Hep B safety as found on the AMA web page

[Guest guest]

Thought this might be interesting to everyone. I found this on the AMA web

page at this URL:

http://www.ama-assn.org/med-sci/98jan03.htm

Who should be vaccinated?

The Advisory Committee on Immunization Practices (ACIP)

recommends

hepatitis B vaccination for everyone 18 years of age and

younger, and for

adults over 18 years of age who are at risk for HBV

infection, which include:

Sexually active heterosexual adults with more than one

sex partner in

the prior 6 months, or have a history of sexually

transmitted disease;

Homosexual and bisexual men;

Illicit injection drug users;

Persons at occupational risk of infection;

Hemodialysis patients;

Household and sex contacts of persons with chronic HBV

infection;

Clients and staff of institutions for the

developmentally disabled.

Why is vaccination recommended for all children as opposed to

children living in families where there is the highest risk

of HBV

infection?

Routine vaccination of all children and adolescents is

recommended because

a major part of the disease burden of HBV is due to the

large number of

HBV infections that occur among children. As discussed

earlier, a significant

number of our chronic carriers of HBV were infected as

children and if it

were not for the vaccine, over 30,000 children would be

infected annually.

Most of these infections occur among children of mothers

who are not

infected with HBV and thus cannot be protected by perinatal

hepatitis B

prevention programs. Additionally, it is impossible to

identify and selectively

vaccinate only those children who would be at risk for HBV

infection.

While it is true that most HBV infections occur in older

adolescents and

adults, it has been difficult to reduce the incidence of

new HBV infections by

selectively vaccinating older adolescents/adults in

high-risk groups. In fact,

over 30% of people infected with HBV have no idea where

they might have

got their infection! By vaccinating children for hepatitis

B, they will now be

protected against HBV infection when they become older

adolescents and

adults.

Is the hepatitis B vaccine safe?

Yes. The hepatitis B vaccines have been administered to

more than 20 million

people in the United States and more than 500 million

people in the world.

The most common side effects of vaccination are pain at the

injection site

(3%-29%) and/or a mild fever (1%-6%). However, these side

effects are

related to the injection event and not to the hepatitis B

vaccine itself as

persons receiving placebo injections also reported similar

reactions.

What are possible serious side effects?

Serious side effects after administration of the hepatitis

B vaccine are

extremely rare. There have been some anecdotal reports of

the association of

hepatitis B vaccination with chronic illness such as

autoimmune disorders.

However, there have been no scientific data supporting

these claims.

Large-scale immunization exercises have been ongoing in

many other

countries and in the United States, and thus far there has

been no association

of hepatitis B vaccination with serious adverse events. No

clear association

has been demonstrated between hepatitis B vaccination and

disorders such

as Guillain-Barre syndrome, transverse myelitis, optic

neuritis, and seizures.

Even then, such alleged associations are still being

studied to further ensure

the safety of the vaccine. A recent study demonstrated that

persons who

developed rheumatoid arthritis following hepatitis B

vaccination were actually

genetically susceptible to rheumatoid arthritis, making it

difficult to correlate

the occurrence of rheumatoid arthritis with hepatitis B

vaccination.

Considering the large number of doses of HBV vaccine

administered and the

very low numbers of serious adverse reactions, it is

possible that adverse

reactions reported after hepatitis B vaccination may

represent coincidence

rather than causation.

Finally, as with any vaccination, the risk of anaphylaxis

(hives, difficulty

breathing, shock) is a real. There is an estimated

incidence of about I

anaphylactic reaction per 600,000 vaccine doses

distributed. Thus, further

administration of hepatitis B vaccine would be

contraindicated (not

recommended) for persons who have demonstrated a previous

anaphylactic

reaction following a previous dose of hepatitis B vaccine.

Any presumed risk of adverse side effects associated with

the hepatitis B

vaccine must be balanced with the expected 4,000 to 5,000

chronic

HBV-related deaths and 30,000 childhood HBV infections that

would occur

in the absence of HBV immunization. Given the frequency and

severity of

hepatitis B infection, the benefits of vaccination far

outweigh the known and

potential risks.

What is the relationship between hepatitis B vaccination and

multiple sclerosis (MS)?

Currently, there are NO scientific data that supports such

an association. An

expert panel convened by the World Health Organization

(WHO) in

September 1998 analyzed all available data on hepatitis B

vaccine and

concluded, " No evidence presented at this meeting

indicates a need to

change public health policies with respect to HBV

immunization. "

The actual cause of MS is still unknown but MS is believed

to be an

autoimmune disease in genetically susceptible persons where

degradation of

the myelin sheath that protects nerves in the central

nervous system occurs.

