Advocate Says Government Should Release Flu Shot Data

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KD Weber <wvadreamin

 

Friday, 12 December 2003 9:03

Advocate Says Government Should Release Flu Shot Data

 

 

Advocate Says Government Should Release Flu Shot Data

http://www.newsmax.com/archives/articles/2003/12/10/181636.shtml

NewsMax.com Wires

Thursday, Dec. 11, 2003

Washington, D.C. - A leading vaccine safety and informed consent advocate is

calling on federal health officials and flu vaccine makers to be honest with

the American people about the effectiveness of this year's flu vaccine.

" Public health officials knew last spring that it was highly likely that the

A/Panama strain in the current vaccine was not going to protect against the

mutated, more dangerous A/Fujian strain of flu. If there is solid new

evidence that the vaccine is protective against Fujian, then it should be

released. If there is no such evidence, then it is not right to lead people

to believe that if they get vaccinated now, they will be protected against

it, " said Barbara Loe Fisher, president, National Vaccine Information Center

(NVIC).

 

Federal officials were prevented from replacing the A/Panama strain with the

Fujian strain emerging out of Asia and being detected in Europe and the

U.S.last spring because scientists in labs around the world were unable to

isolate and grow the virus in a way that would allow vaccine production.

 

Transcripts from the February 20 and March 18, 2003 meetings of the FDA

Vaccines and Related Biological Products Advisory Committee (VRBPAC) reveal

that health officials around the world knew the genetically mutated Fujian

strain was associated with significant morbidity and mortality and that last

year's vaccine showed little protection against it.

 

Fisher, who was the consumer voting member of the FDA Advisory Committee,

abstained from the strain selection vote on March 18, saying " I feel

uncomfortable voting for inclusion of an A/Panama-like virus, when what may

really be needed is an A/Fujian-like virus. So I am going to abstain and

urge that the public be informed that next year's flu vaccine may not be

protective against an emerging strain. "

 

The National Vaccine Information Center is a non-profit, educational

organization founded in 1982 by parents whose children were injured or died

from reactions to the DPT vaccine. Dedicated to preventing vaccine injuries

and deaths through public education, NVIC also advocates for the inclusion

of informed consent protections in national vaccine policies and laws.

 

" This is a matter of the public's right to have full and truthful

information about the benefits and risks of a particular vaccine in order

for us to make an informed choice. Although there were technological

limitations with making the switch this year to the new emerging strain, it

does not serve either public health officials, industry or the public to not

be honest about what the current vaccine can and can't do. At the end of the

day, it is a matter of respecting the public trust, " she said.

 

Every year, health officials at the World Health Organization (WHO) and the

U.S. Department of Health and Human Services (DHHS) gather information about

influenza activity around the world in order to try to make an educated

guess about which three flu strains to include in the current year's flu

vaccine.

 

Nasal Vaccine

 

This year, in addition to the inactivated (killed) flu vaccine, which is

injected, a new live virus nasal flu vaccine is available in the U.S. Both

the inactivated and live virus vaccines contain the same three flu strains.

 

Neither flu vaccine this year contains the mutated Fujian strain that is

causing the most severe flu in the U.S. this season. The new live virus

vaccine (FLUMIST), which is squirted up the nose, was licensed by the FDA in

June 2003 for use in healthy individuals between the ages of five and 50. It

is not recommended for pregnant women or those with asthma, chronic lung or

heart disease; chronic underlying medical conditions such as diabetes or

kidney disorders; immune suppression or immune system problems; children or

adolescents receiving aspirin therapy, anyone allergic to eggs; or those

with a history of Guillain Barre syndrome.

 

It should not be given simultaneously with other vaccines. FLUMIST's vaccine

live virus is shed after vaccination so the vaccinated are advised to avoid

close contact with immune compromised individuals for at least 21 days.

 

Some hospital personnel are asking those recently vaccinated with FLUMIST to

avoid visiting patients in hospitals to prevent the risk of transmitting the

vaccine strain virus to sick patients. The most common reactions to the live

flu vaccine are similar to the flu: runny nose, nasal congestion, cough,

sore throat, headache, muscle aches, fever, chills, and weakness.

 

The killed flu vaccine, which is injected, has historically been used in

individuals over 60 years old who are at high risk for dying or becoming

seriously ill during a bout with the flu. However, in recent years, the CDC

has been asking all age groups to get an annual flu shot and now recommends

that all healthy children older than 6 months of age get an annual flu shot.

 

 

Contraindications for the killed flu vaccine are: fever, an impaired immune

system, egg allergy, mercury allergy or a history of Guillain Barre

syndrome.

 

 

Pregnancy

 

 

In the past, pregnancy was a contraindication but now the CDC recommends flu

vaccine for women more than 14 weeks pregnant. However this recommendation

is controversial since most flu vaccines still contain the mercury

preservative, Thimerosal, and mercury has been associated with brain damage

and developmental delays in fetuses whose mothers were exposed to high

levels of mercury during pregnancy. (ED NOTE: SEE ALSO: Surge in Flu Among

Young Pregnant Women

http://www.newsmax.com/archives/articles/2003/12/10/220954.shtml .... About

80 expectant mothers have been diagnosed with the flu since early October,

said Dr. Jeanne Sheffield, a maternal and fetal medicine specialist at

Parkland Health and Hospital System. More than 60 were admitted, with one

treated in the intensive care unit, she said. Pregnancy weakens a woman's

immune system, making her more vulnerable to the virus. Only two of the

women had the flu shot, and they had it just before they became ill, so they

were not protected. But Sheffield said it is rare to see so many pregnant

women get sick. Most were in their teens and early 20s; all recovered and

are out of the hospital. " Maybe we may have admitted five or 10 a year in

the past, " Sheffield said. " This is much different than normal. " )

 

The most common reactions to killed flu vaccine are fever, fatigue, painful

joints and headache. The most serious reported reaction, which usually

occurs within two weeks of vaccination, is Guillain Barre syndrome, an

immune mediated nerve disorder characterized by muscle weakness, numbness,

pain and paralysis.

 

Flu vaccine only protects against the three specific viruses which are

included in any given year's flu vaccine formulation and does not protect

against throat, respiratory, gastrointestinal and ear infections caused by

bacteria and other kinds of viruses. When the match between the vaccine and

circulating viruses is close, the flu vaccine is thought to provide a 70 to

90 percent chance of temporary immunity to selected strains in healthy

persons less than 65 years old.

 

For those over 65 years old, the efficacy rate drops to 30 to 40 percent,

although it is considered to be 50 to 60 percent effective in preventing

hospitalization or pneumonia and 80 percent effective in preventing death

from flu caused by the covered strains. For more information on flu vaccine

and selection of this year's flu vaccine strains, go to NVIC's website at

www.NVIC.org/Diseases/Influenza.htm.

 

(By permission of the National Vaccine Information Center)