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Photo: Lisa Maree Williams/Getty Images

AstraZeneca's COVID-19 vaccine trial has been put on pause after researchers suspected an adverse reaction in a participant in the United Kingdom, a spokesperson for the company told Stat News.

Why it matters: There are presently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is one of the most promising candidates, and is the first known Phase 3 vaccine trial to be halted.

Of note: It is unclear what the unfavorable reaction was and when it occurred, but the participant is expected to recover. It's also not known who paused the study, how severe or rare the reaction may be and how long the hiatus could last.

  • A variety of responses may be flagged for possible adverse reactions, including hospitalization, life-threatening illness and death.

What they're saying: The halt is “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials," AstraZeneca said in a statement per Stat News.

"In large trials illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimize any potential impact on the trial timeline."

The big picture: AstraZeneca started its Phase 3 trial in the U.S. in late August. The process is taking place across 62 sites throughout the country.

  • Phase 2 and 3 trials previously began in the U.K., Brazil and South Africa.

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 13 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.