Swine flu vaccine FAQ’s: Is the vaccine safe?

We recently discussed the five most common misconceptions about flu vaccines, and answered questions about who should get the vaccine. Today we answer some common questions about the safety of the vaccine. We’re going to continue to answer your questions, so keep them coming in the comments.0

Q: Isn’t the swine flu vaccine untested and being rushed into use?

A: No. Here at Consumer Reports, we’re often skeptical about new drugs and treatments since they don’t yet have a long track record to establish their safety and effectiveness. But the 2009 H1N1 vaccine isn’t really a new drug, any more than the regular (seasonal) flu vaccine is. That vaccine is made from scratch each year using the strains of influenza virus most likely to circulate in the coming season, and decades of evidence show that it’s quite safe and moderately effective (some years are better than others) at preventing cases of the flu. The H1N1 vaccine is just like the regular vaccine, except it contains the new virus that causes the swine flu. Several clinical trials have shown the vaccine’s effectiveness at preventing H1N1 infection, and they revealed no significant safety problems, according to researchers. Those studies weren’t big enough to rule out rare adverse effects, which usually don’t emerge until a drug or vaccine has hit the market and been used by a large number of people. But there’s no reason to suspect that the swine flu vaccine is any more likely to produce such events than the seasonal flu vaccine. Health officials have put monitoring systems into place that are designed to catch any rare side effects that occur once the vaccine becomes available.

Q: I heard the swine flu vaccine has an untested ingredient called squalene. Is that true?

A: It is not true. None of the H1N1 vaccines approved for use in the U.S. contain that ingredient, which is used in some other countries in what’s called an adjuvant—a substance added to a vaccine to induce a greater immune response. In fact, the Food and Drug Administration has never approved any influenza vaccine that contains adjuvants. It’s true that the government is studying the safety and efficacy of adjuvants, but according to the CDC there are currently no plans to recommend developing an H1N1 vaccine that contains one. That could potentially change at some point—for example, if the virus mutated and an adjuvant helped provide better protection, or a vaccine shortage occurred and an adjuvant allowed limited supplies to stretch further—but it is not the case now.

Q: I’ve heard that the swine flu vaccine can cause Guillain-Barré syndrome. Is that true?

A: It’s very unlikely, though the risk can’t be completely ruled out. A swine flu vaccine developed in 1976 was associated with a heightened, though still rare, risk of developing Guillain-Barré syndrome (GBS), a serious neurological disorder. An additional case of GBS occurred in one out of every 100,000 people who were vaccinated against the 1976 swine flu. In comparison, only one in about every million people vaccinated against the typical seasonal flu develop GBS—and some studies have found no increase in GBS cases after seasonal flu vaccination at all. Researchers aren’t sure why the 1976 swine flu vaccine appeared to pose a greater risk of GBS, but health officials don't expect the same to happen with this year's vaccine. Moreover, the vaccine's protection against illness and complications from the flu, including pneumonia, hospitalization, and death, far outweigh the risks for most people, especially those in the priority groups for vaccination. What’s more, people are four to seven times more likely to develop GBS after having the flu itself than after the vaccine.

Q: Should I have the swine flu (H1N1) vaccine if I’ve had Guillain-Barré syndrome?

A: That depends in part on your risk of getting swine flu and becoming seriously ill if you do. GBS may be more likely to develop in people who have already had this serious neurological disorder. But the flu itself can also cause GBS, as well as complications such as pneumonia. If you’re among the priority groups for vaccination—including pregnant women, health-care workers, and people ages 25 to 64 with underlying health conditions—the shot’s benefits probably outweigh its risks. If you’ve had GBS within six weeks of getting vaccinated, avoid the H1N1 nasal spray, which has a weakened live virus, and discuss with your doctor whether to get the shot.

--Kevin McCarthy, associate editor

Comments

[Sonja]

In Canada, squalene is included in the vaccine for H1N1. For this reason, I will not be getting it, nor will I be allowing my child to receive it, unless they offer the unadjuvanted vaccine which is currently only given to pregnant women.

I personally think that this flu is being hyped up for no apparent reason. What's next, a vaccine for squirrel flu? The common cold?

If we constantly get vaccinated for every bug that comes out, how are our bodies ever going to be able to fight things on its own?

