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US Officials Do Not Expect More Flu Vaccine Delays

Reuters

Friday, March 9, 2001

By Lisa Richwine

BETHESDA, Md., Mar 09 (Reuters) - US health and industry officials said on Friday they did not expect delays in shipping this season's influenza vaccine to be repeated in the fall when people start getting the shots for next winter.

Production glitches hampered arrival of the potentially life-saving shots for the flu season still in progress, which officials said is mild and on the decline after peaking at the end of January.

One flu strain used to make the vaccine grew more slowly than expected. Makers resolved that difficulty and production "is now acceptable," said Dr. Roland Levandowski, a supervising medical officer in the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research.

Also, two of the four companies that made the vaccine experienced production problems. Levandowski said the three manufacturers working on next season's US vaccine expect they can produce about 80 million doses, enough to meet the usual demand.

Production difficulties are not uncommon, and typically companies and regulators can fix them in time, he added.

"We don't anticipate there would be some insurmountable problem" with the vaccine for the upcoming season expected to start around November, Levandowski told a meeting of FDA advisers.

An estimated 114,000 Americans need hospital treatment and 20,000 die each year from the flu. Peak months in the United States are November through March.

Most Americans get flu shots during the last three months of the year to protect them through the winter, but officials must monitor flu activity around the world months in advance to identify the most active strains and the ones that vaccine makers can grow quickly.

A committee of FDA advisers met on Friday to try and help health officials pinpoint the strains for a vaccine that would best protect Americans next flu season.

The panel recommended that vaccine strains of Type A, which causes most flu cases, stay the same but urged a change in the Type B flu component. US health officials will determine exactly which strains manufacturers should use.

But much of the discussion focused on what authorities were doing to prevent troubles with vaccine shipments. In some areas last fall, flu vaccines arrived at grocery stores, where they were available to anyone, before they reached high-risk patients, such as seniors, pregnant women and people with weak immune systems, panel members said.

Dr. Michael Decker, a vice president for flu vaccine maker Aventis Pasteur, said distributors have agreed to changes aimed at helping make sure needy patients get the shots. For example, distributors will ship only partial orders early in the flu season, leaving more flexibility if problems arrive.

"Distribution didn't work well, and steps have been taken to address that," Decker said. "Supply ... shouldn't be a problem."



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Last updated: 11 March 2001