Trust the BAXTER H1N1 vaccine when there is NO INDEPENDENT TESTING? TOTAL MADNESS
Can You Trust the H1N1 Vaccine?
Confused by conflicting opinions about the H1N1 vaccine? You're not alone. We sifted through the hype to address a few of the most common concerns.
By Michelle Vellucci
Medically Reviewed by Kevin O. Hwang, MD, MPH
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Sasha and Malia Obama got one. TV personality Mehmet Oz, MD, did, too — but his wife and children did not. As the H1N1 vaccine makes its way into clinics, doctor’s offices, and schools across the country, it seems that everyone is wrestling with the same question: to vaccinate or not to vaccinate.
Health officials from the U.S. Centers for Disease Control, National Institutes of Health, and other agencies assure us that the vaccine is safe and that it provides the best protection against H1N1. Meanwhile, equally impassioned opponents — from doctors and media pundits to parents — are questioning whether the risks outweigh the benefits. Their argument is twofold: First, with clinical trials still ongoing, they fear the vaccine hasn’t been tested enough to prove its long-term safety and efficacy. And second, unlike polio or tuberculosis, H1N1 doesn’t seem severe enough to warrant vaccination in the first place.
A recent Marist Poll shows that Americans remain divided on the issue. According to the poll, 52 percent say they would get the vaccine if given the opportunity, 42 percent say they wouldn’t, and 6 percent are on the fence. (The poll had 1,026 respondents with a +/- 3 percent margin of error.) Here, we examine some of the most common concerns about the H1N1 vaccine with doctors on both sides of the issue.
Will the H1N1 vaccine give me swine flu?
No. There are two types of H1N1 vaccine available, an injection and a nasal spray. The injected form contains a killed, inactivated virus, and the nasal mist contains a weakened form of the live virus. "The inactivated vaccine absolutely cannot give you swine flu," says Bill Lewis, MD, senior vice president of medical operations for national healthcare company Concentra. "The inhaled vaccine comes with a slight risk of developing flu-like symptoms, but nowhere near the extent of the full-blown swine flu. Occasionally people will have a minor reaction with a low-grade fever." The nasal mist is not recommended for pregnant women, children under 2, or adults over 49. It is also not recommended for individuals with certain chronic medical conditions, allergic reactions to eggs, or a prior episode of Guillain-Barre syndrome related to flu vaccine.
Is the H1N1 vaccine effective?
Scientists study the effectiveness of vaccines based on how well they trigger an antibody response. In a study with Australian adults, 86 percent of those who had no significant antibodies before the vaccine mounted an adequate antibody response within 21 days of receiving a single dose of the vaccine. "It’s not a 100 percent guarantee, but if it can give you an 80 percent chance of avoiding the flu, it’s worth it," says Mary Ellen Renna, MD, a pediatrician in Woodbury, N.Y.
However, another study showed that the single dose is not as effective in children. Only 36 percent of children 3 to 9 years old and 25 percent of those 6 to 35 months old had an adequate antibody response after a single dose. Health officials recommend that children under 10 receive two shots about three weeks apart.
Some doctors, like Erika Schwartz, MD, say other forms of prevention are more effective. "I vaccinated thousands of people for seasonal flu in my career, and I was a big fan of it until I realized that it really wasn’t doing anything and was oftentimes an excuse for people to not take responsibility for taking care of themselves," says Dr. Schwartz, an author, TV commentator, and national medical expert. "What will prevent the flu is how we take care of ourselves and each other."
Is the H1N1 vaccine safe for pregnant women?
Seasonal flu shots, administered to pregnant women for decades, have not been shown to cause harm to mothers or their babies, and health officials say the H1N1 vaccine is no different. The CDC recommends that pregnant women receive the killed, inactivated vaccine rather than the live nasal spray. "This vaccine has been prepared in the same way as the seasonal flu vaccine," says Miles Varn, MD, chief medical officer of PinnacleCare in Baltimore, Maryland. "The same companies are using the same processes in the same labs and same factories."
Dr. Varn adds that the swine flu itself poses a much greater danger. "Pregnant women are the highest risk group in terms of complications related to infection with H1N1 — roughly a 30 percent chance of hospitalization[k1] ," he says. "They are a top priority in terms of vaccination."
Because clinical trials are still ongoing, Schwartz says she would advise against the vaccination. "I wouldn’t recommend that any pregnant woman take a vaccine when I don’t know what it’s going to do to their children and to them," she says.
What are the possible side effects of the H1N1 vaccine?
The known side effects are similar to those associated with seasonal flu shots, including tenderness at the injection site, muscle soreness, headache, mild fever, and fatigue. People with egg allergies may have an adverse reaction to the vaccine, which contains egg antigens. Physicians may recommend that they avoid getting vaccinated.
In 1976, an earlier form of swine flu vaccine resulted in several cases of Guillain-Barre Syndrome, a nervous system disorder that causes muscle weakness and sometimes paralysis. That year, about one out of 100,000 people who received the vaccine developed the illness. The risk of GBS associated with seasonal flu vaccines since that time is about one in 1 million, according to the CDC. Whether the current H1N1 vaccine will be associated with GBS or other side effects remains to be seen. "Because we didn’t have as much time to test it, there may be some adverse reactions we don’t know about," says Dr. Lewis.
All adverse reactions will be monitored and reported by the Vaccine Adverse Event Reporting System, a national vaccine safety surveillance program run by the CDC and Food and Drug Administration.
Is the thimerosal used in some H1N1 vaccines harmful to children?
The vaccine preservative thimerosal is composed of ethyl mercury, which is different from the highly toxic methyl mercury, which we can be exposed to by eating contaminated fish. "The most recent and rigorous scientific research does not support the hypothesis that thimerosal-containing vaccines are harmful," says Varn. "The H1N1 vaccine is available in thimerosal-free formulations for children and for those who, despite the evidence, still have a concern."
Is H1N1 severe enough to warrant a vaccine?
President Obama has declared the H1N1 virus a national emergency, and yet, says Lewis, "the severity of the swine flu is still low — a Category 1 pandemic by the CDC’s standards — although this could change as the swine flu evolves."
Schwartz adds that, because most people are no longer being tested for H1N1, it’s impossible to know just how widespread the virus is. "We know that, as of now, 1,000 people [in the U.S.] have died," she says.
Are the drug companies or health care providers in it for the money?
Varn notes that vaccines in general are not money-makers, as evidenced by the fact that many pharmaceutical companies no longer produce them. "None of the large vaccine production companies derive more than 10 percent of their revenue from vaccine production," he continues. "Moreover, all of the H1N1 vaccine in the United States has been purchased by the federal government and provided free of charge to the states. It is illegal for a provider to charge anything other than the cost of administering the vaccine."
In the end, the decision to get the H1N1 vaccine is a personal one. "I’m not saying don’t take the vaccine — take it if it’s right for you," says Schwartz. "People should make their decision from a position of empowerment and strength, not fear and intimidation.
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