How to accelerate vaccine development for COVID-19
I was telling some friends last night that the reason I have not posted about COVID-19 for over a month is because I have nothing new left to say. This is not quite true. There is one more idea I really want to make mainstream, but I have been holding back because it is quite controversial. This is about how long vaccine development should take. In a layperson’s mind, it might be the case that vaccine development is slow because creating the vaccine compound is slow. But this is not the case. The bottleneck is the clinical trial process. One thing I have talked about in the past is skipping Phase 2 and going straight from Phase 1 to 3. I am happy to see this is happening already with some drug trials. But now let us talk about how one can make Phase 3 quicker for a vaccine.
In a typical Phase 3 trial, the vaccine must be shown to be safe and effective in natural disease conditions. But this means letting people live their lives for several months to see if the control arm and the vaccine arm have different incidence of disease. This several-month process can be reduced to one month. How, you ask? In Phase 1, data is collected about antibody production. By the end of phase 1, it is known how long it takes for a person to develop antibodies. From this data you can calculate the time it takes for 99% of the cohort to develop antibodies. Here is my proposal: we do a single arm trial at Phase 3. This arm gets the vaccine at the dose that was determined to be effective in Phase 1. After the time required for 99% of patients to develop antibodies has passed, everyone is given the live virus at a dose that causes disease in a non-vaccinated person, and monitored for 15 days under hospital conditions to check how many get the disease. Those who may develop severe disease are prioritized in terms of intensive care.
People above 50 will be excluded from this trial, as will anyone with underlying conditions. This is because the risk of developing severe COVID-19 is much lower in people under 50 with no underlying conditions. How will we know if the vaccine works for people who are above 50 or have underlying conditions? My solution is that we do not give them the vaccine, we give everyone else to vaccine and develop herd immunity this way. For people above 50 or with underlying conditions, if they still develop severe disease, we treat them with convalescent serum from recovered patients and any drugs that are approved for treatment. This is a much better strategy because we know from other respiratory diseases like flu that vaccines typically do not work for the elderly. So the idea of developing a COVID-19 vaccine and using it to inoculate the elderly first is likely to be a failure. Extending the vaccine to those aged 50–60 may be considered at a later stage.
A typical phase 3 trial has 3000 patients, and in a country which is not made up of pussies, it should be possible to find 3000 such people. I understand that “civilized” countries like those in Europe and America will never design a trial this way. But I have hope for other nations to have the courage to do what is needed. I see several governments using the language of war when talking about this disease, and there would never be any hesitation to put the lives of 3000 soldiers at risk for a “just” war (say American soldiers during WWII). About 4500 US soldiers have died in the Iraq war, and that war had no purpose except making brown people miserable. So hey Trump, if this is a war, find some soldiers. For those of you who think I am asking something of others that I would never do myself, I would gladly participate in a single-arm trial that had shown exceptional promise in Phase 1.
