Warp Speed – A Rushed Job?

Sixty percent of people questioned in November said they would “definitely or probably” take the coronavirus vaccine. In September, the number was 51%, so the trend is good. However, the Pew Research Center said 39% of people polled would definitely or probably not take the vaccine, and 21% of people polled said they won’t take the vaccine and are “pretty sure” more information won’t change their minds. The poll found differences in willingness to get vaccinated based on political affiliation, race, and ethnicity. Whatever the perception, the forecasted numbers are a problem. The exact threshold to achieve herd immunity is not known, but Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said recently 75% to 85% of the population will need to get the vaccine to stop the spread of the virus.

What is going through the minds of the nearly 40% naysayers? Some people don’t trust government, and government has been much more visible than usual because of the high stakes of the pandemic situation. Some would say the politicization of the pandemic situation is part of the problem. I believe one of the factors in the doubters’ minds is the perception the vaccine development process was “rushed” and involved a lot of “cutting the corners”. Statements saying it “usually” takes up to ten years and naming the vaccines project Warp Speed fuel those feelings. To me, the key question is what is it which is different between the “years” case versus the “months” case?

My hypothesis is the difference is paperwork and related inefficiency. I don’t know anything about the internal workings of the FDA and CDC, but if it is anything like our healthcare system, there is likely a lot of paper and a lot of inefficiency. Reports said the FDA has 150 people working night and day on the analysis of the data. That doesn’t sound right to me. 150 people to analyze the data from a clinical trial?

Healthcare provider offices are well stocked with clipboards and Post Its. The authors of a new report which collected data from more than 20,000 physicians in nearly 30 specialties described the time physicians are spending on paperwork as “mind-boggling.” Nearly a third of physicians said they spend 20 hours or more a week on paperwork and administrative tasks. I wonder how much time of the 150 people at the FDA is spent with paperwork as opposed to cloud-based analytical and collaborative apps. I know there are many issues involving privacy, incompatible systems which collect the data, etc.

I was in a clinical trial once. It was all driven by paper forms. Just like with paper ballots, clinical trials are research investigations in which people volunteer to test new treatments. Researchers look at how people respond to a new intervention and what side effects might occur. The trials extend over four phases and involves a lot of paper. I believe the time can be shortened, and that is what Warp Speed has done.

Investors think time can be shortened also. When I last looked at angel.co, there were 255 startup companies focused on improving the efficiency of all aspects of clinical trials. There are 13,866 investors who have bet more than $1 billion on the startups. They are promising cloud-based technologies for collaboration and artificial intelligence to accelerate data analysis. I am 100% certain new technologies will have a big impact on the time and cost of getting new drugs and treatments available to patients.  It seems Warp Speed somehow broke through the barriers. Lets hope the trend continues beyond the current work on Covid-19 vaccines.

Mark Toshner is a University Lecturer in Translational Respiratory Medicine at the University of Cambridge and an Honorary Consultant Physician. Somebody referred me to a series of tweets he made last week about the subject I have been discussing in this post. I made some minor edits to make the multiple tweets flow as one story. Following is what Dr. Toshner had to say,

More on vaccines. I’m going to get boring and geeky on this (no apologies) on the 10 year thing. Vaccines “normally take 10 years”. This is being used as a reason to be fearful (ie rushed job). I’m a clinical trials doc. I can tell you most of that time is spent doing …. nothing. It’s spent submitting funding requests, then resubmitting them, then waiting, then submitting them somewhere else, then getting the money but the company changes it’s mind or focus, then renegotiating then submitting ethics, then waiting  for regulators …then having problems with recruitment and having to open other sites, then dealing with more regulatory issues, then finally when you eventually get to the end of all of this you might have a therapy … or not. At this point it may not be deemed profitable or any number of other obstacles.

However we have collectively now shown that with money no object, some clever and highly motivated people, an unlimited pool of altruistic volunteers and sensible regulators. That we can do amazing things (necessity being the mother etc). These trials have been nothing short of miraculous, revolutionary but in the context perhaps it is not surprising given our ability to innovate when we REALLY need to and we really needed to. Safety hasn’t been compromised. 100s of thousands of great people volunteered for experimental vaccines. The world watched closely. The press reported every serious adverse event. There have so far been a handful. A triumph of good people/good process. I am confident that when regulators and scientists pour over the safety data (and we will because we are a bit that way inclined) that vaccines will only be used if we are confident that the risk is definitively outweighed by benefit. This should give you confidence too.

Well said, Dr. Toshner. As I wrote in the Spring, there are a lot of positive things which will come from the silver lining of the dark cloud. One of the many things is what we have learned collectively. Data analysis and processes can go faster. As the startup companies promote their advances, at least one of them will introduce breakthrough technology which will enable warp speed to be part of the new normal.