1/06/09 The U. S. Food and Drug Administration (FDA) has approved a new high-dose vaccine designed to better protect seniors from seasonal influenza.
People older than age 65 are at highest risk of seasonal influenza, but they typically have the worst response of any age group to the flu vaccine because immune function declines with age, which often prevents vaccines from offering seniors adequate protection.
The newly approved vaccine, called Fluzone High-Dose, contains four times the antigen dose given in a standard flu vaccine. Antigens are the active ingredients in vaccines that prime the immune system to respond when the real threat comes along.
“Elderly persons are at increased risk for complications of influenza. This is the first influenza vaccine that uses a higher antigen dose,” says FDA Spokeswoman Shelly Burgess.
Previous research from the Center for Vaccine Development at the University of Maryland in Baltimore, had demonstrated that elderly study participants needed this four-fold stronger dose in order to stimulate the same immune response as adults less than age 40.
Fluzone High-Dose is a single injection in the upper arm and will be available for the 2010-2011 flu season. It does not contain any new ingredients compared to the standard vaccine, and because it is inactivated, it is considered safe for people with immune systems that have been weakened by illnesses or medication.
In clinical trials, a total of 3,876 individuals 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone at multiple centers, and the FDA says the results were promising.
“The data demonstrated that vaccination with Fluzone High-Dose resulted in higher immune responses in older individuals,” Burgess says.
In the study, roughly twice the number of the participants on Fluzone High-Dose as those taking the standard vaccine, 48.6 percent compared to 23.1 percent, had detectable antibodies to an influenza A strain.
The FDA says because of the higher dose, there was an increase in side effects, but they were not serious.
Common complaints during clinical studies included pain, redness and swelling at the injection site, headache, muscle aches, fever and malaise. People with hypersensitivity to egg proteins or people who have had life threatening reactions to previous influenza vaccines, should not be vaccinated with Fluzone High-Dose.
Martin Gorbien, MD, director of geriatric medicine and palliative care at Rush University Medical Center in Chicago says he takes influenza in the elderly very seriously and applauds the idea of a new flu vaccine better tailored to seniors.
“There are a number of changes which happen to the immune system with age. They happen to everyone and with that in mind, the idea of having a vaccine that is designed to give a heightened response is a very appealing idea,” Dr. Gorbien says.
But because the study involved here only included 3,800 participants, he’s not sure that’s enough information for him to suggest the vaccine yet to his patients.
“It’s unclear to me if I would be recommending the vaccine without a bit more information,” Dr. Gorbien says. “I think I would want to see more trials.” But, he adds, “I think there is a very good chance this will turn out to be safe. There’s no doubt that if it adds to the effectiveness of the existing flu shot I think we’re on to something very exciting. “
As part of the vaccine’s accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination. The FDA says a large clinical study intended to provide this information is currently underway.
<a href="http://www.simplehealthguide.com/flu-shot-side-effects-jab-reactions" >flu shot symptoms 2011</a>
My mother is 90 years old and has been taking the flu shot all of her adult life and never had any adverse reaction. However, this year my mother received the high dose shot (without her knowledege that is was the 'high dose' new shot) and for the first time became very ill from the flu shot.
It is 10 days now since she had the shot and the immediate reaction within hours of receiving the shot.
Her adverse reactions continue to be weakness, sore muscles, diarrhea, a fever, anxiety, and trouble walking. She lives in a retirement community where many other people are having this severe reaction, as well, for the first time, from the flu shot and don't know why they are suffering so much this flu shot season.
Also, the nurses administering the shot did not tell her is was a new 4x stronger antigen shot. In fact, I've never heard about the new "High-Dose" now I discovered it on: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm1128 54.htm shot and I am reading the news every day.
This news needs to be reported to the US public in newspapers, on TV and Radio and in magazines. The lack of knowledge of this new flu shot for people over 65, without their consent, is not right. We should know what we are receiving as a flu shot and be able to understand the new formulas and reactions and be given a choice
This news needs to be reported to the US public in newspapers, on TV and Radio and in magazines.
The lack of knowledge of this new flu shot for people over 65, without their consent, is not right. We should know what we are receiving as a flu shot and be able to understand the new formulas and reactions and be given a choice whether or not to take it or to take the regular flu shot.