[Linda Piercy]

In 1976 I received the swine flu vaccine, not knowing that I was pregnant. My daughter was born prematurely at 7and 1/2 months gestation and did not survive. At the time of her birth, doctors could see no reason for early delivery, and we accepted this as "God's will". Several years later I had come across an article with possible link to swine flu vaccine regarding premature delivery. I have been unable to relocate information as yet. Any information on this would be appreciated, and helpful, as I now am faced with decision as a caretaker of my new grandchild.

[hal]

The nasal spay is a live virus. If you receive the spray you need to stay away from anyone who has a weakened immune system (for 21 days). That is what the insert reads. The nasal spray (in my opinion) puts many people at risk!!!! I don't care if someone wants to shoot up with poisons but when they could infect innocent people it's wrong.

[maryannekociper]

I recently read some very scary side effects of the swine flu
vaccine. Some people have said it was potentially deadly. Help
to reassure me that it is not or I am not letting my 11 year oldj
get it, even if she has ashthma or me.

[James]

Thanks for this. It puts my mind at ease. I wasn't sure whether to get the shot for myself and my children but this article made that decision a lot easier. I did a lot of research and I also came across this one which helped. Maybe ya'll will find it useful too.
http://www.life123.com/beauty/cosmetic-procedures/botox/are-botox-injections-and-flu-vaccines-dangerous.shtml

[Odette Batik]

Those who are able to be vaccinated should do so not only for themselves- but to protect the most vulnerable among us.

Choosing not to be vaccinated or not to vaccinate our children can be lethal to others.
We who have good immune systems can kill the elderly, infants, and those among us who have underlying illnesses (diabetes, autoimmune disease, bad asthma) - and we ourselves may have nothing but a bad cold. Some poor stranger in the supermarket could be your next victim.

There is something called the common good. The risks of this vaccine are over inflated in this discussion. I am seeing infants and the infirm near death- this flu can kill and it isn't pretty.
So - please - if it seems a risk to take the vaccine - get over it - your minor inconvenience could save several lives - Got my vaccine a week ago - doing FINE.

[john]

It's a toss up whether to get the swine flu shot or not, but I would say that the possibility of getting an adverse reaction is great at this time, since the clinical trials were not large. Soooo, I will not be getting the shot because the jury is still out as to the safety of this so called vaccine. I would first need to know if it is made in the USA or does it come from China like everything else does??? The government scare tactics are massive and try to convince us to "follow the crowd" and get vaccinated, but for now, I take a wait and see attitude.

[TFlora]

My family and I don't typically get the flu vaccinations, but opt rather to just get the bug once a season thereby building our immunities. I don't understand what the big hype is over the H1N1 flu vaccine...what makes this flu any different from the "typical flu"? The symptoms sound the same.

[Charles]

You posted a video on MSN.com and the interview stated that there was no association between thimerisol (mercury) and autism. Perhaps you should tell the National Autism Association that! A study by the University of Calgary, among many others, disputes that statement. http://www.nationalautismassociation.org/thimerosal.php

Google "thimerosal autism" and see what you get!!!

Please get your facts correct. Thank you...

And...mercury is poisonous to your brain and nervous system. What's a "safe" level???

[Annie]

Jennifer,

The CDC website can answer most of the questions you have about the nasal spray vaccine.

http://www.cdc.gov/FLU/about/qa/nasalspray.htm

Live attenuated (weakened) vaccines work by triggering an immune response, but not being strong enough to cause disease in most people. Transmission of virus from those vaccinated with nasal spray to close contacts is rare. General infection control techniques (hand washing, covering coughs and sneezes) should minimize this risk.

[Jennifer Morey]

Recently my child was sent home from school with a pamphlet from the Tuolumne County Health Department, which stated that the Health Department will be doing H1N1 vaccinations at all schools in Tuolumne County. However some children do not qualify to get the nasal spray vaccine, which is the "live virus". My concern is that when the Health Department comes to the school and gives so many children the "live virus" what will happen to the children that where not able to get vaccinated because the "dead virus" will not be available until mid November? From my understanding this virus is spread in the air, so if my child whom did not get vaccinated is sitting next to a child that just got the "live virus" and that child sneezes, how will my child be protected? I called the Tuolumne County Health Department regarding this and I was told that the "live virus" vaccination has been weakened so there should be no threat, but isn't that virus been weakened for the patient receiving the vaccination?

[John Swankly]

One of my biggest concerns is if the vaccine is safe. I hear every year that they use dead cells to make the vaccine so it is safe. This does not make sense to me. I feel like I get sick every time I get a flu shot.