FDA: New Flu Vaccine Approved

The U.S. Food and Drug Administration (FDA) has approved Afluria®, an additional seasonal influenza vaccine for the immunization of people ages 18 and older.

According to the FDA, Afluria® is intended to protect adults from influenza type A and type B flu viruses. Influenza, commonly known as the flu, is a contagious respiratory illness that can cause annual epidemics.

Influenza viruses are transmitted through the air in tiny droplets when someone with the infection coughs, sneezes or talks. Individuals are then exposed to the virus through inhalation, or by contact with objects such as telephones, door handles, railings or computer keyboards. An infection may occur when the virus is then transferred to the eyes, nose or mouth.

Every year in the United States, an average five to 20 percent of the population gets the flu, and more than 200,000 people are hospitalized from flu complications, such as dehydration (loss of water), high fever (over 102 degrees Fahrenheit) and extreme fatigue. About 36,000 people die from flu every year.

Some patients, such as older people, young children and people with certain health conditions that lower immunity, including cancer, human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS), are at high risk for serious flu complications. Children are two to three times more likely than adults to get sick with the flu.

The approval of Afluria®, which is manufactured by CSL Limited of Parkville, Australia, brings the number of seasonal influenza manufacturers licensed for the U.S. market to six, the FDA reports.

The U.S. Centers for Disease Control and Prevention (CDC) estimates that the six manufacturers will supply a record 132 million doses of influenza vaccine for the 2007-2008 influenza season, based on current manufacturing trends.

The FDA suggested that it is best to be immunized as soon as the vaccine is available, usually in September. However, getting a flu shot any time during influenza season is also appropriate because the influenza season often peaks late.

The most commonly reported adverse events associated with Afluria® were tenderness, pain, redness and swelling at the injection site and headache, fatigue and muscle aches.

Afluria® contains inactivated influenza viruses grown in chicken eggs. People who are allergic to eggs or any other component of the vaccine should not receive Afluria®.

The vaccine is administered as a single injection in the upper arm, and is available in both a single-dose, preservative-free, pre-filled syringe and a multi-dose vial with thimerosal, a mercury derivative, as a preservative.

Comments

[Justin A]

Does anyone know if there are side effects for this or any flu vaccine? I have never gotten one before, and I am wary because I'm unsure if it is safe. I understand many people get it every year, but are there any populations that are at risk and should not get the vaccination?

[Ernie]

Hmm, I'm not sure what the potential side effects are, but I do know I had a bad experience the one time I had a flu shot. I was nauseous for a full day after getting the shot, and I don't think I'll get one again...at least not until I'm at high-risk of experiencing complications from the flu.

[Tiffany]

The side effects for Afluria were reported as - tenderness, pain, redness and swelling at injection site; systemic adverse reactions were headache, malaise and muscle aches. As with all flu vaccines there is the potential for some mild side effects, but I do not think any of these side effects should stop anyone from getting the vaccine. Additionally, the flu vaccine does not cause the flu because there is no live influenza virus in the vaccine.

[Alan]

What makes this new flu vaccine any better than the ones that are currently available? Are there less side effects? Is it more effective? Does it protect against more types of the flu virus?

[Liz]

Alan, the influenza virus is constantly changing, and when it appears each season, it is usually resistant to the vaccines used in the years before. Often times, viruses have the ability to mutate in order to immunize themselves against the medications we use to combat them. Scientists try to predict these mutations in order to develop a vaccine each year. Sometimes they are more successful than others. Afluria is just another type of vaccine that can be used in addition to the one regenerated every year.

[Cass]

As far as side effects go, they're usually pretty minimal. As an asthmatic, I need to get the vaccine every year. Typically, the injection site is extremely sore for about a week. The soreness is worth it, however, to avoid the complications associated with the flu.

[Maria]

I think it is a great idea to get the flu shot. I am not really sure of the benefits of the new one, Afluria, or if there are any other added benefits, but why not avoid the flu and all the aches and pains that come with it, if you can?

[Bill Flemming]

I thought most of this discussion was supposed to be about "natural" therapies? I'll pass on the flu shot. I haven't had the flu yet. You can help protect yourself from the flu with immune supplements, such as Kan Jang or other andrographis-based products. However, the Swedish version (Kan Jang) is the only clinically tested one. There are other immune-boosting herbs as well as this one, but I read the National Standard review of Kan Jang and was impressed.