Please take on the job of reporting of adverse reactions on this flu shot item for those over 65 and who are administered this "Fluxon High-Dose" without their knowledge or consent.
I am 67 years of age. I am in excellent health. I take no medications and weigh 140 lbs. I am allergic to shellfish, peanuts, saffron and unknown fresh produce preservatives. I am not allergic to egg product.
I have received the standard flu vaccine, administered at work, for the previous 12 years. The only reaction I had to the standard flu vaccine was localized muscle ache and low fever.
This year I received Fluzone High-Dose 2011-12. In less than 2 hours I was violently ill with the first two stages of allergic reaction: rash, vomiting, etc. I was too sick to seek medical care and know that I was dehydrated from the experience. I do know how to rehydrate and did so on my own. I reported the allergic reaction through a pharmaceutical hot line.
Because of my other allergies, I am careful with food. My reaction was not due to any food intake. The allergic reaction did not last long enough to have been caused by a virus passed on by a chance encounter where I received the vaccine.
I do know that each subsequent encounter with an allergen has the potential to increase the severity of the reaction.
I will never have another flu vaccine, normal dose nor high dose.
He did not tell me that this vaccine is 4x stronger than the previous one.
I have very bad muscle aches, nausea, (sore arm of course); feel very strongly that this is not a one-size-fits-all shot.
I weigh only 120 lbs. (for someone weighing 150 , lbs +it may be ok)- will not take this high-dose again; less than 24 hrs when I got it and it has ruined my day so far-feel nausea and am miserable. No MORE!! Just the standard will do.
I am 68 and every year I have received the seasonal flu shot with no side effects.
This year it was recommended at the flu
clinic that I should take the 'high dose'
shot. I did so on 9/16/2010 at 4:00 in the
afternoon. Felt fine. Then at 7:30 in the
evening I experienced ALL of the symtoms
listed. I called my BS/BS on call nurse who
told me to call 911. After 8 hours in the
ER, I was then admitted into the hospital.
I had to stay there until the afternoon of
9/18, before I was stable enough to go home.
Between the ER and the hospital, I had 2
EKG's, xrays, a lot of blood tests, 7
bags of IV fluid, blood thinner shot, etc.
I have NO medical problems and this is what I
experienced. I think more studies should be
done before this 'high dose' flu shot is
given to any one. They do not tell you that
it is 4 TIMES the regular dose.
Correction (my apologies): There were not 3833 people in the clinical trial but 3876 to begin with, age 65 or older. In the final analysis there were 3851 total in the randomized double-blind, etc., study. Of those, 2576 had Fluzone High Dose and 16 died. 1275 had Fluzone regular and 7 died. As I stated in my first post, it is reported that the majority of the deaths occurred in people with serious health problems. 14, Clinical Trials, http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProduc ts/UCM195479.pdf (product information as of July 2010)
I emailed Sanofi Pasteur and asked what the additional concentration factor was. I received an email back, saying that was proprietary information. They would not tell me.
I think we are entitled to know every single ingredient in a vaccine that would be injected into our bodies and the law should protect that right.
The FDA allowed expedited approval on Fluzone before all the clinical trials were done. "This is the first influenza vaccine that uses a higher antigen dose,” says FDA Spokeswoman Shelly Burgess.
There were more side effects from the Fluzone High Dose than with regular Fluzone.
What is that "additional concentration factor?" Why will Sanofi Pasteur not tell?
The high dose Fluzone is being targeted at the elderly over age 65, some of the most frail and specially protectable among us.
The majority of the deaths in the clinical trials (23 out of 3833; 16 Hi-Dose, 7 regular Flu-zone) occurred in those with a medical history of cardiac, hepatic, neoplastic, renal and/or respiratory disease. Id., 6.1, Clinical Trial Experience, http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProduc ts/UCM195479.pdf
Please at least discuss your specific health risks with your doctor before having the shot.
"There have been no controlled clinical studies demonstrating an decrease in influenza after vaccination with Flu-Zone High Dose." Id., 1, Indications and use, http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProduc ts/UCM195479.pdf
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