Chiron Corp. of Oxford, United Kingdom, was to supply the United States with 46 million to 48 million does of its influenza vaccine, Fluvirin, but British authorities blocked the release of the doses due to concerns that some batches had developed bacterial contamination.
The U.S. Department of Health Human Services said Tuesday it was sending a team to England to discuss possible solutions with Chiron and British health authorities, with the aim of determining whether the issue could be resolved, but it appears the potential for contamination may make all of the vaccine doses too risky, said Dr. William Schaffner, a professor at Vanderbilt University School of Medicine in Nashville, Tenn.
Those doses are now "off the table," Schaffner said. He also serves as a liaison representative to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, which held an emergency meeting Tuesday. "Not a single dose of Chiron vaccine will be used in the United States this year," he told UPI.
Dr. Gregory Poland, director of the Vaccine Research Group at Mayo Clinic College of Medicine in Rochester, Minn., and a member of ACIP, echoed those sentiments.
"The best guess at this point is that we will not have vaccine from (Chiron) this year," Poland told UPI. "You could not take the risk of injecting something into somebody that has bacteria in it," he said.
Chiron did not return a call from UPI.
HHS referred calls about the Chiron vaccine issue to the U.S. Food and Drug Administration. FDA spokeswoman Lenore Gelb told UPI there was no new information about the vaccine and new developments would be released when they were known.
HHS had planned to have a supply of 100 million flu vaccine doses this year in an effort to avert the problems last year, when a particularly virulent strain of the flu resulted in an increased public demand for vaccinations and ultimately a shortage. The current available supply is now down to about half of the anticipated amount, with 54 million doses coming from Aventis Pasteur and another 1 million to 2 million doses coming in the form of the FluMist nasal spray vaccine, which is manufactured by Medimmune of Gaithersburg, Md.
The public health implications of the vaccine shortage are difficult to predict, but some officials are concerned about the possibility of an increase in flu infections and deaths among the high-risk groups -- particularly the elderly.
"We're worried about that," Schaffner said. "We're hoping for a mild flu year," he added.
"I expect we'll see a lot of flu," said Dr. Samuel Katz, a professor at Duke University Medical Center in Durham, N.C., and a liaison representative to the ACIP. "If this is a significant influenza outbreak this year, we'll have a lot more people who will be susceptible," because they will not have been vaccinated, Katz told UPI.
So far, there have been only a few flu cases in both the United States and Canada, but that is not entirely unexpected, because it is still early in the flu season, Schaffner said.
"No one can predict what's going to happen at this point," Dr. Georges Benjamin, executive director of the American Public Health Association in Washington, D.C., told UPI. It depends on a lot of unpredictable factors, such as the severity of the strain of flu virus, its infectiousness and the number of people who get vaccinated, Benjamin said.
One problem is some clinics and hospitals were depending entirely on Chiron for their vaccine supply, so now they will not have any doses to distribute and it is unlikely they will able to obtain any, Schaffner said.
Patrick Libbey, executive director of the National Association of County and City Health Officials in Washington, agreed, saying the absence of the Chiron doses will create shortages within communities and even among states and regions. Shortage or distribution issues are not unusual -- they have occurred in five of the past six years -- but this year's problem is different, because it will not be uniform across the system, he said.
The result could be isolated pockets -- even within major cities -- without vaccine.
"I think there will be substantial shortfalls and difficulties all across the country," Schaffner said. He added that Vanderbilt Hospital officials, which ordered their vaccine supply from Chiron, held an emergency meeting Wednesday morning to assess what could be done. It is unlikely, however, they will be able to procure any vaccine, he said, meaning people who reside around the hospital -- including Schaffner himself -- may not be vaccinated.
"Things look bleak right now," he said.
In order to ensure those at highest-risk for flu complications receive the vaccine, there will have to be voluntary cooperation from the public health community, the medical community and other places that offer mass vaccinations. They will have to limit inoculation to those most at risk, Libbey said. These include adults over age 65 and infants ages 6 to 23 months.
Others considered priority subjects for vaccination are those with underlying chronic medical conditions, women who will be pregnant during the flu season, nursing home residents and health care workers. Healthy people are being urged to forgo receiving the vaccine voluntarily.
One hopeful note, Katz said, is some people already may have developed natural immunity -- if they were exposed last year and the same strain hits the United States this year.
Other options for the elderly include getting the pneumococcal vaccine, which helps protect against some types of pneumonia, one of the most serious consequences of influenza, Schaffner said.
Another option is anti-viral drugs -- such as Relenza, Tamiflu, Symmetrel and Flumadine -- that can both prevent the flu and reduce the duration of illness. These drugs are only available in limited quantities, however, and neither physicians nor patients have much experience with them, so it is unlikely they will play a major role, Schaffner said.
Those not in the high-risk groups can take precautions as well. Libbey said basic sanitation practices, such as washing hands, covering sneezes and avoiding going to work or school when ill, can help reduce the spread of the disease.
The flu vaccine shortage comes at a time when health officials are worried about the possibility of a strain of bird flu in Asia -- which already has killed 31 people in Thailand and Vietnam -- making its way to the United States.
The Chiron flu vaccine would not protect against the bird flu strain, but if the latter were to hit the United States at the same time as the peak of the normal flu season, it could be "a major public health issue," Benjamin said.
"We'd have to mobilize all our public health resources to deal with that" and it could even include mobilizing the emergency flu pandemic plan on the state and national level, he said. That plan, which still is in development, has protocols for producing a vaccine and inoculating large numbers of people rapidly to prevent disasters, such as the 1918 flu pandemic, which killed more than 50 million people worldwide. HHS announced last month it has awarded a contract to Aventis to manufacture 2 million doses of bird flu vaccine.
The current shortage highlights the fragility of the vaccine-manufacturing system in the United States. This needs to be corrected and incentives need to be enacted to induce more manufacturers to produce vaccine, Schaffner said.
Shortages in recent years include not only the flu vaccine, but also some childhood vaccines, such as measles, tetanus/diphtheria and meningococcal vaccines, because often there is only one manufacturer of a given medication, Katz noted.
Poland said it was important to tackle flu vaccine-manufacturing difficulties, because the viral illness is a dangerous disease that kills approximately 36,000 people in the United States each year.
"Imagine if somebody told you that as many people who died in the Sept. 11, 2001, World Trade Center disaster would die every month over the next year. What would you do to prevent this?" he asked. "That's how important it is."
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