WASHINGTONLiterally hundreds of vaccines are winding through the development and licensure process, setting the stage for a staggering array of choices.
These choices will result in a multitude of possible combinations and will challenge the method by which the Centers for Disease Control and Prevention (CDC) procures government-purchased vaccines.
The government purchases large volumes of vaccine for distribution to states to supply public health clinics. Because contracts are awarded annually, long-term strategic planning is hampered, according to Philip Russell, MD, Professor of International Health at Johns Hopkins University in Baltimore. It may be time to explore a different system for vaccine procurement. "As the menu of pediatric vaccines increases, [the federal procurement system] will face difficult choices, and it is not structured to deal with those choices...We need a system that buys compatible vaccines and combinations and reduces the problems at the clinic level of making choices among products and determining compatibility and suitability. Therein, perhaps, lies the most important aspect of future strategies," Russell said recently at a National Vaccine Advisory Committee (NVAC) meeting.
Instead of continuing to buy individual vaccines, Russell envisions the government purchasing complete pediatric vaccine systems through multi-year contracts. A set of performance criteria would be established, and any vaccine packages that best meet the criteria would be purchased. The criteria, for example, might seek a vaccine package that prevents specific diseases or that keeps the number of injections or visits to a minimum.
"This type of procurement is not easy to do...but I argue strongly that a performance-based procurement of a complete package is more likely than the current system to procure the best full set of complementary vaccines for use by vaccine programs and providers," said Russell, who is also President of the Albert B. Sabin Foundation. "It will, if done right, reduce decision-making at the clinic level...The CDC will be faced this year or next year with some very difficult choices. This is one option for solving them."
The proposed procurement system would shift the arena of competition from the marketplace to the laboratory. Overlapping productssuch as the competing combinations of diphtheria-tetanus-pertussis-Haemophilus influenzae type b and diphtheria-tetanus-pertussis-hepatitis B vaccineswould be eliminated.
"Industry would have to make alliances among themselves to meet [the criteria]," Russell said. "If we set the criteria properly, and the group that makes the final decision does its job properly, we could wind up with the optimal system available from industry. It would be a single system, it would minimize logistical problems, and it would minimize decision-making at the clinic level."
The proposal, however, raises questions concerning monopolies, the pros and cons of choice, and the affect on future research and development.
"One of the principle criticisms [of the procurement system] is it may create new monopolies in vaccine manufacturing," Russell said. "I believe that the issue can be managed appropriately within the context of a performance-based purchasing system. I also believe that an inevitable set of changes are occurring in the vaccine industry that are creating larger and larger consortia, and this is only another small nudge in that direction."
The creation of ever-larger vaccine developers may drive smaller players out of the market, raising questions concerning federal trade regulations and future development.
"If we had done this 3 years ago, where would we be, for example, in the development of acellular pertussis vaccine," asked NVAC member Robert Ross, MD. "In fact, at this point, would we have fewer choices in development? It strikes me that there would have been at least a couple of companies that would have said, 'forget it.' It's wonderful for the winner. I just wonder if we will end up with actually less competition for the development of vaccines." Ross is Director, Department of Health Services, San Diego County.
Committee member R. Gordon Douglas, MD, President of Merck Vaccine Division, noted that research may also be adversely affected if the criteria are too narrow or if developers are asked to look too far into the future.
"What I am most concerned about is no one is able to predict accurately what is going to happen with [combination] products," Douglas said. "If the government writes a set of procurement criteria 2 or 3 years in advance, or with some long-range strategy involved, it may preclude certain avenues of research...The potential for suppression of innovation exists in this program, and that worries me. Are we going to get the best for our children in the future through such a program?"
The fundamental question is whether limiting vaccine choices will be a benefit or a liability.
"We are at the threshold of a period where we are going to have great choice in immunization selection," according to John LaMontagne, PhD. "My feeling is that choice is healthy, frankly. It is a product of the tremendous emphasis that medical research has exerted over the last 30 to 40 years. The investment has now paid off in different options and ways of immunizing children.
"It is not going to be easy to eliminate the problems that the variety of choices will have for the purchasers of vaccines. That is going to be a problem, but I am not sure it is a problem we want to eliminate right no...It may be too difficult to try to solve this problem with one particular initiative, and we need to think about it from all points of view. Choice is a healthy reflection of the vigor of the vaccine community." LaMontagne is Director, Division of Microbiology and Infectious Diseases, National Institutes of Health/National Institute of Allergy and Infectious Diseases.
Too much choice, however, may cause confusion and polypharmacy at the clinic level, said Walt Orenstein, MD, Director of the National Immunization Program, CDC.
Russell's procurement proposal was offered for discussion only. NVAC's Subcommittee on Future Vaccines will explore the proposed planincluding Federal Trade Commission regulationsand alternatives. The subcommittee will also investigate short-term procurement options to prepare for upcoming contract renewals.
A future strategy must be determined, and time may soon run out as prospective vaccines near licensure.
"Regardless of the long-term outcome, there will be procurement issues over the next several years," Orenstein said. "For the most part, the CDC federal contracts have not had to deal with partial overlapping combinations. We've generally had competition based on individual vaccine antigens. Coming down the pike, however, are overlapping combinations, and we will have to develop a procurement policy that may be somewhat different than we've had before... It has to be resolved one way or another."
You can express your views on this article, or other relevant themes, in the Infectious Diseases in Children Specialty Forums.