Johnson & Johnson's Covid-19 Vaccine Produced Immune Response in Earlier-Stage Study
September 25 2020 - 03:50PM
Dow Jones News
By Peter Loftus
Johnson & Johnson's experimental Covid-19 vaccine induced
immune responses in most people who received the shot in a small,
early-stage trial, and also displayed an acceptable safety profile,
according to a study posted online Friday.
The findings added more detail to J&J's announcement earlier
this week that the results from the Phase 1/2 trial were positive,
and mean the vaccine, one of the leading candidates in development,
has taken another step toward proving whether it works safely.
The results supported J&J's decision to start a larger
late-stage study of up to 60,000 people that will provide more
definitive evidence of whether the vaccine safely protects people
from Covid-19, according to the company.
The large Phase 3 study could yield initial results by the end
of the year or early 2021. If they are positive, the company said
it would seek government authorization of emergency use.
J&J, of New Brunswick, N.J., started the first human study
of its vaccine, code-named Ad26. COV2. S, in July in Belgium and
the U.S., with a target of enrolling more than 1,000 adults.
Various dose levels and dosing regimens were tested on the study
subjects.
Detailed interim results from the study were posted on the
online preprint server medRxiv. The site publishes medical
manuscripts before they are vetted by peer reviewers and published
in medical journals.
Among the vast majority of certain subgroups of study subjects,
the study said, a single dose of the vaccine induced so-called
neutralizing antibodies to the coronavirus, when measured in blood
samples about four weeks after vaccination.
Neutralizing antibodies are agents of the immune system that
researchers believe can block the virus and ward off Covid-19.
The concentrations of neutralizing antibodies induced by the
vaccine were comparable to levels seen in the blood of people who
had recovered from Covid-19, the study said. The neutralizing
antibody responses among those vaccinated were comparable between
younger adults and older adults, the study said.
The early-stage study didn't, however, show whether these immune
responses prevented Covid-19. That will be tested in the new,
larger study.
Some people in the early-stage study experienced injection-site
pain, fever, fatigue, headache and muscle pain after vaccination.
Researchers said no one discontinued participation in the study due
to adverse events.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
September 25, 2020 15:35 ET (19:35 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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