President Biden and his COVID-19 response coordinator Dr. Ashish Jha rightfully have been raising concern that “new variants may make some existing protections ineffective for the immunocompromised” and that some of the main tools we’ve had to protect this population may not work moving forward. Similar alarm bells sounded when thousands of infectious disease experts gathered for the annual conference of the Infectious Diseases Society of America (IDSA) where emerging news circulated that new strains of omicron were escaping the only two monoclonal antibodies available to prevent and treat COVID-19. How is it that we are in our third winter of COVID-19 variants with such a dangerously empty medicine cabinet?
The simple answer is that the virus is outpacing our regulatory review process. And the good news is that we have everything we need to change that — and to change it now.
As a pediatric nephrologist, I am deeply concerned about why almost three years into this pandemic we do not have a robust arsenal of updated therapeutics so providers can treat and protect the most challenging and vulnerable COVID-19 patients, like cancer and transplant survivors. The science exists because since the pandemic began, we have amassed a treasure trove of global data about the coronavirus that scientists are using to generate the best-in-class medicines to get ahead of not just the next variants but the next pandemic. Several companies are mining hundreds of antibody candidates and engineering the best ones to be potent, durable and broadly neutralizing. As evident in the dramatic decrease in deaths and hospitalizations from COVID-19 by deploying vaccines, antibodies and antivirals over the last three years, medical ingenuity can indeed boost human immunity.
The problem we’re facing now is that ingenuity and prowess alone are not enough. We still need a way to get medical innovations into the clinic — and, importantly, that pathway must be faster than the virus.
We are losing ground to the rapid and unpredictable mutations of the coronavirus. We must sharpen our focus and leverage lessons learned from the bleakest days of the pandemic when a vaccine was nothing more than a lab concept. Quarantined at home, with schools and businesses shuttered, our collective desperation and urgency forged an unprecedented partnership between federal agencies and the biopharma industry to streamline and support the entire process of researching, developing and distributing a novel vaccine. Operation Warp Speed worked. Now, is the time to renew that focus and urgency and apply it to next-generation therapeutics beyond vaccines.
There are 7 million to 10 million Americans who are immunocompromised, according to an estimate from the Centers for Disease Control and Prevention (CDC), and some patient health advocacy groups, including the Autoimmune Association, believe those numbers could be even higher. Many of these patients need monoclonal antibodies because their bodies are unable to mount a sufficient immune response to vaccines or boosters to protect them from COVID.
As a kidney transplant recipient, I’m one of those patients. That means that without a concerted effort to continually update therapeutics like monoclonal antibodies so that they work against prevailing variants, patients who have survived leukemia, live with kidney failure, have advanced HIV or are on immunosuppressants for multiple sclerosis are at grave risk for severe or fatal COVID-19 every time the virus mutates.
Antibodies have proven safe and effective in treating and protecting vulnerable COVID-19 patients. Getting monoclonal antibodies and other therapeutics through review at the Food and Drug Administration (FDA) and to the millions of patients at risk of being left behind is critical to winning our war against COVID-19 and must happen now. If only vaccines are afforded that expedited pathway, the virus will ravage our most vulnerable, have greater opportunity to mutate, and may outpace even our best-laid pandemic response capabilities.
As the president’s fact sheet on COVID-19 states, the administration’s plan to manage COVID-19 focuses on “making vaccines and treatments readily available to all Americans as cases rise.” Let’s make sure we streamline approval and access to therapeutics beyond vaccines so we have lifesaving tools that can help every American, including our most vulnerable.
Dr. Ken Sutha is a pediatric nephrologist and a kidney transplant patient who practices medicine at Stanford Medicine Children’s Health.