US trial of AstraZeneca Covid-19 vaccine may resume this week: Sources

CHICAGO/WASHINGTON - AstraZeneca Plc's Covid-19 vaccine trial in the United States is expected to resume as early as this week after the US Food and Drug Administration completed its review of a serious illness, four sources told Reuters.

UK regulatory officials previously reviewed the illness and determined there was"insufficient evidence to say for certain" that it was or was not related to the vaccine. It permitted the trial to resume in the UK, according to a draft of the updated consent form shared with Reuters. AstraZeneca, which is developing the vaccine with Oxford University researchers, had been seen as a frontrunner in the race to produce a vaccine for Covid-19 until its trials were put on hold to investigate the illness. Early data from large-scale trials in the United States of vaccines from Pfizer Inc and Moderna Inc are expected some time next month.

Vaccines are seen as essential to helping end the pandemic that has battered economies around the world and claimed more than 1 million lives - over 220,000 of them in the United States. The Health Research Authority, which helps oversee UK medical research, said in an email to Reuters that it vetted the communication to make sure it was suitable to ensure informed consent among study volunteers. It could not confirm that the letter had been issued.

Dr Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia who reviewed the document, said it can be difficult to link a rare side effect specifically to a vaccine to the exclusion of other potential causes.

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