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Photo: Rafael Henrique/SOPA Images/LightRocket via Getty Images

AstraZeneca announced on Friday that the Food and Drug Administration has authorized the company to restart phase 3 clinical trials for its coronavirus vaccine, which were paused in early September.

Why it matters: All clinical trials were temporarily halted in September after a volunteer became ill with transverse myelitis upon receiving a second dose of the vaccine.

  • AstraZeneca had resumed its trials in the U.K. with permission from the Medicines Health Regulatory Authority days after the participant fell ill.

Driving the news: Johnson & Johnson — the only company testing a single-shot vaccine — also plans to resume its vaccine trial, the Washington Post reports. It paused on Oct. 12 after a participant suffered from a stroke, but it was concluded to be unrelated to the vaccine shot.

What they're saying: "The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic," AstraZeneca CEO Pascal Soriot said. "We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use."

  • "It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety," the company said in its Friday announcement.

What to watch: AstraZeneca said it expects results from late-stage trials to be released later this year, depending on infection rates where the trials are being held.

Go deeper

Dec 3, 2020 - Health

WSJ: Pfizer expects to ship half as many COVID vaccines as planned in 2020

A Pfizer factory in Puurs, Belgiam on Dec. 3. Photo: Kenzo Tribouillard/AFP via Getty Images

Pfizer and BioNTech have halved their original estimates for how many coronavirus vaccines would be shipped globally by the end of this year, citing supply-chain issues, the Wall Street Journal first reported.

Why it matters: The U.K. government has ordered 40 million doses of Pfizer-BioNTech's vaccine — enough to inoculate some 20 million people. The companies now expect to ship 50 million vaccines by the end of 2020, per WSJ.

Updated Dec 4, 2020 - Health

Fauci apologizes for criticizing U.K. regulators over Pfizer vaccine approval

Photo: Jabin Botsford/The Washington Post via Getty Images

Anthony Fauci, the U.S. government's top infectious-disease expert, on Thursday walked back his earlier comments criticizing British regulators over their recent approval the Pfizer-BioNTech COVID-19 vaccine.

What he's saying: "I have a great deal of confidence in what the U.K. does both scientifically and from a regulator standpoint," Dr Fauci told the BBC on Thursday after saying earlier in the day that U.K. regulators "rushed" their approval of the vaccine.

Updated 11 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Politics: Fauci says he accepted Biden's offer to be chief medical adviser "on the spot" — The recovery needs rocket fuel.
  2. Health: CDC: It's time for "universal face mask use" — Death rates rising across the country — Study: Increased testing can reduce transmission.
  3. Economy: U.S. economy adds 245,000 jobs in November as recovery slows — America's hidden depression: K-shaped recovery threatens Biden administration.
  4. Cities: Bay Area counties to enact stay-at-home order ahead of state mandate
  5. Vaccine: What vaccine trials still need to do.
  6. World: UN warns "2021 is literally going to be catastrophic"
  7. 🎧 Podcast: Former FDA chief Rob Califf on the vaccine approval process.