October 01, 2020
New York Daily News
As with everything else, Donald Trump likes to boast about how quickly we are moving toward developing a coronavirus vaccine. By historic standards, he has a case. We may have a vaccine through the final Phase 3 tests and approved by the Food and Drug Administration (FDA) before the end of the year.
However, this pace may still leave us months behind China, which has four of the nine vaccines in the world now in Phase 3 testing. One or two months matters a great deal in this story. If we can begin to get people vaccinated sooner, it can mean hundreds of thousands fewer people will get infected and tens of thousands fewer will die. It will also mean that the economy and our lives can get back to normal one or two months sooner.
If we end up needlessly waiting for a vaccine, it will be because of the way Trump chose to pursue the vaccine’s development. In the first months after the pandemic broke out, scientists made extraordinarily rapid progress in understanding the virus’ key features. This resulted from an unprecedented level of international cooperation in which scientists quickly and freely shared their results on the web so that others could learn from successes and failures.
We could have continued in this mode of collaborative open research in the pursuit of treatments and vaccines. But this was not the path we pursued. As Trump pushed $10 billion of taxpayer dollars out the door to finance further research, it was with the understanding that any vaccines or treatments would be subject to government-granted patent monopolies, with the companies determining who gets a vaccine or treatment.
This is the basis for the vaccine race, where it now looks like we will be a second-place finisher, at best.
If we had gone the collaborative research route, we wouldn’t be a situation where we might be watching China jump ahead and begin vaccinating frontline workers and vulnerable populations while we still see the pandemic spread unabated. In that world, as soon as China, or any country, had developed a successful vaccine, everyone would have access to it, or at least every country with manufacturing capability. Since there would be no patent monopolies, we would just need the technical expertise (which we have) to begin to manufacture and distribute whatever vaccine(s) seemed the most promising.
If we had gone this route, we would have needed some international agreement on sharing research costs. This would presumably be based on a countries’ size and wealth. While we would not have time to work out a deal that all countries would see as perfectly fair in the rushed time frame we faced, in a context where we see more than a million deaths and the loss of trillions of dollars of economic output worldwide, it really doesn’t matter if we ended up paying $100 million too much or too little for research.
If we had gone the collaborative route, all the test results would be fully public as soon as they were available. That means that when China had results of its Phase 1 and Phase 2 trials, everyone would see how promising their vaccines were. As they moved forward with Phase 3 tests, the results would be available to the whole world at the same time that China’s researchers had them.
This raises two questions.
First, can we trust China to be fully open? We can never know for sure without having a deal, but the reality is that China has complied reasonably well with the international agreements into which it has entered. In any case, if China did not meet its commitments to openness, this would be a very visible breach. That presumably makes it less likely that China would back out of its commitments as opposed to something that is less transparent, like prohibited subsidies for exports.
The other point is that we may not be satisfied that China meets our standards in approving a vaccine. For example, it has already pursued widespread use of its vaccines for frontline workers through emergency use authorizations. In general, the FDA would not grant such authorizations until there were strong results from Phase 3 trials.
This issue should not be a concern. The FDA would make its own determination based on the evidence available. If it turned out that Phase 3 trials of China’s vaccines were not sufficient to determine that they were safe and effective, then the FDA would not approve them. We would use our safety standards, not theirs.
The failure to pursue a cooperative vaccine development is a real tragedy. This could have been an incredibly important example of the value of global cooperative medical research. As it is, it is lining up to be just one more Trumpian failure.