By Peter Loftus and Jared S. Hopkins
Two of the most advanced experimental coronavirus vaccines
entered the pivotal phase of their studies on Monday, with the
first subjects receiving doses of Moderna Inc.'s vaccine and Pfizer
Inc. readying to inject participants in its trial.
Researchers evaluating the vaccines plan to enroll 30,000 people
in separate last-stage, or phase 3 trials, results of which will
determine whether the vaccines protect against symptomatic
Covid-19, and whether they should be cleared for widespread
Moderna's two-dose vaccine will be administered at sites across
the U.S. The Cambridge, Mass., company also received an additional
commitment of up to $472 million from the federal government to
support the large study, on top of the $483 million in funding
earlier in the year for development, testing and preparations to
manufacture at large scale.
Moderna, which codesigned the vaccine with the National
Institute of Allergy and Infectious Diseases, previously reported
promising results of the first study of the vaccine, showing it
induced immune responses and was generally safe in a small number
The new phase 3 trial, titled Cove, is being conducted at nearly
90 sites in the U.S., including many in states such as Texas where
the virus has surged in recent weeks.
Pfizer's trial, which will begin in the U.S. but expand overseas
to include about 120 sites, will evaluate a vaccine developed with
partner BioNTech SE. The shot is one of four candidates the
As vaccines proceed through the final stages of testing,
countries are jockeying to secure enough shots, should they prove
safe and effective, and the supplies to transport them.
Last week, the U.S. agreed to pay Pfizer and BioNTech nearly $2
billion to secure 100 million doses of their experimental Covid-19
vaccine to provide to U.S. patients free of charge. Pfizer is
targeting October to file for regulatory approval or an emergency
No vaccine has proven to work safely against the coronavirus.
Many vaccines developed to target other pathogens have failed in
testing, including in phase 3 trials.
U.S. officials said Monday it was the fastest time from the
design of a new vaccine to the start of phase 3 testing in the U.S.
NIAID researchers helped design the vaccine, code-named mRNA-1273,
in January after the genetic code of the virus was posted to a
"Yes, we're going fast, but no, we are not going to compromise
safety or efficacy," National Institutes of Health Director Francis
Collins said on a conference call with reporters Monday. NIAID is
part of the NIH.
The start of the pivotal Moderna vaccine trial is the latest
sign that the most advanced coronavirus vaccine candidates are
moving into the final stages of testing, and could be ready for
wider use before year's end if results are positive.
A vaccine co-developed by the University of Oxford and
AstraZeneca PLC started a large study in May in the U.K., and is
due to enter a phase 3 study in the U.S. in August.
Another company expected to be a major player in the vaccine
hunt, Johnson & Johnson, started dosing participants in the
first U.S. human study of its experimental shot Monday. A larger,
phase 3 study of J&J's vaccine may start in September.
Moderna hopes its large study, which is being conducted in
collaboration with the NIH, will yield positive results and
possible vaccine availability in the fall, with J&J aiming for
similar milestones by early 2021.
In the new Moderna vaccine study, about half of the adult
volunteers will receive two shots of the vaccine four weeks apart,
while the other half will get two doses of a placebo. Starting two
weeks after the second dose, researchers will track whether the
rate of symptomatic Covid-19 disease in the vaccinated group is
lower than in unvaccinated people.
NIAID Director Anthony Fauci said researchers may learn in
November or December whether the Moderna vaccine works, but the
answer could come sooner, depending on infection rates in the
places where the study is being conducted.
Moderna has been manufacturing doses even before getting an
answer on efficacy, but if it gets a green light from the
government for wider user, it is unlikely there will be enough
doses for all Americans right away.
Chief Executive Stéphane Bancel said there could be enough doses
initially for "millions and millions" of people, which could be
prioritized for at-risk groups like health-care workers.
The NIH and the Centers for Disease Control and Prevention have
asked a National Academy of Medicine committee to come up with a
plan for equitable allocation of any effective Covid-19
Moderna expects a wider rollout of the vaccine next year if the
study is positive. It says it is on track to deliver about 500
million doses a year, and possibly up to one billion doses,
starting in 2021.
Moderna shares rose 9% to $79.91 in trading Monday.
Write to Peter Loftus at email@example.com and Jared S.
Hopkins at firstname.lastname@example.org
(END) Dow Jones Newswires
July 27, 2020 18:38 ET (22:38 GMT)
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