The initial associations between hepatitis B vaccination

and MS were from

case reports, not scientifically controlled studies.

However, these case

reports have been picked up by the news media, first in

France, and now in

the United States. It is more than likely that these MS

case reports are purely

coincidental to hepatitis B vaccination. However, to ensure

continued safety

of the vaccine, carefully controlled scientific studies are

now underway.

Otherwise, there is no evidence that HBV vaccination causes

MS or any

other chronic disorder. In fact, negative evidence

supporting the safety of the

HBV vaccine is overwhelming. First, extensive clinical

trials of the vaccine

prior to its licensure did not document a single such

association. Second,

there have been hundreds of millions of people immunized

worldwide that

have not developed MS or any other autoimmune disease.

Thus, if HBV

vaccination does cause MS, it is an extremely rare event.

Third, studies of

MS patients have shown that stimulation of the immune

system may lead to

an exacerbation of the clinical disease. Thus,

immunization, which will

stimulate the immune system, may cause exacerbation of MS

in those already

suffering from the disease, and there have been some case

reports of this.

Even then, another well-controlled clinical trial has

demonstrated that within

the MS population, exacerbation of disease due to

immunization does not

happen, and if it did, could only happen in a very small

minority of MS

patients. However, NO evidence is available that suggests

that HBV

vaccination increases the MS rate in healthy persons. In

order to establish

causation, carefully controlled scientific studies such as

the ones currently

ongoing are needed.

There are currently at least 6 research projects underway

to examine the

relationship between hepatitis B vaccination and MS, if any

exists. Results

from most of these studies will begin to emerge in 1999,

and it is reported

that some preliminary data from some of these studies were

available to the

September 1998 WHO expert panel. Hopefully these results

will clarify once

and for all the recent unproven hypotheses that have caused

significant public

concern by suggesting an association of MS with HBV

immunization.

How is vaccine safety monitored?

The Vaccine Adverse Event Reporting System ensures the

safety of vaccines

distributed in the United States. Health care professionals

or vaccine

manufacturers usually submit these reports, but anyone can

do submit a

VAERS report if they wish. Persons wishing to report a

possible health effect

related to a vaccine should notify their health care

provider and can also call

1-800-822-7967.

Are there more serious reactions to HBV vaccine than there are

cases of hepatitis B in children under 14 years of age?

No. This is a recent allegation and data from the VAERS

database was used

in its support. It has now been addressed by Bruce Gellin,

MD, Director of

the Vaccine Initiative, a special project of the Infectious

Diseases Society of

America and the Pediatric Infectious Diseases Society.

Briefly, it is not

possible to determine the number of adverse reactions

simply by examining

the number of VAERS reports associated with that vaccine.

This is because

the VAERS database is used to examine overall trends and

unusual

occurrences for further study, not to quantify the numbers

of case reports.

VAERS will therefore accept ALL reports health effects that

follow

vaccination, regardless of whether they are correlated to

the vaccine or not.

Thus, many of the VAERS reports have a coincidental rather

than causal

relationship with vaccination. Other cases may be reported

more than once

such as when a health care provider, a parent, and the

vaccine manufacturer,

all file reports for the same effect, or if the child has

several effects with one

vaccine and a report is filed for each side effect.

In fact, a published review of the VAERS data between 1991

through 1994

actually showed that there were no unexpected adverse

events in over 12

million doses of HBV vaccine administered to infants.

Additionally, data from

the National Center for Health Statistics show no increase

in reports of infant

deaths since 1991, the year routine hepatitis B vaccination

was introduced.

Where can I find more information on hepatitis B?

Kids Health at the American Medical Association

http://www.ama-assn.org/insight/h_focus/nemours/index.htm

The National Immunization Program at the Centers for Disease

Control and Prevention

1-800-CDC-SHOT

http://www.cdc.gov/nip/

The Hepatitis Branch at the Centers for Disease Control and

Prevention

1-8888-4HEP-CDC

http://www.cdc.gov/ncidod/diseases/hepatitis/index.htm

The Immunization Action Coalition

Tel: 651-647-9009; Fax: 651-647-9131

http://www.immunize.org/

The National Coalition on Adult Immunization

http://www.medscape.com/Affiliates/NCAI/factsheets/

The Vaccine Initiative

http://www.idsociety.org/vaccine/resources.htm

For information on the Hepatitis C Lookback, go to

http://www.ama-assn.org/med-sci/98oct13c.htm