PRESS RELEASE FROM THE NATIONAL VACCINE INFORMATION CENTER
for immediate release Wednesday, December 10, 2003
INFORMED CONSENT ADVOCATE SAYS GOVERNMENT AND INDUSTRY SHOULD RELEASE FLU VACCINE EFFECTIVENESS DATA
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. 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. 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. 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. -end-