By Peter Loftus
Governments and drugmakers are weighing how to roll out
coronavirus vaccines, including reserving the first batches for
health-care workers, as several shots race to early leads.
Of more than 100 vaccines in development globally, at least
eight have started testing in humans, including candidates from
Moderna Inc. and Pfizer Inc. At the same time, pharmaceutical
giants like Johnson & Johnson, AstraZeneca PLC and Sanofi SA
are building capacity to make hundreds of millions of doses of
their own or their partners' vaccines.
The efforts are part of a larger rush, including at the White
House, to line up funding for accelerated testing and expanded
manufacturing capacity, all to make doses available in the U.S.
starting as soon as this fall.
A safe and effective vaccine is the best way to prevent
Covid-19, the respiratory disease caused by the new coronavirus,
and to curb its transmission, public-health officials say.
Drugmakers say they are developing potential coronavirus vaccines
at remarkably fast speeds.
Yet there isn't a guarantee that any of the most advanced
vaccine candidates will prove to work safely on such a short
timetable. Some, like vaccines from Pfizer and Moderna, are based
on relatively new technologies that haven't been approved
Once a vaccine is proved in clinical testing to work safely,
drugmakers expect the U.S. Food and Drug Administration would move
quickly to permit its use, even if the agency doesn't have all the
evidence it typically collects before granting an approval.
The FDA authorized such an emergency use of the drug remdesivir
from Gilead Sciences Inc., for treating hospitalized Covid-19
patients on May 1, days after a study showed it shortened hospital
The agency, which regulates drugs and vaccines, "will make use
of all appropriate regulatory authorities and provide rapid advice
to expedite the development and availability of a safe and
effective Covid-19 vaccine," an FDA spokesman said.
Several drugmakers that have been building up their capabilities
to make coronavirus vaccines, have pledged to deliver millions of
doses this year. Yet a fuller supply to vaccinate the general
population might not become available until well into 2021,
according to company projections and estimates by vaccine
Public-health officials and vaccine experts hope more than one
vaccine will cross the finish line, to boost the total number of
"Ideally we'd want seven or eight billion doses the day after
licensure, so we can vaccinate the whole world," said Walter
Orenstein, associate director of Emory University's vaccine center
in Atlanta. "The likelihood is we won't have enough to vaccinate
even the entire U.S. population" when a vaccine first becomes
available, he said.
The prospect of limited initial supplies has triggered
maneuvering over which countries get first dibs. Companies
receiving U.S. federal grants, including J&J, Moderna and
Sanofi, are expected to reserve some doses for Americans, according
to industry officials.
The nonprofit Coalition for Epidemic Preparedness Innovations,
which promotes the equitable allocation of vaccines around the
globe, recently agreed to give more than $380 million to Novavax
Inc., of Gaithersburg, Md., to help develop a vaccine that would be
made in various countries for distribution world-wide.
In the U.S., a government agency such as the Centers for Disease
Control and Prevention would probably decide where newly authorized
vaccines should be delivered and which groups should get immunized
first, public-health experts say.
State health officials are discussing whether to mobilize for
coronavirus immunizations an existing network of state agencies
that run childhood vaccination programs at public clinics and via
private health-care providers under the CDC's supervision, said
Claire Hannan, executive director of the Association of
Immunization Managers, which represents state immunization
Groups likely to be at the head of the line for access are
front-line health-care workers and first responders, plus essential
workers like grocery, pharmacy, food-supply and mass-transit
employees, said Paul Offit, director of the Vaccine Education
Center at Children's Hospital of Philadelphia, who serves on a
committee with federal and drug-industry officials that is trying
to accelerate coronavirus vaccine development.
Johnson & Johnson expects to have some batches of its
vaccine ready by early 2021, which Chief Scientific Officer Paul
Stoffels said should be sufficient to vaccinate health-care workers
globally. The company expects to eventually make more than a
Moderna is expanding its vaccine production capacity, including
via a partnership with Swiss contract manufacturer Lonza Ltd., to
make tens of millions of doses a month by the end of this year, and
eventually as many as one billion doses a year, said Chief
Executive Stephane Bancel.
Drugmakers probably won't seek to tweak or improve vaccines that
enter distribution because that would require another regulatory
approval, said Florian Krammer, professor of vaccinology at the
Icahn School of Medicine at Mount Sinai in New York.
Testing of early vaccines could show the way for subsequent
shots, however, by giving researchers a better idea of the level of
immune response needed to provide protection against the virus,
Emory's Dr. Orenstein said.
One open question is whether the elderly will benefit from a
coronavirus vaccine. Immune systems decline with age, which can
reduce vaccines' effectiveness in older adults.
Some of the uncertainty lies in the design of some early
coronavirus vaccine trials, which enrolled healthy volunteers from
18 to 55 or 60 years old to get a quick read on safety in people
more likely to endure any side effects.
"Older adults tend to have less robust immune responses to
vaccines, so we can't necessarily extrapolate what happens in
younger adults to what might happen in older adults," said Dr. Lisa
Jackson, a senior investigator at one of the study sites for the
Moderna vaccine, the Kaiser Permanente Washington Research
The National Institute of Allergy and Infectious Diseases,
however, recently expanded enrollment in a continuing trial of the
vaccine it co-designed with Moderna to include adults older than
Write to Peter Loftus at email@example.com
(END) Dow Jones Newswires
May 17, 2020 05:44 ET (09:44 GMT)
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