Recent News and Articles on the Keywords: flu + vaccine + fda  Related to the article below (Last Update: 8/7/2008)


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Adverse Events Reported Following Live, Cold-Adapted, Intranasal Influenza Vaccine -
HS Izurieta, P Haber, RP Wise, J Iskander, D Pratt … - JAMA, 2005 - Am Med Assoc
... 1-2 In June 2003, the US Food and Drug Administration (FDA) licensed a trivalent
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[PDF] How the delayed distribution of influenza vaccine created shortages in 2000 and 2001 -
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… , Efficacy, and Effectiveness of Live, Attenuated, Cold-Adapted Influenza Vaccine in an Indicated … -
RB Belshe, KL Nichol, SB Black, H Shinefield, J … - Clinical Infectious Diseases, 2004 - UChicago Press
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… immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled … -
I Leroux-Roels, A Borkowski, T Vanwolleghem, M … - The Lancet, 2007 - Elsevier
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FDA clears seasonal flu vaccine

Vaccines that protect against three strains of seasonal influenza considered most likely to strike the Northern Hemisphere this winter have received federal approval.

The Food and Drug Administration said Wednesday that four manufacturers licensed to sell their vaccines in the United States should have 100 million doses available for the 2006-2007 flu season. Barring any changes, that record number would end years of flu shot shortages and production delays.

The seasonal formulation includes one strain used in last year's vaccines and two new strains, the FDA said.

The vaccines do not protect against bird flu, which is caused by different strains of the virus. Scientists are developing vaccines that could protect against avian influenza.

 

Since different seasonal influenza strains crop up each year, experts tinker with the formulation to protect against those strains thought most likely to infect people in the upcoming flu season.

Each year, the flu hits between 5 percent and 20 percent of the U.S. population, according to the Centers for Disease Control and Prevention. More than 200,000 people are hospitalized and approximately 36,000 die. The elderly, children and people with certain chronic medical conditions face the greatest risk of serious complications.

The four vaccine manufacturers approved to sell flu vaccines in the United States are: Chiron Corp., GlaxoSmithKline PLC, MedImmune Inc. and Sanofi Pasteur SA.

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On the Net:

Food and Drug Administration: http://www.fda.gov/

 
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Test may be able to tell if CPR is futile

August 2, 2006 02:01:25 PM PST

If your heart suddenly stopped, how long should rescue workers try to save you? Should you be taken to the hospital even if you can't be revived and are likely to die?

Canadian researchers say they've devised a test that helps rescue workers spot those futile cases and save a frantic trip to the hospital.

Some paramedics with advanced training — those who can give drugs and start IVs — already are allowed to stop giving CPR if their efforts fail and they have consulted a doctor, said lead researcher, Dr. Laurie J. Morrison of the University of Toronto.

But 60 percent of Americans and Canadians, mostly in rural areas, are served by rescue workers who only have basic skills and don't have that option, she said.

"Now they make no decisions whatsoever," Morrison said. "They just start the resuscitation, put them in the back of the ambulance and drive."

Taking such lost causes to the hospital ties up ambulances and emergency departments and the race to get there is hazardous for rescue workers and other motorists, researchers said.

Morrison said her group studied the issue after she was approached by two frustrated paramedics. The researchers reviewed old cases, devised a three-point rule, then tested it in urban and rural areas of Ontario. Their findings are in Thursday's New England Journal of Medicine.

Few people survive a cardiac arrest, which is caused by an abnormal heart rhythm and brought on by a heart attack or heart disease, electrocution, drowning or choking. The victim loses consciousness and stops breathing. More than 300,000 Americans die of cardiac arrest each year.

In the Canadian experiment, only 41 of 1,240 patients, or 3 percent, survived. All were given cardiopulmonary resuscitation at the scene, hooked up to a defibrillator to try to shock their hearts back into normal rhythm and taken to the hospital.

Later, the rescue workers filled out a form, applying the three-criteria test to each case to see if it would have signaled that CPR be stopped. Termination was advised if a pulse couldn't be restored, if the defibrillator determined that an electric shock shouldn't be given, and if the cardiac arrest wasn't witnessed by a rescue worker.

The researchers said the test closely predicted who was likely to die. Overall, 776 patients met the three criteria, and all except four died, a survival rate of 0.5 percent.

If the test were applied, it would reduce by about two-thirds the number of patients taken to the hospital, the researchers said.

When two more criteria were added — paramedic arrival time of more than 8 minutes and the attack wasn't witnessed by a bystander — the test worked even better.

Morrison said surveys suggest that families often accept the decision to stop CPR.

Dr. Gordon Ewy, of the University of Arizona College of Medicine, said the guidelines are needed but shouldn't replace medical judgment and won't necessarily apply in every case.

"They're transporting patients that have practically no chance of survival," said Ewy, who wrote an accompanying editorial. "I think that this publication is extremely important because it gives guidelines for that."

The experiment was done before the American Heart Association revised its CPR guidelines last year, putting more emphasis on chest compression than mouth-to-mouth resuscitation. The researchers say the new CPR will likely help revive more people, but their guidelines would still identify those unlikely to survive.

Michael Perkins, director of the Coshocton County Emergency Medical Services in rural northeast Ohio, said there are certain circumstances where emergency medical technicians should be able to decide to stop CPR. He said his paramedics can make that call, but he said the majority of patients are still taken to the hospital.

"As a paramedic, myself included, if you make that commitment to start, you don't want to stop until you get to the hospital," said Perkins.

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On the Net:

New England Journal: http://nejm.org

 

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