Chapter 1: Uniting Against COVID-19

The global medical research community is joining forces in unprecedented ways to combat COVID-19. Universities, public health organizations, biotechnology firms, and pharmaceutical companies are collaborating to repurpose existing medications, devise new treatments, and create effective vaccines. What progress can we anticipate and when might it arrive?

This overview highlights the current "pandemic pipeline":

1. Repurposed Medications

The most immediate options for assisting patients with severe COVID-19 cases involve strategically utilizing existing medications. Healthcare professionals worldwide, eager to save their patients' lives, are experimenting with established drugs for "off-label" use.

The leading candidates for COVID-19 treatment focus either on the virus itself (such as Remdesivir, Lopinavir/Ritonavir, or Chloroquine/Hydroxychloroquine) or on modulating the immune response (like Tocilizumab, an anti-inflammatory). This second approach is based on the observation that some patients may suffer from harmful immune reactions, known as "cytokine storm syndrome."

To fully understand the safety and effectiveness of these investigational drugs, thorough clinical trials are essential — ideally employing the gold standard of large, randomized, placebo-controlled studies. Many such trials are currently in progress globally, with results expected in the coming months.

The World Health Organization is overseeing a significant global mega-trial, the SOLIDARITY trial, which will compare four candidate treatments against standard care: (1) Remdesivir; (2) Lopinavir/Ritonavir; (3) Lopinavir/Ritonavir combined with interferon beta; and (4) chloroquine.

While there is hope surrounding these treatments, it is crucial to remember that they remain unproven. Their potential stems from anecdotal evidence and small, often poorly controlled trials. Experimental use can be risky and may affect the availability of these drugs for their established purposes (for instance, using chloroquine for systemic lupus erythematosus).

The guidance for healthcare providers and the public is clear: these drugs should only be used within the framework of clinical trials (as recommended by the US Centers for Disease Control).

Read more about investigational COVID-19 treatments: BMJ best practice.

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2. Convalescent Plasma

Similar to how breast milk protects infants through its antibodies, plasma from individuals who have recovered from COVID-19 may provide temporary antibody-mediated protection to others. Antibodies work by binding to and neutralizing pathogens, akin to law enforcement apprehending a criminal.

This method, which involves collecting plasma from recovered patients, has been utilized in previous outbreaks, including the 2009–2010 H1N1 influenza pandemic, the 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic, as well as Ebola, with mixed results.

As with other experimental therapies, clinical trials are necessary to evaluate the effectiveness of convalescent plasma for COVID-19. Trials are already underway (such as a small study in China expected to conclude in July 2020). The US FDA is also facilitating clinical testing by permitting an emergency IND pathway for licensed physicians (although they do not supply the plasma directly). Even if convalescent plasma proves safe and effective, widespread use would face significant logistical challenges.

3. Emerging Treatments

Currently, there are over twenty-five potential new therapies for COVID-19 in development, led by numerous biotech companies along with a few academic initiatives. Most of these therapies leverage the established antibody approach, while others explore various novel methods, including siRNA (small interfering RNA), nanoparticles, and recombinant proteins.

The journey to market for a new drug typically spans several years, even once a strong candidate is ready for human testing (with timelines averaging 5–7 years, particularly for precision oncology) at a cost of hundreds of millions of dollars. Novel technologies often take much longer (over a decade from initiation).

These lengthy timelines reflect the numerous hurdles a drug must overcome, from Phase 1 safety trials (to determine dosing) to smaller Phase 2 efficacy trials, and finally to larger Phase 3 trials that provide insight into efficacy in target populations through randomized, placebo-controlled studies. Concurrently, developers need to establish methods for scaling up production without compromising drug purity and safety.

Regulatory agencies may allow expedited approval for groundbreaking drugs intended for life-threatening conditions; however, even accelerated timelines imply "few" years instead of "many." A 2017 report on ten cancer drugs, half of which received expedited approval, revealed an average development time of 7.3 years (ranging from 5.8 to 15.2 years). Thus, even in 2021, the timeline for new therapies to become available (beyond clinical trials) appears optimistic.

4. Vaccine Development

A protective vaccine stimulates the host's immune system to enhance its response to future encounters with the pathogen. Essentially, it prepares a reserve of immune cells to act swiftly upon encountering the virus. When a vaccine is successfully deployed, it can halt viral transmission by creating "dead-end" hosts.

Remarkably, within just a few months of COVID-19 emerging, more than sixty potential vaccines are already in various stages of development, pursued by numerous biotech firms, often in collaboration with leading academic institutions. These candidate vaccines utilize diverse mechanisms, including attenuated live viruses, adenovirus vectors, recombinant proteins, and free DNA or RNA.

The speed of vaccine development is constrained by many of the same challenges faced in drug development — extensive safety and efficacy testing and scaling up production — and is complicated by the necessity for multiple doses. Consequently, although some phase 1 safety trials are already enrolling participants, widespread availability of vaccines is unlikely before early 2021, assuming all goes well.

Will the Results of COVID-19 Research Arrive Too Late?

Although the medical research conducted today may be too late for many affected by COVID-19, the potential benefits remain significant. Repurposed drugs present the most immediate opportunity for enhancing standard care, provided production can meet demand, which could occur in just a few months.

Novel therapies and vaccines might become available as early as 2021. These developments will be crucial for preventing future waves of COVID-19, whether from the original strain or emerging mutations. Furthermore, they can aid in combating new pathogens that may arise in the future, just as we are currently repurposing existing tools to address COVID-19 (SARS-CoV-2), some of which were designed for earlier pandemics.

The Bottom Line

The extraordinary collaborative efforts and investments being made by biotech firms, pharmaceutical companies, and academics worldwide are commendable, inspiring, and hopeful, yet the timelines are sobering.

Good science necessitates time. Even with unprecedented acceleration, there are limits to what can be achieved swiftly. Over time, we can learn how to best utilize existing drugs, develop new treatments, and safeguard ourselves with vaccines. All of this can be done safely and effectively.

While some barriers to the pace of medical research are fixed, others can be dismantled through groundbreaking technological and regulatory advancements, alongside the funding to support these endeavors. When this pandemic subsides, my greatest hope is that the global community channels the extraordinary energy and resources currently focused on combating COVID-19 into significantly enhancing our preparedness for future outbreaks.

In 2015, following the Ebola outbreak, Bill Gates delivered a TED Talk titled "The Next Outbreak, We’re Not Ready." The surge in views of his talk (over 19 million as of March 26) suggests that the public is ready to listen. The question remains: Are we prepared to act and invest? To prevent a sequel to the COVID-19 crisis, we must take action.

Finally, do not underestimate your role in alleviating the pandemic. The impact of COVID-19 on our society rests as much in your hands as in the hands of scientific progress. Please contribute to flattening the curve: maintain physical distancing (2 meters from others), wash your hands frequently and thoroughly, refrain from touching your face, and seek testing if you suspect you may be infected.

About Me

I hold a PhD in human genetics and spent the first decade of my career in cancer research, drug development, and personalized medicine.

Now, I focus on empowering others to make informed health choices grounded in facts, not fears. I am also passionate about inspiring individuals to embrace the benefits of plant-based nutrition.

The second video explains COVID-19, along with methods for prevention and treatment.