The pandemic may yet again be at a turning point. But this time, it's not due to rising or falling case rates, newly authorized vaccines, or new variants—it's because we may have a new way to treat Covid-19 and view the disease overall.
On Friday, Merck & Co. and Ridgeback Biotherapeutics released new data from a clinical trial showing that their oral antiviral drug molnupiravir reduced the rate of hospitalization or death by roughly 50% in participants with mild or moderate Covid-19. The drug was most effective when given early in the course and was effective regardless of whether patients had the delta or other coronavirus variants.
The results were so promising that the trial's independent monitoring committee recommended stopping the clinical trial early. Merck and Ridgeback plan to ask the FDA for emergency authorization "as soon as possible."
It's not every day that a trial is stopped early for such favorable results—yet while most news coverage of the data was favorable, it largely treated molnupiravir as just one more tool in our toolbox for treating Covid-19.
But to me, this is much bigger than just "one more tool." It represents a potential paradigm shift from focusing on Covid-19 prevention to focusing on mitigation. Such a shift could have several positive and negative ripple effects on the pandemic response.
7 reasons why Merck's new data is a bigger deal than most people think
- The treatment may be a game-changer for Covid-19 treatment accessibility. Today, authorized treatments for Covid-19—including antibody therapies from Regeneron, Vir Biotechnologies, and Eli Lilly—face significant barriers to access and use. Patients must go to a hospital or infusion center to receive the IV-based treatment, and they must do so within a narrow time window after diagnosis. Merck's antiviral therapy, which is an oral pill akin to Tamiflu, is significantly easier to manufacture, distribute, store, and administer—all of which make it drastically easier for the treatment to reach patients.
- Yet the availability of an effective anti-Covid-19 pill may discourage some people from getting vaccinated. If, as a result of molnupiravir's availability, vaccination rates decline or remain stagnant, we may find it even harder to reach herd immunity—which could mean the virus continues to circulate and new variants emerge.
- Regulators could shift their views on booster shots with such effective treatments on the horizon. If molnupiravir is approved or authorized and successfully prevents hospitalizations, public health experts and regulators may question whether booster shots are actually needed in low-risk populations.
- Insurers may face big decisions about who gets the drug—and how much they'll pay. The U.S. government has already purchased 1.7 million courses of molnupiravir for $1.2 billion, which suggests that each treatment course costs around $700. Whether public and private insurers will fully cover this treatment or demand cost-sharing—and whether they restrict access based on patients' vaccination status, pre-existing conditions, age, demographics, or other risk factors—will play a critical role in determining the treatment's reach. To better inform these decisions, it will be essential for the manufacturers and regulators to collect data to understand the drug's success in a broader range of use cases.
- Sick patients may demand access to molnupiravir—even if they aren't like the patients who participated in clinical trials. The trial studied the drug only in adults at high risk of severe Covid-19. It's possible that the treatment will be initially authorized only for people resembling those who were included in the study: specifically, patients with at least one risk factor for developing severe disease. But other patients with Covid-19 may demand the treatment, raising difficult questions for doctors and insurers.
- If we aren't careful, molnupiravir's rollout could actually exacerbate disparities and health inequities. If demand for the drug significantly exceeds supply—and especially if relatively low-risk patients seek access—there's a risk that wealthier, better-connected patients could benefit more than historically marginalized populations. Among the open questions that could exacerbate inequalities:
- If FDA authorizes treatment and there is limited initial supply, will unvaccinated or vaccinated people get priority access?
- Will regulators reserve doses for states or counties with the highest case rates or hospitalization rates?
- Will providers prescribe the treatment off-label— or face pushback from patients for refusing to do so?
- Will manufacturers reserve doses for countries struggling to access the vaccines?
- Molnupiravir could drive a new rush for widespread, early Covid-19 testing. Because the drug is most effective when given shortly after infection, health care facilities, employers, and frontline organizations may need more robust infrastructure to quickly identify people with Covid-19. This will likely require increased investment in reliable rapid testing, both in clinics and at home.
While molnupiravir is the first oral antiviral to show such promising results against Covid-19, more treatments could be on the horizon, including promising drugs from Pfizer and Roche. If those prove successful, the above factors could become even more important. Further, Merck is studying molnupiravir's potential as a preventative medicine, so it may one day help high-risk individuals avoid getting infected in the first place.
We'll continue to watch the data, open questions, and opportunities and challenges. In the meantime, if you're a health care leader, it's time to start thinking proactively about these treatments and their potential impact on your pandemic response.