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NIH panel: No data to support effectiveness of plasma treatment for COVID-19

Convalescent plasma donated by a recovered COVID-19 patient. Photo: Alex Edelman/AFP via Getty Images

A panel of experts at the National Institutes of Health on Tuesday weighed into the FDA's emergency use authorization (EUA) of convalescent plasma as a coronavirus treatment, stressing that "there are insufficient data to recommend either for or against" the use of plasma to treat COVID-19 patients.

Why it matters: President Trump and other officials pressured the FDA to grant an EUA for plasma despite warnings from public health experts, including those at the NIH, that data from randomized clinical trials was needed to determine the effectiveness of the treatment.

  • The objections against the authorization continued after FDA Commissioner Stephen Hahn oversold the benefits of convalescent plasma as a coronavirus treatment at a press conference with President Trump. He later apologized.

What they're saying: "There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19," the NIH COVID-19 Treatment Guidelines Panel wrote.

  • The panel added that convalescent plasma "should not be considered standard of care for the treatment of patients with COVID-19."

The bottom line: The NIH panel called for "prospective, well-controlled, adequately powered randomized trials" to "determine whether convalescent plasma is effective and safe for the treatment of COVID-19."

Go deeper: The tug of war over the FDA

Go deeper

Axios
Dec 4, 2020 - Podcasts

Former FDA chief Rob Califf on the vaccine approval process

The U.S. Food and Drug Administration (FDA) is reviewing two emergency use authorization requests for COVID-19 vaccines, with an outside advisory committee scheduled to meet next Thursday to review data from Pfizer and its German partner BioNTech.

Axios Re:Cap digs in with former FDA commissioner Rob Califf about the EUA process, the science and who should make the final call.

Shawna Chen
Dec 4, 2020 - Health

CDC: It's time for "universal face mask use"

Photo: Paul Hennessy/SOPA Images/LightRocket via Getty

The CDC is urging “universal face mask use” for the first time since the coronavirus pandemic began, citing recent case spikes as the U.S. has entered a phase of “high-level transmission” before winter officially begins.

Why it matters: Daily COVID-related deaths across the U.S. hit a new record on Wednesday. Face coverings have been shown to increase protection of the wearer and those around them, despite some Americans' reluctance to use them.

Go deeper (1 min. read)Arrow
Axios
Dec 4, 2020 - World

UN: "2021 is literally going to be catastrophic"

David Beasley, executive director of the World Food Programme. Photo: Souleymane Ag Anara/AFP via Getty Images

Next year is "going to be catastrophic" in terms of worldwide humanitarian crises, World Food Program executive director David Beasley warned on Friday, per Reuters.

Driving the news: The stark outlook comes as many countries contend with not only the coronavirus pandemic, but also possible famine, economic instability, conflict and other humanitarian crises. A record 235 million people will need humanitarian assistance and protection next year, a nearly 40% increase from 2020, the UN projected earlier this week

Go deeper (1 min. read)Arrow