Are influenza vaccine policies based on good science?

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It’s almost flu season and public health departments all over the world are fervently promoting influenza or flu vaccines. Like in the US, the Canadian government recommends the flu vaccine for the entire population over the age of 6 months. However, the majority of Canadians pass on getting a shot. Less than one-third of Canadians over 12 years old opt for the flu vaccine, according to Statistics Canada. The province of Quebec has the lowest flu vaccination rate in Canada at 24%.

Why this disparity? According to Statistics Canada, the majority of the unvaccinated just don’t feel it’s necessary – and they may be right. If you take a hard look at the science, our health policies and intense marketing around the flu vaccine are founded on poor, incomplete and biased evidence.

Some major concerns about seasonal flu vaccine policies are detailed below and referenced with numerous peer-reviewed studies.

Questionable estimates of influenza death rates

The number of deaths from influenza is often cited as a reason for the flu shot. For healthy adults, the flu poses little risk and a few days of rest are all that is needed for a complete recovery. The very old, the very young and the sick are at a higher risk of hospitalizations and death from influenza. The elderly are said to account for about 90% of seasonal flu deaths.

According to Health Canada, annual influenza deaths are the range of about 3,500 people (these numbers pale in comparison to diabetes, cancer and heart disease deaths). However, no one is actually counting laboratory-confirmed deaths from influenza and there are no real figures collected. Influenza is rarely listed on death certificates, lab testing for influenza is infrequent and autopsies are almost never done.

The numbers cited for influenza deaths are estimates based on computer models, which consider death from heart or lung disease a possible influenza death. Pneumonia deaths are also counted as flu deaths, yet the vast majority of cases are unrelated to influenza. Deaths from influenza-like illness are included in the estimate, yet only 7-8% of influenza-like illness in a given season is actually caused by the influenza virus. There are over 200 other pathogens that can cause flu-like illness in winter. The model also assumes that the flu virus will cause more deaths across all causes in winter. However, few excess deaths in winter are actually caused by the flu.

The influenza deaths cited by health agencies are likely overhyped, “more PR than science” and based on a “marketing of fear”, as stated in this article in the British Medical Journal.

The flu virus

The flu virus

Low efficacy of the influenza vaccine

Influenza viruses constantly evolve and mutate. Since it takes months to develop the right vaccine, by the time flu season arrives, the flu shot may or may not match strains circulating. A Canadian study based at the British Columbia Centre for Disease Control found the 2014-2015 seasonal flu vaccine offered no protection to Canadians because of a mismatch in strains. The 2015-2016 vaccine, which was considered a good match, offered protection of just below 45%. In general, the flu vaccine is only about 10-60% effective, yet these estimates have been shown to be inaccurate and biased.

Many robust scientific studies, systematic reviews and meta-analyses have consistently found the flu vaccine to be of low efficacy or completely ineffective in various populations.

For example, this extensive meta-analysis by the Cochrane Collaboration, which included almost 10 million people, found the following results:

  • 6% of unvaccinated participants versus 9.9% of vaccinated participants developed influenza-like symptoms.

  • Only 2.4% of unvaccinated and 1.1% of vaccinated participants developed laboratory-confirmed influenza.

  • Vaccination had a modest effect on time off work and had no effect on hospital admissions or complication rates.

  • The number of healthy adults needed to vaccinate with inactivated flu vaccine to avoid one influenza-like illness was at least 40 people; 70 people would need to be vaccinated to prevent 1 case of influenza.

  • There was no significant effect of vaccination for pregnant women or their newborns.

"There is no reliable evidence that inactivated influenza vaccines [i.e. the standard flu vaccine] affect either person-to-person spread of influenza or complications such as death or pneumonia…and [this] relates both to healthcare workers, community-dwellers and people in institutions," says Dr Tom Jefferson, epidemiologist and researcher for Cochrane collaboration working on acute respiratory infections and vaccines.

What about children and seniors?

