Lessons Learned as Unused H1N1 Vaccines Expire

July 23rd, 2010 by CHHS RAs

By Meaghan McCann
CHHS Research Assistant, summer 2010

There is a surprising addition to list of lessons learned from the U.S. response to the 2009 H1N1 outbreak: sometimes being over-prepared has its own risks.

As of July 2010, more than 40 million doses of swine flu vaccine have expired and 30 million more are expected to expire by early fall, which means that nearly half of the entire U.S. supply of the vaccine will have gone unused. Combined, the cache of 70 million expired doses will be one of the largest in history, nearly four times the volume of leftover seasonal flu vaccines that get thrown out every year. Now consider the cost: the 40 million doses that have already gone bad carried a price tag of $260 million when they were purchased in 2009, and taxpayers footed the bill. Was the unprecedented procurement of H1N1 vaccine worth it, especially in a time of fiscal belt-tightening?

Health officials have been quick to defend such large vaccine stockpiles. The U.S. Department of Health and Human Services (HHS) commented that “although there were many doses of [H1N1] vaccine that went unused, it was much more appropriate to have been prepared for the worst case scenario than to have too few doses.” Some health experts share the same sentiment. “We made a conscious decision to have more than enough vaccine instead of less than enough vaccine,” said Dr. Anne Schuchat, director of the National Center for Immunization at the Centers for Disease Control.

Many federal health officials blame the excess vaccines on the gap between the emergence of swine flu cases and the actual vaccine production. H1N1 was detected in multiple states in April 2009, much earlier than normal flu season. The early wave prompted U.S. health officials to contact the five major pharmaceutical companies that manufacture the vaccine with an order for 229 million doses, to be ready for distribution by October 2009. However, the fall flu season brought fewer cases of H1N1 than expected, and only a fraction of the vaccines actually reached the population.

Now faced with the reality that 70 million doses could go to waste, some lawmakers are wondering if such large orders of vaccine are necessary. In June Senator Chuck Grassley (R-IA) wrote a letter to HHS secretary Kathleen Sebelius asking how much vaccine was currently left over and when it would expire. In the letter, Grassley noted that he understood “it is not uncommon for some seasonal flu vaccines to be discarded each year,” but expressed his concern because “the H1N1 vaccines were paid with taxpayer dollars.” Yet, it seems Grassley’s concerns have yet to be taken seriously. In a response to Grassley’s letter, HHS said “we have asked states to hold onto any vaccine that has not expired, in case we continue to have regional upticks in disease, another wave or another early start to flu season.”

For now, it does not appear that federal requests for large amounts of the H1N1 vaccine will be slowing down anytime soon, but the U.S. government appears to be taking small steps toward streamlining the vaccine production process. The health agencies in the U.S. government plan to enter into a joint venture with vaccine manufacturer Novartis to reduce excess production. The possible venture is designed to bring two benefits: first, Novartis would use “cell line technology” to create the vaccines, which is faster than traditional vaccine-making methods; second, the vaccine would be produced in the United States as opposed to overseas, reducing the risk that distributors will have to wait for the vaccine in the event of an outbreak. While the venture is a step in the right direction toward restructuring procurement, last year’s overproduction and over-stockpiling indicates a residual need for better planning and preparedness in the future.

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