Professor Dorit Rubinstein Reiss, a frequent contributor to this and many other blogs, has published an important article, “The COVID-19 Vaccine Dilemma,” regarding the pitfalls and challenges to bringing a new COVID-19 vaccine to the market.
Professor Reiss, for those of you who may not know, is a Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), writes in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
The paper, published online on SSRN (and can be found here), discusses significant points regarding how we should proceed with the development and manufacture of a new COVID-19 vaccine. As I’ve discussed before, the rush to getting a new vaccine is necessary, but we should be aware of all that is necessary to get a safe and effective vaccine for the people of the world.
I’m going to hit the most important points of the article that I think is important to the conversation about developing a new COVID-19 vaccine.
“The COVID-19 Vaccine Dilemma”
Let’s start with the abstract, which obviously sets up the whole premise of the article, establishes the key points about the critical considerations in our high-speed drive for a new vaccine.
COVID-19 has led to large numbers of deaths, harms, and financial costs. Without an effective vaccine, those will continue. The pressure to find a vaccine is high; and that pressure creates a risk that the safeguards in place to assure that vaccines are safe and effective will be ignored. The U.S. has an extensive apparatus to oversee vaccine safety before and after licensing, including multiple federal committees and several monitoring systems, and that apparatus gave us, in 2020, an extraordinarily safe vaccine supply. This article explains the different pressures that push for and against using the same apparatus for COVID-19 vaccines, including the extensive harms from the disease on one side and the need for a vaccine that is, in fact, safe and effective from the other. It examines the options for speeding up the process without sacrificing too much oversight. It examines which “shortcuts” are reasonable, which may be challenging, and which are bad ideas. Finally, it addresses three messaging challenges – overselling, undersharing, and responding to misinformation – and suggests how to handle them.
Professor Reiss sets up how we should proceed with the development of this new vaccine:
Generally, the vaccine development process takes many years. But waiting the usual years or decades will lead to many deaths and extensive harms. The pressure to get a vaccine to market fast is immense because the costs of allowing COVID-19 to go unchecked are very high – but speeding up the process comes with real risks. The United States has a very robust system for testing vaccines and monitoring their safety. That system has resulted in an extraordinarily safe vaccine supply. Some things can and likely should be done to speed it up; there are things that may be done that are more controversial – and there are things that likely should not be done. This article examines what can or should be done to speed up COVID-19 vaccine development, but also what shouldn’t be.
Pressures may lead to errors and failures in three spheres: oversight failures, ethical failures, and messaging failures. The pressure could lead to unjustified corner-cutting in the testing process for the vaccine and pressures on oversight bodies to ignore problems even after the vaccine is licensed. Yet, in the pandemic context non-action also carries real costs, and in such times, there is no cost-free or risk-free choice. Both sides of this dilemma need to be considered when
Other concerns are about messaging failures, such as over-optimistic messaging promising more than reality supports, as well as messaging that creates concerns in the public that the vaccine produced will be unsafe – even when that’s not the reality.
Prof. Reiss takes on this topic in four parts:
- The regulatory framework. Professor Reiss reviews the normal considerations that govern vaccine licensing and monitoring during non-pandemic times. She examines the clinical studies and regulatory pathways for a “normal” vaccine plus other important factors about vaccines. And she reminds us that most of the time vaccines frequently need to be re-developed to improve its safety and effectiveness. Sometimes I think people believe that once we have a vaccine candidate, it’s a slam dunk to get a viable vaccine. This section should disabuse the casual reader of that notion.
- COVID-19 and the challenge to vaccines. There will be, and frankly already is, substantial pressure to speed up the process to get a new COVID-19 vaccine on the market. Getting a safe and effective vaccine on the market even one week early could save thousands of lives. Of course, bring a vaccine that is neither to the market could also cost us thousands of lives. It is a Hobson’s Choice, almost making it feel like there’s nothing but bad choices. However, it’s important to note that for all vaccines on the market, the safety issues are vastly lower than the risk of the disease – it’s a standard that, despite the claims of the anti-vaccine world, has given us the best vaccines. Professor Reiss wants us to maintain that standard.
- Our options. The article lays out how we might push ahead with a vaccine, even if it only comes to the market just a few months earlier. Prof. Reiss examines vaccine challenge trials, something that are being pushed by a lot of people, even though they may not actually speed up the process for a new COVID-19 vaccine.
- Messaging challenges. Reiss examines three major pitfalls of pushing out a new vaccine too quickly – overselling selling the data creating overoptimism about the vaccine, underselling safety concerns, or enabling misinformation that could lower confidence in a new vaccine. If every agency that is involved in bringing this vaccine to us ignores the potential contradictory messages from certain groups like anti-vaccine activists, there could be major issues with the uptake of the vaccine.
These would be critical concerns for “normal” vaccine development, but they become evermore crucial while trying to develop a new vaccine for this particular pandemic. Because of the rush to get a COVID-19 vaccine, we may not do this right, and we don’t protect ourselves from this deadly epidemic.
Professor Reiss wraps her article with these words:
Practical and political pressures can combine to push to inappropriately rushed vaccine development – and can backfire.
We have a remarkable system for testing vaccines and monitoring their safety, and we should let it work in this case, too. While we should make adjustments where we can do so without sacrificing safety, we should make sure we are, indeed, not sacrificing safety or effectiveness.
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