Is the flu vaccine effective for people who need the protection? Unfortunately, people who need protection from the flu, the elderly and the sick, have immune systems that are least likely to respond to the vaccine. Should we then vaccinate the young and healthy, for whom the flu is benign? Should we vaccinate the healthy to protect the most vulnerable?

While the Canadian and US Health Agency urge every person over the age of 6 months to get vaccinated, there may be no benefit for healthy adults and children. Vaccinating healthy people to protect the very young, old or sick has not been shown to be very effective. Furthermore, the vaccine’s low efficacy and low adoption offer no chance of herd immunity.

In fact, despite the increasing proportion of seniors who are vaccinated for influenza, rates of hospitalization for acute respiratory illness and cardiovascular diseases have been increasing for seniors during recent annual influenza seasons.

This Belgian meta-analysis found no efficacy of the flu vaccine in children under the age of two and in institutionalized elderly. They also found a striking lack of evidence that the vaccines prevent pneumonia, hospitalization and influenza-specific and overall mortality.

A meta-analysis of 75 studies and another meta-analysis published in the Lancet found the available scientific evidence was lacking and of poor quality for the efficacy of influenza vaccines for people over the age of 65. The studies assessed provided no guidance regarding the safety, efficacy or effectiveness of influenza vaccines for seniors.

Similarly, this meta-analysis found the efficacy of the inactivated vaccine similar to the placebo for healthy children under the age of two and children over the age of six. They also found that 28 children would need to be vaccinated to prevent one case of influenza (infection and symptoms). There was no effect of the vaccine on respiratory illness, medication prescriptions, ear infections or any socioeconomic impact.

What about health care workers?

Many health care workers are urged and even obliged to get flu vaccines to protect their patients – but about 50% refuse. A “vaccinate or mask” policy has been in place in the province of British Columbia since 2012, which forces nurses to get a flu shot or wear a surgical face mask for the entire flu season.

This 2017 study published in PLOS One by epidemiologists from Canada, Australia and France found that the benefits of vaccinating health care workers were exaggerated and based on flimsy science. They found that at least 6000 to 32,000 hospital workers would need to be vaccinated before a single patient death could potentially be averted.

Repeated flu shots may blunt effectiveness  

Sometimes the flu vaccine does the opposite of what it's supposed to do: repeat flu shots may blunt the efficacy of the vaccine, putting people at an increased risk of contracting the flu.

Canadian infectious disease specialists found that people who did not get a flu shot the previous year appeared to get more protection from the vaccine the following year than people who got shots both years. The study found vaccine 43% effective for those who hadn’t received the 2013/14 vaccine but 15% effective for participants who received both seasons’ vaccines. 

This is similar to what happened in 2009, when the World Health Organization declared the H1N1 flu outbreak a pandemic. Governments everywhere ordered billions of dollars worth of vaccines and antiviral drugs as fear of an epidemic spread around the world.

Canadian researchers noticed that people who received the seasonal flu shot for the 2008-2009 winter had almost double the risk of contracting the H1N1 flu than unvaccinated people. Five other studies confirmed the same results.

Initially, this was dismissed by other researchers as the “Canadian problem”. Some jurisdictions in Canada however, were unsure whether to provide the seasonal flu vaccine they had purchased along with the H1N1 vaccine. The province of Quebec opted not to offer the seasonal flu vaccine that year that they had purchased because of these studies, and the public received only the H1N1 vaccination.

This 2014 randomized controlled trial published in PLOS One confirmed the findings in a laboratory experiment using ferrets (the best animal model for predicting how influenza will affect humans). Half were vaccinated with the seasonal flu vaccine and half were given a placebo. The researchers did not know which ferrets received which shot. Afterwards, the ferrets were infected with the H1N1 virus. The ferrets who had received the seasonal flu vaccine group became significantly sicker than the other animals, though all recovered. Since the pandemic, researchers in other countries have reported a similar interaction.

