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 AstraZeneca's large, late-stage U.S. 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.
The sources, who were briefed on the matter but asked to remain
anonymous, said they have been told the trial could resume later
this week. It was unclear how the FDA would characterize the
illness, they said.
An FDA spokeswoman declined to comment.
The agency 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.
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.
“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.”
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 Inc <PFE.N> and Moderna Inc <MRNA.O>
are expected some time next month.
Johnson & Johnson <JNJ.N> last week paused its Phase 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 medical information before deciding
to restart the trial. J&J noted last week that its "study pause" was
voluntary. By contrast, AstraZeneca's trial is on "regulatory hold,"
which is imposed by health authorities.
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.
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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 says 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 including the
MHRA," the letter 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.
An AstraZeneca spokeswoman 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," she said. The Oxford study
team did not respond to requests for comment.
NOT ENOUGH EVIDENCE
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 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, which the study volunteer is believed to have developed,
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 individuals.
Other viruses including those that cause West Nile and polio can trigger the
condition, as can physical trauma.
The regulators have to weigh whether a rare side effect is vaccine-related and
could occur again against the sickness and deaths linked with COVID-19, Offit
said. "That's always the line that you walk."
(Reporting by Julie Steenhuysen and Marisa Taylor; Editing by Bill Berkrot and
Leslie Adler)
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