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H1N1 Vaccine Provokes Backlash over Safety Concerns and Lack of Availability

girl receiving H1N1 vaccine SOURCE: AP/Stephen Chernin The vaccine, while safe and effective, has provided a vehicle for the anti-vaccine movement to launch attacks on some of our most vital tools for protecting public health.

For the second holiday season in a row, Wall Street firms are drawing public ire for enormous bonuses paid to their employees. But earlier this month, some of the unpopular investment banks like Goldman-Sachs, along with numerous other large corporations, came under additional fire for requesting and receiving doses of the scarce H1N1 influenza vaccine. The news only exacerbated public anger over unmet government promises about the vaccine. Large employers often set up their own vaccination clinics and companies have been quick to issue statements that they are adhering to Centers for Disease Control and Prevention guidelines, requesting only enough doses for employees in at-risk groups. The CDC has corroborated this account, but it remains a political landmine not only for local governments, but also for the federal government. There is no way to spin this favorably at a time when people across the political spectrum are furious with Wall Street and when embarrassing mistakes have been made in the vaccine distribution process.

Too many people are skeptical of the safety of this vaccine and others.

But the story of the H1N1 vaccine has spawned other public relations wreckage. Notably, it provided a new vehicle for the anti-vaccine movement to launch attacks on some of our most vital tools for protecting public health. Other factors compounded the problems. The federal government set high expectations for how many vaccine doses it could deliver in a few short months and failed to meet its promises. Moreover, it appears that the severity of the H1N1 pandemic this season is much less than public health officials anticipated, leading to claims that the government unnecessarily exaggerated the crisis.

The Department of Health and Human Services and the CDC are fighting fears about vaccines and rumors about the dangers of the H1N1 vaccine more specifically. Fortunately, concerns about a pandemic have abated somewhat of late—due to improved treatment and vaccinations, it seems like the number of deaths will not be any higher than those caused normally by seasonal flu, and may even end up being lower. This is good news, but complacency would be dangerous, especially as the H1N1 virus could re-emerge in a more lethal form and young adults, one of the at-risk groups, are the most apathetic about getting vaccinated. The government should push drug companies and researchers to develop new, more efficient ways to produce the vaccine and enforce distribution policies to ensure that those most at risk get the vaccine. Long-term, health officials face a trust gap that may continue to undermine future public health campaigns. Too many people are skeptical of the safety of this vaccine and others. Efforts need to be focused not only on ensuring and publicizing vaccine safety, but also on educating the public that the small risks associated with vaccines pale in comparison to the dangers associated with illnesses like the flu.

If someone had told me a year ago that talk show hosts, provocateurs, and political polar opposites Glenn Beck and Bill Maher would publicly agree on something, I would have thought they were crazy. Then, just a couple of months ago, there Beck and Maher were—denouncing the H1N1 vaccine on their syndicated television programs and Twitter feeds as unsafe and foolish. Apparently, frustrations over the H1N1 vaccine have what it takes to promote bipartisanship. How can this be?

A recent ABC News-Washington Post poll shows that a clear majority, 62 percent, of the American public believes that the government has not exaggerated the dangers of the H1N1 flu virus (more commonly known as swine flu). The World Health Organization, or WHO, the CDC, and HHS have all heavily promoted the vaccine. In spite of these efforts, many Americans are unsure about whether they are in one of the at-risk groups. More importantly, the same ABC News-Washington Post poll indicated that nearly half, 45 percent, of all parents do not plan on having their children vaccinated, and two-thirds, 66 percent, do not plan on being vaccinated themselves. The backlash to the vaccine seems to be primarily driven by questions regarding safety and availability. Strangely, the way the government handled the H1N1 vaccine has managed to unite both vaccine foes and those desperate to get it. The former have exploited the newness of the vaccine to rehash concerns about preservatives, adequate testing, and the necessity of vaccines for public health. The latter have grown frustrated with a lack of access to vaccines when sufficient numbers were originally promised.

By June, WHO had raised the pandemic alert for H1N1 to its highest level and governments began to prepare plans for vaccine manufacture and distribution. Typically, flu vaccine design is an imperfect and slow process that relies on educated guesswork about which flu strain(s) will be present during the flu season. The H1N1 virus was robustly characterized, so this aspect of the process was not a concern. However, production was sped up in order to avert a pandemic and this has people concerned that it has not undergone sufficient, thorough testing. The vaccine has in fact been evaluated (in all age groups and in pregnant women) in a series of clinical trials sponsored by the National Institutes of Health, and since distribution began, careful monitoring has taken place to ensure that any irregularities are reported quickly. This system seems to be working well. Just this week, almost one million doses of a special H1N1 vaccine for infants (lacking preservatives) were voluntarily recalled because the vaccine manufacturer noticed that the potency of the vaccines had dropped since shipment.

