More countries have signed up for the COVID-19 antiviral pill. Here’s what you need to know

These results are so promising that a review committee recommended stopping the trial now and trying to get an Emergency Use Authorization (EUA) for it, which is the same thing the Moderna and Johnson & Johnson vaccines have right now.

What is it?

• Pharmaceutical giant Merck & Co., Inc. partnered with Ridgeback Biotherapeutics LP in clinical trials to look for more COVID-19 treatment options.

• And, they’ve recently released data in the middle of their phase 3 trial for the new antiviral molnupiravir.

• Molnupiravir is the first antiviral pill for COVID-19. We’ve had effective antivirals before, but taking this pill by mouth is, of course, easier and more practical than getting an IV.

• Although the trial isn’t completely done, the data shows a 50% reduction of risk for hospitalization or death.

• The trial included patients who were confirmed to have COVID-19 and at least one risk factor – diabetes, old age, heart disease or obesity. 

• These results are so promising that a review committee recommended stopping the trial now and trying to get an Emergency Use Authorization (EUA) for it, which is the same thing the Moderna and Johnson & Johnson vaccines have right now.

Who’s making it?

• Merck is one of the largest pharmaceutical companies in the world, with their revenue hitting almost US$48 billion last year. 

• They’ve had a fair bit of experience navigating the drug development process and the United States Food and Drug Administration (FDA) across multiple diseases and treatments. 

• This includes previous treatments for HIV, diabetes, autoimmune disorders and a vaccine for human papillomavirus, or HPV.

• On the other hand, Ridgeback is a pharmaceutical company that focuses on hard-to-treat and underserved diseases, most notably Ebola. 

• Other pharma companies like F. Hoffmann-La Roche AG, more commonly known as Roche, and even our friend Pfizer Inc. are hot on Merck’s tails, with trials for their own antiviral pills starting earlier this year, and interim data expected soon.

Do I still need to get vaccinated?

• The best option we have in the fight against COVID-19 is still the vaccines, and experts say these pills shouldn’t be seen as a replacement for vaccinations.

• “These shouldn’t be seen as replacements for vaccination – the two should be seen as two strategies that can be used together to significantly reduce severe disease,” said Andrew Pekosz of Johns Hopkins University

• The vaccine prevents enough cases so that any breakthrough cases can be effectively managed with any antiviral pills like molnupiravir.

• But, some experts are worried about the public perception of vaccines after the release of the pill. 

• Dr. William Schaffner, a professor at Vanderbilt University Medical Center’s Infectious Diseases Division, said, “It certainly is likely that some people will take, if you will, refuge that should they become infected, a pill might be available that could help them avert serious disease.”

• In fact, the perception of vaccines changed so much that shares in Moderna Inc., J&J and Pfizer all fell with the announcement of Merck’s data on September 23. 

Who has it, who’s going to get it and for how much?

• Merck has previously said it is committed to widespread global access for its products. 

• For molnupiravir, this comes in the form of a tiered pricing structure based on World Bank country income, meaning the price of the drug will change relative to how wealthy or poor a nation is.

• Merck has also announced nonexclusive, voluntary licensing agreements with manufacturers in lower-income countries, which will just help these poorer countries produce their own generic version of the drug without fighting patents and all that. 

• An agreement with the US government has already been made to provide 1.7 million courses of medicine for US$1.2 billion. This works out to around US$700 per five-day treatment.

• This is compared to other more pricey antivirals like Roche’s influenza treatment, which is US$150 for a course.

• Australia has already bought 300,000 courses, while South Korea, Thailand, Taiwan and Malaysia has struck a deal with Merck to build their own stockpile. Singapore and Merck also just signed a deal this week.

What’s next?

• Molnupiravir is basically in limbo until either the EUA is approved or they finish their phase 3 trial. 

• Other companies working on a COVID-19 antiviral are expected to announce their data soon. And so, keep an eye on Pfizer and Roche for any updates about their phase 3 trials.

• At first, the antiviral pill will probably only be approved for unvaccinated patients. They are the ones who need it most.

• Once FDA approved molnupiravir is likely to quickly spread to countries across the globe, hopefully with a smaller price tag, which is likely as other companies release their phase 3 data. 

You drive the stories at TMS. DM us which headline you want us to explain, or email us.