, if

any, of thimerosal.

KBC/nt