First COVID Vaccine Tested on Humans Shows Promise
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Dr. Tal Zaks: Likely to be on the market by start of 2021
Moderna’s Israeli top medical officer: We’ve shown today that our vaccine works
US biotech firm’s shares soar as it claims tests of first volunteers show its vaccine candidate produces immune response, ‘has potential to prevent COVID-19’; Phase 3 tests in July
The Israeli chief medical officer of US biotech firm Moderna
said Monday that its experimental anti-COVID-19 vaccine “actually
works,” after tests on a small number of volunteers, and that it will
start Phase 3 testing on thousands of people in July.
“We got the first results today… and today we are showing that it actually works… we are able to stimulate the immune system,” Dr. Tal Zaks said.
In an interview with Israeli television, Zaks said he was confident that, toward the end of the year, “we’ll be able to present first results that prove that our vaccine indeed prevents the disease.”
“By about the end of the year, the start of next year, there’s a reasonable likelihood that we’ll see this vaccine on the market, at least on the American market,” he said in the Channel 12 interview from Moderna’s headquarters in Massachusetts.
Zaks said the battle against COVID-19 marked the firm’s ninth bid to
develop vaccines against viruses, “and we succeeded with the previous
eight.” Thus, he said, “the degree of confidence within the company was
always high” that it would succeed this time, too.
News of the company’s progress, revealed in a release earlier Monday, lifted shares of Moderna more than 22 percent, and helped drive the broader stock market higher.
The company said the vaccine candidate, mRNA-1273, appeared to
produce an immune response in eight people who received it, similar to
that seen in people convalescing from the virus.
At the lowest dose, Zaks elaborated in the TV interview, the vaccine candidate produced a similar response to that “naturally” produced by patients who recovered from the virus. At a medium dose, of 100 micrograms, he said, the vaccine candidate created “more antibodies” than those created naturally by recovered patients.
The Phase 2 trial, with 600 subjects, has already received the green
light from the US Food and Drug Administration and Moderna said they
should begin this quarter.
“We got the first results today… and today we are showing that it actually works… we are able to stimulate the immune system,” Dr. Tal Zaks said.
In an interview with Israeli television, Zaks said he was confident that, toward the end of the year, “we’ll be able to present first results that prove that our vaccine indeed prevents the disease.”
“By about the end of the year, the start of next year, there’s a reasonable likelihood that we’ll see this vaccine on the market, at least on the American market,” he said in the Channel 12 interview from Moderna’s headquarters in Massachusetts.
Moderna’s Chief Medical Officer Dr. Tal Zaks. (Channel 12 screenshot)
News of the company’s progress, revealed in a release earlier Monday, lifted shares of Moderna more than 22 percent, and helped drive the broader stock market higher.
A sign marks an entrance to a Moderna,
Inc., building, on May 18, 2020, in Cambridge, Mass. Moderna announced
May 18, 2020, that an experimental vaccine against the coronavirus
showed encouraging results in very early testing, triggering hoped-for
immune responses in eight healthy, middle-aged volunteers. (AP Photo/
Bill Sikes)
At the lowest dose, Zaks elaborated in the TV interview, the vaccine candidate produced a similar response to that “naturally” produced by patients who recovered from the virus. At a medium dose, of 100 micrograms, he said, the vaccine candidate created “more antibodies” than those created naturally by recovered patients.
Three groups of 15 patients aged
18 to 55 received three different doses of the vaccine in the Phase 1
test, the complete results of which are not yet known.
A pharmacist gives Jennifer Haller, left,
the first shot in the first-stage safety study clinical trial of a
potential vaccine for COVID-19, the disease caused by the new
coronavirus, at the Kaiser Permanente Washington Health Research
Institute in Seattle, on March 16, 2020. The vaccine by Cambridge,
Massachusetts-based Moderna Inc., generated antibodies similar to those
seen in people who have recovered from COVID-19 in a study volunteers
who were given either a low or medium dose. (AP Photo/Ted S. Warren,
File)
A Phase 3 trial, the largest and most important to validate the efficacy of a vaccine, should begin in July.
“These interim Phase 1 data, while early,
demonstrate that vaccination with mRNA-1273 elicits an immune response
of the magnitude caused by natural infection,” Zaks stated in the firm’s
official release. “These data substantiate our belief that mRNA-1273
has the potential to prevent COVID-19 disease and advance our ability to
select a dose for pivotal trials.”
Moderna, which was founded nine years ago,
said the vaccine “was generally safe and well tolerated” and that
patients suffered no more than redness or soreness from the shots.
In a conference call, Moderna CEO Stephane
Bancel said the preliminary tests inspired confidence that mRNA-1273 has
“a high probability to provide protection” against the virus.