But roughly one third, 33 percent, of the American public is not confident in the safety of the H1N1 vaccine. In 1976, vaccinations for a different strain of swine flu led to an inexplicable spike in diagnoses of Guillain-Barré syndrome (a rare autoimmune disease). While flu treatment options and vaccine design have improved since then, the CDC is aware that the general public may associate swine flu vaccines with adverse side effects. Bad news, like a novel virus, has a tendency to spread rapidly. For example, a clip of an Inside Edition piece on a young, healthy cheerleader who supposedly developed dystonia, a neurological disorder that causes uncontrolled muscle contractions and contortions, a few days after receiving the H1N1 vaccine already has more than 900,000 views on YouTube. Upon video evaluation, neurologists expressed doubt and dystonia advocacy groups distanced themselves from the report, but the story has already done its damage, judging by the comments posted on the video (and duplicates of it). As well, numerous anti-vaccine groups and blogs have distributed the cheerleader’s story, including Jenny McCarthy and Jim Carrey’s group Generation Rescue.

Widespread safety concerns seem largely specific to this vaccine, suggesting that past associations with Guillain-Barré syndrome and the perception that the vaccine was not adequately tested have affected its image. However, the release of the H1N1 vaccine also comes at a time of severe and growing distrust of vaccines in general, due to a supposed causal link with autism. Anti-vaccine advocates have grown particularly vocal in the past few years, despite repeated research demonstrating there is no credible evidence whatsoever linking vaccines to autism.

About one-third of people unconfident in the safety of the H1N1 vaccine also said they were not confident in the safety of any vaccine. In spite of numerous studies countering their claims, the anti-vaccine movement has managed to convince significant numbers of parents and guardians that routine childhood vaccinations are not just risky, but also unnecessary. Many of the medical students I spoke with believe that the anti-vaccine movement has contributed to the backlash against the H1N1 vaccine. In response to an emailed question, one student wrote: “The anti-vaccination movement has stepped up their efforts during this time, both on the Internet and in the mainstream media. They see this as an opportunity to further their agenda of casting doubt on the safety of vaccines.”  The success of the anti-vaccine movement in vilifying one of the greatest advances in modern medicine highlights the wide gaps in communication between researchers and the general public, the increased use of the Internet as a source of potentially untrustworthy information, as well as a general lack of familiarity with how horrible diseases such as flu can be.

In order to ensure protection for entire societies, vaccination rates for certain diseases must reach very high thresholds in order to protect people who either lack immunity or did not develop immunity from prior infection or vaccination. If enough people are vaccinated, the odds of the disease being present and spreading are significantly reduced, an effect called “herd immunity.”

Anti-vaccine advocates point to preservatives such as thimerasol, a mercury derivative that is present in the inactivated, injected H1N1 vaccine but not the intranasal spray vaccine, as a potential danger. Concerns stem from a study conducted by Dr. Andrew Wakefield and published by the medical journal Lancet in 1999. The study contended that the measles-mumps-rubella, or MMR, vaccine was linked to autism. Blame was immediately placed on thimerasol and although the initial report was refuted by numerous follow-up studies (and additionally, reports surfaced that Wakefield manipulated the data), the anti-vaccine crowd won—most vaccines no longer contain thimerasol. First, the mercury present in these vaccines is trivial when compared to the levels present in fish (and yet anti-vaccine activists do not recommend that we all stop eating fish). Second, preservatives are in fact very important for preventing multi-vial batches of vaccines from getting contaminated with bacteria, viruses, and fungi. In fact, vaccines without preservatives have led to serious complications and even death. This is not general knowledge and according to several medical students I spoke with, patients wary of the H1N1 vaccine have often cited concerns about preservatives. But so far, significant safety concerns have not materialized.

On December 4, the CDC released a safety review documenting the number and kinds of adverse reports received after administration of the H1N1 vaccine—both the inactivated, intramuscular shot and the weakened nasal spray. Through November 24, 46.2 million doses had been distributed and 3,783 reports of adverse effects had been received—almost 1,000 fewer than those reported for the seasonal flu vaccine—and 13 deaths, 9 of which were likely due to underlying illnesses in the victims. One of those deaths was due to a car crash and three are pending review. It will be interesting to see whether this report reassures worried Americans. Invalidated research and a few very loud voices have tarred the reputation of vaccines. It will take time and effort to restore public faith.

Health officials have tried hard to educate the public about the H1N1 virus and vaccine in order to encourage people, particularly those in at-risk groups, to get vaccinated. However, in promoting the vaccine the federal government promised too much and this likely contributed to the H1N1 vaccine backlash. It was unrealistic to expect that a few companies could produce and test enough vaccines in just a few months time to cover everyone in the at-risk groups, particularly as the number of people at risk is much higher than that for seasonal flu. Additionally, vaccines provided to Europe and Canada are not sanctioned here in the United States due to the inclusion of adjuvants, which improve the potency of the vaccine but have not been reviewed adequately, according to the U.S. Food and Drug Administration. Anecdotes from medical students indicate that many people are in fact eager to get vaccinated (one poll estimated that at the time of the vaccine release, 52 percent of Americans wanted it), but limited supplies and the necessity of first vaccinating at-risk groups have meant that many have been turned away from clinics. This is understandably frustrating.

While the H1N1 situation has provided an opportunity to knock vaccines and their distribution methods, the facts remain: vaccines are a safe and vital tool for protecting our health and well-being.

Saheli Sadanand is a Ph.D. candidate in the Department of Immunobiology at Yale University.

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