The Future of the Flu Vaccine

In the last few weeks, I have written about the various controversies and rumors that commonly swirl around the flu vaccine. What is it made of? How does it work? DOES it work? Having debunked a few myths and discovered a lot of facts, we have learned a lot about what the flu vaccine really is in this day and age. But what does the future of the flu vaccine look like?

Well, throughout my research, I’ve come across several theories and proposals about innovative vaccines that could eliminate some of issues I’ve mentioned in past posts, like the need to reconfigure the vaccine every year to cater to virus mutations.

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For example, Time Magazine published an article last year touting two research papers about the “universal flu vaccine.” As I said, this would be a vaccine that treats all forms of the flu virus, eliminating the guess factor of predicting what strain will rear its ugly head every year. Essentially, these two research papers explore the possibility of isolating the stem of the virus cells, as opposed to the head, and formulating a vaccine from that.

According to the paper published in Science magazine, the head, referred to as “the head region of the hemagglutinin (HA) glycoprotein,” is what is susceptible to “genetic drift” (changes) and is what causes the flu virus to mutate every year. The stem, however, or the “hemagglutinin-stem nanoparticles,” represents a large part of viral cells that remains the same. Using these cells from the stem, scientists are hoping to create a vaccine that will be biologically recognizable to anyone who has fought off the flu virus before. Since the stem of the viral cell remains the same, the “universal flu vaccine” would be strengthening existing antibodies instead of creating a set of new ones every year.

Although this vaccine is not necessarily “universal” yet, it could be a way to protect people from more strains of the flu virus for longer periods of time and lay the groundwork for an idyllic ‘one flu shot per lifetime’ future.

Scientists are also researching new ways to administer the flu shot. If a less invasive means by which to immunize people were patented, perhaps individuals who were originally scared of needles would be more willing to get the shot.

For example, an article by NPR news explained an innovative patch that could feasibly eliminate needles from the vaccination process in general. Mark Prausnitz, a professor of Chemical and Biomedical Engineering at Georgia Tech, is trying to create a small sticker, similar to a band-aid, that an individual would wear long enough to be punctured by 100 microscopic needles that eventually dissolve and spread the vaccination throughout the body. I know what you’re thinking: ‘100 needles as opposed to one? Uh, no thanks.’ But Prausnitz says “it wouldn’t be like sandpaper or scratching, you would have a hard time feeling a difference between the needles being there or not being there.”

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Having worked on this tiny, tear-drop shaped patch for 20 years with researchers from the CDC and Emory University, Prausnitz identifies some of the many advantages to using this vaccine patch. Primarily, the patch would eliminate the need for high-tech refrigeration systems and, thus, clinics and trained medical personnel to handle them. This would make it much easier to administer the flu vaccine to rural areas and could increase the availability of vaccinations to lower-income demographics. Secondarily, there would be no syringes or needles to dispose of, two types of medical waste that often pose a risk to healthcare professionals.

“We would like people to ultimately self-administer their vaccines,” Prausnitz says, when prompted about his vision for the patch. Testing of the patch on human subjects is expected to start in 2017.  

These are just two examples of projects seeking to improve the flu vaccine. Conducted by some of the smartest scientists in the world, this research will undoubtedly result in a brighter, needle-less future for the rest of us. What do you think about these ideas? Would you prefer the patch or the needle? 

The Big Pharma Conspiracy: Are they out to get us?

Having done so much research on the flu vaccine for other posts, I have learned a lot about the science and technology that goes into the flu vaccine every year. I have talked at length about the makeup, effectiveness and target demographics of the flu vaccine, judging whether it really protects us from the influenza virus. 

Now that we have covered all that, I’d like to delve into a more sensitive social topic that surrounds the flu vaccination, and that is whether or not pharmaceutical companies sell vaccines with the best interests of the public in mind, or if they are just out to make a profit.

It is no secret that U.S.  pharmaceutical companies have sweet talked doctors into prescribing their drugs. A story done by National Public Radio entitled “Dollars for Docs” covered this topic by interviewing Matthew Webb, a drug representative in the 1990’s who was accustomed to “entertaining doctors two or three nights a week” with fancy dinners and sports tickets in order to persuade them to buy his product. 

This was a common and accepted practice until 2002, when the “Code on Interactions with Healthcare Professionals” was published by PhRMA, the pharmaceutical industry’s trade group, effectively outlawing this bribery.
 

So, the question remains: Are pharmaceutical companies producing the flu vaccine for their own profit?

