AstraZeneca Covid-19 Vaccine Trials Resume in U.K.--2nd Update
September 13 2020 - 12:53PM
Dow Jones News
By Peter Loftus
AstraZeneca PLC said Saturday clinical trials for its
experimental coronavirus vaccine have resumed in the U.K. after
regulators concluded it was safe to do so, following a pause in
studies globally after a person who received the vaccine had an
unexplained illness.
Trials in other countries, including the U.S., remain paused
while AstraZeneca works with national health authorities, the
company said.
AstraZeneca said Tuesday it paused trials globally of a vaccine
it licensed from the University of Oxford after a vaccinated woman
in the U.K. experienced the unexplained illness, which a U.S.
official described as a spinal cord problem.
The pause gave independent committees and country regulators
time to evaluate the case and determine whether it would be safe
for testing to begin again.
A U.K. committee has concluded its investigation and recommended
to the U.K. Medicines & Healthcare products Regulatory Agency
it would be safe to resume the trials. The regulatory agency
confirmed that it was safe to resume, the company said.
The MHRA couldn't immediately be reached for comment.
AstraZeneca said it couldn't disclose further information about
the study subject's illness. Oxford, which is running a U.K. study
of the vaccine, said it couldn't disclose medical information about
the illness for reasons of participant confidentiality.
The U.K. study of the AstraZeneca/Oxford vaccine was paused once
before, in July, after a person in the trial experienced
neurological symptoms, which were later diagnosed as multiple
sclerosis and deemed unrelated to the vaccine. Testing resumed
after the July pause following a safety review.
An information sheet given to study subjects, updated Friday and
posted on Oxford's website about the trial, says that researchers
have undertaken safety reviews when volunteers in the trials
developed unexplained neurological symptoms including "changed
sensation" or limb weakness. The document said that after an
independent review, "these illnesses were either considered
unlikely to be associated with the vaccine or there was
insufficient evidence to say for certain that the illnesses were or
were not related to the vaccine."
Independent reviewers recommended that vaccinations should
continue, and they will closely monitor the affected study
volunteers and other participants, according to the document.
Also Saturday, Pfizer Inc. and partner BioNTech SE said they
asked U.S. regulators to permit expanding the late-stage trial
testing for their experimental Covid-19 vaccine to about 44,000
people, up from 30,000.
Pfizer expected to reach its initial target of enrolling 30,000
subjects next week. A larger trial will increase diversity and
include people as young as 16 years old, as well as people
diagnosed with viral diseases such as HIV, hepatitis C and
hepatitis B, the company said.
Pfizer still expected to have results by the end of October, and
aimed to file for regulatory authorization or approval, if the
results are positive, by the end of October, a company spokeswoman
said.
Oxford said Saturday about 18,000 people globally have received
its Covid-19 vaccine in trials. Before the study pause, AstraZeneca
had started a 30,000-person U.S. trial of the vaccine.
Moderna Inc. said Friday nearly 23,500 people have enrolled in a
late-stage study of its vaccine in the U.S., toward a goal of
30,000. The company has said it has asked leaders of its study
sites to boost minority enrollment, even if that means taking
longer to complete total enrollment in the trial.
Johnson & Johnson plans to start this month a late-stage
study of its vaccine in up to 60,000 people in several countries
including the U.S.
Jared S. Hopkins contributed to this article.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
September 13, 2020 13:38 ET (17:38 GMT)
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