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AstraZeneca Plc’s COVID-19 vaccine trial in the United States is expected to resume as early as this week following the U.S. Food and Drug Administration completed its review of a severe illness in a study participant, four sources told Reuters.
AstraZeneca’s large, late-stage U.S. trial was on hold since Sept. 6, following a participant at the business’s UK trial fell ill with what was supposed to be a rare spinal inflammatory disorder called transverse myelitis.
The sources, who were briefed on the matter but asked to remain anonymous, said they’ve been advised the trial could resume later this week. It was unclear how the FDA would describe the illness, they said.
The agency is requiring researchers conducting the trial in order to add information about the incident to consent forms signed by study participants, based on one of the resources.
UK regulatory officials previously reviewed the illness and determined there was”insufficient evidence to say for certain” that it was or was not about the vaccine. It allowed the trial to resume in the UK, according to a draft of the updated consent form shared with Reuters.
“In this case, after considering the information, the individual 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.”
Regulators in Brazil, India and South Africa also formerly allowed AstraZeneca to resume its vaccine trials .
AstraZeneca, which is developing the vaccine with Oxford University researchers, was considered a frontrunner in the race to make 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.
Johnson & Johnson last week stopped its Stage III COVID-19 vaccine trial to investigate an unexplained illness in a study participant. 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 health information before deciding to restart the trial. J&J noted last week that its “study pause” was voluntary. By comparison, AstraZeneca’s trial is about”regulatory grasp,” that is imposed by health authorities.
Vaccines are viewed as essential to helping end the pandemic that has battered markets around the world and claimed over 1 million lives – over 220,000 of them in the United States.
Responding to a request about the AstraZeneca trial, British regulators shared with Reuters a draft of a form letter to UK vaccine trial participants, dated Oct. 14 and signed by the Oxford COVID-19 Vaccine Team. It states that the U.S. FDA had”completed their analysis” and said vaccination under the study in the United States would resume shortly.
FDA”has come to the same conclusion as the other drug regulators such as the MHRA,” the letter states.
The Health Research Authority, which helps oversee UK medical research, said in an email to Reuters it assessed the communication to make certain it was suitable to ensure informed consent among study volunteers. It could not confirm that the letter was issued.
An AstraZeneca spokeswoman said the communication is not from the company and it”cannot verify the content,” referring to the draft correspondence to study participants.
“We also cannot comment on a pending FDA decision,” she said. The Oxford study team did not respond to requests for comment.
In another of the documents directed at trial participants, the Oxford vaccine study team noted that there was not enough evidence to link the neurological problem seen in the UK trial to the vaccine.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, who examined the document, said it can be difficult to link a rare side effect especially to a vaccine to the exclusion of other potential causes.
Transverse myelitis, which the analysis is thought to have developed, typically occurs at a speed of 1-in-200,000 people, Offit said, so it would be unusual to see it in a trial of 9,000 people.
The regulators need to weigh whether a rare side effect is vaccine-related and might occur again against the sickness and deaths connected with COVID-19, Offit said. “That’s always the line that you walk.”
