Looking for a better way to make flu vaccines
Officials: Supply good, but some want production overhaul
By Tal Mekel
This year officials are encouraging people to get vaccinated even late in the season.
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(CNN) -- U.S. health officials believe there will be an ample supply of flu vaccine this winter and don't expect a repeat of last year's vaccine panic, but spot shortages have already been reported.
"It's safe to say that it's off to a frustrating start for physicians," said Dr. Nancy Bennett, deputy director of the Monroe County Department of Public Health in Rochester, New York. "There is certainly a perception of shortage because people don't have their vaccine yet."
Bennett said the delay was mainly a result of slow vaccine distribution, but the situation is not as severe as last year, when flu vaccine manufacturer Chiron was forced to close its plant in Great Britain because of contamination, leaving the United States with only half of the anticipated supply.
Federal health officials emphasize that the vaccine supply is good this season, and the shortages will ease as vaccine manufacturers continue to release doses to distributors and clinics. (CDC: Deliveries on the way)
"Patience and persistence is going to be needed in order to vaccinate everyone because not all of the vaccine is out there yet," said Dr. Lance Rodewald, director of the Immunization Services Division at the U.S. Centers for Disease Control and Prevention. "Checking back [with providers] is a reasonable thing to do while waiting for the vaccine to come in."
Since last year, the Food and Drug Administration worked with Chiron to resolve the company's safety issues, and accelerated the approval process to add a new vaccine maker, GlaxoSmithKline.
The CDC expects between 70 million and 90 million vaccine doses to be available this flu season, depending on how many shots Chiron eventually ships.
Chiron said it would supply the United States with fewer than 18 million doses, after initially predicting up to 30 million doses. Sanofi-Pasteur, the largest supplier, is expected to make 60 million shots and GlaxoSmithKline another eight million. MedImmune, which makes a nasal-spray vaccine, has promised three million doses.
While the government does not determine the number of vaccines produced each year or how to distribute the output, the CDC exerts its influence by issuing vaccine recommendations. As a result of last year's shortage, this season's recommendation was to vaccinate only high-risk individuals before October 24. After that, the vaccine was opened to all.
Though the annual flu season starts in early October, peaks in February and can continue until May, the public's interest usually fades after Thanksgiving. This year officials are encouraging people to get vaccinated even late in the season.
"It's important to make sure that people realize that December is not too late and oftentimes January is not too late," Rodewald said. "Vaccination remains the primary and the best way to protect individuals."
The recurring difficulties during flu season highlight the complexities of a market-driven system and the need for changes in how the vaccine is manufactured, produced and distributed, experts said.
Flu vaccine making is a long, expensive and labor-intensive process. The vaccine has to be recreated from scratch every year, because the virus changes rapidly.
Between January and March, the World Health Organization, in cooperation with the FDA and the CDC, decides which three circulating influenza strains to include in the vaccine for the coming flu season.
Vaccine manufacturers then grow the virus in millions of bird eggs, before the virus is killed and included in the shot.
This technology is considered reliable but overdue for an overhaul.
"We use a mechanism of production that was really first used in the 1930s," said Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt University Medical Center in Nashville, Tennessee.
"By the time you start to create a vaccine each year, it is about a five or six month process until certified lots that are effective and safe come rolling off the assembly line."
Researchers in government agencies, the private sector and academic institutes are studying the use of tissue cells to produce the vaccine, instead of relying on eggs. This technology could provide a quicker turnaround, though that's still uncertain.
"We have cell culture based vaccines for many of our routine immunizations," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "It hasn't been as easy for scientists and manufacturers to adopt these techniques in part because of the way the virus grows, but we feel people are making progress and there's a lot of potential there.... We should know a lot more in the next couple of years."
Researchers are also exploring techniques to provide wider protection against genes that are common among influenza strains.
Such diversity and quick turnaround would benefit the annual flu and could be vital in case of flu pandemic, Goodman said. The current flu vaccine doesn't provide protection against bird flu, but companies are working on the matter under government contracts.
President Bush addressed some of these issues on November 1, while unveiling the administration's strategy to prepare for a pandemic flu outbreak.
Bush urged investing $2.8 billion to accelerate development of cell culture technology and "help our best scientists bring the next generation of technology online rapidly."
Bush also pressed Congress to pass liability protection for vaccine manufacturers, saying the number of American vaccine makers has plummeted because of a flood of lawsuits.
Modernizing the manufacturing process and encouraging new vaccine makers to enter the market could help expand the vaccine production capacity, but local health officials say change is also badly needed in the distribution system.
By the time you start to create a vaccine each year, it is about a five or six month process until certified lots that are effective and safe come rolling off the assembly line.
-- Dr. William Schaffner
"Instead of basing the vaccine distribution on the groups for whom it's recommended, the distribution just follows whoever happened to have a contract or made an order and was lucky enough to get their vaccine first," said Bennett. "We need to go back to the drawing board."
Federal officials believe distribution difficulties can be solved by increasing vaccine production and encouraging many more people to get routinely vaccinated.
"The demand over the long term is becoming higher and more stable and that will help keep manufacturers interested in producing vaccine and stay in the market," Goodman said.
Still, companies are left every year with millions of doses of unused vaccine, which go to waste. A 2004 report by an advisory committee of the HHS department said that fewer than half the people for whom the vaccine is recommended actually get vaccinated in any given flu season.
"What we really need is a comprehensive national adult immunization program such that there is funding both for providers and for patients," said Schaffner.
Schaffner said providing the vaccine free to all adults "would create a very large new market that would attract manufacturers."
"The pharmaceutical industry makes much more money manufacturing drugs taken often," Schaffner said. "We have to create incentives for the companies to invest more of their stockholders' money in vaccines ... That's not the lucrative part of being a pharmaceutical manufacturer, but it is terribly important from the point of view of the public's health."
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