FactCheck: Swine Flu Vaccine Fears Greatly Exaggerated

Summary
Wild rumors are flying about the newly developed vaccine for pandemic influenza H1N1, also known as "swine flu." We've seen e-mails stating that the vaccine is tainted with antifreeze or Agent Orange, causes Gulf War syndrome, or has killed U.S. Navy sailors. One says the vaccine is an "evil depopulation scheme." The claims are nearly pure bunk, with only trace amounts of fact.

If you are the sort who trusts anonymous e-mails more than you do doctors and experts from the U.S. Centers for Disease Control and the U.S. Food and Drug Administration, you may wish to stop reading now. For others, here are the facts as stated by the best authorities we can find:

Analysis
We're starting to feel nostalgic for the early days of the swine flu pandemic, when the rumors centered around devastated villages and zombies in Cambodia. The crop of falsehoods about the H1N1 vaccine, though, are potentially much more dangerous, since they encourage the credulous to avoid vaccination at all costs. These myths fall into two loose categories: claims that the vaccine is tainted or dangerous, and claims that the government is going to make it mandatory anyway and punish anyone who doesn't get vaccinated.

The e-rumors claim generally that the vaccine is dangerous; one even claims it's a government "depopulation" plot. We'll say it straight out: There are some real risks to the H1N1 vaccine. There's nothing shady or secretive about them, though – they're exactly the same as the risks of the seasonal flu vaccines. They're mentioned on the Department of Health and Human Services Flu.gov Web site, the Centers for Disease Control's Web site and the package inserts for the vaccines. People who have previously contracted Guillain-Barre syndrome within six weeks of a vaccination shouldn't get the vaccine. People who are hypersensitive to egg protein may want to avoid it because it is grown in eggs. Pregnant women should get the injection, which is made from killed virus, but should not get the nasal spray, which contains live but weakened virus. And, as with the regular seasonal flu vaccine, there's some chance of side effects, ranging from redness around the injection site to allergic reactions. The CDC and the Food and Drug Administration are monitoring for other adverse effects.

In fact, everything about the vaccine is just like the seasonal flu shot, which has been administered to hundreds of millions of people. "It's a new virus, but the vaccine is made the exact same way," Dr. Bruce Gellin, director of the National Vaccine Program Office at HHS, told us. The regular seasonal flu vaccine is a mix of the three viruses experts predict will be most likely to cause problems in a given year. But it's only an accident of timing that H1N1 is not included in this year's batches of regular flu vaccine. Had the H1N1 virus shown up several months earlier, Gellin told us, it's "very likely" that it would have been a component of the seasonal vaccine. Instead, there's a separate H1N1 vaccine, but it's otherwise no different. And just like the seasonal flu vaccine, it's been clinically tested and approved by the FDA.

A common theme in the scare stories is that the vaccine contains harmful ingredients. The "tainted vaccine" rumors aren't new to swine flu vaccine – they're old suspicions about vaccinations writ large, pinned to the most recent public health concern. Most of the problems posited with the H1N1 vaccine originated with other vaccines and date back as much as 30 years.

For instance, we've heard from people concerned about the vaccine containing thimerosal, a preservative that contains mercury and that has long been the subject of suspicion without a lot of scientific support. FDA regulations prevent adding thimerosal to primarily pediatric vaccines. The H1N1 vaccine is not specifically formulated for children, and the multidose version – but not the single-dose version – does contain thimerosal. However, the CDC stresses that even flu vaccines with thimerosal should pose no danger to children.

The thimerosal anxiety stems from the fact that it contains ethyl mercury, which is related to the type of mercury (methyl mercury) that can be harmful in food. Thimerosal was removed from pediatric vaccines mainly as a precautionary measure – a 1999 FDA review found that most children's mercury exposure from thimerosal-containing vaccines would be well within the guidelines for methyl mercury, and ethyl mercury may be less likely to affect the brain, especially in the dosage one would get from a vaccine. But the move to phase out thimerosal piqued concern from some parents and activists, who posited a link between mercury in vaccines and developmental disorders like autism.

A 2001 report by the Institute of Medicine found that the idea that thimerosal exposure could lead to developmental disorders was "biologically plausible" but "is not established and rests on incomplete and indirect information." A 2004 report went a step further and recommended rejecting the hypothesis that thimerosal caused autism. The biological mechanism that would account for the causal connection is theoretically possible, IOM said – but only theoretically. Numerous other studies also find no link between thimerosal and developmental disorders. Ironically, thimerosal is added to vaccines to keep them from being tainted. Multidose vaccines require repeated needle insertions, which can push bacteria into the vial. Thimerosal prevents bacterial contamination of vaccines, which can cause illness and toxic shock.

As for formaldehyde and antifreeze, we'll deal with those claims further down.

Some of the messages make a false claim that the vaccine contains an ingredient linked to Gulf War syndrome and, in the words of one e-mail, "is one of the most dangerous vaccines ever devised." But unlike thimerosal, squalene is not an ingredient of the vaccine. The claim is simply wrong.

