MESSAGE
| DATE | 2020-09-23 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout - NYLXS] good news on vaccines
|
wsj.com
Johnson & Johnson Begins Final-Stage Testing of Covid-19 Vaccine
Peter Loftus
5-6 minutes
Johnson & Johnson JNJ -0.61% 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.
Governments around the world are debating the timeline for offering
Covid-19 vaccines to the public, as drugmakers speed up development.
WSJ’s Daniela Hernandez explains the potential health risks linked to
fast-tracking vaccines. Photo: Siphiwe Sibeko/AP
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-at-wsj.com
--
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