FLU VACCINE SEASON IS REVVING UP AGAIN
By Catherine J. M. Diodati, M. A.

As summer wanes, and fall approaches, flu vaccine season is revving up again and the mandate still looms heavily over the heads of our valued health care workers (HCWs). The issue is one of coercion, selectively abrogating the legal and ethical rights of one sector of society, with the unsupported promise that their vulnerable patients will be protected from disease.

What do the studies reveal? After an extensive review of various trials, studies and articles, it has become very clear that the documentation used by officials to support the flu vaccine mandate are methodologically flawed.

Studies will suggest that HCW vaccination will prevent influenza transmission to patients but they invariably fail to establish any actual source for influenza outbreaks. It is just assumed that HCWs are responsible for transmitting influenza rather than visitors, other patients, delivery persons or anyone else who may come into contact with vulnerable patients. In one study, for example, vaccination was strongly recommended for HCWs following 3 confirmed cases of flu in a neonatal intensive care unit. (1) At the time, there were 4 unit nurses off duty due to an influenza-like illness. Although it was suspected that they introduced influenza into the unit, they were never tested for influenza and none of these nurses had attended the ill infants. Still, the authors stated that HCW vaccination is "the most effective strategy to diminish nosocomial [(hospitalderived)] infections." This is pure conjecture. There simply are no studies that unequivocally demonstrate that HCWs are responsible for nosocomial influenza infections. There is no evidence.

In nearly every study read, the researchers have failed to actually determine whether upper respiratory infections, in either their unvaccinated control groups or their vaccine groups, were caused by influenza. There are many other pathogens that are known to circulate during flu-season. Adenovirus, RSV (respiratory syncytial virus), coronavirus, rhinovirus, etc., all can cause exactly the same symptoms and complications as the influenza virus and cannot be distinguished unless proper tests are performed.

This was precisely the case for one of the central documents used to support the vaccine mandate for health care workers. (2) In this case, only 5% of all unvaccinated patients, in 12 geriatric care facilities, demonstrated a rise in antibody titre, indicating exposure to the influenza virus, but when symptomatic patients were tested, nasopharyngeal swabs failed to produce a single influenza-positive result. All symptomatic patients were either positive for RSV or adenovirus. Attending HCWs, whether vaccinated or not, were never tested for influenza and no mention was made of any respiratory illness amongst the staff. Nonetheless, without any direct evidence whatsoever, the authors concluded that vaccinating health care workers reduced mortality and influenza-like illness in geriatric patients and Health Canada cites this article in support of HCW influenza vaccination. (3) The same holds true for almost every article Health Canada cites to support the vaccine mandate: no one is ever tested for influenza but HCW vaccination is said to prevent transmission of the disease. There is no evidence.

Safety and efficacy assertions are similarly fraught with flaws. Of particular note, is the frequency with which systemic reactions are dismissed. In one study, for example, 86% of vaccinees experienced local reactions (soreness, redness, swelling) and 49% experienced systemic reactions such as fever, chills, aching/myalgia, tiredness/weakness, lightheadedness/dizziness, sore throat, runny nose, stomach upset/cramps, vomiting, painful neck glands and insomnia. (4) The authors stated that such symptoms are commonly associated with the vaccine but that "the vaccine could not have been responsible for such illnesses." How convincing is this argument when 49% of the vaccinees experienced systemic symptoms, which are the same as flu symptoms, and 24% experienced a cluster of symptoms? If these systemic symptoms are accompanied by viral shedding then we are exposing vulnerable patients to influenza because we are vaccinating our HCWs. Local reactions are of importance too, even if they are transitory, because they will affect HCWs abilities to perform their duties. Lifting patients, intubations, suturing, surgery, etc., all require precision and fitness.

Studies typically state that the influenza vaccine is effective in preventing the flu for at least 70% of the population under 65 and approximately 30%-40% effective in preventing the flu in those over 65. Rarely do these studies ever compare the match between the vaccine strains and the circulating strains for the given year. If the strains do not match-well, how useful is a rise in antibody titre? Even when the strains do match, influenza vaccination creates a cost-deficit. A US study found that during a year when the strains were well-matched, the cost of vaccination was $11.17 per person more than the costs associated with not vaccinating. (5) During another year, when the strains were not wellmatched, the cost of vaccination was $65.59 US over and above the costs associated with not vaccinating. From a financial perspective, this does not comprise a good use of our health care dollars.

Italian Epidemiologist Dr. Vittorio Demicheli made some interesting observations regarding influenza vaccine efficacy. Demichei et al. conducted a metanalysis of existing literature examining live and inactivated flu vaccines and anti-virals. (6) He found that the vaccine could only claim a 24% reduction in clinical influenza cases. Although the vaccine may elicit an antibody response in 70%-90% of individuals, this is not the same thing as preventing clinical influenza. Further, the metanalysis revealed that 69% of vaccinees experienced some type of local reaction and 26% experienced systemic reactions. Antivirals fared no better. Reactions included CNS depression/excitation and gastrointestinal effects. Some individuals (10%-27%) "secreted drug-resistant virus within 4-5 days of commencing treatment." The antivirals were 61%-72% effective in preventing influenza but only reduced the duration of existing illness by about 1 day. Demicheli et al. did state that the inactivated influenza vaccine was the most cost-effective intervention of those studied but this assertion was based upon a "lesser of all evils" philosophy. The other interventions were either extremely ineffective or associated with such horrendous adverse events that the inactivated vaccine won a place of honour by default. In the end, Demichei concludes:

"If assessed from an effectiveness and efficiency point of view, vaccines are undoubtedly the best preventive means for influenza in healthy adults. But when safety and quality of life considerations are included, parenteral vaccines have such low effectiveness and high incidence of trivial local adverse effects that the trades-off are unfavourable. This is so even when the incidence of influenza is high and adverse effect quality of life preferences are lowly rated. We reached similar conclusions for antivirals and NIs even at high influenza incidence levels. We condude that the most cost-effective option is not to take any action."

Studies do not provide any evidence that HCWs are responsible for transmitting influenza to patients. They do not provide evidence that the influenza vaccine reduces transmission or improves the quality of life for HCWs. They do not demonstrate that the benefits of vaccination are greater than the risks and they cannot legitimately claim that this is a wise use of our diminishing health care dollars. Although only a few studies are mentioned here, methodological problems abound in existing literature and there is absolutely no justification, ethically, legally or medically, for abrogating the rights of health care workers.

References.

1. Flor M. Munoz et al., "Influenza A Virus Outbreak in a Neonatal Intensive Care Unit," Pediatric Infectious Diseases Journal 18 (1999): 811-815.
2. J. Potter et al., "Influenza Vaccination of Health Care Workers in Long-Term-Care Hospitals Reduces the Mortality of Elderly Patients," Journal of Infectious Diseases 175 (January 1997): 1-6.
3 Health Canada, "Statement on Influenza Vaccination for the 2000-2001 Season," Canada Communicable Disease Report 26 (ACS-2) (1 June 2000).
4 David W. Scheifele et al., "Evaluation of Adverse Events after Influenza Vaccination in Hospital Personnel," Canadian Medical Association Journal 142 no.2 (1990): 127-130.
5. Carolyn Baxton Bridges et al., "Effectiveness and Cost-Benefit of Influenza Vaccination of Healthy Working Adults," Journal of the American Medical Association 284 no.13 (4 October 2000): 1655-1663.
6 V. Demicheli et al, "Prevention and Early Treatment of Influenza in Healthy Adults," Vaccine 18 (2000): 957-1030.