Question of the Week
October 18, 2004

Four years ago, in the fall of 2000, there was news about the flu vaccine:

"Although safe and effective influenza vaccine will be available in similar quantities as last year, much of the vaccine will be distributed later in the season than usual. Distribution of approximately 75 million doses is anticipated for the 2000--2001 season and this number should meet expected annual demand."

That same year, CNN reported that:

"Flu vaccine will be available later than usual this fall, but shortages are not expected, federal health officials say. About 75 million doses of vaccine are expected to be available this season, according to the Centers for Disease Control (CDC). Last year 74 million doses were distributed out of 80 to 85 million produced."

Three years ago, the CDC (Centers for Disease Control and Prevention) was saying:

"Vaccine manufacturers continue to project that 77.1 million doses of influenza vaccine will be distributed this season. Some delays in distribution are still anticipated. ... Manufacturers currently are projecting that the final 27.3 million doses of the total supply will be distributed in November and December 2001."

In September of 2002:

"Projected influenza vaccine production for the 2002-03 season, based on aggregate manufacturers‚ estimates, is approximately 94 million doses. All three manufacturers report that influenza vaccine production is proceeding satisfactorily. According to the manufacturers, approximately 80 percent of the total production is anticipated to be distributed before November 1."

By November of that same year:

"Current projections suggest about 93 million doses of influenza vaccine are available in the U.S. market this season and several million doses remain available for purchase."

Just last year, in 2003:

"Last year saw about 87 million doses generated and about 83 million shipped, officials say. The vast bulk of the difference was with unused doses of FluMist, a new nasal spray vaccine that has more restrictions than flu shots. It also costs much more than the injected version... Although this flu season wasn't particularly severe, it did have its moments. According to health officials, the percentage of deaths attributable to flu and pneumonia --a major complication of influenza -- topped the level considered epidemic for nine straight weeks. ... Every year holds the potential for a vaccine shortage -- after all, the CDC's inoculation guidelines include roughly 185 million Americans, while manufacturers typically produce fewer than 100 million doses of vaccine. The 2003-04 season did see a shortage, though how large it really was remains unclear, Strikas said."

Just last month (September 2004), CNN was reporting:

"Of the Americans who most need a flu shot, fewer than half actually get one, federal health officials warned Thursday as they called for special attention to babies, toddlers and the elderly as vaccinations begin next month. A record 100 million doses of flu vaccine will be available this year, the vast majority of it shipped to doctors' offices by the end of October, said Dr. Keiji Fukuda of the Centers for Disease Control and Prevention. That assurance comes a month after one major supplier, Chiron Corp., delayed its shipments because a small amount of vaccine failed sterility testing, suggesting contamination. That was 'a precautionary move,' and close monitoring so far suggests the rest of Chiron's supply is fine, Fukuda said."

It is now October, and the CDC was reporting something quite different earlier this month:

"On October 5, 2004, CDC was notified by Chiron Corporation that none of its influenza vaccine (Fluvirin) would be available for distribution in the United States for the 2004-5 influenza season. The company indicated that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, where Chiron's Fluvirin vaccine is produced, has suspended the company's license to manufacture Fluvirin vaccine in its Liverpool facility for 3 months, preventing any release of this vaccine for this influenza season. This action will reduce by approximately one half the expected supply of trivalent inactivated vaccine (flu shot) available in the United States for the 2004-05 influenza season."

So, what happened?

"U.S. regulators were trying to decide whether to allow the release of 48 million doses of Chiron Corp.'s flu vaccine when British authorities stepped in to block the company from shipping the vaccine, FDA officials said Friday. ... The British regulators' move could leave the United States with only about half of the 100 million doses of flu vaccine that health officials had expected to have on hand...."§ion=news

How did this happen?

In August Chiron warned both British and U.S. regulators that its influenza vaccine had been contaminated with a bacteria called Serratia. Both the FDA and Britain's Medicines and Healthcare products Regulatory Agency (MRHA) inspected Chiron's plant and had regular calls with the company. ...'What we have heard from the British is that they documented systemic deficiencies within the firm related to sterility issues as well as a finding of contamination in some of the lots,' said John Taylor, assistant commissioner of regulatory affairs for the FDA.... 'For a sterile product, you routinely do sterility testing,' she said. 'If there is contamination you know those lots are not sterile. The question is whatever it was that predisposed those lots to become contaminated.' There could be low-level contamination of all the product, she said -- too low to detect by conventional testing."§ion=news

Is there anything we can do so that this doesn't happen again?

"If the United States wants to avoid future shortages of flu vaccine it must take steps to draw drug companies back into the business of making the inoculations, flu experts say.... The basic problem is that 'we've lost most of our domestic manufacturers' of flu vaccine, said Richard Webby at St. Jude Children's Research Hospital in Memphis. 'When you're relying on two manufacturers ... and one goes down, you're up the creek.' Drug companies have pulled out of flu vaccine production because it's not very profitable and it's financially risky, health experts said. One big problem is that demand for flu shots fluctuates from year to year as public interest waxes and wanes. ... If a flu shot isn't used during the season, it must be discarded. So companies generally throw away millions of doses a year, Poland said. What's more, making vaccines requires massive capital investment and involves the costs of complying with federal regulations, and the market is relatively small, he said."

Even if part of the reason they exist is to serve the greater good, drug companies are in business to make money."So what can be done to draw more companies into making flu vaccines? One strategy would be to make demand higher and more reliable by getting more healthy adults to get flu shots regularly ...' All of this I think is certainly raising public awareness.' Other experts suggest having the government commit to buying a certain number of doses at a given price each year, buffering the uncertainty. Currently, most flu vaccine in the United States is bought by the private sector. Not only could government buy more flu vaccine and promote flu shots more aggressively, it could also require health insurance companies to cover flu shots as well as other vaccines for adults, Schaffner said. A companion public program could provide flu shots for uninsured people, he suggested."

Who should take the loss if doses go unused, the companiesmanufacturing the product, those who distribute the product, or the government? In years past, healthy people were being asked to get vaccinated so that vaccine left unused by "high risk" individuals would not go to waste.

"Of the Americans who most need a flu shot, fewer than half actually get one..."

Whether those high risk individuals who are considered to need a flu shot are just avoiding getting poked, don't know they are high risk, or don't feel they can afford the price of the vaccine, millions who would benefit have not received the shot in years past.

Questions of the Week:
Who benefits when healthy people get the flu vaccine? What impact does it have on public health, the drug companies, and the economy as a whole? How do you know if you (or someone you love) is considered high risk? How does vaccinating healthy people help those who are high risk? In years like this when otherwise healthy individuals are unable to get vaccinated, how can making an extra effort to not get the flu (good personal hygiene, getting lots of rest, ... ) help those who are in need of the vaccine and may or may not have received it? If you do think you are sick with the flu, what is your responsibility to the community to stay out of the community? On the other hand, what is your responsibility to your school, job, team, and others who depend on you? How useful are you to their cause if you show up sick? How could you be hurting them by still showing up--even when you are sick? How can a person balance their needs with those of the community? What information do you need to make these decisions, and where can you find that information?

Please email me with any ideas or suggestions.
Note: Due to increasing amounts of SPAM sent to this account, please include "QOW" in the subject line when sending me email.

I look forward to reading what you have to say.

[email protected]
Health Community Coordinator
Access Excellence @ the National Health Museum

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