This research indicates there might be many potential unknowns about the influenza vaccine and that it is capable of wreaking havoc with our immune systems

Cohort studies vs. placebo-controlled trials

The only real way to really measure flu vaccine efficacy is through placebo-controlled trials. This means taking a group of people at risk of getting the flu, randomly assigning half to get a flu shot and the other half a placebo. Researchers count people in each group who contract laboratory-confirmed influenza or other serious illnesses, and deaths. Only such large, well-constructed, randomized trials can show with any precision how effective vaccine really is, and for whom.

The problem is few of these studies exist because of ethical concerns. Instead, estimates for flu shot efficacy come from cohort studies, which compare death rates from people who choose to be vaccinated, against death rates in groups who don’t.

These cohort studies have been shown to be biased and flawed because people who choose to be vaccinated differ from those who are not. Education, lifestyle, income and many other confounding factors can muddy the data. Some of these confounding variables can be adjusted but there is always the chance of missing some critical confounder that renders the results entirely wrong.

One of the few double-blind placebo-controlled studies for the influenza vaccine was conducted by researchers in Hong Kong. They followed the health of children ages 6-15 years old that were vaccinated with trivalent inactivated influenza vaccine and those receiving a placebo for 272 days. They found that the flu vaccine actually made children more prone to both influenza and non-influenza virus acute respiratory infections.

  • The trial concluded the influenza vaccine holds "no health benefits".

  • Vaccinated children had a 550% higher risk of contracting non-influenza virus acute respiratory infections.

  • Among the vaccinated children, there were 116 influenza cases compared to 88 among the unvaccinated.

This study suggests that the flu vaccine can indeed "make you sick" by increasing susceptibility to other strains of flu or another virus.

Flu vaccine risks

Many people claim (including myself) that they have contracted the flu or an influenza-like illness after getting the flu shot. Most people just get a sore arm or low-grade fever from the flu shot.

This 2017 study published in the journal Vaccine found that pregnant women who were vaccinated against flu may be at a higher risk of suffering a miscarriage — but only if they had also received a flu shot in the previous year as well.

This study found that flu vaccination elicits a measurable inflammatory response among pregnant women. Inflammatory responses are linked to adverse perinatal health outcomes including preeclampsia and preterm birth.

The flu shots have also been linked to a rare nerve disorder called Guillain-Barre syndrome in a very small number of people. The 2009 H1N1 influenza vaccine Pandermix caused more than 1300 people to develop narcolepsy in Europe. For children and adolescents who had received the flu vaccine, there was a 6.6 fold increased risk of narcolepsy.

In the US, if you are harmed by a vaccine, you cannot sue the manufacturer because pharmaceutical companies have immunity against lawsuits for injuries or deaths resulting from vaccines. Instead, you must sue the Federal Government and try to obtain compensation from the National Injury Compensation Program, which is funded by taxes paid on vaccines. According to their most recent report, the influenza vaccine caused by far the most vaccine injuries. In 2016, the US government paid out over $230 million for vaccine injury compensation. 

Canada does not have a vaccine injury compensation program and therefore there are no individuals compensated for vaccine injury in Canada.

The verdict

Fighting the flu is largely hit or miss. Vaccines, in general, affect every person differently. Depending on what previous vaccinations a person has had, flu shots may or may not provide any protection at all. In some cases, flu vaccines can make a person more prone to illness and may cause negative health outcomes.

Even more striking is the poor, incomplete and biased evidence on which the science policy and intense marketing of the flu vaccine are founded. Much of these studies are funded or partially funded by pharmaceutical companies who profit from the manufacture and sale of these vaccines, and tend to generate results favorable to their products.

Many suspect the hand of “Big Pharma” in the ardent promotion of a vaccine that is moderately effective at best and in reality, probably not very effective at all. Much of the hype around the benefits of the flu vaccine is marketing propaganda masquerading as science. People who are skeptical of the influenza vaccine are not rejecting science per se, but rather distrust overzealous health policies.