October 18, 2004
Hello! "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...."
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." 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: Please email me with any ideas or suggestions. I look forward to reading what you have to say. Cindy |
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