International regulators plan meetings early next year to agree on ways to speed the production of vaccine to fight a potential bird flu pandemic, a U.S. official said on Wednesday.

Fears about the H5N1 avian flu virus have accelerated the need for better global agreement on vaccines, but such a pact would also improve production of the annual influenza vaccine, said Dr. Jesse Goodman, director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research.

Goodman said the FDA had become more active in helping companies get approval of flu vaccines.

“Our goal is to have vaccines that are safe and effective and to have them approved and available ahead of time,” he told a meeting of the U.S. National Vaccine Advisory Committee.

The H5N1 avian flu virus has infected 133 people in Asia since late 2003 and killed 68 of them. Several countries in the region are regularly reporting more suspected cases in people and outbreaks in poultry.

Annual flu kills about 250,000 people globally in an average year.

Scientists fear H5N1 could kill millions of people if it mutates into a form that passes easily among humans. The regular flu vaccine is useless against avian flu and there is no cure, although drugs can help reduce its severity.

Several companies are producing an experimental H5N1 vaccine, but hundreds of millions if not billions of doses would be needed if there were a pandemic. Flu vaccine production, now based on chicken eggs, is slow, unwieldy and uncertain.

Since flu viruses mutate so quickly, any vaccine made now would almost certainly provide poor protection against whatever strain eventually causes a pandemic, meaning a new vaccine would need to be formulated.

International officials have been warning for years about the dangers of influenza and the poor structures in place to defend against epidemics and pandemics.

The weaknesses were highlighted last year when British regulators took away Chiron Corp.’s license to make vaccine at its British plant — costing the United States nearly half its anticipated flu vaccine supply. The British move took the FDA by surprise.

NO SURPRISES

Officials do not want any such surprises if H5N1 or any other strain of influenza does cause a pandemic.

Goodman said the FDA had been in discussions with the World Health Organization and other regulatory agencies about how to coordinate approval of a vaccine against H5N1 or some other strain of pandemic flu.

“Vaccine manufacturing is no longer a U.S. issue — it is a global problem,” Goodman said.

He said there were plans for two global regulatory meetings early next year, the first probably in Canada and a second in the United States. Issues would include what criteria are needed for approving new flu vaccines.

“The differences are not dramatic,” he said.

Another benefit would be global agreement on approval of the annual influenza vaccine, he said. Companies will only make pandemic flu vaccine if they can use the facilities to make annual flu vaccine, Goodman said.

“Nobody is going to produce 600 million doses every 50 years and then every 49 years something else,” he said.

“The ideal thing would to be perpetually prepared for a pandemic, not just this year when everybody happens to be really freaking out about it.”

The regulators may release written guidance on the criteria for approving a new vaccine, and Goodman said the FDA was making similar moves in one-on-one meetings with flu vaccine manufacturers.

“We have adapted to what I think are extraordinary circumstances through a number of extraordinary actions,” Goodman said.

By Maggie Fox