As the novel coronavirus pandemic continues to rage across the U.S., people are yearning for a win after Washington’s spectacular failures to secure adequate supplies of testing kits and personal protective equipment. Success hinges on whether any of the fast-tracked Covid-19 vaccine candidates supported by the almost $10 billion federally funded Operation Warp Speed will save the day. With the aim of getting 300 million doses of safe and effective vaccines delivered by January 2021, the challenge is enormous.
This time frame of months rather than years poses many problems. A strategy of focusing on only the fastest methods may, in the end, yield no successful candidates. With funding concentrated on faster development, slower-to-develop solutions have been shunned. The priority must be to fund a balanced portfolio of vaccine prospects that may take longer to develop.
The vaccine for tuberculosis took 13 years, rotavirus 15 years, and chickenpox 28 years. Clearly with Covid-19, which has already had devastating economic and social consequences, that would be too long. The world has not seen a pandemic of this scale since the 1918 flu. This time around, scientists are armed with advanced methods, including genetic and viral vector prospects for vaccine development. Nevertheless, Dr. Gregory Poland, a leading vaccinologist at the Mayo Clinic, warns that the U.S. is in a “hare and tortoise” race that is not over until a vaccine is proven safe, effective, and scalable.
At face value, Operation Ward Speed carries a sense of national pride and has the potential to bring the pandemic to an end. The nationalistic element that shuns international cooperation, however, is particularly alarming. Washington has repeatedly made numerous missteps in its faltering battle against Covid-19. The most fateful one was perhaps the lost month between February and March 2020, during which the Centers for Disease Control and Prevention attempted to develop its own coronavirus test despite the availability of a German-designed test that had been used over 250,000 times worldwide. There is no reason to believe the same mistake will not occur again.
As of this writing, researchers around the world are developing over 155 Covid-19 vaccines. Most of them belong to one of four types: genetic, viral vector, protein-based, and whole virus. Operation Warp Speed selected a portfolio of eight vaccines: four of them are viral vector (developed by Johnson & Johnson, AstraZeneca, Merck, and Vaxart), three are genetic (being developed by Pfizer and BioNTech, which refused federal funding; Moderna; and Inovio), and one is protein-based (developed by Novavax).
Why is there no support for whole virus vaccines? The short answer is that they are antithetical to “warp speed.”
Whole virus vaccines use a mature technology that has been licensed for commercial use for over 70 years. Once verified as safe and effective, they can be produced with existing manufacturing facilities around the world and administered with minimal technical hurdles. The catch? Developing whole virus vaccines can take many years because scientists need to find an ideal amount of virus that protects individuals without making them sick. The fastest record of developing a whole virus vaccine is for mumps, which took four years. Therefore, “warp speed” is creating warped incentives: it rules out those whole virus vaccines judged too slow to develop.
Because Operation Warp Speed has a prespecified deadline, it becomes clear why seven of the eight U.S.-funded vaccines are viral vector and genetic candidates. These two types are fast-moving in the development process, and if proven successful in Phase III clinical trials, have some chance of meeting the January 2021 deadline. However, no genetic vaccine has been approved for human use, and viral vector vaccines have been used for animals and in some cases proven safe for human use, but yet to be determined to be effective.
Without any proven track record, there is a real possibility that none of these candidates will make it, especially under this artificially short time frame. The CEO of Merck, Ken Frazier, has said promising a vaccine by the end of 2020 is a “grave disservice to the public.” Even if one of the seven fast-track vaccines turns out to be safe and effective, scaling up volume and distribution will be a huge challenge. Viral vector vaccines face significant manufacturing hurdles, given the need for building new vaccine production facilities. Genetic vaccines have their own challenges, which include requiring very different delivery systems and stringent cold-chain handling requirements.
When making investment decisions, risks are reduced by investing in a balanced portfolio of stocks. Investing in Covid-19 vaccines with remarkably uncertain safety, effectiveness, and scalability should follow the same logic. Unfortunately, Operation Warp Speed is now betting on vaccines built with unproven technologies, which is highly risky. This strategy lacks diversification and does not combat the underlying risk because these methods share a common set of uncertainties. The sheer number of unknowns calls for a more prudent portfolio selection, one that involves a balanced portfolio to prepare for the unexpected.
Dr. Anthony Fauci and his scientific colleagues consider a safe and effective Covid-19 vaccine “an absolute necessity.” Yet this federally funded program is creating warped incentives for vaccine development. In fact, some fear that Washington may declare victory prematurely without fully understanding the side effects of the chosen vaccine. It is important for policy makers in Washington to realize that vaccination success, much like that in coronavirus testing, requires more than a speedy development process. Failure in any stage—verification, delivery, or administration—can mean failure of the entire effort.
To win the vaccine race, diversifying the portfolio should be a mandate. Haste may indeed make waste.
Tinglong Dai is an associate professor of operations management and business analytics at the Johns Hopkins University Carey Business School. Christopher S. Tang is a University Distinguished Professor and Edward W. Carter chair in business administration at the UCLA Anderson School of Management.