AstraZeneca’s COVID-19 vaccine trial resumes in US; J&J’s to start soon

AstraZeneca announced on Friday that the Food and Drug Administration (FDA) has allowed the company to restart its phase 3 COVID-19 vaccine trial in the U.S. 

The company has said the FDA has reviewed all data and concluded that it is safe to resume the trial. It expects results from its trials later this year. 

The Wall Street Journal first reported the approval on Friday. 

“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 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.”

The news comes just days after a volunteer who was a part of the trial in Brazil died. Reuters reported on Wednesday that Brazil’s health regulatory Anvisa said the trial would still continue. 

Reuters cited a Brazilian news outlet that reported the volunteer was part of the placebo group, and did not receive the actual vaccine.  

The British pharmaceutical company was the first to halt its trials worldwide in early September to assess whether the vaccine was responsible for an adverse reaction in some subjects. Not long after, the trials resumed in Brazil and South Africa. 

Also on Friday, Johnson & Johnson announced that it is preparing to restart its trial following consultation with the FDA.

The company became the second to pause its trial earlier this month after a person suffered an “unexplained illness.” 

The company said that no clear cause of the incident was identified following review by an independent safety committee, and that there was “no evidence that the vaccine caused the event.” 

Johnson & Johnson said preparations to resume the trial in the U.S. are now underway, and that “discussions with other regulators around the world to resume the clinical trial program are progressing.” 

The Washington Post first reported the approval. The Post, citing anonymous people familiar with the trial, reported that the committee examined medical data from the event, and safety data from 100,000 people who received vaccines that use the same technology.