Merck applies for approval of first COVID-19 antiviral pill

Woman with mask taking pills
Woman with mask taking pills

Drazen Zigic / iStock

Today, pharmaceutical giant Merck submitted an emergency use authorization (EUA) application to the Food and Drug Administration (FDA) for molnupiravir, its oral antiviral medication, for the treatment of mild to moderate COVID-19 in adults at risk for severe disease.

This category includes patients over 60 years and those diagnosed as having obesity, diabetes, or heart disease.

The drug, named after Thor's hammer in Norse mythology, would be the first pill authorized by the FDA to treat COVID-19. Other antivirals used to fight COVID-19 have to be injected or administered intravenously. Merck has previously said that, if approved, the company is ready to supply the US government with 1.7 million doses of the antiviral.

The submission is based on positive results from a phase 3 trial of the drug, which showed that molnupiravir reduced the risk of hospitalization or death by approximately 50%.

"The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," said Robert M. Davis, Merck chief executive officer and president, in a company press release.

The suggested use of molnupiravir would be four capsules twice a day for 5 days.

COVID-19 cases continue to drop

According to the New York Times tracker, the country recorded 96,549 COVID-19 cases yesterday and 2,000 deaths. The newspaper said cases are dropping most significantly in Southern states that saw the biggest activity during the nation’s fourth wave this summer, which was fueled by the Delta (B1617.2) variant.

Florida, for example, is averaging fewer than 4,000 new cases a day, down from more than 20,000 a day at the end of August.

Northern and western states, including Alaska, Montana, North Dakota, Wyoming, and Minnesota, lead the nation in recent cases per capita; Minnesota's daily case counts increased 36% in the last 2 weeks.

The 7-day average of new daily COVID-19 cases is 95,926, with 1,778 daily deaths, according to the Washington Post tracker. New daily cases fell 10.1% in the past week, deaths fell 6.8%, and hospitalizations fell 8.2%.

FDA to consider Moderna, J&J boosters

The Centers for Disease Control and Prevention (CDC) COVID Data Tracker shows that, as of Oct 9, 56.4% of Americans are fully vaccinated against COVID-19, 65.3% have received at least one dose of vaccine, and 4.2% of fully vaccinated people have received a booster dose.

The number of boosters administered will likely go up by next week, as the FDA's Vaccines and Related Biological Products Advisory Committee will meet later this week to discuss booster doses for Moderna, Johnson & Johnson, and mix-and-match boosters, a practice used widely in Europe.

In related news, the Washington Post reports that hundreds of thousands of US service members remain unvaccinated or only partially vaccinated against COVID-19 as the Pentagon's first compliance deadline nears, and rates vary among the individual services.

Most service members have until Nov 28 to be fully vaccinated against COVID-19.

Global COVID-19 headlines

  • In Australia, a 4-month lockdown in the hot spot Sydney started easing today, with sites like restaurants and gyms opening to fully vaccinated people, according to Reuters. New South Wales state officials warned that infections will likely rise after reopening, but the vaccination rate has risen to 74% toward a goal of 80% by late October.

  • The United Kingdom's National Health Service today encouraged pregnant women to get vaccinated against COVID-19, based on new data that shows nearly 20% of patients with the most critical infections are unvaccinated pregnant women.

  • The CDC last week signaled that international visitors can enter the country if they have received one of six COVID-19 vaccines approved by the FDA or listed by the World Health Organization (WHO), according to Reuters. The step comes in advance of the November lifting of restrictions for fully vaccinated air travelers from 33 countries.

  • The global total today topped 238 million and is at 238,136,719 cases, along with 4,855,635 deaths, according to the Johns Hopkins online dashboard.

CIDRAP News editor Lisa Schnirring contributed to this story.

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