COVID Vaccine – 4 Lessons from Speedy Development

The development of a COVID vaccine is one of the most closely watched human experiments in modern medical history. A defining moment shaped by global coordination, federal and private funding and will.

I’ve been thinking how this has played out. Here are a few thoughts on what we might take from the speedy creation of the COVID vaccine.

What has been done?

From the first identification of the SARS-CoV-2 sequences phase 1 trials were conducted in just six months. And now we have 2 viable vaccines in distribution inside of 10 months. Normally the sequence to develop, test and launch a vaccine takes 3-9 years. In the pain of the pandemic and the fog of the U.S. election we’ve lost sight of the fact that this is such a defining moment.

Here is a timeline of milestones compiled by Dr. Eric Topol and published on Twitter. Just look at this sequence and how quickly the steps in the sequence moved:

December 1 COVID-19 illness documented
January 10 SARS-CoV-2 virus sequenced
January 15 NIH designs mRNA vaccine in collaboration with Moderna
March 16 Moderna Phase 112 trial begins
May 2 Pfizer/BioNTech Phase 112 Trial begins
July 14 Moderna Phase 112 trial published in NEJM
July 27, 28 Moderna and Pfizer/BioNTech Phase 3 trial begins
August 12 Pfizer/BioNTech Phase 112 published in Nature
October 22, 27 Enrollment in both Phase 3 trials complete; >74,000 participants
November 9 Pfizer/BioNTech announces interim anaylsis efficiency >90%
November 16 Moderna announces interim analysis efficacy 94.5%
November 18 Pfizer/BioNTech announces 95% efficacy as final result
November 20 1st EUA submitted by Pfizer/BioNTech
November 27 Distribution of vaccine by UAL charter flights throughout U.S.
December 10 FDA External review of Pfizer/BioNTech EUA
December 11 Phase 1a Vaccination begins for health care professionals
Provisional on positive external review

Interestingly, once the viral genome was sequenced the creation of the vaccines was not particularly challenging compared to the trial logistics. In fact, Moderna’s COVID vaccine was reportedly developed in just 2 days.

All of this came together as part of a perfect storm. A new method poised and waiting to be applied (using mRNA to create a harmless antibody-stimulating ‘spike’ – no virus had to be cultured). Blistering infection rates drove the success of clinical trial recruitment. And the U.S. government, among others, were willing to put a lot on the line to accelerate parts of the process.

4 lessons from COVID vaccine development

And what were the broader forces that allowed this kind of high speed COVID vaccine development?

1. Urgency | With urgency we can accomplish amazing things

The most powerful force driving this timeline was urgency. As we watch the undulating behavior of SARS-CoV-2 across the globe we can see that a delay of a matter of months can come with the cost of thousands of lives. It was a race against time.

When working against a hard deadline, focused endpoints can force us to ship the most remarkable things. This defining medical moment should serve as a form of inspiration in what we do as individuals, start-ups, systems, and nations.

Most importantly, how might we apply this level of urgency going forward to solve some of healthcare’s most pressing challenges?

2. Collaboration | Industry and government can work together

The successful development of these vaccines was a collaborative effort between public and private stakeholders. Individually this success would have been considerably more difficult, if not impossible.

As an example of that cooperation the National Institutes of Health invoked a sweeping public-private partnership between Pharma and federal researchers (ACTIV) which objectively aligned stakeholders toward a standardized, measurable end-point. In terms of federal support of industry, Moderna’s 2.5 billion in federal funding was critical to its product development (Pfizer deferred federal money for vaccine R&D).

3. Process | For the first time a vaccine might be eclipsed by its developmental process

How we got to today from early 2020 is less about the novelty of vaccines as much as it is our capacity to put things together in such an accelerated way. When you think about it, the process of getting the vaccine somehow seems more remarkable than the vaccine itself. Kevin Kelly in The Inevitable: Understanding the 12 Technological Forces That Will Shape Our Future describes how products will ultimately be eclipsed by processes:

Processes are now more important than products. Our greatest invention in the past 200 years was not a particular gadget or tool but the invention of the scientific process itself. Once we invented the scientific method, we could immediately create thousands of other amazing things we could have never discovered any other way. This methodical process of constant change and improvement was a million times better than inventing any particular product, because the process generated a million new products over the centuries since we invented it. Get the ongoing process right and it will keep generating ongoing benefits. In our new era, processes trump products.

Think CRISPR and other scalable technologies. I suspect that these 21st century processes of biological engineering will eclipse the small minded widgets that impress us now.

4. Open Science | The global hive is critical to 21st century public health

In a world more interconnected than ever, today’s medical challenges don’t obey political or geographic boundaries. Pandemics are equal opportunity events. And so the hive mind of scientists across the globe will be critical to future challenges like The COVID-19 pandemic. Developed nations should be motivated to see the health of the global community as central to the health of their own citizens.

While open science certainly wasn’t central to what happened this year, the COVID-19 pandemic showed some hint of public health globalization. Labs and data repositories crossed silos to make information more readily available to those doing critical research — Digitalization made this kind of data sharing easier. Early on Chinese scientists shared the genome of the virus which was a critical first step toward vaccine development. Institutions and publications have done their part. Over 115,000 publications have published related to COVID-19 and more than 80% can be viewed by the general public.

While competition and IP incentives remain critical for innovation, open dialog and open science can and should be shaped to be mutually beneficial for all stakeholders.

A blueprint for our post-COVID next normal

Physicist George Dyson once said that the universe is a probability space in which all kinds of possible things can happen (2011 in the now defunct European Magazine). The combined human-tech intelligence that helped develop the COVID-19 vaccines will serve as an example of what’s possible when technology meets human will.

But could the urgency that brought us COVID vaccine success be part of the ‘next normal’ as described by Rasu Shrestha. Contrasting new norm and next norm: The new norm has a connotation of apprehension, uncertainty and the unknown. The next norm is what we’re purposefully creating and strategically going after. This next norm mindset embraces the power of pandemic will. The future is something that we create, not something that we wait for.

The distribution and adoption of the COVID vaccine, assessment of vaccine durability, and nimble response to SARS-CoV-2’s creeping evolution will bring new challenges in 2021. How we mobilize communities and social technology to combat vaccine hesitancy will be our next great challenge. But for now we should celebrate this historic feat.
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Image via the National Library of Medicine.

 
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