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US Considers Importing
European Flu Vaccines

From Patricia Doyle, PhD
dr_p_doyle@hotmail.com
12-10-3

Hi Jeff -
 
I am very concerned about this. I think it would be a BIG BIG MISTAKE to "rush" vaccines through the process. Given the new legislation, manufacturers who produce inferior vaccine that do harm, might not be held liable for their products. Manufacturers might give more detail to quantity then quality.
 
Patricia
 
US Considers Importing Influenza Vaccine
By Lawrence K. Altman
NY Times
12-10-3
 
The Federal Centers for Disease Control and Prevention said yesterday that they were exploring ways to import influenza vaccine from Europe and redistribute supplies to meet any shortages in this country.
 
"We have a gap between what we wish we had and what we have," Dr. Julie L. Gerberding, director of the centers in Atlanta, said.
 
Dr. Gerberding added that health officials were "just doing the best we can to try to get vaccine to the people who need it the most."
 
A shortage seems to exist in some regions while supplies appear adequate in others, she said in a telephone news conference. She did not specify the areas.
 
Still, the director acknowledged that there was no way that the 185 million Americans deemed eligible to receive flu shots would receive them. Drug companies made 83 million doses for this season, a number based on demand in past years.
 
Dr. Gerberding added that government rationing of the remaining stocks was not an option, because most vaccine is in the hands of practicing physicians, who dispense it according to patient need and demand.
 
Last week, the two leading American makers of flu vaccine said they had shipped all their supplies and could not make any more for this season because of the complexity and time needed to produce it.
 
A spokesman for Dr. Gerberding, Tom Skinner, said that later this week the C.D.C. expected to receive information from surveys to gain a more complete picture of stocks.
 
Flu vaccines in this country are made entirely by private companies, and in the past producers have had to discard tens of millions of doses when most of the people eligible to receive it did not heed advice from doctors and health officials to be immunized.
 
"For the last five years, we have thrown a lot of flu vaccine away," Dr. Gerberding said. Last year, she said, the two companies that manufacture vaccine for this country, Aventis Pasteur and Chiron, made 95 million doses but discarded 12 million because of low demand. So they reduced production to 83 million for this season.
 
Even if the government can import vaccine from Europe, the amount is likely to be relatively small. Dr. Gerberding said the government was exploring the possibility of securing a half-million doses of vaccine from the British unit of Chiron. That vaccine is licensed but not approved for use in the United States, Dr. Gerberding said, and her agency is working with the Food and Drug Administration to determine whether it can be used in time.
 
"The trick here," she said, "is what we can do as a federal agency to assure the manufacturers will make more doses than we need on average."
 
Dr. Gerberding said the health and human services secretary, Tommy G. Thompson, had asked for recommendations to work on the problem. One option is for the government to pay manufacturers to increase production in the future.
 
Dr. Gerberding was cautious in assessing the state of flu activity.
 
"It has not reached what we call the epidemic threshold yet in terms of deaths from influenzalike illness," she said. "But we wouldn't be surprised to see that happen, given the pattern that's emerging right now."
 
The flu season began early and has not peaked, she said, adding, "We will expect more cases." In Denver, Dr. Tom Langston, a pediatric emergency medicine fellow at Children's Hospital, said the number of patients with influenza or parents concerned that their children might have it had remained steady after an abrupt start.
 
"Basically, four weeks ago, kind of overnight, our numbers went up," Dr. Langston said in a telephone interview yesterday.
 
Doctors in the hospital's emergency room are treating 70 to 100 additional patients each day compared with usual, Dr. Langston said.
 
"It's the flu," he said, "and we see it every winter. Why it's worse this year, I don't know. Why did Colorado have more West Nile cases this summer? I don't know."
 
Last week, the Centers for Disease Control reported that influenza was widespread in 13 states, mostly in the West: Alaska, Arkansas, Colorado, Idaho, Nebraska, Nevada, New Mexico, Pennsylvania, Tennessee, Texas, Utah, Washington and Wyoming.
 
Only the District of Columbia and Massachusetts have not reported significant activity as of their last report, but activity may have increased since then, Dr. Gerberding said.
 
Health officials here and in Europe had earlier reported that a new Fujian strain of flu virus was causing a vast majority of cases of the respiratory illness. Also, Dr. Gerberding has said early laboratory tests show that the current vaccine offers some protection against Fujian flu.
 
But protection in humans is another issue, and that has to be measured by determining what percentage of individuals vaccinated come down with influenza. Even the best vaccine is not 100 percent effective. Infectious disease experts and health officials debate the degree of protection that the vaccine will afford. Many say it will be adequate; others contend that it will be weak.
 
Dr. Gerberding said it would take several weeks before officials learned from studies how well this season's vaccine was protecting against the Fujian strain.
 
Meanwhile, she prescribed "common sense" measures to protect against the spread of flu, advising parents to keep children with fever, sneezing, coughing and aching out of school and adults with similar signs and symptoms to stay home from work.
 
Copyright 2003 The New York Times Company
 
Patricia A. Doyle, PhD
Please visit my "Emerging Diseases" message board at:
http://www.clickitnews.com/ubbthreads/postlist.php?Cat=&Board=emergi ngdiseases
Zhan le Devlesa tai sastimasa
Go with God and in Good Health
 

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