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CHICAGO / WASHINGTON: AstraZeneca’s COVID-19 vaccine trial in the United States is expected to resume as soon as this week after the U.S. Food and Drug Administration completed its review of a serious illness, they said. four sources to Reuters.
AstraZeneca’s large late-stage American 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 myelitis. transverse.
The sources, who were briefed on the matter but asked to remain anonymous, said they were told that the trial could resume later this week. It was unclear how the FDA would characterize the disease, they said.
An FDA spokeswoman declined to comment.
The agency requires investigators conducting the trial to add information about the incident to consent forms signed by study participants, according to one of the sources.
Regulatory officials in the UK previously reviewed the disease and determined that there was “insufficient evidence to say for sure” that it was or was not related to the vaccine. He 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 independent reviewers and the MHRA (Medicines and Health Products Regulatory Agency) recommended that vaccines should continue,” the draft consent form states. “Close monitoring of the affected person and other participants will continue.”
Regulators in Brazil, India and South Africa also previously allowed AstraZeneca to resume its vaccine trials there.
AstraZeneca, which is developing the vaccine with researchers at the University of Oxford, had been considered a pioneer in the race to produce a vaccine for COVID-19 until its trials were suspended to investigate the disease. Preliminary data from large-scale trials in the United States of vaccines from Pfizer Inc and Moderna Inc are expected next month.
Johnson & Johnson paused its COVID-19 phase III vaccine trial last week 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 received his vaccine or a placebo.
A J&J spokesperson said Tuesday that the study remains on hold while the company continues its review of medical information before deciding to restart the trial. J&J noted that its “study pause” was voluntary, in contrast to AstraZeneca’s “regulatory suspension”, which is imposed by health authorities.
Vaccines are considered essential to help end the pandemic that has hit economies around the world and claimed more than a million lives, more than 220,000 in the United States.
In response to a request about the AstraZeneca trial, UK regulators shared with Reuters a draft form letter for UK vaccine trial participants, dated October 14 and signed by the COVID-19 Vaccine Team. from Oxford. It says the US FDA had “completed its analysis” and said vaccination in the United States would resume shortly.
The FDA “has reached the same conclusion as the other drug regulators, including the MHRA,” the letter says.
The Health Research Authority, which helps oversee UK medical research, said in an email to Reuters that it examined the communication to make sure it was adequate to ensure informed consent among study volunteers. He could not confirm that the letter had been sent.
A spokeswoman for AstraZeneca said the communication is not from the company and it “cannot verify the content,” referring to the draft letter to study participants.
“We also cannot comment on a pending FDA decision,” he said. The Oxford study team has not responded to requests for comment.
NOT ENOUGH EVIDENCE
In another of their papers for trial participants, the Oxford vaccine study team noted that there was insufficient evidence to link the neurological problem seen in the UK trial with the vaccine.
Dr. Paul Offit, director of the Center for Vaccine Education 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.
Transverse myelitis, thought to have been developed by the study volunteer, typically occurs at a rate of 1 in 200,000 people, Offit said, so it would be unusual to see it in a trial of 9,000 people.
Other viruses, including those that cause West Nile and polio, can trigger the condition, as can physical trauma.
Regulators have to weigh whether a rare side effect is related to the vaccine and could occur again against the disease and deaths related to COVID-19, Offit said. “That is always the line you walk.”
