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E-mail Print A Deadly Chicken/Egg Situation
Health Care Op-Ed
By: Peter Pitts
11.17.2004

November 17, 2004

The action by British regulators to nix half of the U.S. supply of flu vaccine will result in more dead Americans this winter. No matter how well the U.S. redistributes remaining vaccine stocks, no matter how far and wide we search for safe and effective replacement doses, some vulnerable people will go without needed shots. It didn’t need to be this way, which begs the question: would the British have nixed the entire vaccine supply had those shots been earmarked for use in Great Britain?

The British action may look rash, but the real culprit is a failed market for new vaccines. It’s a market where science has stagnated, leaving us overly reliant on a few large suppliers and dependent on production processes that are antiquated and needlessly expensive. And that’s not even bringing into the debate the very real tort issues.

It’s an actual chicken/egg situation. Today chicken eggs are at the heart of a protracted process of producing flu vaccine, a practice that has changed very little since the first flu shot was introduced in the 1940s.

It still takes as many as eight months to collect millions of these delicate incubators from special chicken farms, using them to grow the viruses for the next season's vaccine. That means our health care leadership needs to guess, a full year in advance, what the prominent strains of flu will be so they can decide what should go into the chicken eggs and how many lots it should purchase.

According to many experts, two techniques, reverse genetics and mammalian tissue culture, hold the promise to accelerate the vaccine-making process while raising its quality. With cell culture, a flu virus is made to infect a cell line able to replicate itself over and over in large fermenting vats filled with special growth nutrients. This production process bypasses the egg as a factory altogether. The advantage is it can be scaled up quickly to meet rising demand, and it does not rely on chickens, so it can be done in a short timeframe.

These are not pie-in-the-sky processes. Polio vaccine is made using mammalian cell culture, and reverse genetics was used last year to re-create a SARS virus. While reverse genetics is farther off, the ability to grow vaccines on cultures filled with animal cells is well understood.

However, regulators inside the Food and Drug Administration have viewed these techniques with trepidation. Among other things, there is the theoretical fear that genes could jump from the cell cultures into the vaccine. Instead of pointing out problems and saying why it can’t be done, regulators must work collegially with industry and academe to develop both the basic and clinical science that will provide the sound science necessary to certify this process.

Another hurdle to a more modernized pipeline is the capital required to get into the business. It costs about $300 million to build a chicken egg factory and it takes almost five years to get a facility built and inspected. And unlike the economics of drugs, with vaccines grown in chicken eggs, the variable costs – those that need to be paid every year on each vaccine that is produced – are high. So manufacturers need both high price and high volume to recoup their investments.

However, with governments around the world buying a big share of each year’s production run, high prices are hard to extract. So vaccine makers must make up in volume and through lower production costs what they cannot make up on price.

It is a classic chicken/egg situation – vaccines cannot be sold at a low price unless there is very high volume, but it’s not possible to assure high volume without lower prices to dangle before governments and other bulk purchasers.

The result is why we are where we are today. Without the ability to innovate by incorporating cheaper and better production methods, vaccine makers have cut costs by squeezing their antiquated manufacturing processes to the chicken bone.

This is no way to run a market for a medical product so vital to the public health. Right now, our entire supply of flu vaccine is dependent on a few companies and a few factories. New technology would allow production costs to fall, and with it barriers to entry for many small suppliers. Companies should not have to supply half the U.S. market just to reach the kind of scale that makes vaccine production profitable.

The solution is to facilitate sound science and high quality technology. This public health double play will lower production costs and offer the opportunity for more manufacturers to broaden the production base. As the government looks for ways to fix the vaccine market, here is an immediate opportunity -- actively promote vaccination to stimulate demand.

Let’s take all the negative media attention and turn it into a long overdue public health communications effort. The public is primed for action.


Peter J. Pitts is Senior Vice President for Health Affairs at Manning, Selvage & Lee, Senior Fellow at the Pacific Research Institute, and a former Associate Commissioner for External Relations at the FDA.
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