By Peter Loftus
New details about the first human study of Moderna Inc.'s
experimental coronavirus vaccine emerged Tuesday, which researchers
said reinforced their decision to take the shot into a large,
decisive clinical trial scheduled to start in late July.
The new results, published online by the New England Journal of
Medicine, showed that the vaccine induced the desired immune
response for all 45 people evaluated -- a larger group than in the
preliminary data Moderna released in May -- and was generally safe
"This is really quite good news," Dr. Anthony Fauci, director of
the National Institute of Allergy and Infectious Diseases, said in
an interview Tuesday. NIAID co-developed the Moderna vaccine and
led the study.
"The gold standard of protection against a viral infection is
neutralizing antibodies," he added. "And the data from the study,
small numbers as it may be, are pretty clear that this vaccine is
capable of inducing quite good [levels] of neutralizing
Researchers said they found no serious safety risks, though some
participants had injection-site pain and symptoms such as fatigue,
headache and chills.
Dr. Fauci said it is possible that the coming large study would
yield an answer by year-end about whether the vaccine induced
immune responses sufficient to protect people safely from Covid-19.
A positive answer would clear the way for wider use and potentially
help curb the deadly pandemic.
The new "Cove" study, scheduled to start July 27, will aim to
enroll about 30,000 adults at nearly 90 different U.S. locations.
Many of the study sites will be in states where the virus is
surging, such as Texas, Florida, California and Arizona, according
to information posted Tuesday on a federal database of medical
Among the people researchers plan to enroll are those at
appreciable risk of infection because of where they live. Testing
the vaccine in coronavirus hot spots could help generate answers
about the vaccine's efficacy sooner, because people there are more
likely to be exposed to the virus in everyday living compared with
people in places where new cases have declined.
Researchers will give about half of the participants the Moderna
vaccine -- two doses four weeks apart -- and the others placebo
shots, then compare what portion of each group contracts
symptomatic Covid-19, the disease caused by the new coronavirus.
The study is scheduled to run through October 2022, but it is
likely researchers would have preliminary results well before
Moderna said Tuesday it has made enough doses to start the new
study and is on track to deliver about 500 million doses a year,
and possibly up to one billion a year starting in 2021.
Testing of the Moderna shot is one of a series of large,
federally funded clinical trials planned in coming weeks of
experimental coronavirus vaccines, including one codeveloped by the
University of Oxford and AstraZeneca Plc, and another from Johnson
& Johnson. Planning to start a large trial this month of their
experimental coronavirus vaccine are Pfizer Inc. and BioNTech
Some of the vaccine developers, including Moderna, say if
studies are successful, a vaccine could become available for
emergency use by the end of this year. Public-health officials say
it is likely that several vaccines would be needed to help bring
the deadly global pandemic under control.
Researchers are trying to line up tens of thousands of
participants for the studies, recruiting at pharmacies, enlisting
churches in searches for subjects and even requesting employees and
families to ask around.
Last week a government-funded group of researchers leading the
studies, the Covid-19 Prevention Network, started an online
screening registry that would find and route potential volunteers
to the various studies.
Since the online registry went live, about 62,000 people have
signed up, according to a spokeswoman for Fred Hutchinson Cancer
Research Center in Seattle, which is helping to lead the study
Larry Corey, a Fred Hutchinson vaccine specialist who is helping
to lead the effort, said the initial number of registrations was
encouraging, though it is possible that not all the volunteers
would end up in the trials.
Dr. Corey said researchers are looking for diverse study
populations that include people at risk for severe disease because
of their age, ethnicity and race. Older people are more vulnerable
to the virus, and rates of hospitalization and death are higher in
The National Institute of Allergy and Infectious Diseases, which
codesigned a coronavirus vaccine with Moderna, of Cambridge, Mass.,
started the first study of the shot in March, after Moderna quickly
manufactured the first batch. The vaccine is designed to deliver
the genetic code of a portion of the new coronavirus, which
instructs the body's cells to make that protein and in turn induce
an immune response against the virus.
In May, Moderna said preliminary results showed that the vaccine
induced desired immune responses in a small number of people and
was generally safe and well-tolerated.
The new results are from 45 people, ages 18 to 55, who enrolled
in the study in Seattle and Atlanta. The study was later expanded
to include people older than 55, but they weren't included in the
Study subjects received two shots, about four weeks apart.
Researchers tracked safety and whether the vaccine induced certain
immune responses as measured in blood samples.
Researchers found antibody production generally increased after
the second dose. They found neutralizing activity similar to that
seen in the top half of blood specimens taken from 41 people who
had recovered from Covid-19 and who weren't in the vaccine
The neutralizing activity was detected up to nearly two months
after the first injection, a longer follow-up period for more
people than was available at the time Moderna released preliminary
results in May, said Dr. Lisa Jackson, a senior investigator at
Kaiser Permanente Washington Health Research Institute in Seattle,
and lead author of the study.
Researchers, however, still don't know what level of a
neutralizing immune response would be needed to guard against
either infection or severe disease, and for how long a vaccine
could provide such protection.
"This provides some essential first information on how the
vaccine is tolerated and how the doses affect immunity, and I think
it's essential information to progress onward," Dr. Jackson
More than half of the study participants had side effects
including fatigue, chills, headache and injection-site pain. Three
participants who received the highest dose level tested had one or
more severe adverse events, the researchers said. That highest dose
level isn't being tested in the large phase 3 study.
Write to Peter Loftus at firstname.lastname@example.org
(END) Dow Jones Newswires
July 14, 2020 17:57 ET (21:57 GMT)
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