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  • A general view of AstraZeneca's Australia headquarter in Sydney, Australia. August 19, 2020.

    A general view of AstraZeneca's Australia headquarter in Sydney, Australia. August 19, 2020. | Photo: EFE/EPA/Dan Himbrechts

Published 23 October 2020
Opinion

After approval from regulators, AstraZeneca has resumed its U.S. COVID-19 vaccine trials, whereas Johnson & Johnson will resume trials on Monday or Tuesday, the companies said.

One of the world's leading vaccine developers, AstraZeneca, paused its U.S. vaccine trials on September 6 after a severe neurological illness report, believed to be transverse myelitis in the company's U.K. trial. J&J also halted its U.S. late-stage trial last week after a participant became ill.

Both companies have lucrative contracts with the U.S. and other governments worldwide to provide the vaccine worldwide.

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The news signals progress as more than 41 million people globally, and more than 8 million in the U.S., have contracted the virus, with second waves hitting much of the world this fall.

Around a quarter of U.S. respondents to a recent survey said they were hesitant to take a COVID-19 vaccine as officials and experts alike have expressed concerns that federal regulators overseen by the Food and Drug Administraiton (FDA) will be undermined by political pressure. 

J&J said Friday that a safety panel, called the Data and Safety Monitoring Board,  recommended that the drugmaker resume trial recruitment after finding no concrete evidence that the vaccine caused the volunteer to fall ill.
 
J&J's chief scientific officer Paul Stoffels said that it would resume its U.S. trials either Monday or Tuesday and produce and present data on the vaccine's effectiveness by the end of 2020 or the beginning of 2021. The company is in talks with regulators to resume trials outside of the U.S.
 
The FDA gave AstraZeneca, whose vaccine is being co-developed with researchers from Oxford University, the green light to continue testing the vaccine in the U.S. as their trials resumed last month in the United Kingdom, Brazil, and South Africa. 
 
“As this trial resumes, I am hoping the message communicated to the public is that we are following procedures to highest ethical standard and not interfering with the FDA regulatory process,” said Matthew Hepburn, head of vaccine development for Operation Warp Speed, a public-private partnership to speed-up inoculation efforts.
 

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