Flu vaccine available in Vernon County despite supplier shut-down

By Steve Moyer

Nevada Daily Mail

Safety concerns at the Chiron Corporations British plant mean that United States' supplies of flu vaccine could be cut in half for the 2004 flu season that starts in November, but the local supply should be sufficient, health officials say.

British authorities suspended the license of Chiron Corp. for three months because of problems at its vaccine manufacturing plant in Liverpool, England, which primarily supplies the American market.

The action means the company can't supply any flu vaccine during that time, and Chiron said it would provide no U.S. vaccine this year.

The news means the United States will face ''a significant shortage,'' said Dr. Anthony Fauci, the National Institutes of Health's infectious disease chief. American vaccine experts suggested shots this year would likely be rationed.

Supplies in Vernon County should be adequate even in the face of the national shortage because the Vernon County Health Unit did not order vaccine from the affected company according to Beth Swopes, administrator.

"This shortage shouldn't affect us too much," Swopes said. "We didn't order our vaccine from Chiron. We've received some vaccine from our supplier already and we've been guaranteed we'd have the rest by the end of the month."

Swopes made the caveat that the health department wasn't aware of how the individual doctors in the area might be affected.

"I can't say whether it will affect the individual doctors, that depends on where they got their vaccine," Swopes said.

Swopes said that in the event the health unit sees an unusual demand for the vaccinations because of a shortage in individual doctors inventories the shots would be prioritized based on an individuals health needs.

"We'll do whatever it takes to protect the most people who are most vulnerable," Swopes said.

U.S. health officials were caught off-guard, learning of the developments only during a midmorning phone call. ''We need to regroup,'' Fauci said shortly afterward.

The Centers for Disease Control and Prevention issued new recommendation in light of the situation.

It is asking that people who are not in one of the priority groups it has identified as being in greater need defer or forego getting a flu shot this season.

The priority groups that the CDC recommends getting the shot include: all children age 6--23 months; adults age 65 years and older; persons aged 2--64 years with underlying chronic medical conditions; all women who will be pregnant during the influenza season; residents of nursing homes and long-term care facilities; children aged 6 months --18 years on chronic aspirin therapy; health-care workers involved in direct patient care; and out-of-home caregivers and household contacts of children aged less than 6 months.

In addition the CDC identified two groups who should not be given the vaccine without discussing it with their doctor: persons with a severe allergy to hens' eggs and persons who previously had onset of Guillain-Barré syndrome during the six weeks after receiving influenza

Chiron had planned to ship 46 million to 48 million doses, but that already had been delayed by a contamination problem discovered in August in the English factory where the vaccine is made. At the time, the company said only 4 million doses were tainted but that the entire supply would be held up and re-tested.

Flu shot campaigns usually start in October, a month before the flu season typically begins in the United States.

In an average year, flu kills 36,000 Americans and hospitalizes another 114,000 -- mostly the elderly.

Less than two weeks ago, top U.S. health officials assured the public that close FDA monitoring of the rest of Chiron's supply suggested it was fine and that there would be plenty of supplies.

Dr. Walt Orenstein, formerly the top vaccine expert at the U.S. Centers for Disease Control and Prevention and now the associate director of the Emory Vaccine Center, said the government may have to ration available vaccine.

''It's a very serious concern. We're already in October, which is vaccine season. If we have to ration at this stage, it becomes more complicated.''

If problems prevent the Chiron vaccine from being used at all this year, it's unlikely that other manufacturers could fill the gap. Aventis Pasteur, which expects to supply 52 million doses, said earlier that federal officials had asked it to make additional vaccine but that it already was at capacity and couldn't produce more until after November when existing orders are filled.

A third manufacturer, MedImmune, which makes FluMist, a new nasal spray flu vaccine for use in healthy 5- to 49-year-olds, said it couldn't produce more than the 1.5 million doses it had planned to make for this year's flu season.

That vaccine is made from modified live virus and isn't considered safe for the elderly or people with medical problems.

Chiron is the second leading flu vaccine manufacturer, behind French pharmaceutical company Aventis, which makes about 45 or 50 percent of the world's supply, Stohr said.

Chiron, based in California, makes four influenza vaccines, including Fluvirin, the top flu vaccine in Northern Europe and the No. 2 vaccine in the United States.

The company also has facilities located throughout Europe, the United States and Asia. Fluvirin is also made in the company's plants in Italy and Germany, but those doses have already been promised.

''Chiron deeply regrets that we will be unable to meet public health needs this season,'' Pien said. ''What happened was unexpected.''

The timing of the license suspension is particularly worrying because vaccine production goes in cycles.

The manufacturing cycle for the Northern Hemisphere vaccine finished in August and manufacturers are now gearing up to make the shots for the Southern Hemisphere.Vaccine makers do not have a lot of spare stock because they produce on demand.