An article in the magazine of Johns Hopkins Bloomberg School of Public Health would suggest that this is not true. In fact, the article states that the production and distribution of vaccines is so unprofitable for drug companies that most seem to do it out of sheer goodwill towards the community. Citing a $300 to 400 million dollar start-up price for any vaccine, the article states that the costs of manufacturing have actually discouraged most drug companies from producing them at all.

After this huge initial investment, the Johns Hopkins article also states that drug companies have a lot to do before they can actually administer their vaccine to the public. Due to “conflicting pressures at all stages of their development and distribution,” it is extremely difficult to get a new vaccine approved by the FDA. This applies especially to the flu vaccine, whose construction is so much more complex than a formula because of the annually mutating virus it treats.

Even if the flu vaccine passes all of the stringent FDA regulations, the drug companies are faced with an extremely low profit margin, only 2 to 3% according to an article published in The Atlantic. This is because public agencies in charge of distribution buy at a capped price, which is predetermined and not subject to greediness or other monkey business. In fact, according to the Johns Hopkins magazine, the federal government’s large scale purchases of the flu vaccine at these capped prices are a main disincentive for producing vaccines that “historically have been high-volume, low-profit items anyway.”

Between the huge start up investment, and all of the risks of failure along the way, it is evident that drug companies are not producing vaccines as a sure fire way to make a profit.

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These risks, however, are incredibly discouraging for drug companies, and have had a negative effect on the supply of vaccinations in the U.S. According to an article published in the U.S. National Library of Medicine, there were 26 manufacturers of the flu vaccine in 1967, a number that dropped to 17 by 1980, then to 12 in 2015, only four of which are large-scale producers, like GlaxoSmithKline, one of the largest U.S. vaccine manufacturers.

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As drug manufacturers abandon their flu vaccine programs, a nationwide shortage could be taking place. For example, Erin Fox, manager of the drug information services for the American Society of Health System Pharmacists, told the Washington Post in 2011 that the shortage of vaccines was a worsening crisis that unnecessarily “puts patients at risk.”

Now that we’ve ascertained that pharmaceutical companies are not gouging U.S. citizens, we should ask: Can this problem solved?

Phil Russel, an MD and senior adviser at the Office of Public Health Preparedness, tackles this debate by defining the problem. He states that the U.S. market for vaccines is artificially skewed by corporations like the WHO, who both produce and buy vaccines in bulk, essentially cornering the market and creating very little incentive for other drug companies. This, combined with the amount of people who simply refuse to get vaccinated, is why vaccines are so unprofitable.

“We have to come back to some basic understanding of how valuable vaccines are to us, and how we translate that knowledge of value into a market,” Russell states, confronting anyone who protests the importance of vaccines in modern life.

 I think Phil Russell said it well, "We know how valuable fighter aircraft are to our defense and we pay the cost for them. Nobody bitched about the price for the smallpox vaccine. Whatever we needed, we paid." 

According to him, if the federal government gave more subsidies for the flu vaccine, drug companies could afford to spend more time matching them to each annual strain, and if people stopped doubting drug companies motives, perhaps the flu wouldn't be spread so commonly every year. 

What do you think?

How effective is the flu shot?

Last week, I discussed the side effects of the flu vaccine, which can range from anything mildly uncomfortable to more serious illnesses. In that post, I also mentioned which groups of people are considered “high risk” for flu-related complications and should definitely be vaccinated, including babies, pregnant women, and seniors.This week, let us delve into the effectiveness of the flu vaccine in fighting influenza.

According to the CDC, how well the shot works, or the vaccine’s “efficacy,” depends on a few different factors. The two main influences, however, are the characteristics of the person being vaccinated and how well “matched” the vaccine is to that particular strain of the flu.

First and foremost, the vaccine’s efficacy relies on the age and health status of the recipient. By studying polls taken after every flu season, doctors and scientists at the CDC estimate that the flu shot is effective in preventing this illness in about 60% of healthy individuals under the age of 65 years.

The graphs shown below were made after the 1982-1983 flu outbreak in Genesee County, Michigan. By comparing the incidence rate of infection amongst vaccinated and unvaccinated Nursing Home residents, the results suggest that the flu shot was largely effective in immunizing healthy adults surrounded by sick patients.

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Although they also say that the flu shot is less effective in older individuals, the CDC holds that this vaccine reduces complications related to the flu and other common illnesses. Some studies show that the shot was 50-60% effective in reducing hospitalization and 80% effective in lowering the death rate amongst older recipients.

Now, why would the vaccine have a different effect on older individuals?

Human immune defenses naturally become weaker with age. With this in mind, the standard flu shot can actually be risky for older people because they may have a diminished immune response and might not produce as many antibodies as they could have in the past.

