Data Snapshot: The rise and fall of monoclonal antibodies for Covid-19.
We've gone from seven to one, and we now have none for outpatient use. The government needs to incentivize pharmaceutical companies to step up.
Monoclonal antibodies got a lot of hype early in the Covid-19 pandemic. Were they the game changers that people hoped for? No, perhaps not. But for some populations, the immune-compromised in particular, they added important protection.
Notice I’m using the past tense? That’s because of the seven monoclonal antibodies (mABs) that the FDA ever authorized for Covid-19 only one remains on the market. The rest have been pulled because they don’t work against new variants.
And in fact, the only one that remains in use is a repurposed monoclonal antibody that was found to help hospitalized patients with severe Covid disease (tocilizumab, an Interleuken-6 modulator that may turn out to help patients with a variety of viruses).
You don’t need to remember the names of most of these. The point is that in 2020, we had no mABs. By the end of 2021, we had 6 that worked. But when Omicron showed up, researchers started to test them and the results were not good. One by one, the FDA revoked the “emergency use authorization” (EUA) for each.
In early 2022, we got one new one. Then none for the rest of the year. But by early 2023, all but one mAB had lost its EUA. Only the most general weapon in our cache (tocilizumab) remains authorized.
The big question is this: Where are the new mABs? Why did the pharmaceutical companies stop churning out new versions of these agents that would keep up with the latest variant?
The answer is simple. Money. When I visited the White House in the fall, I spoke to Coronavirus Taskforce members about this. It was clear that, in their view, the companies that made these mABs were spooked by the prospect of pouring tons of money and effort into a product that would likely just become obsolete in a matter of months anyway. If the government couldn’t guarantee that it would buy enough up front, the companies couldn’t take the risk.
No money, no mABs.
So, the reason we don’t have mABs right now is not due to any scientific problem. It’s related to political will. The budget for Covid-19 keeps getting smaller and smaller. Choices are necessary. Funding for mABs has not make the cut. That’s unfortunate—and it misses the point that the immunocompromised are where our focus needs to be when we divvy shrinking Covid budgets.
Inside Medicine takes you inside. Thus the name! Thanks for your support!
There’s one mAB whose name is worth remembering and that is Tixagevimab/Cilgavimab, or “Evusheld.” Evusheld stood out because it was shown to decrease infections—that is, it was a prophylactic. That meant that immunocompromised people could take Evusheld and the odds of an infection were lower for a few months. Agents like Evusheld should be the priority going forward. You can’t have a bad outcome if you don’t get sick. Using mABs in this way makes sense.
As the pandemic progresses, immunocompromised people increasingly have the most at stake here. Congress should incentivize pharmaceutical companies to make mABs that prevent infection and that can be reserved for the immunocompromised. If we end 2023 without a new mAB on the market for outpatient use, our leaders will have failed. If this happens, we should notice it and register our discontent, the same way popularity polls reflect gas prices.
Thanks to Benjy Renton for curating Data Snapshot.