⁍ AstraZeneca’s large, late-stage U.S. trial has been on hold since Sept. 6.

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⁍ A participant in the company’s UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis.

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– An H1N1 vaccine trial in the US is expected to resume this week after the FDA completed its review of a serious illness in one of the participants, sources tell Reuters. Johnson & Johnson halted the trial last week after one of its participants developed what is believed to be a rare spinal inflammatory disorder called transverse myelitis. The FDA is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources. AstraZeneca’s large, late-stage US trial has been on hold since Sept. 6, after a participant in the company’s UK trial fell ill with what was suspected to be a rare spinal inflammatory disorder called transverse myelitis. Regulators in Brazil, India, and South Africa also previously allowed AstraZeneca to resume its vaccine trials there. 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 and Moderna Inc are expected some time next month. Johnson & Johnson last week paused its Phase III COVID-19 vaccine trial to investigate an unexplained illness in one of the study participants. At the time of the announcement, the company did not know whether the volunteer had been given its vaccine or a placebo. A J&J spokesman on Tuesday said the study remains on pause as the company continues its review of medical information.