ATLANTA (Reuters) - A nationwide
shortage of important childhood vaccines may be just about over, but another
could come at any time because most of the causes still exist, health and
industry officials say.
The vaccines, which save millions of
lives, are only made by a few companies. The regulatory restrictions that keep
vaccines safe cause headaches for the manufacturers and the government has yet
to formulate a better plan for stockpiling vaccines.
While everyone agrees that companies must be given better incentives to get
into the vaccine business and stay there, coming up with a realistic way to do
so is proving difficult.
The General Accounting Office (
news -
web sites), the investigative arm of the U.S. Congress, issued a report on
Tuesday that said shortages of childhood vaccines forced 49 of the 50 U.S.
states to ration shots in recent months.
It said the government had the authority to stockpile childhood vaccines, but
had done so with only two and did not have a plan for creating stockpiles in the
future.
"We are working on it," said Dr. Walter Orenstein, head of the National
Immunization Program at the Centers for Disease Control and Prevention (
news -
web sites). "I think stockpiles are important, but they are not a panacea."
The main issue is that only four companies make most of the childhood
vaccines, and that any one can drop out of the business at any time, Orenstein
said in an interview. Or one can run into problems -- one of the issues that
caused this last shortage.
VULNERABLE SUPPLY
With five of the eight vaccinations made by one company each, this leaves the
nation's supply highly vulnerable.
Even the vaccine makers, who have a virtual monopoly, say they would welcome
competition. "I don't think anybody wants more competition from a business
perspective," said Wayne Pisano, executive vice president of Aventis-Pasteur
North America .
"But it is difficult for us to invest and expand. Changing the system will
invite competition but it will also help us."
Still, no one is sure how to do that -- by subsidizing vaccines, giving
financial incentives, or simply by making the vaccine approval process easier.
The CDC recommends that all babies get 11 routine vaccines in eight shots.
Over the past year, five vaccines have been in shortage -- the MMR vaccine,
pneumococcal disease vaccine, DTaP, the tetanus and diphtheria booster and
chicken pox. Many are not fully effective until a child has received several
doses.
Doctors have tried to give babies the vital first doses of vaccines, but in
many cases have had to delay the last shots in the series to ensure that every
baby gets at least some cover.
One problem was that some companies were having trouble producing enough
supplies, but did not tell the CDC in time for the agency to get other makers to
ramp up efforts.
Companies could consider a supply shortage to be a trade secret and may be
reluctant to tell the CDC.
Pisano hopes for even better communications with CDC.
"We believe CDC should have the power and authority to take confidential
information and share it with other companies when there is a shortage," Pisano
said in a telephone interview.
The GAO also suggested that the U.S. Food and Drug Administration (
news -
web sites) be allowed to "fast-track" approval of new vaccines, an idea
Orenstein favors.
Pisano had a final suggestion: make it harder to sue vaccine manufacturers.
The Vaccine Injury Compensation Program is supposed to be a no-fault
insurance fund for people injured by the very rare side effects that vaccines
have. But Pisano said some people are starting to sue companies directly, and
Aventis-Pasteur was spending millions of dollars litigating 100 or so cases.
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MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
"A foolish faith in authority is the worst enemy of truth."
-- Albert Einstein, letter to a friend, 1901
"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."
-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820
"What's the point of vaccination if it doesn't protect you from the unvaccinated?"
-- Sandy Gottstein
"Who gets to decide what the greater good is and how many will be sacrificed to it?"