Merck’s COVID drug and why BARDA did not fund it.

First the disclaimer. I’m the former global head of the vaccine division at Merck and still own significant stock in the company.

Merck on Monday submitted an application to the Food and Drug Administration for emergency use authorization (EUA) for the first oral antiviral drug to treat Covid. The drug, molnupiravir, would be a true advance against COVID-19, because it is a relatively inexpensive treatment that can reduce severe outcomes of SARS-CoV-2 infection in high-risk, unvaccinated people

Remarkably, it took over 18 months into the pandemic before we finally have an antiviral drug that appears to make an impact on COVID-19 infection and prevent hospitalizations. Many of us, myself included, felt that this would occur much more quickly than a vaccine, but more on that later.

Merck’s pill screws up the ability of the virus to replicate, or make copies of itself. It is taken as four capsules twice a day for five days and needs to be started as soon as a person is infected. The drug  halved hospitalizations and deaths in a clinical trial. This was, however, a very specific population that included only unvaccinated adults who had begun showing Covid symptoms within the previous five days and were at very high risk for serious outcomes from the disease.

Merck is seeking authorization to treat high-risk adults, which in the clinical trial involved mostly people over 60 years of age. In addition, the EUA would also include younger, unvaccinated people with obesity, diabetes, or heart disease. Merck is planning on selling the drug for $700 in the US and proportionately lower prices in the developing world. Compared to a COVID-19 hospitalization, this is a bargain.

Several caveats: Reducing hospitalizations by 50% still means a lot of unvaccinated people will get sick, especially compared to the 90% reduction in hospitalizations achieved with vaccination. The drug likely won’t be approved for vaccinated individuals without an additional clinical trial. Pregnant individuals, a very concerning unvaccinated risk group, also likely won’t get the drug. Finally, if you are a fan of “natural immunity”, a drug that suppresses coronavirus infection likely will lead to a reduced immune response to the virus and therefore require a vaccination after infection for protective immunity.

The Merck drug is a triumph of private investment. The drug was passed over for funding by BARDA and the small biotechnology company that was commercializing it, Ridgeback Biotherapeutics, was not able to move forward with development until they partnered with Merck. Merck invested the money for the clinical trials in no small part stirred on by their vice president for infectious disease, Daria Hazuda, who is an expert in antiviral therapeutics.

According to an OpED piece in the WSJ, the person who refused to fund this drug is Rick Bright, the “celebrated” whistleblower from the Trump administration. Bob Kadlek (Bright’s boss and a great person) and others who tried to get the Ridgeback drug funded were pilloried while Mr. Bright did his performance art in Congressional hearings.

It is true Bright had much more experience in vaccines being a former Novavax employee. At BARDA he funded billions to Novavax for their yet to be seen vaccine. Mr. Bright’s personal support for Novavax’s vaccine provides little solace to the hundreds of thousands of people who have died from COVID without an antiviral drug in the interim.