U.S. Commits $2 Billion for Covid-19 Vaccine, Drug Supplies -- Update
July 07 2020 - 12:30PM
Dow Jones News
By Peter Loftus and Joseph Walker
The federal government awarded $2 billion to two drugmakers to
support development and manufacturing of an experimental drug and a
potential vaccine against Covid-19.
Novavax Inc. said it would receive $1.6 billion from the federal
government to fund clinical studies of its experimental coronavirus
vaccine and establish large-scale manufacturing of doses. With the
funding, Novavax said it would deliver 100 million doses of its
vaccine for use in the U.S., possibly by the end of this year.
Regeneron Pharmaceuticals Inc. said it has received a $450
million federal contract to manufacture thousands of doses of its
experimental Covid-19 treatment that the government will distribute
at no cost to the public if the drug is authorized for use by
regulators.
Shares of Novavax soared nearly 29% to $102.24 Tuesday morning.
Shares of Regeneron rose 3.5% to $648.90.
The new funding shows the federal government is taking steps to
try to ensure that more effective tools against the pandemic are
ready by fall and winter. But there is no guarantee that the drug
and vaccine will work safely in clinical trials.
The exact number of treatment courses covered by the Regeneron
contract is uncertain, the company said, in part because clinical
trials have yet to show what the most effective dose will be.
Regeneron is testing its drug, a combination of two antibodies,
as both an antiviral treatment for people already infected, and as
a method of providing temporary preventive treatment against new
infections. The Tarrytown, N.Y., company said Monday it is
advancing the drug into later-stage studies.
The contract will cover 70,000 to 300,000 treatment doses as an
antiviral treatment. If used preventively, a lower dose of the drug
would be needed and the estimated treatment doses would range from
420,000 to 1.3 million, Regeneron said. Initial doses could be
ready as soon as late summer, and the total contracted amount of
drug should be manufactured in the fall, the company said.
The U.S. government will receive nearly all of its supply until
the contracted amount of drug is completed, a Regeneron spokeswoman
said. The company will keep a small portion of the drug for
clinical trials, she said.
The contract was awarded as part of the government's Operation
Warp Speed initiative and will be funded by divisions of the
Department of Health and Human Services and the Department of
Defense, Regeneron said.
Regeneron was previously awarded $167.5 million in federal
funding to help develop its Covid-19 drug.
Regeneron is working to set up other manufacturing arrangements,
potentially with nongovernmental organizations or other
pharmaceutical companies, to meet demand for the drug outside of
the U.S., if it is authorized for use, the spokeswoman said.
Operation Warp Speed is a federal initiative to accelerate the
development and manufacturing of drugs and vaccines for Covid-19.
The government also is backing vaccines developed by Moderna Inc.,
AstraZeneca PLC and Johnson & Johnson.
Novavax, of Gaithersburg, Md., started testing its vaccine,
NVX--CoV2373, in May in a small study in Australia, for which
initial results are expected by the end of July. The new federal
funding will support a pivotal, "phase 3" study with up to 30,000
participants beginning in the fall, Novavax said.
"We've got all the tools to allow us to get the vaccine made in
large scale," Novavax Chief Executive Stanley Erck said in an
interview. "We just need data to show it works." He said the
company has seen promising results of its experimental vaccine in
animal tests so far.
Novavax's vaccine contains proteins resembling those found on
the surface of the new coronavirus, which are supposed to trigger
an immune response to the virus once injected. Novavax manufactures
the proteins in insect cells.
Novavax, founded in 1987, has no products on the market. It is
developing vaccines against influenza and other viruses.
The company's efforts have gotten a boost from the Coalition for
Epidemic Preparedness Innovations, an Oslo-based nonprofit that has
pledged as much as $388 million in funding for Novavax's
coronavirus vaccine.
The CEPI funding is helping the company run clinical trials and
begin ramping up production of doses. In return, Novavax has
pledged to expand manufacturing outside the U.S. and to participate
in a global allocation system for doses. Novavax manufactures
portions of its developmental vaccines in the U.S. and Sweden, and
recently acquired a manufacturing plant in the Czech Republic.
Write to Peter Loftus at peter.loftus@wsj.com and Joseph Walker
at joseph.walker@wsj.com
(END) Dow Jones Newswires
July 07, 2020 12:15 ET (16:15 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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