“Warp Speed” is a name that does not inspire confidence. It is a politically inspired slogan, not a serious name for a campaign to save lives. It suggests speed, not carefulness. It suggests politics, not science. The success of Warp Speed is going to depend on the American public accepting the vaccine and believing that it is both safe and effective. We must not let politics interfere with this process. We all need to be vaccinated for this to work. I take this personally because I have an immune deficiency. I need everyone to be vaccinated to not transmit COVID to me (or to anyone else). And because I do not make immunoglobulins reliably, I am not sure that a vaccine will protect me. So, I really need everyone to be vaccinated. If many refuse vaccinations, I am in trouble (and so is the rest of the United States). If people see the Warp Speed program as tainted by politics, they may be less likely to take the vaccine. Already polls have revealed a significant number of people who doubt that they will accept the vaccine. To win their trust, we must be open and transparent about the program. There are potential problems in Warp Speed. While I hope they do not occur, we should be pointing them out now. And we should be emphasizing the reasons for moving ahead now. Warp Speed prioritized getting a vaccine as fast as possible, and it has succeeded. But speed raises other potential problems. The studies that are being submitted to the FDA for approval have two months of follow up. Thus, we only know that the vaccines are safe and 95% effective for two months. They may be safe and effective for a longer time, but we do not know that yet. The first doses are planned to be given to health care workers and residents of long-term care facilities. The health care workers should realize that they are the population that will test whether there are long term adverse effects after two months and whether the vaccine is effective for more than two months. If the first doses are given in December, we will find out if there are problems at the earliest in February or March and possibly not until months later. There were older adults included in the original trials. They were community-dwelling seniors who volunteered to be inoculated. The older adults who reside in long-term care facilities will be older, frailer, and have more co-morbidities than those in the trials. Those older adults will be testing whether the vaccine is safe and effective for them. We will have the initial results by February or March and the longer-term results perhaps later in the spring. In a non-COVID world, a new vaccine would be developed and tested over the years. In today’s world, vaccines are being brought to the FDA for approval in months. The two-month testing was done under double-blind, randomized, carefully controlled conditions. The follow-up will be done in the real world, first in front line health care workers and the frail elderly. Most of the rest of us will probably not be receiving the vaccine until the spring or summer, and we will all be watching to see the long-term results for the health care workers and the frail elderly in facilities. Because they are in the real world and not in a randomized controlled trial, it will be more difficult to parse the results. We are betting the health of millions of people that Warp Speed is going to work. As we have too much to lose by delay, I believe that we should be going ahead with this bet. For Warp Speed to be successful, we all must be ready to step up for vaccination. While I hope that there are no problems in the real world two months after vaccination, that remains to be seen. More vaccines coming to market might be safer and more effective for longer than the two months that we know about for the current vaccines. To keep trust in vaccines, we should be explaining to everyone what could go wrong and what we will do next if there are problems. Protecting me (and everyone else) from COVID depends on doing this right. David Galinsky is an internal medicine physician. Source
