To address it, Dr. Cox points at the roughly 226,000 annual flu-related hospitalizations. Flu death rates range from 49,000 to 70,000 in years when prevalent strains are especially virulent. Worldwide, as many as 1 million people die of flu each year.
Though hardly the Black Plague, influenza is not as benign as many people want to believe, argues Dr. Cox. Elders are especially vulnerable, as are healthcare workers, particularly those in hospitals and large clinics.
Among medical professionals, vaccination rates are higher. According to the CDC, last year’s rates were 64% for healthcare workers in aggregate, 82% for physicians, and 86% for nurses and PAs.
Those numbers are largely driven by local-level mandates.
Mandates & Exemptions
There are no federal or state laws requiring any adult to get any vaccine (the exception being people entering the military). But many hospitals and clinics require vaccination—including annual flu shots—as a condition for employment.
In facilities with requirements, the flu shot rate is roughly 86%; in those without vaccine policies, it is half as high (43%).
Institution-level mandates have strong buy-in from many mainstream medical organizations including the American College of Physicians, the American Academy of Pediatrics, and the American Academy of Family Physicians.
In the trenches, though, the rank and file seems unconvinced. The CDC reports that, “among unvaccinated health care personnel who did not intend to get the flu vaccination…the most common reason…was that they don’t think that flu vaccines work.” Last year’s strain mismatch, and the generally poor efficacy of the shots did little to engender confidence.
In some regions, practitioners are fighting vaccine requirements. Ohio legislators are reviewing HB 170, a bill that would, “prohibit an employer from taking an adverse employment action against a person who has not been or will not be vaccinated against influenza.”
Innovation & Inertia
By creating a more effective, additive-free vaccine using an eco-friendly method, Dr. Cox hopes to increase the number of people who choose to take the shot.
So far, though, response has been tepid. Simply put, economics favor the older egg-based products.
Flublok has wholesale price of $32.75 per dose. Many of the old-school flu shots wholesale at $10-$25. Private clinics and pharmacies have been lukewarm toward Flublok, because payors reimburse more or less the same amount no matter what product is used. To the clinic, the profit margin is higher on the older, cheaper, egg-based products.
Likewise, cash-strapped public programs have not rushed to embrace the more expensive newcomer. They promote Flublok solely as an option for people who have egg-allergies, though it is approved for wider use.
Converting the Un(sero)converted?
Flublok’s appeal is clear for people concerned about thimerosal, aluminum, and antibiotics. But it won’t likely convince practitioners or patients who are opposed to vaccines in principle.
Kelly Brogan, MD, a New York City-based functional medicine practitioner and outspoken critic of vaccines, believes that in general the public health benefits of vaccines are grossly overstated and the potential risks greatly downplayed by a profit-driven industry.
A psychiatrist by training, with a special focus on women’s health, Brogan holds that immune system reactions to vaccines do play a role in the etiology of a number of disorders including autism and depression (Brogan K. Altern Ther Health Med. 2015; Suppl 3: 18-26). She contends that vaccines would be largely unnecessary if people were living and eating in ways that supported rather than taxed their immune systems, and that engendered a healthy gut microbiome.
“We will never “win the war on microbes.” Not with antibiotics. Not with vaccines. Not with bleach and hand sanitizers,” she wrote in a recent post to her Mindful Birthing and Mothering blog.
Regarding flu shots, Dr. Brogan cites a number of studies challenging their efficacy, including a 2010 Cochrane Collaboration metanalysis of 75 trials involving people 65 years or older.
The Cochrane group reported that of these studies, only one was a randomized controlled trial. It showed a modest benefit against flu symptoms but was not sufficiently powered to detect complications, making risk-benefit analysis impossible.
Of the remaining 74 studies, the authors wrote: “…the general low quality of non-RCTs and the likely presence of biases, make interpretation of these data difficult.” They were, therefore, “unable to reach clear conclusions about the effects of the vaccines in the elderly.” (Jefferson T, et al. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD004876.)
Also in 2010, Canadian researchers published an analysis of four observational trials of trivalent influenza A vaccines. They reported that prior receipt of a 2008–09 vaccine was associated with increase—rather than a decrease—in risk of H1N1 illness during the subsequent Spring–Summer of 2009 (Skowronski DM, et al. PLoS Med 7(4): e1000258).
Flu shot critics point out that the CDC’s Vaccine Adverse Events Reporting System (VAERS) has logged more than 93,000 adverse reactions claimed to be caused by flu shots, including 1,080 deaths. The veracity of these reports is questionable because anyone can report to VAERS, the CDC does not verify all reports, and even when they do, a causal relationship is not always established.
Harder to dismiss is the National Vaccine Injury Compensation Program’s payout of more than $944 million to 1,124 individuals with injuries caused by flu vaccines between 2006 and 2014. But these numbers must be put in perspective: during that period, Americans received roughly 1.08 billion doses of flu vaccine.
Even in cases where there is evidence of injury, it is seldom clear whether it was viral antigens themselves or the adjuvants and contaminants that caused the problems.
Potentially neurotoxic adjuvants like mercury are one of the issues critics like Dr. Brogan have with vaccines. But in an interview, she said an alternative like Flublok is not likely to shift her position. While it eliminates the adjuvant issue, Flublok raises other concerns.
“When you are taking viral DNA and inserting it into animal cells, you don’t really know what will happen,” she told HPC. “You don’t know what all the unknowns are. It’s the same issue as with GMOs. What it comes down to is you have to ask whether the benefit is worth the risk. And the risks may be unknown in the sense that we don’t even know to look for it until something happens. You can’t really account for what you don’t even know you should measure.”
Dr. Cox and her team at Protein Sciences realize they may never convince people who question the fundamental principles behind immunization. But they believe they are providing a safe, effective, and environmentally friendly option for those who have questions about the previously available formulations, especially healthcare professionals who may be required to take vaccines.
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