By Carl O'Donnell and Michael Erman
Feb 5 (Reuters) - Drugmakers racing to find a vaccine or
effective treatment for the deadly new coronavirus in China
cautioned that they have a long way to go.
That runs counter to reports of a supposed "breakthrough"
that on Wednesday boosted financial markets and spurred optimism
not necessarily backed by reality.
At least a dozen drugmakers are working on vaccines or
antivirals and other treatments to help those infected with the
fast-spreading contagion.
Investment costs for vaccines could run as high as $800
million in a process that, even if accelerated, will likely take
more than a year until approval, according to executives from
companies involved in the effort.
"It will take at least 12 to 18 months, which means in the
acute situation we are in now - at least in China - that will
not create a benefit," said Thomas Breuer, chief medical officer
of GlaxoSmithKline's vaccine unit. GSK is working with
developers by providing a technology that could make their
vaccines more potent.
The virus, which emerged in December in China, has killed
nearly 500 people and shows no sign of abating, with thousands
of new cases reported each day, mostly in central China's Hubei
province. But its spread to some 27 countries and regions has
caused global alarm.
To be sure, companies developing treatments for patients who
are already sick may be able to get a drug approved faster than
a vaccine that would be given to healthy people. Even so,
logistical and regulatory challenges remain, according to two
executives at Gilead Sciences Inc, which is working on
an experimental antiviral treatment.
"There is a distinction there between a therapeutic and a
vaccine. Having said that, I think it is true that this won't be
super fast and it will involve us investing at risk right now,"
said Gilead Chief Medical Officer Merdad Parsey.
Clinical trials for treatments can be smaller and of shorter
duration than for vaccines, Parsey acknowledged.
Challenges in making sure therapies are effective and then
scaling up production still remain. Gilead has only a limited
supply of its remdesivir, which will be tested against the
coronavirus after previously failing in trials as a treatment
for Ebola.
'LOOKING FOR A MAGIC BULLET'
Dr. Thomas Frieden, who was director of the U.S. Centers for
Disease Control and Prevention during the also deadly MERS
outbreak, said the benefit of antiviral treatments for such
emergencies in the past has been modest.
What worked with MERS and SARS, for example, was better
infection control in healthcare facilities, he said of two other
types of coronaviruses that also caused global alarm.
"It doesn't mean we shouldn't try, but we're often looking
for a magic bullet and the bright shiny object. Sometimes we
need to just have the basics," Frieden said.
A Chinese TV report on Wednesday said that a research team
at Zhejiang University had found an effective drug for the
virus, while researchers in the UK told Sky News separately they
had made a "significant breakthrough" in finding a vaccine.
Reuters could not independently verify the reports, but
several traders cited them for sharp upticks in global stock
markets.
"There are no known effective therapeutics against this
2019-nCoV," said World Health Organization spokesman Tarik
Jasarevic, using the current designation for the new
coronavirus, when asked about reports of "drug breakthroughs."
Health officials in the United States and China have set
ambitious goals for getting a vaccine to initial human testing
within the next few months.
Newer vaccine platforms, such as one developed by Moderna
Inc, allow scientists to create a potential vaccine in
record time just based on knowing the genetic code of the novel
coronavirus. With the genetic code in hand, scientists can start
vaccine development without needing a sample of the virus.
Anthony Fauci, director of the U.S. National Institutes of
Allergy and Infectious Diseases, which is using Moderna's
platform, said the agency is on the fastest pace ever to develop
a vaccine candidate.
He hopes to have a vaccine available for initial safety
testing within two and a half to three months from the time
scientists determined the genetic sequence of the virus.
Novavax Inc research chief Gregory Glenn told
Reuters his company has taken vaccines from discovery to
clinical testing in 90 days and believes it could do something
similar for the new coronavirus.
But to move vaccine candidates from the lab to widespread
use in patients involves a number of hurdles, according to
health experts and executives for drugmakers working on
coronavirus vaccines and treatments.
In addition to scaling up manufacturing capacity and
building distribution networks, there are regulatory hurdles
such as conducting large clinical trials to make sure a vaccine
not only confers immunity to the virus but is safe for use in
the general population.
"The earliest you could even know if it's going to work is a
year," Fauci said.
Whether even a highly effective vaccine will prove
profitable for companies is another big question.
"The outbreak could be abating by the time a vaccine is
deemed safe," Karen Andersen, who follows biotech companies for
Morningstar, said in a research note.
The Coalition for Epidemic Preparedness Innovations (CEPI)
has raised around $800 million from donors to aid in preventing
pandemic diseases and has allocated some of those funds to
biotechs, including Inovio Pharmaceuticals Inc, Moderna
Inc and CureVac, which are working on coronavirus
vaccines.
"We stepped into this with no economic expectation," said
Paul Stoffels, Johnson & Johnson's chief scientific
officer. "We'll see whether in the end it gives a reward."
(Reporting by Carl O'Donnell and Michael Erman in New York;
additional reporting by Julia Steenhuysen in Chicago; Editing by
Bill Berkrot)