Influenza and HPV: A Closer Look at Two “Controversial” Vaccines—Point-Counterpoint, Part 3
In a controversy, the instant we feel angry, we have already ceased striving for truth, and begun striving for ourselves.
—Thomas Carlyle
In 1918, the world saw the worst influenza pandemic in its history. Called the Spanish flu for reports of its particular devastation in Spain, nearly 50 million people died worldwide. Nearly one-third of the world’s population was infected and practically every family lost a loved one, or multiple loved ones (Figure 11.1).This was before the development of the influenza vaccine, and it wouldn’t be until 1933, when the influenza virus was isolated, that we would have some hope of protection against this devastating illness.
Until more recent times, cervical cancer was the leading cause of cancer deaths among women worldwide. This number was reduced in the 1950s when Dr. Georgios Papanikolaou developed a test (the Pap smear) to detect precancerous changes of the cervix. Through the use of this routine screening test, many cases of cervical cancer were averted. However, women of color and women of lower socioeconomic standing were still particularly affected. Lack of access to preventive care was a major barrier for many women. It wasn’t until the 1980s that work on a human papillomavirus (HPV) vaccine began in earnest because of decades of work by a German virologist named Harald zur Hausen. He looked at HPV as a trigger for cancerous changes of the cervix, and finally concluded that HPV types 16 and 18 were highly oncogenic.1 In 2006, a vaccine that protected against two strains of cancer-causing HPV and two strains of genital wart-causing HPV was licensed and first recommended for girls. Then, in 2011, as we increasingly recognized the role that HPV plays in male genital and throat cancers, the vaccine was also approved for use in boys.
Millions of deaths. Tens of thousands of cases of cancer. One would think that the public would clamor to get their hands on vaccines that can prevent the serious morbidity and mortality that accompany infection with these viruses. Yet, even though we have access to highly successful vaccines, rates of influenza vaccination and HPV vaccination are some of the lowest out there. During the 2016-2017 flu season, the influenza vaccine success rate in the United States was only 59% in children and 43.3% in adults.2 That same year, even though all three vaccines (Tdap, meningococcal,
and HPV) are recommended to be given at the same 11- to 12-year well-child visit, only 60% of boys and girls had received one of the HPV vaccine series and an even more dismal 43.4% were up-to-date with the full course of HPV vaccines. This compares to the 82% success rate for meningococcal meningitis and 88% success rate for Tdap administration.3
and HPV) are recommended to be given at the same 11- to 12-year well-child visit, only 60% of boys and girls had received one of the HPV vaccine series and an even more dismal 43.4% were up-to-date with the full course of HPV vaccines. This compares to the 82% success rate for meningococcal meningitis and 88% success rate for Tdap administration.3
 FIGURE 11.1 Obituary showing the toll on one family during the influenza pandemic. (Reprinted from the Samoan Times, 14-Dec-1918. ‘Samoan influenza obituaries’, https://nzhistory.govt.nz/media/photo/samoan-influenza-obituaries, (Ministry for Culture and Heritage), updated 20-Dec-2012. Licensed by Manatū Taonga for re-use under the Creative Commons Attribution-Non-Commercial 3.0 New Zealand License.) |
Where is the disconnect? What is it about these vaccines that makes them so much more difficult to convince people of than other vaccines? The remainder of this chapter will try to gain perspective on these questions by looking at the history of the influenza and HPV vaccines and their initially recommended target populations. We will address particular concerns voiced about each of these immunizations and highlight the statistics that should make our vaccination case for us (see Appendix B: Fast Facts about Vaccines for Patients and Clinic Staff for concise influenza and HPV vaccine talking points that can be provided to patients for their review).
INFLUENZAIn 1933, influenza subtypes A and B (and rarely C) were first identified as the causative agents of the influenza illness. This led to production of the first influenza vaccine in 1938. In 1942, the Armed Forces Epidemiological Board developed a polyvalent vaccine, containing both A and B influenza strains. This vaccine was licensed in 1945 for use in the military and then in 1946 for general public use.4 However, the vaccine proved ineffective in subsequent years and scientists eventually recognized influenza’s capacity for rapid mutation. A process of observing the circulating, or active, flu strains from around the world began, and scientists started work to anticipate which strains would be affecting the United States in the coming season (see Appendix C: Vaccine Topics Explained for a video explaining how the flu vaccine is made). More than 100 countries conduct year-round surveillance for influenza and then send data to the World Health Organization,
which makes yearly recommendations for strains to be included in the influenza vaccine. The Food and Drug Administration (FDA) is responsible for the final decision regarding which strains to include in each year’s US-licensed influenza vaccines.5 Let’s look at the most common concerns voiced about the flu shot and how you can respond.
which makes yearly recommendations for strains to be included in the influenza vaccine. The Food and Drug Administration (FDA) is responsible for the final decision regarding which strains to include in each year’s US-licensed influenza vaccines.5 Let’s look at the most common concerns voiced about the flu shot and how you can respond.
