Informed-Consent Advocate Says Government and Industry Should Release Flu Vaccine Effectiveness Data

WASHINGTON -- 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 of the 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 Feb. 20, 2003 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 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 US 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, 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

Source: National Vaccine Information Center