FDA approves remdesivir as global COVID-19 total tops 41 million

Remdesivir bottles
Remdesivir bottles

Manjurul / iStock

Today the US Food and Drug Administration (FDA) approved remdesivir for hospitalized patients, as the global COVID-19 total surged past the 41 million mark, driven by rising US cases that are pushing into rural areas and daily record-setting numbers in several European countries.

Also, the World Health Organization (WHO) today reported the biggest global 1-day rise in cases, with 423,819 added to its total, based on information reflected on its dashboard.

FDA approves remdesivir

Gilead Sciences today announced that the FDA has approved the antiviral drug remdesivir for treating hospitalized COVID-19 patients—adults and children ages 12 and up who weigh at least 108 pounds—marking the first approved treatment for the disease.

The company said the approval is based on results from three randomized controlled trials, including one recently published by a team from the National Institute of Allergy and Infectious Diseases (NIAID) that found meaningful improvement against multiple clinical outcomes. In its statement, Gilead said the FDA also issued a new emergency use authorization (EUA) for treating certain pediatric patients.

Last week, however, the WHO found little or no benefit for survival for the drug in a large phase 3 trial that looked at four different treatments, including remdesivir. Gilead had raised concerns about the WHO-led trial, noting that its findings were inconsistent with other trials, they hadn't gone through rigorous peer view, and the trial design had limitations.

Rural areas swept up in expanding US case rise

Yesterday, the United States reported 62,735 new cases, along with 1,124 new deaths, according to the Johns Hopkins online tracker. Some of the highest per capita rates of infection are now occurring in rural counties in states like Kansas, South Dakota, Montana, and Nebraska, straining small hospitals that don't have the beds or staff to handle the crush of cases, NPR reported.

However, cases are also rising in urban areas that brought down their cases during earlier spikes, such as Boston, which is reverting to fully remote learning today due to its rise in cases, WBUR reported.

Regarding deaths, the latest projection released yesterday by the US Centers for Disease Control and Prevention (CDC) pointed to an uncertain trend in the month ahead, predicting 3,500 to 7,600 new deaths for the week ending Nov 14, which could push the total to between 235,000 to 247,000.

In a related development, the authors of a new preprint study estimate that COVID-19 has claimed more than 2.5 million years of potential life in the United States since the pandemic began.

Evolving CDC guidance on close contacts, student quarantine

The CDC yesterday updated its definition of who is a "close contact" of an infected individual. In its latest guidance, the CDC now defines a close contact as someone who has been within 6 feet of an infected person for a total of 15 minutes or more over a 24-hour period, rather than 15 consecutive minutes (see related CIDRAP News scan).

Meanwhile, the CDC is exploring ways to shorten the 14-day quarantine for school children who have been in contact with an infected person as a way to speed their return to the classroom, the Wall Street Journal reported.

In other US developments:

  • On the economic front, the number of Americans who sought unemployment benefits fell to 787,000 last week, possibly signaling that pandemic-related job losses have eased slightly, the Associated Press And airline industry groups have sent a letter to federal departments and governors pleading for uniform predeparture testing and contact tracing systems to help boost air travel, according to CNN.

  • Regarding vaccines, Illinois Gov. JB Pritzker said yesterday that he wants the state's own experts to evaluate a COVID-19 vaccine before distributing it, joining similar announcements from the governors of New York, California, and Michigan. And Moderna said today that it has finished enrolling 30,000 participants in the phase 3 trial of its candidate vaccine, which includes 11,000 from communities of color including groups disproportionately hit harder by the virus.

  • The US total has now reached 8,386,634 cases and 222,766 deaths, according to the Johns Hopkins tracker.

France, Spain lead Europe's surge

In international developments, cases in Europe continued to soar, with a number of countries reporting new record daily numbers of cases and Spain and France becoming the latest countries to cross the 1 million case mark.

France today reported 41,622 new cases, marking a record daily high. Prime Minister Jean Castex called the situation grave and announced that a curfew in place for greater Paris and eight other cities will be expanded to 38 more administrative regions, France 24 reported.

In Spain, health officials reported 20,986 new cases today, also a daily record high, CNN reported. And at a press briefing today, health minister Salvador Illa warned that the country is facing tough weeks ahead and that the central government and 17 regional governments have agreed on criteria for a joint response to the country's second wave.

Other countries reporting daily record highs include the Netherlands, Poland, Czech Republic, the United Kingdom, and Germany.

In other developments, the WHO today announced a collaboration with the Wikimedia Foundation—the nonprofit group that administers Wikipedia—to expand access to the most current and reliable information about COVID-19, according to a statement.

The WHO said the agreement will make public health information available under a creative commons license at a time when countries are grappling with virus resurgence and as social stability increasingly hinges on a shared public understanding of the facts. The WHO's infographics, videos, and other public health assets will be widely available on Wikimedia Commons, a digital library of free images and multimedia items.

Today the global total climbed to 41,524,733 cases, and 1,134,716 people have died from their infections, according to the Johns Hopkins online dashboard.

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