1. The flu shot doesn’t work that well. What’s the point if I’m still going to get the flu?
As stated above, the flu shot represents a very educated guess about what strains of flu are going to be circulating that year. Some years’ predictions are better than others. Consequently, people are keenly aware of the limitations of the flu shot. At its best, the influenza vaccine is about 60% effective.6 As a result, people have received the flu shot and still gotten the flu or have known others to whom this has happened.
We have good data to show, though, that a person vaccinated for influenza is significantly less likely to suffer severe consequences or death from an influenza illness than if they had not received the vaccine.
Retrospective studies looking at deaths during each flu season show that, of those that died, typically greater than 80% had not received the flu shot.7 The flu vaccine significantly reduces the risk of death from influenza.8
Yes, many people may get the flu, feel temporarily unwell, and recover. However, despite our advances in medicine and technology, we still see an average of 140,000 to 720,000 hospitalizations and 12,000 to 56,000 deaths annually in the United States from influenza. The flu is not a mild illness (Box 11.1).
The 2017-2018 flu season saw the greatest numbers of deaths in decades—80,000 people died, 185 of whom were children.7 This influenza death rate is the equivalent of up to 152 crashes of a Boeing 747 jetliner (carrying an average of 524 passengers each).10 Can you imagine the uproar that would occur if this were happening in our airline industry?
We need to change our expectations of the current flu vaccine. We need to start thinking of it as a way to decrease the severity of the illness and limit hospitalizations and death from influenza, not as a way to prevent the flu entirely.
Box 11.1 Did You Know?
Our ability to fight off illness decreases as we age. Likewise, our ability to mount an immune response to vaccination decreases as we age. The elderly are at higher risk of complications from influenza (70%-85% of flu deaths occur in people older than 65 years), so it is important to make sure that they have a vaccine that is effective. There are a couple of different options for augmented vaccines for our senior population. The “high-dose” flu vaccine (a trivalent vaccine), approved in the United States since 2009, includes four times the amount of antigen as the regular flu shot in order to induce a stronger immune response. A clinical trial looking at 30,000 participants aged 65 and older showed a 24% greater reduction in influenza infections in seniors who received the high-dose vaccine compared with those that received the standard flu vaccine. The adjuvanted flu vaccine (a trivalent vaccine using the MF59 adjuvant to augment immune response) is another option for seniors. In a small study comparing the adjuvanted vaccine to regular-dose flu vaccine, the adjuvanted vaccine was 63% more effective. To date, we have no studies comparing the “high dose” to the “adjuvanted” vaccine. Each of these boosted vaccines may result in more frequent mild side effects (such as redness, swelling, malaise, etc.). Currently, the CDC and Advisory Committee on Immunization Practices do not recommend one flu vaccine over another for patients older than 65 years.9
2. I’m healthy. I don’t need to take the flu shot.
The flu shot was originally advised only for the very young, the elderly, and the medically fragile (people thought to be at greatest risk of suffering from severe consequences of the flu). But in 2010, the Advisory Committee on Immunization Practices (ACIP) recommended use for all persons older than 6 months in order to better limit the spread of influenza.11
One of the difficulties in convincing questioning patients regarding the importance of the flu shot is that the majority of today’s adults still remember when flu shots were not recommended annually. They remember being in the “low-risk” group and don’t see what has changed that now requires them to get the influenza vaccine each year.
Not everyone who suffers severe consequences or death from the flu is in a high-risk group, however. A recent study in the journal Pediatrics looking at pediatric flu deaths in the United States from 2010 to 2016 noted that 50% of the children that died from influenza had no preexisting conditions. They were entirely healthy.12 Those of us who are in good health may be at lower risk, but we are not immune to the possibility of severe consequences or death. And, what we can’t predict is when the virus will mutate and create a particularly virulent and damaging strain from which we won’t recover so easily.
Remember the 1918 influenza pandemic that we spoke of earlier? Nearly half of the people who died from that flu strain were in the healthy 20- to 40-year age range and the virus was so virulent that it sometimes killed within hours.13 So, while researchers continue to search for a way to make a more universally effective influenza vaccine, we must stay vigilant.
