By Jared S. Hopkins and Jonathan D. Rockoff
The race for a vaccine to combat the new coronavirus is moving
faster than researchers and drugmakers expected, with Pfizer Inc.
joining several other groups saying that they had accelerated the
timetable for testing and that a vaccine could be ready for
emergency use in the fall.
Pfizer said Tuesday it will begin testing of its experimental
vaccine in the U.S. as early as next week. On Monday, Oxford
University researchers said their vaccine candidate could be
available for emergency use as early as September if it passes
muster in studies, while biotech Moderna Inc. said it was preparing
to enter its vaccine into the second phase of human testing.
Johnson & Johnson said earlier this month it shaved months
off the usual timelines for developing a vaccine, and expects to
start human testing of a coronavirus candidate as soon as
September, with possible availability on an emergency-use basis in
early 2021.
"This is a crisis right now, and a solution is desperately
needed by all, " said Pfizer Chief Executive Albert Bourla.
The experimental vaccines still face a gauntlet of testing to
make sure they work safely, which could derail efforts. Many
promising drugs and vaccines wind up faltering during rounds of
study.
Adding to the potential obstacles, researchers say, is the
fast-moving nature of the virus and measures to limit its spread.
They have complicated efforts to set up some studies and find
patients for research, delaying efforts and even closing some
trials.
Yet research into a coronavirus vaccine has moved at a
relatively rapid clip, infectious-disease experts say.
"I'm not aware of any vaccine that's been developed after only a
year to a year-and-a-half after identifying a pathogen. It usually
takes years," said Walter Orenstein, associate director of the
Emory Vaccine Center in Atlanta. "People are moving very, very
quickly with this."
The effort has been expedited, Dr. Orenstein said, by rapid
discoveries about the virus and vaccine-making technologies. Yet he
said he is skeptical a safe and effective vaccine could be
available soon, given all the testing required.
Vaccines can take years to hatch and then test to make sure they
work safely -- so long that researchers weren't able to ready
vaccines against previous viral outbreaks like Ebola in West Africa
before they had petered out.
There aren't any drugs or vaccines that have been proven to
fight off the new coronavirus and are approved for use. Before
granting approval, federal health regulators can authorize an
experimental vaccine's use during a public health emergency.
New York-based Pfizer is working on vaccine candidates with
Germany's BioNTech SE. The shots are based on an emerging
gene-based technology known as messenger RNA, or mRNA, which carry
instructions from DNA to the body's cells to make certain
proteins.
Testing of a vaccine, which has already started in Germany,
could start in the U.S. as early as next week if health regulators
sign off, Pfizer's Mr. Bourla said. Results from the study could
come as early as next month, he said.
If further testing also proves successful, Pfizer could start
distributing the vaccine on an emergency basis in the fall and
receive approval for widespread distribution by year's end, Mr.
Bourla said.
Pfizer is investing $500 million in coronavirus vaccine and drug
research, and is spending another $150 million to ready its
manufacturing capabilities so the company can quickly make large
quantities of antiviral agents, including a vaccine that succeeds
in testing.
"You can imagine the demand for something like that will be
extremely, extremely high," Mr. Bourla said.
Oxford University researchers last week began vaccinating people
for a 1,100-subject study testing the safety of their candidate and
monitoring its efficacy, according to Adrian Hill, director of the
university's Jenner Institute, which develops vaccines.
If the vaccine candidate proves safe, the researchers aim to
explore whether it protects against the coronavirus in a
5,000-subject trial starting in late May, Dr. Hill said.
The researchers could know whether the vaccine works by
September, and emergency distribution could begin as early as that
month. "That is the target timeline. It will be tough to do that,
but it is not impossible," Dr. Hill said. The New York Times
reported Monday on the Oxford group's progress.
Moderna, which is also developing an mRNA vaccine, said it had
asked the U.S. Food and Drug Administration to authorize the next
phase of testing, a standard request before starting a new vaccine
trial, and it could begin as early as May.
The study would test the experimental vaccine in about 600
healthy volunteers to see if it was safe and triggered the
production of antibodies that could neutralize the coronavirus.
If the vaccine shows signs of working safely in the study,
Moderna said the third and final phase of testing could start in
the fall. The company said it could seek FDA approval to sell the
vaccine by year's end, if it succeeds in testing.
Merck & Co., a longtime maker of vaccines, said it is
talking to potential partners about three different technologies to
manufacture coronavirus vaccines.
Merck Chief Executive Ken Frazier said Tuesday drugmakers will
need to develop more than one coronavirus vaccine to meet demand
world-wide. He also said different vaccines might have different
profiles that could benefit certain groups of people over
others.
"It could be that the vaccines that very older people need who
are very vulnerable may be different, for example, than the
vaccines that you would give to healthy children," Mr. Frazier
said.
Mr. Frazier wouldn't provide potential timing for Merck's
coronavirus vaccine efforts, though he said he doesn't view the
company as behind rivals even as their vaccines have begun testing
in patients.
--Peter Loftus contributed to this article.
Write to Jared S. Hopkins at jared.hopkins@wsj.com and Jonathan
D. Rockoff at Jonathan.Rockoff@wsj.com
(END) Dow Jones Newswires
April 28, 2020 17:33 ET (21:33 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Pfizer (NYSE:PFE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Sep 2023 to Sep 2024