The UK-based pharmaceutical firm AstraZeneca’s COVID-19 vaccine trial in the United States is expected to resume as early as this week, sources claim.
They suggest that the resumption is likely as the US Food and Drug Administration (FDA) has completed its review of a severe illness in a participant in the research.
Since September 6, after a participant in the company’s UK trial fell ill with what was believed to be a rare spinal inflammatory condition called transverse myelitis, AstraZeneca’s big, late-stage US trial has been on hold.
The sources confirmed that they were informed that the trial could resume later this week. How the FDA will characterize the illness was uncertain, they said.
According to one of the sources, the agency is demanding researchers conducting the trial to add information about the incident to consent forms signed by study participants.
The illness was previously reviewed by UK regulatory officials who determined that 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.
“In this case, after considering the information, the independent reviewers and MHRA (Medicines and Healthcare products Regulatory Agency) recommended that vaccinations should continue,” the draft consent form stated. “Close monitoring of the affected individual and other participants will be continued.”
AstraZeneca was also previously approved by regulators in Brazil, India and South Africa to resume its vaccine trials there.
AstraZeneca, which is developing the vaccine with researchers from Oxford University, was considered as a frontrunner in the race to create a COVID-19 vaccine before its trials to investigate the illness were put on hold. Early results from large-scale US trials of Pfizer and Moderna vaccines are due some time next month.
Last week, Johnson & Johnson halted the Phase III COVID-19 vaccine trial to examine a study participant’s unexplained illness.
The study remains on hold while the company continues its analysis of medical evidence before agreeing to restart the trial, a J&J spokesman said. Last week, J&J noted that its “study pause” was voluntary. AstraZeneca’s trial, on the other hand, is on “regulatory hold,” imposed by the health authorities.
Some records indicate that the Oxford vaccine research team noted that there was not enough evidence to link the neurological condition found in the UK trial to the vaccine.
Usually, transverse myelitis, which the study volunteer is thought to have developed, occurs at a rate of 1-in-200,000 people, so it would be rare to see it in a 9,000-person trial, experts claim. Physical trauma or other viruses, including those that cause polio can also trigger transverse myelitis.
Regulators must weigh whether the rare side effect is vaccine-related and can occur again against COVID-19-related illness and deaths, experts say.
In order to help end the pandemic that has hit economies around the world and taken more than 1 million lives, vaccines are seen as vital.