Story at a glance

  • The Washington Post reports Johnson & Johnson will soon resume its phase three trial after the pharmaceutical giant temporarily paused the study on Oct. 12 after a participant suffered a stroke.
  • An independent committee investigated the incident and was able to determine the stroke was not related to the vaccine, the outlet reported.
  • The Food and Drug Administration (FDA) on Friday gave AstraZeneca the green light to resume clinical trials in the U.S. The trial had been paused since September.

Two late-stage clinical trials of key coronavirus vaccine candidates that were recently put on hold after participants became ill are set to restart. 

The Washington Post reports Johnson & Johnson will soon resume its phase three trial after the pharmaceutical giant temporarily paused the study on Oct. 12 after a participant suffered a stroke. An independent committee investigated the incident and was able to determine the stroke was not related to the vaccine, the outlet reported citing two sources familiar with the trial. 


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The experimental vaccine developed by the company’s subsidiary, Janssen Pharmaceutical Companies, went into phase three trials last month and is aiming to enroll 60,000 participants. 

The potential vaccine has several advantages that could make it easier to broadly distribute. Unlike the other potential vaccines, Johnson & Johnson’s will require just one dose instead of two and will not need to be stored in subzero temperatures. 

Stat News reports the study could begin enrolling patients again as early as next week. 

Meanwhile, the Food and Drug Administration (FDA) on Friday gave AstraZeneca the green light to resume clinical trials in the U.S. for the vaccine it developed in collaboration with Oxford University after reviewing safety data. 

AstraZeneca halted vaccine trials on Sept. 6 after two participants in the U.K. developed neurological problems. The studies resumed across the world after regulators confirmed it was safe to do so, but the company did not get clearance to continue trials in the U.S. until Friday. It’s not clear why the study was kept on hold much longer in the U.S. than other countries. 

“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,” Pascal Soriot, CEO of AstraZeneca, said in a statement. “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’s not unusual for some participants to become ill during large scale vaccine trials and most resume shortly after they’re put on pause so cases can be evaluated for safety. 

The two vaccine candidates are among the four in late-stage trials in the U.S. 

Health officials have estimated a safe and effective COVID-19 vaccine could be made available to high-risk groups before the year is out. A vaccine isn’t likely to be broadly available to all Americans until several months into 2021. 


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Published on Oct 23, 2020