Squalene is an organic compound produced naturally by humans (and some of the things we eat). It's commonly found in cosmetics, but emulsions of squalene can be used in vaccines as an adjuvant – a substance that makes a vaccine work better. Chain e-mails claim that this flu vaccine contains squalene as an adjuvant, that the adjuvant has never been tested, and that squalene will cause severe autoimmune disorders. In fact, flu shots in Europe have used squalene emulsions as an adjuvant since 1997 – according to the World Health Organization, 22 million doses have been administered without ill effects. But no vaccines with a squalene adjuvant have been approved in the U.S. So far, the only approved vaccines that contain adjuvants use aluminum salts.

The idea that vaccines containing squalene were responsible for autoimmune symptoms came from a 2000 article on Gulf War syndrome published in the journal Experimental and Molecular Pathology. The researchers found that of 38 veterans with Gulf War syndrome, 95 percent had squalene antibodies ("anti-squalene") in their blood, and blamed the anthrax vaccines that soldiers received before being deployed. Of 12 veterans without Gulf War syndrome, the researchers said, none had anti-squalene. A letter to the editor in the journal's next issue criticized this study for failing to give enough evidence that the test could detect squalene antibodies in the first place. The critics wrote: "[T]he conclusions… purporting to relate anti-squalene with Gulf War illnesses, in our opinion, rely on circular logic. Positive results with an assay not validated to detect antibodies cannot be used as scientific proof that antibodies to the antigen exist in samples of unknowns."

Since then, the U.S. military has revealed that the vaccines these soldiers received didn't even contain squalene – they used alum, the only adjuvant approved for use in the United States. According to the Institute of Medicine, the Department of Defense requested a study on the squalene content of their vaccines and found that most had no squalene and some had negligible amounts: "The study report, dated August 14, 2001, found that 1 lot of over 30 lots tested contained measurable levels of squalene. Three samples from that lot contained squalene at 7, 9, and approximately 1 parts per billion, respectively. Use of vaccine from that lot has not been associated with elevated rates of adverse events." A later study, published in 2004 in the Journal of Immunological Methods, found that all study participants – veterans who'd gotten the anthrax vaccine and regular joes – had squalene antibodies, and that there wasn't much variation between the groups. They did find evidence that women had higher amounts of anti-squalene, and that the antibodies increased with age.

In any event, the H1N1 vaccine being administered in the U.S. could not contain a squalene emulsion, because there are no approved U.S. vaccines with a squalene adjuvant. And as it turns out, this vaccine, like the seasonal flu vaccine, has no adjuvant at all. The FDA has released the ingredients of the approved vaccines, and none contain squalene.

Another claim is that the vaccine causes Guillain-Barre syndrome, a paralytic illness. It's true that in 1976, adults in New Jersey who received a different swine flu vaccine were found to have an elevated risk of GBS – about 10 extra cases per million people vaccinated. "Thousands of Americans" did not die or become paralyzed due to the vaccine, as one e-mail asserts. According to one study, 532 people developed Guillain-Barre syndrome after having recently been vaccinated. Subsequent monitoring found either a much smaller increased risk or none. The CDC concluded: "Available evidence indicates that any risk of GBS from influenza vaccine appears to be far lower than the risks associated with influenza among persons for whom the vaccine is indicated." The CDC does recommend that people who have already contracted GBS not get the H1N1 vaccine.

One anonymous e-mail claims that the crew of a Navy vessel got H1N1 from the vaccine, and that two crew members died. This, one e-mail author claims, is proof that "their EVIL DEPOPULATION plan is in full swing!" It's true that in May the Navy canceled the deployment of the U.S.S. Dubuque because of a swine flu outbreak combined with what a Navy spokesman called "an abundance of caution." There were no deaths or hospitalizations among the Dubuque crew, who had not been vaccinated, since the vaccine was not yet developed. It's not possible to get H1N1 from the injected vaccine, which does not contain live viruses. The nasal spray contains live but weakened viruses, and also should not be able to cause the flu, though the CDC reports that there is a minor chance of catching the flu from someone who's had the vaccine.

One of the wackiest variations on this claim we've heard is that the vaccine contains the same chemicals as Agent Orange. Agent Orange, which was used to defoliate trees during the Vietnam War, is made of a mixture of herbicides. Some of the vaccine ingredients might sound alarming – for instance, one of the FDA-approved vaccines, made by Sanofi Pasteur, may contain residual amounts of formaldehyde, though not more than 100 micrograms in a dose. But none are herbicides. Most are either salts – the injected vaccine is essentially killed virus in a saline solution – or antibiotics to prevent contamination. The Sanofi Pasteur vaccine and another approved vaccine made by Medimmune also contain gelatin and sucrose, and the Medimmune vaccine has small amounts of arginine, an amino acid. As for antifreeze, the Sanofi Pasteur vaccine has a tiny amount of polyethylene glycol. Ethylene glycol is an antifreeze, but polyethylene glycol has many clinical uses – some research indicates it may even help prevent cancer.

