Nov 17 (Reuters) - Johnson & Johnson's chief
scientist said the drugmaker is recruiting over 1,000 people per
day for the late-stage trial of its experimental COVID-19
vaccine and expects to have all the data needed to seek U.S.
authorization by February or earlier.
"By the end of the year or around the end of the year, we
should have 60,000 people in the study," Dr. Paul Stoffels,
J&J's chief scientific officer, said in an interview ahead of
this week's Reuters Total Health conference.
"And efficacy endpoint should be there in the first few
weeks or months, January or February, of the new year," he
The Phase III trial of the single-dose vaccine started in
late September. The company paused the trial in October because
of a serious medical event in one participant and resumed after
getting the green light from an independent safety panel.
J&J must provide safety data to the U.S. Food and Drug
Administration for at least one-half of trial participants for a
duration of two months after they receive the vaccine. "So that
will bring us around the year end or early next year for having
all the data," he added.
J&J lags some of its rivals in the global race to develop a
safe and effective vaccine against the virus that has killed
over 1.3 million people worldwide and roiled the global economy.
Rival Moderna on Monday said its experimental
vaccine was 94.5% effective in preventing COVID-19 based on
interim data from a late-stage clinical trial, following similar
results from Pfizer last week.
Both Pfizer's and Moderna's vaccines use a new technology
known as messenger RNA, or mRNA. By contrast, J&J's vaccine uses
a common cold virus known as adenovirus type 26 to introduce
coronavirus proteins into cells in the body and trigger the
body's immune system.
J&J's candidate is a single-dose vaccine, whereas the
vaccines from Moderna and Pfizer and another under development
by AstraZeneca all require two shots separated by
"In a pandemic a single shot is definitely important
globally," Stoffels said. "(A two-shot vaccine) is a very
significant operational challenge. More so in healthcare systems
which are less well organized."
Single-shot vaccines will likely benefit in particular
remote areas, Stoffels said.
For more on Reuters Events Total Health click here: https://reutersevents.com/events/healthcare/
(Reporting by Manojna Maddipatla in Bengaluru and Axel
Threlfall in London; Editing by Bill Berkrot and Rosalba