Record shot production may ease waiting this fall; 100 million doses for this winter a record

ATLANTA (AP) _ About 75 million doses of flu vaccine will be in most doctor's offices and clinics by the end of October _ a near record amount that should prevent flu shot rationing this year, health

Wednesday, September 6th 2006, 12:24 pm

By: News On 6

ATLANTA (AP) _ About 75 million doses of flu vaccine will be in most doctor's offices and clinics by the end of October _ a near record amount that should prevent flu shot rationing this year, health officials said Wednesday.

Overall, more than 100 million doses should be available over the next several months, beating the 95 million manufactured in 2002.

``There may still be some lines, but we really think this is promising,'' said Dr. Anne Schuchat, who heads immunization programs for the U.S. Centers for Disease Control and Prevention.

The best time for vaccination is in October or November, before the flu season typically begins, CDC officials said.

In 2004, production problems at one manufacturer caused severe shortages and hours-long lines for shots. Last September, tight supplies caused doctors to limit shots at first to people at risk of severe complications.

``This year, we're not asking people to step aside or hold off. We think people who want to be vaccinated can be vaccinated right away,'' Schuchat said.

The last time early-season supplies were as plentiful was 2003, when more than 80 million doses were distributed by the end of October. Last year, about 60 million doses were distributed by that point.

But CDC officials cautioned that some clinics, doctor's offices and other health care providers still may not receive their full allotment until November or later. It depends on which supplier or manufacturer they used and when they placed their vaccine orders, they said.

Between 5 percent and 20 percent of the U.S. population gets the flu each year. The illness leads to about 36,000 deaths and 200,000 hospitalizations each year, according to federal officials.

Vaccine manufacturers this year include Sanofi Pasteur Inc., which projects 50 million doses; Novartis, which is expected to make more than 35 million doses; and GlaxoSmithKline, which is planning roughly 25 million doses.

Glaxo has two flu vaccines; one of them, FluLaval, has not yet been approved by the U.S. Food and Drug Administration. But that approval is expected this month, said Jennifer Armstrong, a Glaxo spokeswoman.

If FluLaval is approved, it will mean closer to 110 million total flu shot doses for the nation, Schuchat said.

In addition, MedImmune Vaccines Inc. plans to distribute about 3 million of doses of FluMist, a nasal mist recommended only for healthy people between 5 and 49. It contains live virus, and carries with it a slight chance of causing flu symptoms.

Federal officials issued a warning letter to Sanofi in June, after FDA inspectors found the company's Swiftwater, Pa., plant wasn't adequately maintaining sterile conditions.

The failures were corrected, and none of the problems affected the purity or safety of distributed products, said Patty Tomsky, a Sanofi spokeswoman.

Sanofi began shipping flu shots two weeks ago, she added.

The CDC's decision to expand flu shot recommendations is influencing production, Armstrong said. ``There's an unmet need out there,'' she said.

This year, the CDC began recommending that doctors give flu shots to children ages 2 to 5 _ about 5.3 million healthy U.S. children. Vaccinations were already recommended for children ages 6 months to 23 months, pregnant women, people 65 and older, and people of all ages with chronic health conditions, along with a few other groups.

Overall, about 218 million Americans _ or 73 percent of the population _ should get vaccine this year.

Only a fraction of the people who should get flu shots usually do. For example, just 40 percent of health care workers get the vaccinations, Schuchat said.

``We have lots of work to do,'' she said.