In addition to misinformation about what the vaccine contains, we've seen rumors that it is being forced on the population despite H1N1 being a made-up pandemic. The latter claim relies on a semantic misunderstanding we've addressed before – a "pandemic" flu doesn't need to be unusually deadly, just unusually widespread. As it happens, the World Health Organization lists the severity of H1N1 as "moderate," meaning that most people recover without hospitalization and most health care systems are equipped to handle the number of cases. But calling it a pandemic is not scare-mongering. It's an accurate reflection of the disease's international spread.

The CDC estimates that seasonal flu is normally associated with about 36,000 deaths per year in the United States, although flu isn't the primary cause of death in all cases. H1N1 caused about 593 deaths before the CDC stopped differentiating H1N1-related deaths from regular seasonal flu deaths on Aug. 30, 2009, and there have been 2,029 total flu-related deaths (from all strains) since then. The CDC has recorded a total of 83 H1N1-related deaths in children. The CDC's recommendations for the seasonal flu vaccine are similar to its recommendations for who should get the H1N1 vaccine.

And they are just that – recommendations. There's no national or state requirement that everyone get vaccinated, though New York state and some hospitals do require flu vaccination for health care workers. The vaccine does not contain an RFID chip that will track your compliance, nor will tracking bracelets be issued. One computing company, who happens to manufacture RFID technology, did suggest that hospitals – not the government – might issue RFID bracelets to patients and visitors, which could be used to track people's contact with infected patients and thus help stem the spread of the disease.

Some of the e-mails mention a Massachusetts bill that the anonymous authors claim would force vaccinations and force people into quarantine camps. There is a real pandemic preparedness bill, which passed the state Senate as bill number 2028 (a new draft of bill 18), and the House as bill number 4275 (there's no conference agreement yet), but it's being mischaracterized. For starters, the Senate bill is explicit that vaccination will not be required:

Massachusetts Senate Bill 2028: An individual who is unable or unwilling to submit to vaccination or treatment shall not be required to submit to such procedures but may be isolated or quarantined pursuant to section 96 of chapter 111 if his or her refusal poses a serious danger to public health or results in uncertainty whether he or she has been exposed to or is infected with a disease or condition that poses a serious danger to public health, as determined by the commissioner, or a local public health authority operating within its jurisdiction.

In other words, the bills allow for isolation (of sick people) or quarantine (of healthy people who have been exposed to illness) in part so that vaccinations can remain voluntary without endangering public health. Both bills require that isolation and quarantine measures use "the least restrictive means necessary to prevent a serious danger to public health," which may include confining people to their homes or preventing them from going to work. And the House bill allows people to appeal a quarantine or isolation order.

Far from establishing "camps" for flu sufferers, the Massachusetts legislation actually repeals sections of Massachusetts law that established dedicated facilities to isolate disease sufferers and explicitly permitted them to be confined there non-voluntarily. In the House bill, the discussion of quarantine and isolation replaces Massachusetts general law chapter 111, section 96, which allows a magistrate to "issue a warrant directed to the sheriff of the county or his deputy, or to any constable or police officer, requiring him, under the direction of the board of health, to remove any person infected with a disease dangerous to the public health or who is a carrier of the causative agent thereof, or to take control of convenient houses and lodgings." (That's "remove" to a hospital, not "remove" in the organized crime sense.) The quarantine and isolation language in the House bill replaces section 95, which also allows for establishment of and removal to disease hospitals, and section 96 is repealed. (In the Senate bill, section 95 is replaced by language that would allow the state commissioner to require that properties be decontaminated.) Both bills also repeal sections 92 and 93, which deal with the establishment and regulation of isolation hospitals.

Jared Caine, director of communications for the senator who spearheaded the bill, explained in an e-mail: "S. 2028 modernizes the statutes dealing with isolation and quarantine, which date from 1701." The old statutes didn't contain due process regulations, and the new ones do. The same is true of allowing law enforcement to take necessary action to maintain public health, including arresting people who refuse to comply with orders – they are already empowered to do so, but the new legislation would make sure citizens were protected by due process.

What the bills do is allow the governor to declare an emergency (not, as some have said, "martial law") in the case of a pandemic. During an emergency, the commissioner or a local public health authority would have some new powers. For instance, they would be able to close or require the decontamination of public facilities; control movement of people in stricken public areas; get, store and distribute vaccines, antibiotics or medical supplies; and waive state licensing requirements for qualified health care professionals. None of this would apply unless a public health emergency was declared.

And none of it is unexpected for an emergency plan. The Department of Homeland Security provides a list of best practices for a pandemic preparedness plan, which includes having law enforcement "encourage voluntary compliance from public for quarantine/isolation orders issued by public health officials" and "implement isolation perimeters in areas with high infection rate." The National Governors Association best practices list also mentions quarantine and other social isolation tactics (like closing public facilities) as a possible means of containing the spread of disease, though the NGA warns about the potential psychological effects of quarantine and adds that it loses effectiveness over the course of an outbreak. So adding quarantine provisions into a piece of emergency public health legislation is by no means unusual; on the contrary, it's widely recommended.

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