April 2021: From the Editor

I write this the day after US President Joe Biden’s address reporting his administration’s progress on COVID-19. Vaccines and their distribution and delivery are priorities, of course, and the companies working on them over the past year deservedly have received a great deal of attention. But our pandemic response rests on three other important pillars as well: prevention of exposure through masking and social distancing (as the President reminded us), testing and tracing with diagnostics and data, and treatment of those patients who do become infected. And even though Biden did not mention the latter, the biopharmaceutical industry has a lot to offer on that front after a year of working on treatment approaches behind the scenes.

This issue features one treatment under development in India: hyper-immunoglobulin G antibodies purified from the plasma of convalescent patients. Although convalescent plasma has been used as a relatively inexpensive treatment for other infectious diseases, it has not been a successful option against SARS-CoV-2. However, some companies are taking the extra step of concentrating the amount of antibodies in their final products. As you’ll see on page 30 this month, one method shows promise especially for the developing world and as new variants arise over time.

Meanwhile, a number of companies are working on immunomodulators and monoclonal antibodies against specific proteins on the pandemic virus. And as BioProcess Insider’s Gareth Macdonald points out on page 6, regulators are keen to see those products combined into “cocktails.” Certainly antivirals, steroids, and blood-thinning agents have been used. Some companies even have cell therapies in the works for pandemic treatment.

Dr. Ezekiel Emanuel — a former Obama-administration official who served as a COVID-19 advisor during the Biden transition — told Yahoo Finance in March that the US pandemic response has been poor on the therapeutics side. “Operation Warp Speed” did not prioritize treatment research as much as it could have. That will have to change, and according to NIH director Francis Collins and FDA acting commissioner Janet Woodcock, progress already is under way. They told Endpoints News that the US government is focusing on three aspects of biotherapeutic development for COVID-19: clinical trial efficiencies and community-based research infrastructure; public–private development partnerships; and NIH serving in a venture-capital–like capacity to help companies take good ideas forward.

When I wrote about pandemic vaccine development in a BPI eBook last year, I took it as a given that governments and the industry must find ways to serve the entire world’s needs. Any pockets of infection that remain can breed the next variant of concern. Random mutations arise spontaneously — as we have seen in South Africa, the United Kingdom, and California — and infecting more hosts gives a virus more chance at increased virulence. Was it naive to assume that everyone would concur that vaccine nationalism and regionalism are just as bad for us all as “antivax” rhetoric is? Perhaps.
But I hope that we all agree now: The world must be your market for COVID-19 vaccines — and for therapeutics as well.