Tonight, I will receive my first dose of vaccine against COVID-19.
I’m a hospitalist on the front lines, taking care of patients with COVID-19 in Philadelphia.
The progress of this year takes my breath away.
One year ago, in December 2019 in China, people starting falling seriously ill with pneumonia-like symptoms. By January 2020, a novel coronavirus, SARS-CoV-2, was identified as the cause of the disease we now call COVID-19. Scientists immediately sequenced its genome. That code provided key instructions for vaccine developers and drug developers around the world.
By mid-March 2020, around the same time I was taking care of my first patient with severe COVID-19 disease during an overnight shift at the Philadelphia VA, the first messenger RNA-based vaccine candidate, from Moderna, began Phase 1 clinical trials. Last Friday night – less than a year after this novel virus was identified — the Pfizer / BioNTech mRNA vaccine was given Emergency Use Authorization by the FDA. Moderna is likely just a day or so away from similar authorization.
This is a biopharmaceutical marvel.
We’ve seen other paradigm-shifting accomplishments the past few decades. HIV was transformed from a uniformly fatal infection to a manageable, chronic disease. As a medical resident, I went from caring for patients dying from hepatitis C cirrhosis / hepatocellular carcinoma while awaiting liver transplant, to participating as a junior faculty member as a co-PI in the initial sofosbuvir (Sovaldi) trials, to seeing these patients cured -not treated, but cured -s with a pill and HCV disappearing as the leading cause of liver transplant in the US.
Those triumphs were decades in the making.
Speed isn’t the only thing that sets this example apart; the scientific challenges to developing vaccines for SARS-CoV-2 were, and remain, far more tractable than those for HIV or HCV, infectious diseases for which, after decades of research, no vaccine exists. Aside from the science, which is beyond my expertise, a few differentiating principles stand out that are worth calling out:
- Universal urgency – eliminating COVID is a priority for everyone in the world in one way or another; it has already killed at least 1.6 million people worldwide in less than a year. Because it is transmitted through the respiratory route, it has the potential to touch every one of us – anyone and everyone can theoretically get infected. That is not true of HIV or HCV, viral illnesses transmitted by sex, IV drug use and other close contact. Groups that were already marginalized were affected most; their “immoral behavior” was blamed. This wholly uninformed and prejudiced view was used by many as grounds to turn a blind eye, stigmatize those who were suffering and dying, and behave as if it was not their problem. In sharp contrast, as the global economy continues to struggle to reopen, and health systems strain under the burden of 72 million infected and 1.6 million dead worldwide, COVID is everyone’s problem.
- Operational and regulatory efficiency – the studies that lead to EUA designation, run by Pfizer and Moderna, collectively tested vaccine candidates in many tens of thousands of people. The sponsors worked with regulators on trial design early and often. Regulatory steps that were historically serialized were parallelized to ensure time was not lost to administrative delays. Large-batch manufacturing of vaccine candidates began months ago, long before safety and efficacy was demonstrated. These efforts were critical as nearly 3,000 people die every day in the US from COVID-19 disease.
- Massive investment – an unprecedented series of investments in the US exceeding $20B over the past nine months – from industry sponsors, Operation Warp Speed and others like the Gates Foundation – has accelerated critical steps in the process. This capital infusion dwarfs the paltry sums committed to HIV and HCV research in the first decade after their emergence.
- Improved recognition and inclusion of most affected groups in trials. While it was rapidly clear that the elderly and people with chronic health conditions like obesity, diabetes and cardiovascular disease were at high risk of severe disease, it took more time to fully appreciate, and then acknowledge, that Black, Latino and Native American communities were disproportionately affected by COVID-related illness and deaths. Once this was understood however, the Pfizer and Moderna trials were modified to increase enrollment of these historically underrepresented groups, to gather robust data across demographic groups in order to gain Emergency Use Authorization, and bolster confidence in the vaccine among populations that are in need.
- “Collaborative competition” and data transparency – the above factors culminated to create an environment where dozens of vaccine and therapeutic candidates are simultaneously in development globally. Where evolving knowledge is shared early and often through publications, case studies and other means. This creates an arsenal of strategies and shots on goal to fight this virus. It has allowed clinicians to refine and improve treatment strategies as data on therapeutics like remdesivir and dexamethasone was rapidly published and broadly disseminated. As I listened to the FDA advisory committee meeting last week and reviewed the data package for the Pfizer / BioNTech vaccine, I was struck by the unusually high degree of transparency from industry. This gives me confidence.
I am in no way suggesting that the process to get to this point was perfect. It is also not nearly over; additional studies will be required for full BLA approval, and the operational lift to vaccinate the majority of the global population is enormous.
But, in the face of extreme adversity, our system adapted. We can use this opportunity to learn, and to change how drugs and vaccines are tested, developed, approved, manufactured, distributed and used.
I am enormously grateful for the opportunity to care for some of the most vulnerable patients during this pandemic. I am equally honored to be among the first to receive a vaccine against COVID-19.
We will all take different things away from our experiences throughout this pandemic, and more broadly from this year of turbulence on so many other levels, societal and political. I choose to focus on what is possible if we adapt, focus resources in the right places, and come together around a common goal.
Today that target is COVID. What could be next?