As the COVID emergency ends, monoclonal antibodies remain essential

After more than 100 million documented cases, 1.1 million deaths, and massive disruptions to American life over the past three years, the public health emergency for COVID-19 will officially end next month. 

The pandemic may already be in the rearview mirror for millions of Americans thronging to airports, restaurants and other gathering places, but the virus remains especially threatening for those with compromised immune systems, the elderly and the unvaccinated.  

That is why — for the sake of equity as well as the nation’s overall public health — we must continue to pursue every possible means of preventing and treating COVID. Although close to 700 million vaccine doses have been administered in the United States, saving an untold number of lives, researchers are concerned that vaccines may not offer sufficient protection for immunocompromised people like transplant recipients, people with blood cancers or HIV and those taking immunosuppressive steroids and other medications.  

Monoclonal antibodies (mAbs) — laboratory-grown proteins that work like natural antibodies to help the body fight illness — have been a valuable tool for treating COVID in this population. Monoclonal products such as bamlanivimab, casirivimab and imdevimab (which are administered together) and sotrovimab were found to be particularly beneficial in reducing the risk of hospitalization and death for the estimated 3 percent of Americans with weakened immune systems. In addition to reducing the severity of infections, mAbs have been shown to help prevent COVID among the immunocompromised and in the general population.  

One complicating factor with monoclonal antibodies is that they have been designed to target specific structures of the COVID spike protein, and because the virus mutates so quickly, mAbs that worked against one variant are unable to fight new variants. As a result, the Food and Drug Administration (FDA), which granted several mAbs emergency use authorizations in 2020 and 2021, has since revoked them because they were no longer effective against the omicron variant.

Meanwhile, the Biden administration’s COVID preparedness plan focuses on vaccines, antivirals like Paxlovid and testing, with no mention of mAbs. To healthy individuals, this may seem like a reasonable approach. Unfortunately, it leaves those who are immunocompromised without options, since many cannot take advantage of vaccines or antivirals due to dangerous drug interactions. With the FDA not currently approving mAbs and the federal government no longer buying them, monoclonals seem to have been expunged from America’s COVID-fighting strategy. 

The problem with this is twofold: First, if we are committed to equitably protecting all Americans, we must ensure that treatments are available for the immunocompromised and for people of color, who have higher COVID infection rates than whites and may be more wary of vaccines because of the legacy of racist medical research like the Tuskegee syphilis study. Indeed, for the 1 in 6 Americans who say they will not get vaccinated for any number of reasons, we need a more inclusive Plan B for prevention and treatment.

That means developing as broad a range of approaches as possible to safeguard against infection and mitigate the effects of the disease. Scientists in industry and government are actively working on “antibodies that are likely to work against not just the [current] coronavirus, but whatever may come,” Joshua Tan, chief of the Antibody Biology Unit at the National Institutes of Health, told NPR. 

Second, since it is eminently possible to develop new monoclonal antibodies that can combat the next strains of the virus, the FDA must be nimble enough to approve these quickly, before they are supplanted by the next strain. Ideally, the review process for mAbs should be streamlined to use existing safety and dosage data, so that each new potential treatment does not have to repeat basic clinical-trial requirements, wasting valuable time. The president’s plan explicitly calls for “new FDA processes to expedite regulatory review of variant-specific versions of vaccines and treatments, so Americans can get them quickly if needed.” Let’s do this for monoclonals.  

Pursuing a vaccines and antivirals-only approach could create a two-tiered system of dealing with COVID-19, in which those who are immunocompromised or have concerns about vaccines are left behind, while everyone else moves on. The current approach is not equitable, nor is it an effective policy, and we should aim to do better. 

No matter how much we want to return to a pre-2020 “normal,” COVID is not going away. It will soon be endemic if it isn’t already. We are not going to convince everyone to be vaccinated and boosted, and for many, that isn’t a viable option. And we will forever be in a race against a mutating virus. 

To protect all Americans and to keep winning that race, it is essential that we have a diverse, robust and accessible array of tools to prevent and treat COVID. 

Andrew L. Yarrow, a former New York Times reporter who teaches at George Mason University, writes on public policy and health.