http://abcnews.go.com/wire/US/reuters20020612_491.html
June 12
— By Maggie Fox, Health and Science Correspondent
WASHINGTON (Reuters) - A vaccine shortage that has prevented infants and toddlers across America from getting regular shots will not ease until next year, U.S. officials said on Wednesday, but they have seen no evidence of any outbreaks of disease.
The Food and Drug Administration and the Centers for Disease Control and Prevention both said they were seeking ways to encourage more companies to make vaccines.
"We want to send a signal here that we want to be as creative as possible in dealing with these processes," Lester Crawford, deputy commissioner at the FDA, told a Senate hearing.
Crawford said FDA would try to help companies in any way to become vaccine manufacturers. "We can provide consultations with them and meet with them at their behest," he told the hearing of the Senate Committee on Governmental Affairs.
"What we need to do is find a way to facilitate other companies to come and get their vaccine licensed," agreed Dr. Walter Orenstein, director of the CDC's National Immunization Program.
The vaccine shortage has hit hospitals and clinics across the country, forcing schools to relax requirements for children to start classes and leaving children unprotected.
The CDC says there are shortages of the vaccines against diphtheria, tetanus and pertussis (DTaP) vaccine, measles, mumps and rubella, chickenpox, pneumococcus, and the diphtheria-tetanus vaccine.
"We ... have not seen, as yet, outbreaks of disease relating to these shortages but we certainly remain very concerned," Orenstein said.
MONTHS TO RAMP UP MANUFACTURING
The shortage is expected to last until next year because it takes months for makers to ramp up manufacturing.
Only four pharmaceutical companies now make the vaccines recommended for routine childhood use -- Merck and Co. Inc., GlaxoSmithKline Plc, Wyeth and Aventis-Pasteur. In the 1960s, 30 companies made vaccines.
Immunization wiped out smallpox 25 years ago and is on the verge of wiping out polio. It has saved millions of lives, according to the American Academy of Pediatrics.
Orenstein said there is 40 percent less tetanus vaccine available this year compared to last. "There clearly is an increase in vulnerability to disease when children remain unvaccinated," he said.
Price is one factor. Regulators, doctors and drug companies agree there is not much profit incentive to make vaccines.
"However, the issue of vaccine prices cannot fully explain the shortages we are seeing today," Orenstein said. "We are having more problems with the higher-priced vaccines than the lower-priced vaccines."
For instance, Wyeth's pneumococcal vaccine, Prevnar, costs $40 to $50 per dose, yet is in short supply.
Wayne Pisano, executive vice president of Aventis Pasteur North America, agreed that price was only one factor. His company, for instance, was taken by surprise when Wyeth decided suddenly to stop making tetanus vaccine.
It took 11 months to catch up.
And the government's decision that it would be safer to remove a mercury-based preservative, thimerosol, from vaccines meant a complex reformulating process. This then had to be approved, and the vaccine had to be re-packaged into smaller units, cutting output by 25 percent, Pisano said.
Companies also complain that a government program limiting their liability for side-effects from vaccines needs to be strengthened.
Orenstein said the National Vaccine Advisory Committee and the General Accounting Office were both looking into the situation and would report on five areas: economic incentives, streamlining the regulatory process, getting the government involved in supplying vaccines, better stockpiles and reduced liability for vaccine makers.
"We didn't have stockpiles for many of the vaccines in shortage today," he noted.
