We Have a New Tool to Help End the Pandemic—Now the Biden Administration Needs to Step Up and Seize the Opportunity

There’s nothing better than waking up to a great news headline: “Pfizer’s Covid pill remains 89% effective in final analysis, company says.” In a study of unvaccinated patients at high risk of severe outcomes, the final clinical trial results showed that Paxlovid—a single pill taken every 12 hours for five days—reduced the risk of COVID-19 hospitalization by 89 percent. In the placebo group, 44 patients ended up in the hospital and 9 died; but in the treatment group, just 5 patients were hospitalized, and no deaths were recorded. This positive news is also a relief given the disappointing final results for Molnupiravir, a Merck product which narrowly received an FDA advisory committee recommendation for Emergency Use Authorization despite just 30 percent efficacy in final analysis, the requirement of 40 pills over five days, and serious concerns related to mutagenicity.

So, hoorah! Together with vaccination, Paxlovid is the kind of tool that can advance us toward the end the pandemic—not by getting rid of COVID-19 altogether (it’s clearly here to stay), but by reducing the risk of serious/severe outcomes to a sufficiently low/acceptable level, even in the most vulnerable patients. A world in which our friends and neighbors are fully vaccinated—and have access to Paxlovid upon falling ill—is one in which could confidently resume our normal lives, finally reducing COVID-19 risk to “just the flu”. (Yes, the flu is bad, but risk is relative; American/global society has clearly decided flu risk in a normal year is something we are willing to mitigate and live with.)

So now comes the next step: getting the drug to everyone in need, all around the world. To Pfizer’s enormous credit here, the company has already taken important steps to increase access to the therapy, even among the poorest countries. A previous press release committed to tiered pricing based on country income, and a non-exclusive license via the Medicines Patent Pool (MPP) allows for generic manufacturing to serve many low- and middle-income countries, though it excludes some larger markets (including Brazil, Mexico, Russia, China, Colombia, and Peru, to name a few). The combined effect of these two measures should make the drug affordable in almost all countries, taking one big access concern off the table (or at least putting it on a backburner).

Except…keep reading. “Pfizer says that it will have 200,000 courses of the medicine available this year and 80 million available next year.” That is not nearly enough. For context, the US is currently averaging about 120,000 new cases of COVID-19 every day—and that’s before the Delta wave peaks, at least in northern states entering winter, and as a baseline before Omicron hits in earnest. Cases in Europe and Southern Africa are also skyrocketing. It appears that MPP is still processing sub-license applications, so we can’t count on generic manufacturing in the immediate future. And Pfizer’s own direct production is scaling, but not nearly fast enough to meet expected need and demand. Added to the mix: due to early investments in manufacturing and licensing, Merck’s Molnupiravir may be available sooner and in larger quantities than Paxlovid—but it appears to be an inferior product that might have serious negative externalities in driving emergence of new variants.

And there’s yet another complication: unlike vaccines, which can be administered in advance and prevent severe outcomes at the population level, therapies require prompt diagnosis and integration into an individual-level continuum of care to be effective. It is the challenge in executing these steps—not (primarily) the absence of effective therapies—that lead to millions still dying every year from HIV/AIDS, malaria, and tuberculosis. The trial results show Paxlovid is effective when taken up to five days past the onset of symptoms—which is better than the three-day window previously expected. But it’s still quite short, and the health system requirements for case finding, testing, diagnosis, and prescribing are significant.

That has a few implications. For one, we need way better testing and case finding in the US; our testing bottlenecks present a huge problem. And second, Paxlovid will likely be most useful in high-income countries, which already have high levels of vaccination; it is not a substitute for vaccination campaigns in LMICs with low coverage rates. Nevertheless, it’s still an important tool that should be on hand everywhere—to mitigate and treat at least the subset of cases that can be promptly diagnosed by the local health system.

The bottom line is we need more of this drug, we need it yesterday, and we need it integrated into a continuum of care that includes case finding/prompt diagnosis, which means much better testing. At current death rates, getting this pill out in the world could save 1,200 American lives every day—and another 5,000 across the world. We don’t have a moment to lose.

Today, I want President Biden to call a press conference in the Rose Garden. His announcement should throw the entire weight and resources of the US government behind scaling up production and effective deployment of this pill as his administration’s number one priority. Let’s get all hands on-deck, invoke the defense production act, do whatever is needed to run an effective industrial policy. Pfizer should be a partner in this effort, compensated generously and celebrated for its ingenuity—but with the clear (and enforced) expectation of full cooperation. We need to (finally!) fix our testing infrastructure so we find cases in time to start the treatment and offer support abroad to do the same. And efforts to scale and globally disseminate vaccination must also grow in parallel, offering a one-two punch joint offensive against mortality and morbidity.

We have a chance to end this pandemic…again. Please, President Biden, let’s seize that opportunity.