IT IS going to take a lot more than a vaccine to ease the COVID-19 crisis.
Disease-fighting drugs, testing kits and eliminating bureaucratic stumbling blocks will get us out of the woods.
The international scientific and medical communities are scrambling to quell the COVID-19 emergency, searching desperately for vaccines and antiviral treatments.
As a researcher for a biotechnology company at the forefront of the pandemic response, it’s been exciting to witness the phenomenal progress being made by the industry and the speed records being broken nearly every week.
All eyes are now on a potent coronavirus vaccine as the best way for preventing people from falling ill. Effective vaccines, however, take a long time to develop and even longer to test. Expert opinions suggest that in a best-case scenario, a vaccine against SARS-CoV-2 infection may only be available towards the end of 2021.
Questions around the affordability, reimbursement and approval of a future vaccine are still up in the air as leaders grapple with more immediate concerns. While research funding mechanisms are being put into place, not everyone is racing to cash in on being the first to market with a COVID-19 vaccine. A hive of behind-the-scenes activity has been reported, with pharma companies coming together to bridge scientific and technical gaps collaboratively, putting aside matters of margins, market potential and intellectual property.
Ultimately, a COVID-19 vaccine will serve as a durable long-term solution, but its widespread availability will undoubtedly be restricted as production scalability, politics and economics create barriers to global immunization.
While vaccine development proceeds in the background, right now, healthcare systems in coronavirus epicenters and the global economy are on the verge of collapse. Stopgap therapeutic solutions and agile regulatory processes are urgently needed to help forge a permanent path out of the COVID-19 crisis.
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COVID-19 Therapeutics: Short-lived But Immediately Available Protection
The quickest way to tackle COVID-19 is to use already-approved drugs to reduce viral replication and inflammation in patients’ lungs. Medications for diseases such as malaria, Ebola and HIV have been flagged as low-hanging fruit.
Repurposed drugs don’t need to be subjected to the same rigorous safety and efficacy testing and are available in the quantities required for immediate deployment.
Unfortunately, despite some positive anecdotal reports, the 7 ongoing clinical trials with repurposed drugs have yet to yield compelling results in patients with COVID-19 infections.
Another approach is to mine for specific antibodies against the coronavirus in blood samples of patients who have recovered from COVID-19 and use these to develop and manufacture a treatment. Though short-lived, therapeutic antibodies can temporarily protect medical personnel at the frontlines, as well as family members of COVID-19 patients. Antibody drug infusions can also reduce the severity of symptoms in critically ill patients.
According to projections, an antibody-based therapeutic could be ready for global distribution as early as September 2020.
When it comes to triggering a rapid pandemic response, such antibody interventions could be key. Scientists have found a way of further accelerating how quickly antibody drugs can be rolled out to the masses — using genetic material as a drug modality. Biologic medical products like antibodies are notoriously difficult to mass produce and distribute.
Creating antibody drugs using genetic material, however, bypasses these production hurdles. Here, patients are administered with the molecular instructions to manufacture disease-fighting antibodies in their own bodies.
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Digital Technology Turbocharges Drug Discovery Efforts
It typically takes 10 to 15 years and a $2 billion investment to bring a single FDA-approved drug to market. Under pressure from COVID-19, biotech innovators are leaning heavily on artificial intelligence (AI) and other digital technologies to profoundly reduce these timelines. By helping to make sense of the colossal amounts of COVID-19 information that have been generated, AI has continued to make a remarkable impact on the creation of novel solutions.
AbCellera, a Canadian antibody discovery company, screened 6 million immune cells from a blood sample of one of the first US patients to recover from COVID-19. With the help of its AI-powered platform, the biotech identified more than 500 unique human antibody sequences (the largest panel of antibodies against SARS-CoV-2 to date) — all within a week. Top-tier pharma Eli Lilly has partnered with the company to co-develop these antibodies into potent COVID-19 drugs, with the first human trials scheduled for July.
AI is also supporting patient care through better COVID-19 testing kits, yet another pressing need which has been choked off by supply chain shortages. In just two weeks, global health IT start-up Biofourmis, founded in Singapore, developed a COVID-19 biosensor that is worn on a patient’s arm. The device pairs with an AI-driven diagnostic application, which could significantly reduce the risk of infection for doctors and healthcare personnel through remote COVID-19 monitoring.
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Less Red Tape for Faster Patient Access
Even the most innovative and agile team’s progress will eventually come to a grinding halt, in the face of regulatory bureaucracy.
The US Food and Drug Administration (FDA) has a standard drug approval process that involves multiple phases to assess a treatment’s safety and efficacy in clinical trials. The quickly escalating COVID-19 situation has many hoping that the FDA will fast-track testing for promising antiviral therapies. Under such accelerated programmes, regulatory bodies could grant “expanded access” for patients in critical condition to receive experimental treatments before testing is complete.
While the FDA is expediting the approval of COVID-19 diagnostic kits, no announcements have been made about potential therapies following the same track. Presently, expanded access has been granted to only one investigational treatment (that uses the plasma of COVID-19 survivors) and is being authorised by the FDA on a case-by-case basis.
The current lack of incentives for drug developers to invest in COVID-19 treatments might prove to be too little too late for countries in the throes of the pandemic. An exponentially rising number of cases means that drug regulatory bodies need to be adaptable, flexible and decisive to stay ahead of the curve.
The World Health Organization (WHO) recently launched The Solidarity Response Fund, a giant international trial for testing four drugs against COVID-19. Should a potential therapeutic emerge from this Fund and the hundreds of other ongoing trials, regulatory constraints shouldn’t impede patients’ access to life-saving treatments.
There’s no turning back with COVID-19 — a disease that’s already altered history and left global communities reeling in its wake. Innovators are working in synergy to cripple the pandemic, putting potential solutions into development pipelines at an unprecedented pace. In the lead up to a vaccine, leaders and regulators need to match this momentum and adapt the drug development landscape to respond quickly to global emergencies.
Tara Fernandez is a Vancouver-based cell biologist and science writer in the biotechnology industry. She specialises in demystifying the latest scientific breakthroughs and reporting on technology news and trends. For the latest, follow her on Twitter or LinkedIn.
