At a symposium [1] in October, 2020, a panel of scientists, academicians, journalists and public health experts came together to describe the US government’s COVID-19 vaccine trial program and the ways they are protecting the integrity of the process of design, regulation, safety and efficacy assessment, communications, and recommendations for access, allocation and use of the vaccine. Accurate, truthful information about both the development and deployment of vaccines is absolutely critical given both the importance of the topic and the amount of misinformation that continues to circulate.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, gave an excellent overview of all of the companies and researchers involved and their roles in the vaccine development program, Operation Warp Speed. This program has reached unprecedented levels of cooperation and coordination between academic centers, government agencies and industry. At the time of the talk there were four phase 3 trials underway. As to other players, he reminded the audience that it is the CDC who recommends who is vaccinated as well and when and which vaccine. They are also the organization that defines who has the priority to receive the vaccine when there is not enough vaccine for everyone. Following Dr. Fauci, Dr. Moncef Slaoui, the Chief Advisor of Operation Warp Speed, working for $1 per year, went on to describe the progress and coordination of this massive effort.
Dr. Francis Collins contributed perhaps the most interesting summary of the afternoon describing the “unprecedented science going on that should give people confidence that we are trying to arrive at solutions.” He reminded the audience that the title, Operation Warp Speed, in no way suggests that the project will be moving too quickly or too unsafely. Instead, he said, “It is cutting corners with bureaucracy….it is certainly not cutting corners with safety or efficacy.” Perhaps most importantly, the data and safety monitoring board charged with making decisions about moving forward with the vaccines is the only “unblinded group” that will have full access to all results of the studies. The board will have access to all of the groups and companies’ data, all except Pfizer. Having a group that is able to look across the data from all of the different groups is absolutely key to safely and rapidly developing vaccines. The companies, he said, are fully onboard for not putting anything forward that does not meet the “high expectations” of the board. The FDA has put forward “clear guidelines for safety and efficacy” that must be met before release. At that point, there will also be a public discussion where all interested parties can review the data. Dr. Collins then reassured the group saying, “It would be pretty darn hard for mischief to derail this process.”
As an optimistic participant in this project, Dr. Collins is hoping for one or more vaccines to be ready by early January. He described that we do have a National Academy panel ready for distribution, but he reminded the group to be sure we are focusing our attention globally. He went on, “We in the US have been so focused on ourselves for the most part that we haven't paid enough attention to the fact that we're part of a global community, and we have a moral imperative to consider that as part of any plans that we make. That clearly needs to be worked on probably and talked about a bit more than it has so far given the tendency we have to look in the mirror at ourselves.” He concluded his section that we must address the issue of “vaccine hesitancy” through public education and reminding the group with the following words, "Let's not slip into this polarization of everything circumstance that seems to be the only way we talk about any topic these days."
Dr. Ellen Mackenzie, Dean of the Johns Hopkins Bloomberg School of Public Health, concluded the afternoon with the following words, “The importance of scientific integrity, data integrity, and the fundamental principle that while our science does need to impact the body politic it must be free of political interference....The primacy of science must be vigorously defended and upheld by us all. And our science must be conducted in a way that benefits all segments of our society.” Scientific integrity, thankfully, has not been and will not be compromised in this important race to develop a vaccine for COVID-19.
[1] Preserving the scientific integrity of getting to COVID-19 vaccines. 6 Oct 2020. A Johns Hopkins University + University of Washington Symposium
https://coronavirus.jhu.edu/live/events/covid-19-vaccine-symposium
- Claire Hillier
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