Much of H1N1 vaccine unused, almost expired

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Nearly half the 162 million doses of H1N1 vaccine produced to fight the deadly flu in the United States have gone unused, and some batches have either expired or are nearing their expiration date.

Allegheny County Health Department will be throwing out 9,400 expired doses of the vaccine mist spray soon, as well as 730 expired doses of the injectable vaccine, said spokesman Guillermo Cole.

Statewide, some 4.6 million doses of H1N1 vaccine have been distributed, but state officials say they don't know how many were administered, how many are still available or how many have expired.

They do know that more than 683,575 doses were sent to health department district offices and the 60 state health centers, said spokeswoman Stacy Kriedeman. Of those, 26,897 doses have been thrown out because they expired. Overall an estimated 800,000 doses were recalled because they didn't meet potency standards.

Michael Huff, assistant secretary of health planning and assessment, said that of the 683,575 doses sent to state health centers, "We have less than 40,000 doses left. That is an incredible success story." But Ms. Kriedeman confirmed that most of the 4.6 million doses Pennsylvania received went to private providers, and said, "We do not have the number of doses expired or unused available."

Unlike the seasonal flu vaccine, for which the county health department pays manufacturers about $10 a dose, the H1N1 vaccine was supplied free of charge from the Centers for Diesease Control and Prevention in response to last year's alarming spread of the new flu strain.

But it didn't come cheap.

The CDC paid $1.6 billion to four manufacturers for enough vaccine bulk antigen and other material to produce 229 million doses of H1N1 vaccine, according to spokesman Tom Skinner. From that, 162 million doses have been produced and more than 90 million doses were administered - just over half the supply.

With H1N1 concern abating locally, there is little current demand for the vaccine. The CDC has reported a flu outbreak in the southeastern states of Georgia, South Carolina and Alabama.

Mr. Skinner said, "We're developing a plan for providers on what to do with unused vaccine, and we'll be sharing that plan soon."

That's quite a contrast from the last four months of 2009, when physicians and hospitals were scrambling to get enough H1N1 flu vaccine.

It was left to individual states how to distribute the limited doses. Pennsylvania officials decided to ship doses directly to providers who requested it, giving preference to those treating at-risk groups such as children and pregnant women.

But people whose physicians didn't ask for vaccine or couldn't get sufficient quantities were left scrambling. In some instances, that resulted in children with histories of respiratory illness being unable to get the vaccine, while healthy children could. It also has made tracking where the vaccine went more difficult.

Some H1N1 doses will not expire for another year, because of the way they were produced, and could be used as a booster for next flu season. Others are at or near their expiration date now.

One of the vaccine manufacturers, Switzerland-based Novartis, received two contracts totaling $979 million for H1N1 bulk vaccine and the company's proprietary additive, which have a one-year shelf life, according to Novartis spokesman Eric Althoff.

As for accepting returns of unused vaccine, he said, "Novartis will evaluate government requests on a case-by-case basis within the framework of the contractual agreements, which we consider binding."

Trying to predict the need for a vaccine can be tricky.

Allegheny County Health Department staff administered 12,979 shots for seasonal flu in 2004-05, but that dropped to 6,210 the following year; and the last two years, they've administered only about 2,000 flu shots.

Mr. Cole attributed the drop in demand to the proliferation of pharmacies and retail stores that have started offering flu shots since 2005. "Also, we believe some of the steady customers we had over the years passed on."

Because manufacturers will not take back unused seasonal vaccine, he said, the county has to absorb the cost of excess seasonal flu vaccine. Fortunately, this year the county forecasted accurately - Mr. Cole said it finished the season with fewer than 10 doses of seasonal flu vaccines still available.

H1N1 is a different matter.

Allegheny County received 44,000 doses of H1N1 vaccine and, as of March 23, had administered 19,158. About 14,000 were sent to other providers who needed them. The county still has 10,820 doses available.

Assistant Health Secretary Huff said officials were still encouraging people to get vaccinated.

Next fall the H1N1 vaccine will be incorporated into the seasonal flu vaccine, so those getting a shot now will enjoy a booster effect, he said.

"The disease will be back. It may not be back before next fall, but it will be back."


Steve Twedt: stwedt@post-gazette.com or 412-263-1963.


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