This is why a different kind of vaccination is given to people over 65 years old. Called the Fluzone High-Dose influenza vaccine, this injection contains four times the amount of antigen, otherwise known as the substance that causes your body to produce antibodies, than the standard flu shot administered to younger people. This is intended to create a stronger immune response in the recipient, and would explain why the flu shot is so useful in preventing complications related to the flu virus.

One question remains: Does this special shot actually bring about a better immune response?

According to data from clinical trials of older recipients, it definitely results in levels of antibodies being produced. Whether or not these antibodies actually reduce the chances of getting the flu virus, however, is subject to ongoing debate. According to a study in the New England Journal of Medicine, though, the high dose vaccine was 24.2% more effective in preventing the flu amongst older individuals, so scientists are confident that the higher antigen dose is a good idea.

After having explored how age and health status influence the effectiveness of the flu vaccine, let us discuss the second factor that I mentioned before: the relationship between the shot and the strain of virus it is fighting.

Earlier in this post I mentioned how well “matched” the vaccine and the illness are. What did I mean by this?

Well, the vaccine has proven to be most effective when its antigens match those of circulating strains. If they match, then the pathogens introduced to the body by the vaccine will bring about an initial production of antibodies that will successfully fight off the current flu virus.

That being said, it is very difficult to predict which strain of the virus will break out each year and created a corresponding flu vaccine, so sometimes the vaccinations do not “match” and are less effective at fighting the illness.

This exact situation occurred during the 2014-2015 flu season when the CDC released a warning that the flu season would be particularly unpredictable and harsh due to an outbreak of the H3N2 virus.

According to CDC officials, a vaccine was made and ready to go until the virus “drifted” in March, a mutation that came too late to be included in the vaccine.

"It's clear that the laboratory tests we're using to understand how closely related this virus is to the vaccine virus are good, but they're imperfect markers of how well the vaccine will function in the field," said Joseph Bresee, chief of the CDC's Influenza Epidemiology and Prevention Branch.

Although this seems scary for recipients of the flu vaccine, we can rest assured that, even when the shot is not perfectly “matched” to the strain, they still provide some protection against the harsher effects and complications of the flu virus.  

It's Flu season, do you know where your antibodies are?

Last week, I covered what the flu shot is, how it works, and the ingredients that go into this pestilence-fighting cocktail.

This time, let us discuss the side effects of this vaccine.

Now, whenever the flu shot is administered today, it typically comes with a series of possible side effects that, while annoying, are not awful and are expected to pass within a few days.

They include headache, fever, nausea, muscle aches and pains, and fainting.

So, why do we have this adverse reaction to inactive viral cells?

It’s actually quite interesting, so gather ‘round, children.

These are all autoimmune responses. The human body senses the presence of the flu virus, although it is not being actively invaded, and prepares to expel the pests in any and every way (thus, nausea.)

That being said, fevers are the body’s way of gaining an advantage over an infectious agent. By raising the temperature, the body is essentially making itself as inhospitable as possible to viruses and bacteria.

Although the viral cells are inactive, they still trigger this immune response.

Muscle pain, also known as Myalgia, is also explained as an immune response to viral cells that could potentially infect healthy ones.

So, the body is working so hard to increase your temperature and produce antibodies that you are basically getting a cardiovascular workout just by existing. Very similar to a post-workout state of being, the muscles can be tired and sore.

After all of this “exercise,” an individual might faint as well.

Now that I have explained the most common and mild symptoms associated with the flu vaccine, are there any more serious adverse effects that we should be worried about?

Although it is quite rare, there have been reported cases of Guillain-Barre Syndrome as a result of the flu vaccine.  

This is a disorder in which the body’s own immune system damages nerve cells in an effort to protect itself from infectious agents. This condition is very serious and can lead to paralysis and permanent nerve damage.

Overall, studies estimate that Guillain-Barre Syndrome has been associated with 1 or 2 cases per one million people vaccinated.

For example, there was a distinct correlation between GBS and the 1976 strain of the swine flu vaccine. Scientists at the Institute of Medicine, a non-profit non-government based agency, found that there was one more diagnosed case of Guillain-Barre Syndrome for every 100,000 vaccinations that year.

They presume that the GBS was caused by the re-activation of “dead” viral cells and the subsequent flu infection, but they are still unsure as to the cause.

It is a tiny chance, but food for thought.

Now that we’ve covered the mild and harsh side effects of the flu shot, I am wondering who is most vulnerable to this unpleasantness?

Moreover, is there anyone who should not get that shot at all?

I was surprised to find that the Centers for Disease Control and Prevention recommend that anyone over the age of 6 months should get vaccinated against the flu.

