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Photo: Scott Eisen/Getty Images

The FDA announced on Monday it has issued an emergency use authorization for Eli Lilly's antibody therapy, bamlanivimab, to treat mild to moderate cases of COVID-19.

Why it matters: The treatment is authorized for people "who are at high risk for progressing to severe COVID-19 and/or hospitalization," including people who are 65 and older, and/or people with certain chronic illnesses.

  • "[T]he safety and effectiveness of this investigational therapy continues to be evaluated," the FDA wrote in a news release, but the drug was shown to reduce coronavirus-related hospitalizations or emergency room visits for high-risk patients within 28 days after treatment.
  • It's not authorized for people who are already hospitalized or are receiving oxygen.

What they're saying: “As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen Hahn.

  • Eli Lilly Chairman and CEO David Ricks said in a statement, "This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic."
  • Eli Lilly said it would immediately begin shipping bamlanivimab to AmerisourceBergen, which will distribute the drug as directed by the U.S. government's allocation program.

Worth noting: Eli Lilly announced in October that it sold the U.S. government 300,000 vials of bamlanivimab for $375 million, pending the FDA's emergency authorization.

Go deeper: Pfizer says its coronavirus vaccine is more than 90% effective

Go deeper

Jan 29, 2021 - World

EU grants conditional approval of AstraZeneca vaccine

Photo: Sunil Ghosh/Hindustan Times via Getty Images

The European Commission on Friday granted conditional approval of the Oxford-AstraZeneca coronavirus vaccine for people 18 years and older.

Why it matters: This is the third vaccine to receive approval from the commission, coming hours after the Emergency Medicines Agency recommended its authorization.

Updated Nov 26, 2021 - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Vaccines: U.S. to mandate vaccines for anyone who crosses borders starting in January — Shots lagged data by months — The next big bottleneck in the global vaccination effort.
  2. Health: The Thanksgiving bouncers — Axios-Ipsos poll: Thanksgiving roulette — Experts criticize CDC's language on vaccine boosters — America's Thanksgiving gamble.
  3. Politics: Biden administration asks appeals court to reinstate vaccine mandate — Michigan recommends face masks for all residents amid surge.
  4. Education: A COVID strategy backfires at schools — Schools across the U.S. offer vaccine drivesBenefits of in-person school outweigh risks, study finds.
  5. World: EU drug regulator recommends Pfizer COVID vaccine for kids — Italy announces new COVID restrictions for unvaccinated people — European health agency urges expanding booster shot access.
  6. Variant tracker: Where different strains are spreading.
Jan 29, 2021 - Health

WHO says most pregnant women can now receive coronavirus vaccine

A doctor administering Moderna's coronavirus vaccine at a university hospital in Essen, Germany, on Jan. 18. Photo: Lukas Schulze/Getty Images

The World Health Organization has altered its guidance for pregnant women who wish to receive the coronavirus vaccine, saying now that those at high risk of exposure to the COVID-19 or who have comorbidities that increase their risk of severe disease, may be vaccinated.

Why it matters: The WHO drew backlash for its previous guidance that did not recommend pregnant women be inoculated with vaccines made by Pfizer-BioNTech or Moderna, even though data indicated that pregnancy increased the risk of developing severe illness from the virus.