First COVID-19 antiviral pill gains authorization

This week, an antiviral pill for COVID-19 was authorized in the U.K. The drug, made by American pharmaceutical company Merck, is the first COVID-19 treatment in pill form to gain approval by any regulatory agency.

Some scientists have called this pill a “game-changer,” and for good reason. In Merck’s clinical trial, the drug approximately halved COVID-19 patients’ risk of hospitalization or death, compared to a placebo. The pill is designed for—and was tested on—adults who are particularly vulnerable to the virus, including seniors and those with preexisting conditions such as diabetes and heart disease.

The pill, formally called molnupiravir, works by interfering with the coronavirus’ ability to replicate itself, stopping it from reaching further into the body and causing severe symptoms. (This STAT News article includes a video that explains the process in more detail.) Adults who show mild or moderate COVID-19 symptoms can take the pill soon after they realize they’re infected, in order to improve their chances of recovery without a hospital stay.

In Merck’s clinical trial, patients started taking the pill five days after they began to experience COVID-19 symptoms. Each patient took four capsules, twice a day, for five days—adding up to 40 pills for a single patient.

The U.K. government has bought almost 500,000 courses of molnupiravir. The U.S. government has brought about 1.7 million courses, and our FDA is slated to consider the pill for emergency use authorization later this month. Several other countries including France, Australia, Malaysia, and Singapore also have contracts in place to purchase the pills.

But unlike other COVID-19 treatments and vaccines, molnupiravir may be more broadly available to people who don’t live in wealthy nations. Last week, Merck announced that it signed a voluntary licensing agreement with the Medicines Patent Pool, a public health organization backed by the United Nations that increases treatment access in over 100 low- and middle-income countries. As a result, a number of companies besides Merck will be able to manufacture and distribute their own versions of molnupiravir.

Still, some global health advocates have criticized Merck for making a deal with the Medicines Patent Pool rather than the World Health Organization’s COVID-19 Technology Access Pool, which would provide access to a broader group of countries. The current deal leaves out some middle-income countries that are particularly poised to manufacture versions of molnupiravir, including countries like Brazil and Peru that have seen high COVID-19 death tolls.

In short, Merck’s efforts to make its COVID-19 drug widely available are much better than anything we’ve seen from the major vaccine companies. But this is still far from the most equitable scenario.

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