This “universal” vaccination policy took effect after a 2010 press release, in which the CDC cited the severity of the H1N1 pandemic as a reason to begin vaccinating people younger than 19 years of age.

The CDC also recommends any they define at “high risk” for developing complications from the flu to get vaccinated. These people include babies (between 2 and 5 years of age), senior citizens, pregnant women, American Indians, and Alaskan natives (They didn’t elaborate on this, so I suppose it’s because of their colder environments.)

Other high risk people include individuals with severe or chronic asthma, neurological conditions, lung disease, and heart disease.

Oh yeah, the people who shouldn’t get the shot?

Basically, individuals with allergies to the vaccine or any ingredient within it. But, even then, the CDC highly recommends that it be administered.

Ironically, doctors will discourage people with egg allergies to get the shot, which would seem like the least worrisome aspect of the whole process.

Overall, I was surprised by my research for this post.

After last week’s formaldehyde discovery, I expected more adverse effects directly correlated to the flu shot. 

So, unless you already have the flu, no need to fear the side effects of the flu shot!

 

What came first, the vaccine or the egg?

The flu season. That time of year when you can hardly hear your professor’s lecture because the 300 people in your economics class seem to be coughing in unison.

Or, as the CDC describes it, the season in which “flu viruses are circulating at higher levels in the U.S. population.”

Before discussing the civic issues surrounding the flu vaccine, one might ask how exactly it works.
 

The modern flu vaccine comes in the form of injections or nasal sprays that contain inactive flu cells. I say inactive, not “dead,” because viruses are not alive and, thus, cannot die.
 

Anyway, exposure to these cells stimulates the body to create antibodies that fight off infection from these little buggers.
 

Now, ever since the first recorded influenza pandemic in 1580, which allegedly claimed 1 million lives, doctors have been finding ways (some more creative than others) to fight off this dreadful illness.
 

From oxygen infusions to bleeding patients, modern and archaic doctors alike have been stumped as to how to cure and immunize their patients against the flu.
 

That is, until Ernest William Goodpasture (below) figured out how to deactivate virus cells inside a hen’s egg in 1931.

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After that, famous scientists like Thomas Francis and Jonas Salk started cultivating dormant viral cells and injecting them into living hosts, namely World War 2 soldiers (in case they didn’t die in the trenches, they could fight off viral cells accidentally reactivated by egg proteins too.)  

So what do flu vaccines look like today?

Well, there are three types of shots that people typically receive today. The first two fight against “Influenza A” (the flu viruses that mutated to transfer from animals to humans) and they cover the H1N1 and H3N1 viruses.

Now, if you’re like me, you have no idea what “H” and “N” refer to. Not to worry, I found out it’s a very simple concept.

These acronyms simply refer to the two different types of spikes flu cells have on their surfaces.

There are 17 types of Haemaglutinin (“H”) and 9 different types of Neuraminidase (“N”), and each virus has on type of each used to disarm and infect healthy cells.

The third type of flu shot protects against “Influenza B,” which is the type of flu that spreads exclusively among humans and causes pandemics. These viruses change every year, making our former antibodies useless and forcing us to get injected every year.
 

Now that we’ve covered the history of the flu vaccine, how it works, and what it’s fighting, that leaves one question to be addressed in this blog post: What are the ingredients for the flu shot?
 

According to the Vaccine Excipient and Media Summary provided by the Centers for Disease Control, the typical flu shot will contain sucrose, egg proteins, and hydrocortisone (a mild steroid) to accompany the inactivated viral cells and encourage a positive physical reaction to the inoculation.
 

This table also mentions other ingredients…like formaldehyde.

Yep, the same strong smelling, flammable chemical used in the preservation of dead bodies.

Along with that morbid function, formaldehyde has also been classified as a carcinogen to humans by reputed sources like the International Agency for Research on Cancer and the U.S. Environmental Protection Agency.

There has also been widespread protest against the use of certain preservatives in the flu vaccine. Thimerosal, for example, is a ethyl-mercury based compound used to prevent germs and contamination in multi-vial packages.  

Although ethylmercury, unlike methylmercury found in fish, is flushed out of the body easier and is unlikely to be toxic, there are still some concerns about the potential effects of mercury exposure to young children and infants, who can be allergic to the compound and have serious side effects.

There is, however, always the option to get the Thimerosal-free injection...but keep in mind that the shot still contains other substances like aluminum salts, latex, and gelatin.

Now, I recognize that people have been getting the flu vaccine for decades now without massive adverse effects from the ingredients listed above.

Just think, though, would you spice your meal with aluminum, eat latex, or drink formaldehyde?

No?

Well, maybe these substances shouldn't be annually injected into your arm, either.