Johnson & Johnson Begins Final-Stage Testing of Covid-19 Vaccine
September 23 2020 - 6:14AM
Dow Jones News
By Peter Loftus
Johnson & Johnson said Wednesday it started a 60,000-person
clinical trial of its single-dose Covid-19 vaccine on three
continents, becoming the fourth experimental Covid-19 shot to enter
final-stage testing in the U.S.
The New Brunswick, N.J., company said it could learn pivotal
results from the trial by early next year, which if positive could
lead to government authorization of the vaccine for emergency use
soon afterward. J&J aims to enroll adult volunteers in the U.S.
and several other countries, including Brazil and South Africa.
The trial follows an earlier study in which the shot showed
promising results. It will now test whether a single dose of
J&J's vaccine can safely protect people from Covid-19. U.S.
government agencies including the National Institutes of Health and
the Department of Health and Human Services are helping to fund the
study, which is expected to cost about $480 million.
A vaccine that Moderna Inc. codesigned with the National
Institute of Allergy and Infectious Diseases started Phase 3
testing in July and has enrolled nearly 26,000 people toward a goal
of 30,000.
Pfizer Inc. and partner BioNTech SE also started a Phase 3 trial
of their vaccine in July and have enrolled nearly 32,000 toward a
goal of 44,000. Interim results of the Moderna and Pfizer studies
could come as soon as October, but possibly later, according to
company executives.
AstraZeneca PLC, which licensed a vaccine from the University of
Oxford, started a 30,000-person Phase 3 trial in the U.S. in August
but that study is on hold while an independent committee reviews a
safety matter.
J&J is collaborating with the U.K. government for a separate
Phase 3 study to test a two-dose regimen of the vaccine.
Public-health officials are counting on one or more of these
vaccines to pass muster in the large trials and become available to
help curb the coronavirus pandemic. The vaccine developers have
already started manufacturing doses that could be ready soon after
regulators clear a vaccine for use.
"We want to do everything we can without sacrificing safety or
efficacy...to make sure that we end up with vaccines that are going
to save lives," NIH Director Francis Collins said in a conference
call with reporters.
J&J started work on its vaccine earlier this year and in
July started the first study in humans in the U.S. and Belgium.
J&J Chief Scientific Officer Paul Stoffels said the vaccine
showed positive interim results in inducing immune responses in the
first study, and was generally well-tolerated. Vaccine recipients
experienced certain side effects, including fever and flulike
symptoms, which Dr. Stoffels said weren't unusual for vaccines. Dr.
Stoffels said full results from the early-stage study would be
published online imminently.
In the Phase 3 study, some subjects will receive the vaccine,
and others a placebo, and researchers will track whether the rates
of symptomatic Covid-19 are lower among vaccinated people than
unvaccinated people.
J&J's vaccine is known as a viral vector shot because it
uses a modified adenovirus -- a virus that can cause the common
cold -- to deliver genetic instructions teaching the human immune
system to build a defense against the coronavirus.
The company in August signed a $1 billion contract with the
federal government to supply 100 million doses for the U.S., if the
vaccine proves successful in testing and gets authorized for use.
J&J expects to produce more than one billion doses globally
during 2021.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
September 23, 2020 06:59 ET (10:59 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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