Biopharmaceutical Industry Fights COVID-19 Pandemic with Innovation and Speed

The COVID-19 pandemic has created unprecedented challenges for almost every industry. Most acute is the clinical challenge facing overwhelmed and underequipped hospitals and health care workers. But in the medium to long term, combating the pandemic will require solutions to scientific challenges. The development and deployment of diagnostic and pharmaceutical products on a short-enough timeline and wide-enough scale will require the marshaling of scientific resources to a degree perhaps unprecedented in history. The biopharmaceutical industry has been racing to meet this crisis.

COVID-19 was first reported in Wuhan, China, in December 2019 after causing an outbreak of severe pneumonia. SARS-CoV-2, the virus that causes COVID-19, was isolated shortly thereafter. As its name suggests, it is related to the virus that caused the severe acute respiratory syndrome (SARS) epidemic from 2002 to 2004, as well as the virus responsible for the Middle East respiratory syndrome (MERS) outbreaks over the past decade, each of which is believed to have originated in bats. These are three of the seven known strains of human coronaviruses; the other four can cause the common cold.

Coronaviruses are RNA viruses, like influenza, Ebola, measles and many other viruses that cause human disease. The coronaviruses are notable for the ring of “spike” proteins on the surface of the virus, which make up the solar corona-like structure that gives the coronavirus its name. Spike proteins are responsible for attaching to and initiating entry into host cells, making them a prime target for antiviral therapeutics. However, much remains unknown about the biology of SARS-CoV-2.

Pandemics are, by their nature, difficult to address. Science and clinical trials are slow enterprises; treatments for diseases can take a decade or more to develop. But pandemics spread quickly, crossing the globe and infecting thousands on the order of days, not years. Viruses do not respect national boundaries, and they do not wait for science to catch up. In this environment, scientific research must proceed at breakneck speed, and the experience of the biopharmaceutical industry with other viruses is essential to answer the crisis.

There are three central scientific needs in addressing this pandemic: developing diagnostic tests, therapeutics and vaccines. Testing is necessary in order to understand the epidemiology of the disease, isolate infected patients and — with antibody testing — identify individuals who have recovered and gained immunity. Therapeutics are being sought to combat COVID-19, which has killed more than 70,000 people so far and continues to spread, overwhelming hospitals with the critically ill. There are more than one million confirmed COVID-19 cases worldwide and billions of people have been sent into lockdown. Vaccines or therapies administered for prophylaxis are a crucial part of the solution. Once they become developed and widely available, entire populations can be immunized to the virus without being infected, ending its relentless march and preventing future outbreaks.

Producing and testing a vaccine or other therapy in time to address the current pandemic is a major hurdle on both the research and regulatory fronts. Companies and regulatory agencies have taken drastic steps to speed up this timeline. The Food and Drug Administration (FDA), for example, has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP), redeploying staff in order to facilitate the rapid review and clinical development of new therapeutics. Companies are working to manufacture therapies on a large scale in order to meet demand as quickly as possible if the therapies prove to be successful.

There is reason for optimism. Vaccine testing, for example, has proceeded at unprecedented speed. A vaccine for SARS-CoV-2, developed by Moderna, was given to a human subject on March 16, a mere two months after the viral genome sequence was published. Johnson & Johnson selected its lead vaccine candidate in March and is aiming to initiate clinical trials in early fall. Regeneron is working toward initiating a clinical trial this summer of an antibody cocktail that can be administered as a prophylaxis. Last week, the FDA approved the first diagnostic test to detect antibodies against SARS-CoV-2, from Cellex Inc., under emergency use authorization. Resources are being mobilized and scientific innovation is being harnessed to meet the pandemic with full force.

The biopharmaceutical industry is engaging its resources in other ways as well. Companies have committed millions of dollars of support for the public health response. Others have shared vital medical resources, such as donating 500,000 test kits to New York State, or provided personal protective equipment (PPE) to hospitals in need. Companies also are employing their expertise to conduct diagnostic tests themselves. But ultimately, it is the rapid advancement of scientific research that will put an end to the current pandemic.

In the next post, we will examine diagnostic testing for COVID-19. Further posts will explore the progress being seen in therapeutic screening and development and the designing and testing of new and varied vaccines. The COVID-19 pandemic presents daunting scientific challenges for the world, but the experience and innovation of the biopharmaceutical industry are rising to meet them and providing hope for a resolution to this crisis.