What could go wrong with the coronavirus vaccine? I have opinions. I am not a virologist or an infectious disease specialist. I am just a doctor who has been following the pandemic in the journals and in the newspapers. But I am worried because there is a lot that could go wrong. There are the usual problems that we all know about. The vaccine will not work because it does not induce enough antibodies; it produces antibodies, but the antibodies do not kill the virus; it kills the virus, but the antibodies only last for a short time; there are bothersome side effects. These are the problems that must be overcome with every newly developed vaccine. But I worry about what else could go wrong. Here are some nightmare scenarios. A pharmaceutical company issues an optimistic press release when an advance in the development of a vaccine occurs. Invariably, the stock market jumps. The country has the sense that we are soon to vanquish COVID. The general public starts to ignore masking and social distancing. Governors relax state guidelines. We know what happens next. Cases, hospitalizations, and deaths rise over the next month. But it could be worse. The vaccine could produce enough antibodies to kill the virus and be effective for a long time but with a low level of serious side effects. What level of serious side effects would regulators accept when approving the vaccine? When balancing public health versus the need for the nation to be rescued from economic collapse, where will the balancing point be placed? In many states, the balancing point has been pushed toward economics over health. So, I have little confidence that the approval process will not be compromised by political considerations. I am also worried about how the vaccine will be tested. It must protect older adults with co-morbidities. How will they populate a test group with elderly, obese, diabetic, hypertensives, with heart disease? It is much easier to test the vaccine on healthy 20 to 40-year olds. We could end up with a vaccine that does not protect the most vulnerable who need protection the most. And it could be even worse. If healthy elderly people are not included in the test group, we could have a vaccine that only protects younger people. As we age, our ability to mount an immunologic response decreases. That is why we have a high dose influenza vaccine for people over 65. The coronavirus vaccine must also be sufficiently immunogenic to be effective in healthy older adults. And worse yet, there could be side effects that come on slowly after the vaccine is given. Under the terms of the “warp speed” vaccine program, pharmaceutical firms have been encouraged to ramp up production facilities so that there will be enough capacity to administer hundreds of millions of doses as s? soon as the vaccine is approved. In normal times, there is a slow ramp-up that allows time for post-marketing studies to be done. With the increased speed, we will not have the post-marketing studies done until after the vaccine has been given to millions and millions of people. If there are long term toxicities, we will not know about them until too many people have been affected. But wait, it could be worse. The coronavirus might mutate. We could dodge all the problems above with a perfect vaccine that is no longer effective against the virus. This happened with the influenza vaccine in 2014 when that year’s virus mutated, and the influenza vaccine became ineffective against it. The coronavirus from Wuhan has been found to have mutated as it spread across the globe. So, it is possible that it could escape from whatever vaccine is finally developed, and then we will be in big trouble. None of these might happen, but these are the nightmares that I am having. I hope that everyone working to develop vaccines and make policies about vaccines are having the same nightmares, so that they do not happen in our waking life. David Galinsky is an internal medicine physician. Source