3. I got the flu from the flu shot. Why would I take a vaccine that could make me sick?
First, make sure to clarify what kind of illness the person experienced after the vaccine. Many still believe that the flu shot protects against the “stomach flu,” but it does not. The “stomach flu” is not influenza. Vomiting is a rare symptom of influenza and diarrhea is not typically part of the flu syndrome.
If an immune-compromised patient received the live-attenuated influenza vaccine administered intranasally, then this statement could well be true. Live-attenuated vaccines can make people sick whose immune systems are suppressed. However, the majority of people who make this claim are misunderstanding the way that the flu vaccine works.
The injectable influenza vaccine (the one most commonly given) is a killed virus vaccine. It has no live, or active, flu virus in it. It triggers the immune system to allow our bodies to recognize and fight off the flu. This sometimes makes us feel achy and tired or may give us a low-grade fever for a short time. This is just our immune system revving up and is an expected result of immunization, but it is not the flu. The actual flu is much worse.
When someone thinks they got the flu from the flu shot, the most likely explanation is that they got exposed to the flu either just before receiving the injection or during the first 2 weeks after receiving the injection, at which time the vaccine is not yet fully effective.
This is why it is important to get the flu shot before flu season begins, so we are fully protected from the flu by the time we may come into contact with it.
4. I have an allergy to eggs so I can’t get the flu shot.
Historically, we did caution people with egg allergies to avoid taking the flu shot. The influenza vaccine is most commonly produced in chicken eggs, though ongoing research is being done to develop non-egg means of production. However, for the 2016-2017 flu season, the ACIP changed its recommendations.
Now, if reactions are mild or patients have difficulty eating only raw eggs, not cooked, then they can get a flu vaccine without concern. If the egg-allergy reaction is more severe (anaphylaxis, recurrent vomiting, etc.), the flu shot is still recommended, but it has to be given by a provider who can recognize and respond to a severe allergic reaction.14 These recommendations are based on a large number of research studies showing no significant reaction in people allergic to eggs who received the injectable flu vaccine.15 The risk of serious consequences of an influenza infection far outweighs the very small risk of serious reaction to a flu shot in this population of patients.
If all else fails and egg-allergic patients still balk at the idea of getting a flu shot, there are currently two egg-free vaccines available, Flublok and Flucelvax. Both are indicated for use in people older than 18 years.
HUMAN PAPILLOMAVIRUS
HPV is a virus that causes tens of thousands of cases of cancer each year in the United States—cervical, vaginal, vulvar, penile, anal, rectal, oral, and throat cancers. It also causes genital warts and a less common condition called laryngeal papillomatosis. Because of its association with sexual activity, the HPV vaccine is an immunization that we have particular difficulty in getting parents to accept for their children. There are many myths and misunderstandings circulating that contribute to this issue and I will address these in turn. However, this is also one of the newest vaccines on the market and this, I believe, plays a large role in why these misunderstandings abound and why we see both patients, and sometimes even health care providers, being hesitant about its use.
The understanding of the role that HPV plays in the development of genital and oropharyngeal cancers is also relatively new in the field of medicine. Most practicing physicians have “grown up” during the era of the Pap smear. We get them. We perform them. We are very comfortable with and used to the procedure of screening for cervical cancer, and this test has gone a long way in early detection of changes so that cancer can be averted. What we are looking at now, however, is an attempt to prevent those precancerous and cancerous changes from happening in the first place. And with regard to the other cancers that HPV causes, there are no current screening exams that work to detect changes before they become a problem. The Pap smear continues to be of great help for women in the area of HPV detection and cervical cancer prevention, but it does nothing to help with the other cancers with which we are also concerned.
When the first HPV vaccine came out in 2006, I was a couple of years out of residency. I was a fledgling physician and was, and still am, exceedingly cautious, particularly when it comes to jumping on a bandwagon with respect to new medicines. I tend to like to use medicines that are tried and true, that are tested by history. I am not naïve to the fact that there are occasional adverse outcomes that come to light after large-scale use of a medicine that were not seen in premarketing studies. I was also uncertain as to why the original HPV vaccine was marketed only to girls and women. As a sexually transmitted infection, it is, by definition, transmitted through sexual contact between two people. Why were we not vaccinating
boys? I certainly gave the vaccine, but did not push the issue if parents and patients expressed doubts. I was happy to rely on discussion of delaying sexual activity, keeping the number of sexual partners to a minimum, and on the success of the Pap smear screening exam.
boys? I certainly gave the vaccine, but did not push the issue if parents and patients expressed doubts. I was happy to rely on discussion of delaying sexual activity, keeping the number of sexual partners to a minimum, and on the success of the Pap smear screening exam.
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