Famine to feast: Vaccine shortage turns to surplus?

Strange flu season goes from outrage to apathy

A most unusual flu season has taken another strange turn, as a national flu vaccine shortage that once dominated headlines and sparked exchanges in the presidential campaign has given way to consumer apathy and supply surpluses in some states. Instead of people lined up outside clinics, there are rows of flu vaccine vials sitting unused in cold storage.

"At least in those parts of those country where there is vaccine, you can’t get rid of it right now," explains William Schaffner, MD, the chairman of the department of preventive medicine at Vanderbilt University in Nashville, TN. "It’s sitting in refrigerators."

With February, the historic peak influenza month, a slow season still could catch fire. "So far, knocking wood, it is a very mild season," he says. "But flu can be late. I’m not predicting it, but I would not be surprised if in February or even into March, we have at least some regional influenza activity."

While most states have adequate vaccine supplies, some were still trying to meet vaccine shortfalls by tapping states with abundant doses. For example, published reports indicate Florida purchased 68,000 doses from California. In addition, advisors to the Centers for Disease Control and Prevention (CDC) recently recommended states with ample supply to begin immunizing beyond the original risk groups.

"There are disparities still in the distribution of the vaccine," Schaffner says. "But if you look at the big picture, the haves and the have nots kind of balance each other out and [overall] vaccine use has diminished. At the moment, we have not been able to generate interest beyond a low level in receiving vaccine."

While the vaccine shortage initially was marked by finger-pointing and a national news frenzy, the influenza season began slowly and then a surprisingly typical immunization pattern unfolded.

"It’s a typical January, I am afraid, especially when there isn’t much flu yet," Schaffner says.

"In every other year that we have measured influenza vaccination, by the time you get into December, vaccination activities really plummet. With the onset of the holidays, people are focused on other things and doctors no longer purchase influenza vaccine because they don’t want to be stuck’ with it," he adds.

Some in high-risk groups never sought vaccine or gave up when lines were forming and supplies were scarce. Regardless, having many unvaccinated high-risk people also is common during an annual flu season.

"We don’t immunize everybody in the risk groups in other years," Schaffner reminds. "We only reach, for example, about 65% of people age 65 or over, which leaves about 35% unvaccinated each year. The people who didn’t get vaccinated last year probably didn’t get it this year, and then there were people who tried to get vaccine and couldn’t and then went home and trimmed the Christmas tree."

CDC survey: Half of high risk forgo vaccine

The situation began last October when Chiron Corp. in Emeryville, CA, notified the CDC that its vaccine (Fluvirin) would not be available for distribution in the United States for the 2004-2005 influenza season. Health regulatory officials in the United Kingdom, where Chiron’s Fluvirin vaccine is produced, cited contamination concerns and suspended the company’s license.

As a result — though additional vaccine was later found from various sources — the United States initially received only about one-half the expected supply.

The CDC asked healthy people to forgo vaccination in favor of those at high risk of flu complications. However, a lot of the high-risk people (e.g., older than 65, chronic illness) originally prioritized for vaccine either couldn’t get it or never tried. In a recent CDC survey of adults 65 years and older, 119 (49%) reported that they tried to get the influenza vaccine during the preceding three months.1 Among those who tried to get the vaccine, 75 (63%) were able to get immunized, but 44 (37%) were unable to get the shot. Similarly, a total of 113 (37%) adults with a chronic illness tried to get the vaccine, but the remaining 63% of those surveyed passed on vaccination. Of those who tried to get immunized, 52 (46%) were able to do so. The remaining 61 people (54%) reported being unable to be vaccinated for a variety of reasons. (See charts.)

Problems cited included finding a location and availability of vaccine when they got there. Though the respondents were indicated for vaccination, awareness of the influenza vaccine shortage was an important reason cited for not trying to get immunized. Others believed they were not at high risk or the vaccine would not protect them. Of concern, 18% of respondents who did not get vaccinated cited fears that they could get influenza from the vaccine. Regarding the latter finding, another CDC survey found that one-third of respondents questioned the safety of the vaccine.2 It is evidence of an historic problem because this CDC survey was taken after the 2003-2004 season, not in the context of the current shortage.

In a finding that stunningly underscores misconceptions about a disease that kills some 36,000 Americans annually, one third (32.8%) of respondents to the survey said "they believed the influenza vaccine causes influenza," the CDC reported. A more encouraging finding in the same survey was that more than 80% of respondents indicated a willingness to wear a mask if they were asked to do so by a health professional. Information about the acceptability of such intervention measures might be useful in managing large outbreaks, including pandemic influenza, the CDC noted.

Perception and reality

If the flu season remains relatively mild, public health officials certainly will be breathing a sigh of relief that the Chiron shortfall was not exacerbated by a bad flu season. But perception almost seems as important as reality when it comes to influenza and flu vaccine. As the vaccine crisis becomes an apparent nonissue, there are real questions about whether the vaccine production system will be improved. That seemed to be inevitable when the problem unfolded, with many expressing shock and outrage that the United States was so dependent on one supplier.

"I don’t know whether this year’s influenza vaccine calamity will have sufficient carryover so that the new Congress and the executive branch will have any serious interest in that question," Schaffner says.

There also was a fledgling campaign under way to immunize an unprecedented number of health care workers, though it’s now unclear whether that effort can regain its momentum.

Without assurances of profitability and protection from liability, pharmaceutical companies will be reticent to get into the flu vaccine production business. In such an environment, it is also unlikely that public health officials could recommend universal flu vaccination to create a huge vaccine market and prepare for the next pandemic.

The CDC’s Advisory Council on Immunization Practices (ACIP) was considering such a recommendation in light of the vaccine shortage and the continuing threat of emerging avian influenza in Asia.

"Some of the steam has gone out of that," says Schaffner, a liaison member of the ACIP panel. "Because you can’t possibly conceive of making a recommendation for universal use [in the absence of congressional action]. Congress has to look at this because there are a number of issues that relate to how much vaccine is produced, the profits the companies make, the distribution system, etc. It’s thought that we won’t get a more secure supply with more manufacturers until some of those questions are addressed. If there is a stimulus here, it is the steady concern about avian flu. That is something that Congress and the executive branch also understand."

Meanwhile, there still are questions about the availability of Chiron vaccine for the 2005-06 season because the company hasn’t cleared regulatory hurdles in the U.K. "If [the] worst case happens, and we don’t have the Chiron vaccine, we’ll be working with the other international suppliers to try to get licensure of their product," Julie Gerberding, MD, MPH, CDC director said at a recent press conference. "We’ll be working with domestic suppliers to see what, if anything, we as a government can do to scale up their production. And we’ll be planning on our immunization programs to take under consideration whatever contingencies are necessary to meet the demands of the high-priority populations. It’s a work in progress."

References

1. Centers for Disease Control and Prevention. Experiences with obtaining influenza vaccination among persons in priority groups during a vaccine shortage — United States, October-November 2004. MMWR 2004; 53:1,153-1,155.

2. Centers for Disease Control and Prevention. Experiences with influenzalike illness and attitudes regarding influenza prevention — United States, 2003-04 influenza season. MMWR 2004; 53:1,156-1,158.