[7-ketodhea]

Will this flu vaccine protect people from the bird flu? I think the bird flu is a type of influenza, right?

[Abelmoschus moschatus]

Is there a chance of a flu vaccine shortage this winter? I remember a few years ago, there were not enough vaccines and some areas had to limit the shots to the elderly, children and healthcare workers. Does anybody know about this?

[Kelly]

Does the Afluria vaccine contain thimerosal?

[Karen]

I didn't realize that getting a flu vaccination was such a serious concern. I've never had one myself, and I've also never seriously entertained the idea of getting it. Is the flu really such a serious threat? I've had the flu in the past and never really considered that it could be life-threatening. Should I be more concerned?

[Achiote]

The end of this article says that the vaccine is available in a multi-dose vial. Do some flu shots take more than one shot to work?

The end of the article also says that there is a mercury derivative in the vaccine as a preservative. Doesn't mercury make people go crazy if it gets into their systems? I also thought mercury was really harmful for kids?

[Tetris]

Now that there is a new flu vaccine, is there any chance of a shortage this year?

[Riley]

Achiote,

The mercury found in vaccines is of a different composition than the mercury typically considered dangerous. The mercury that exists in fish and is dangerous for consumption is methyl mercury, while the mercury used in vaccines - thimerosol - is ethyl mercury. There is still speculation over whether or not this form is safe, but most of the research done in this area has not found any potential health complications at this time. Hope that helps!

[Maddy]

Abelmoschus moschatus,

I might be wrong, but I think the flue shortage a few years ago was due to the development of an ineffective vaccine. As Liz said, scientists have thoroughly researched the influenza virus and attempt to anticipate the mutations that will take place each year. By predicting the strain that will emerge each season, they develop a vaccine in advance so that it can be distributed before the virus begins to spread. I think what happened a few years ago is that scientists did not predict the correct strain and developed a vaccine that was ineffective. They then corrected the formula, but it was too late to develop enough for mass production, and as a result, it was limited to those at high risk. At least that's the way I interpreted the situation. If this is wrong, someone please clarify.

[Cali]

Karen,

The flu can be very dangerous, especially to those at high risk. Anyone with a weak immune system or a weakened respiratory system are at a high risk of developing further complications. As an asthmatic, I skipped my flu shot one season and ended up catching the virus. Through complications associated with the flu, I ended up developing walking pneumonia and accumulated liquid in my lungs. I felt under the weather for a while but assumed I was still recovering. By the time I went to the doctor, she put me in the ER immediately and I stayed there for a week. They had to drain my lungs by literally having my torso hang over the side of a table so that I was upside down, and then they would put pressure (by banging) on my back where my lungs were to force the liquid up and out of my lungs. Obviously I was at a higher risk since I have asthma, but the flu can lead to all sorts of complications, whether or not you are healthy otherwise. It is also important to get the shot simply to spare others from catching it from you.

[Sheila]

I'm not at high risk of experiencing complications from the flu, so I'm not planning on getting flu shot. Does anyone know of any integrative therapies that can help treat or prevent the flu? Also, I've heard that cranberry juice can help prevent infections better than orange juice. Is this true?

[Dorian K.]

Wouldn't you have to drink a lot of cranberry or orange juice to prevent the flu? I just feel like taking the flu shot gives you better chances of avoiding illness this season rather than just drinking juice alone.

[Sasha]

I had no idea the flu could get so complicated. I always felt that you could just "tough it out" and you would be fine, but from Cali's experience it sounds like taking precautions is the best way to go. I have never gotten the flu vaccine before, but I think I definitely will now. Does anyone else know of any measures to take to keep yourself healthy this flu season?

[Mayson]

Should I try to pick which brand of flu shot I get?

[Mandy]

I believe that taking the flu shot is a great idea, especially if you are a college student or come into contact with people at your work. It is also recommended if you are immunocompromised. When I received my shot, the only side effect I had was a little arm soreness at the injection site for about a week - a small price to pay for preventing the flu.

[Joe]

Kelley,

Afluria is thimerosal-free. You can check out their Web site at: http://www.afluria.com.

[Adam]

How do I find a doctor that offers this new vaccine? Is it more expensive than the other ones?

[Ben]

For those people who don't want to get the flu shot, there are several herbs and supplements that might help boost your immune system, including ginseng and zinc. Other integrative therapies, such as astragalus, beta-carotene, cat's claw, and probiotics, may also help enhance the immune system, but the available evidence for these therapies is less convincing.