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Photo: Cristina Arias/Cover/Getty Images

Johnson & Johnson announced Monday has paused a study of its COVID-19 vaccine due to an "unexplained illness in a study participant.

Situational awareness: "This is the normal process. This doesn't mean the illness is related to the vaccine. But these things need to get investigated by an independent committee. Happens in many Phase III trials," Florian Krammer, a professor at School of Medicine at Mount Sinai, noted on Twitter.

  • The AstraZeneca COVID-19 vaccine study was put on hold in early September after a study participant in the United Kingdom had a suspected adverse reaction. The study resumed in the U.K. roughly a week later, but remains on hold in the U.S., per STAT.
  • Johnson & Johnson emphasized its study was paused and not under a "clinical hold," which STAT noted is "a formal regulatory action that can last much longer."
  • The company noted in its statement that "it is not always immediately apparent" if the patient who became sick took the drug or a placebo.

The state of play: Johnson & Johnson began Phase III of its trial on Sept. 23, with the goal of enrolling 60,000 patients.

  • It was the 4th vaccine in the U.S. to enter Phase 3.

Go deeper: Where the vaccine race stands in the U.S.

Editor's note: This article has been updated to include Johnson & Johnson's statement.

Go deeper

Updated 7 hours ago - Politics & Policy

Omicron dashboard

Illustration: Shoshana Gordon/Axios

  1. Health: CDC director says number of U.S. Omicron cases "likely to rise" — Two years of COVID-19 — Prior coronavirus infections may not protect well against Omicron.
  2. Vaccines: Data demonstrates most-vaccinated counties less vulnerable to worst of COVID — Omicron adds urgency to vaccinating world — Omicron fuels the case for COVID boosters.
  3. Politics: Nevada to impose insurance surcharge on unvaccinated state workers — New Jersey GOP lawmakers defy statehouse COVID policy — Oklahoma sues Biden administration over Pentagon vaccine mandate.
  4. World: Vaccine mandates lose steam in the U.S. while Europe doubles downWHO: Delta health measures help fight Omicron — COVID cases surge in South Africa in sign Omicron wave is coming.
  5. Variant tracker: Where different strains are spreading.

Myanmar's deposed leader Aung San Suu Kyi sentenced to 4 years in prison

An anti-coup protest in Yangon, Myanmar.Photo: Hkun Lat/Getty Images

A Myanmar court sentenced the country's ousted leader, Aung San Suu Kyi, on Monday to four years in prison on charges of "inciting public unrest" and breaking COVID-19 protocols, per the New York Times.

Why it matters: It's the first of several verdicts that could result in the 76-year-old Nobel laureate being imprisoned for decades.

The big picture: Suu Kyi has been detained since the military overthrew the elected government and seized power on Feb. 1. Security forces have killed hundreds of activists and arrested thousands of others following massive protests in the wake of the coup.

Editor's note: This a breaking news story. Please check back for updates.

2 hours ago - World

Pope Francis denounces European governments' migrant response

Pope Francis adresses refugees at the Reception and Identification Centre (RIC) in Mytilene on the island of Lesbos on Sunday. Photo: Louisa Gouliamaki/Pool/AFP via Getty Images

Pope Francis criticized European countries' response to migrants and asylum seekers during his visit to a refugee camp on the Greek island of Lesbos Sunday.

Why it matters: The pope said "migration is a humanitarian crisis that concerns everyone," but little had changed in the global response to displaced peoples since his first visit to Lesbos five years ago, per a transcript of his remarks. "Human lives, real people, are at stake. ... let us stop this shipwreck of civilization!"