Running a tightrope towards vaccine development

The name “Operation Warp Speed” brings to mind an image of exploring the galaxy at the speed of light, while stars streak by. This is the name the Trump Administration has decided to give the interdisciplinary effort of the U.S. government to facilitate vaccine development for COVID-19. According to the fact sheet listed on the Department of Human Health Services’ website, the goal of this endeavor is to deliver a COVID-19 vaccine by January 2021. President Trump has moved beyond this already lofty goal, offering an “October surprise.” 

“I would characterize vaccine development as more akin to running along a tightrope, rather than traveling at the speed of light. This high-stakes acrobatic walk must balance safety and efficacy on one side and emergency and necessity on the other."

-- Luke Watson

This begs the question: It is now October, so where are we in this process? My goal today is to build off of my latest article in my Beat here at the CGS Speaks blog, which touched on vaccine development, from idea to distribution. Today I want to discuss the likelihood of having a vaccine this month, given the current state of clinical trial progression. All the while, I will avoid mentioning politics because who really wants to read more about that during an election year. So, here we go!

I would characterize vaccine development as more akin to running along a tightrope, rather than traveling at the speed of light. This high-stakes acrobatic walk must balance safety and efficacy on one side and emergency and necessity on the other. In my previous article, I mentioned that vaccines can take more than 10 years to enter the market. This timeline is largely due to the meticulous efforts in ensuring the safety and efficacy of the proposed vaccine. To an academic, this makes sense. Every “i” needs to be dotted, the data need to look just so, and all of those p values must be below 0.05 (or whatever your threshold may be). But this caution is often highly scrutinized by the lay public who rely on the acquired immunity that vaccines provide to potentially deadly viruses. Lean too far to one side, and these vaccination efforts may just fall off the tightrope completely.

One way around this is to lessen the distance to the end of the rope. I previously pointed out the amount of time it takes to move out of the preclinical space into the clinical one, because of the monumental efforts it takes to find valuable biologic targets for a vaccine. With COVID-19,  vaccine development is different because the federal government and philanthropic organizations are stepping up in a big way to address this. 

Much of the preclinical and clinical development process during normal vaccine development chugs along methodically to avoid wasting time, resources and money. This means that after their average 10- year investment, these companies may have spent many millions (maybe even billions) of dollars in moving a vaccine through the pipeline. This cost sounds staggering; however, the burden is typically borne over the 10 years of research and development and is generally offset by already market-approved therapeutics and seed funding. 

A way to bypass this normal procedure is to infuse organizations with large sums of cash, which is one of the core tenets of the “Operation Warp Speed” mission. This infusion of cash ostensibly eliminates the risk for trial and error with vaccine development, meaning that companies can tackle multiple projects at once. There are now tens of companies that have moved candidates into clinical trials, with a handful in phase 2/3 trials. These trials are each enrolling more than 30,000 participants. Some companies expect to have efficacy data as early as this month.

So, are we likely to have a vaccine widely available this month? 

The answer is unfortunately a resounding no. I do anticipate data from the completed clinical trials to trickle in over the next few months, and that data will give us a better understanding of whether the FDA can approve a vaccine. But then it will take time to produce and distribute the vaccines worldwide. “Operation Warp Speed” is providing money for that, too, and so what may have taken a couple of years may take as little as a few months.

The reality of our situation is that the first COVID-19 vaccine is going to blow the world record for quickest vaccine out of the water. Unfortunately, it is unlikely the vaccine will be widely available at the start of the next year. I hope everyone can remain patient until it is ready, because this is the fastest funambulism, or tightrope walking, to date and I cannot imagine expediting this process any further. Until next time!