Another Flu Vaccine Shortage?
Here We Go Again

From Patricia Doyle, PhD
I was surprised to learn that half of the US flu vaccine is manufactured in the UK. George W. Bush does not want senior citizens to purchase Canadian pharmaceuticals not manufactured in the US, yet, the US government uses flu vaccine not manufactured in the US. Sure is a double standard.
Most senior citizens would rather purchase medications at their local pharmacy however without medicare prescription coverage many cannot afford their medications when purchased in the US.
Of course, the newsmedia did point out that flunase is not part of the shortage.
This is the second year we have heard about a flu vaccine shortage, and I, for one, am very skeptical.
Patricia Doyle
Influenza Vaccine License Withdrawn By UK Authorities
By Emma Ross and Marilynn Marchione
Associated Press
Global and United States health officials warned on Tue 5 Oct 2004 of major influenza vaccine shortages after British health officials abruptly pulled the license of the maker of half the US vaccine just as the influenza season was about to begin. The news means the US will face "a significant shortage," said Dr Anthony Fauci, the National Institutes of Health's infectious disease chief. Other countries will likely face similar problems. "The implications may be significant," said Dr Klaus Stohr, of the World Health Organization.
The British authorities suspended the license of Chiron Corp. for 3 months because of problems at its vaccine manufacturing plant in Liverpool, England. The action means the company can't supply any influenza vaccines to any market during that time, and Chiron said it would provide no vaccine this year.
British officials didn't explain details for the license suspension. Chiron officials said the British action came because of broad concerns about standards at the Liverpool factory, not just worries about the safety of already-produced vaccine. The company has no obligation to recall or withdraw any vaccine, but none has been released anywhere, and none will be this season, Chiron officials said.
US health officials were caught off-guard, learning of the developments only during a mid-morning phone call. "We need to regroup," Fauci said shortly afterward. Chiron had planned to ship 46 to 48 million doses, but that already had been delayed by a contamination problem discovered in August 2004 in the English factory where the vaccine is made. At the time, the company said only 4 million doses were tainted but that the entire supply would be held up and retested. About 1 million doses already had arrived in the United States, but it remains under Chiron's control and has not been released for use.
Influenza vaccination campaigns usually start in October, a month before the flu season typically begins in the US. In an average year, influenza kills 36 000 Americans and hospitalizes another 114 000, mostly the elderly. Less than 2 weeks ago, top US health officials assured the public that close FDA monitoring of the rest of Chiron's supply suggested it was fine and that there would be plenty of supplies.
Dr Walt Orenstein, formerly the top influenza expert at the US Centers for Disease Control and Prevention and now the associate director of the Emory Vaccine Center, said the government may have to ration available vaccine. "It's a very serious concern. We're already in October, which is vaccine season. If we have to ration at this stage, it becomes more complicated."
If problems prevent the Chiron vaccine from being used at all this year, it's unlikely that other manufacturers could fill the gap. Aventis Pasteur, which expects to supply 52 million doses, said earlier that federal officials had asked it to make additional vaccine but that it already was at capacity and couldn't produce more until after November when existing orders are filled. A third manufacturer, MedImmune, which makes FluMist, a new nasal spray influenza vaccine for use in healthy 5 to 49 year olds, said it couldn't produce more than the 1.5 million doses it had planned to make for this year's flu season. That vaccine is made from modified live virus and isn't considered safe for the elderly or people with medical problems.
Worldwide, Chiron is the 2nd leading flu vaccine manufacturer, behind French pharmaceutical company Aventis, which makes about 45 to 50 per cent of the world's supply, Stohr said. Chiron, based in California, makes 4 influenza vaccines, including Fluvirin, the top flu vaccine in northern Europe and the No. 2 vaccine in the US. Chiron Corp. officials cut the company's expected profits by more than half on Tuesday. Trading in Chiron's stock on the Nasdaq Stock Market was temporarily halted Tuesday morning. Share price dropped USD 7.69 a share, or 17 per cent, to USD 37.73 after trading resumed. "Chiron deeply regrets that we will be unable to meet public health needs this season," Chiron chief executive Howard Pien said. "What happened was unexpected."
The timing of the license suspension is particularly worrying because vaccine production goes in cycles. The manufacturing cycle for the northern hemisphere vaccine finished in August and manufacturers are now gearing up to make the vaccine for the southern hemisphere. Vaccine makers do not have a lot of spare stock because they produce on demand.
[The practical difficulties inherent in large-scale production of 2004/2005 northern hemisphere human influenza virus vaccines put in perspective the over-optimistic demands for rapid development and supply of an avian influenza A (H5N1) virus vaccine for use in control of the outbreak of avian influenza in East Asia. - Mod.CP
The above article does not indicate the implications of this withdrawal on vaccination campaigns in other countries. About a quarter of the population in the United Kingdom are invited for annual vaccination against flu on account of advancing age (65 or over) or chronic illnesses likely to make influenza a greater hazard. Vaccine recommendations in the US now include covering children aged 6 to 23 months and those who come in contact with them (Influenza activity update 2003/2004 - worldwide 20040703.1776). - Mod.SH]
Patricia A. Doyle, PhD Please visit my "Emerging Diseases" message board at:
Zhan le Devlesa tai sastimasa
Go with God and in Good Health



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