“We could not be happier about these interim
data,” Bancel said of the Phase 1 test, the first of three in the
development of a vaccine.
Separate tests performed on mice showed that
the vaccine prevented the virus from replicating in their lungs,
according to the company.
The US government has invested nearly half a billion dollars in the development of Moderna’s vaccine candidate.
It is being developed in a partnership with
the National Institute of Allergy and Infectious Disease headed by
Anthony Fauci and the clinical test was carried out by the National
Institutes of Health.
“The Moderna team continues to focus on
moving as fast as safely possible to start our pivotal Phase 3 study in
July,” said Bancel, Moderna’s CEO.
Based on the Phase 1 partial results,
Moderna said they would no longer study the highest dose since the lower
doses appeared to provide some effect.
“The lower the dose, the more people we expect to be able to protect,” said Moderna president Stephen Hoge.
President Donald Trump has said that he
wants 300 million vaccine doses by January 2021 to protect the US
population, and his administration has provided funding to Moderna,
Johnson & Johnson, and France’s Sanofi.
The development of a vaccine usually takes
years but the coronavirus pandemic, which has caused more than 315,000
deaths, has given unprecedented urgency to the search.
A dozen clinical trials are taking place
around the world, half of them in China, according to the London School
of Hygiene & Tropical Medicine.
China has said that it is carrying out tests on humans of five experimental vaccines.
The challenge is not only finding a safe and efficient vaccine, but also producing billions of doses.
Several large laboratories, including
Moderna, have said that they would immediately begin production of an
eventual vaccine even before the completion of all of the clinical
trials.
Moderna recently announced a partnership
with the giant drugmaker Lonza to boost its manufacturing capacity to up
to one billion doses a year.
Worldwide, about a dozen vaccine candidates
are in the first stages of testing or nearing it. Health officials have
said that if all goes well, studies of a potential vaccine might wrap up
by very late this year or early next year.
More than 4.7 million infections and 315,000
deaths from the coronavirus have been confirmed worldwide since it
emerged in China late last year. There are no specific approved
treatments, although several are being used on an emergency basis after
showing some promise in preliminary testing.
Race to ready drug for potential winter outbreak
Scientists in China believe new drug can stop pandemic ‘without vaccine’
Antibodies isolated from the blood of 60 recovered patients key to treatment that shortens recovery time, offers short-term immunity in mice
This
picture taken on May 14, 2020, shows researchers at Peking University's
Beijing Advanced Innovation Center for Genomics conducting tests at
their laboratory in Beijing. (Wang Zhao/AFP)
BEIJING, China (AFP) — A Chinese laboratory has been developing a
drug it believes has the power to bring the coronavirus pandemic to a
halt.
The outbreak first emerged in China late last year before spreading across the world, prompting an international race to find treatments and vaccines.
A drug being tested by scientists at China’s prestigious Peking University could not only shorten the recovery time for those infected, but even offer short-term immunity from the virus, researchers say.
Sunney Xie, director of the university’s Beijing Advanced Innovation Center for Genomics, told AFP that the drug has been successful at the animal testing stage.
“When we injected neutralizing antibodies into infected mice, after five days the viral load was reduced by a factor of 2,500,” said Xie.
“That means this potential drug has (a) therapeutic effect.”
The drug uses neutralizing antibodies — produced by the human immune system to prevent the virus infecting cells — which Xie’s team isolated from the blood of 60 recovered patients.
A study on the team’s research, published Sunday in the scientific journal Cell, suggests that using the antibodies provides a potential “cure” for the disease and shortens recovery time.
Xie said his team had been working “day and night” searching for the antibody.
“Planning for the clinical trial is underway,” said Xie, adding it
will be carried out in Australia and other countries since cases have
dwindled in China, offering fewer human subjects for testing.
“The hope is these neutralizing antibodies can become a specialized drug that would stop the pandemic,” he said.
More than 700 patients have received plasma therapy in China, a
process which authorities said showed “very good therapeutic effects.”
“However, it (plasma) is limited in supply,” Xie said, noting that the 14 neutralizing antibodies used in their drug could be put into mass production quickly.
The new drug could even offer short-term protection against the virus.
The study showed that if the neutralizing antibody was injected before the mice were infected with the virus, the mice stayed free of infection and no virus was detected.
The outbreak first emerged in China late last year before spreading across the world, prompting an international race to find treatments and vaccines.
A drug being tested by scientists at China’s prestigious Peking University could not only shorten the recovery time for those infected, but even offer short-term immunity from the virus, researchers say.
Sunney Xie, director of the university’s Beijing Advanced Innovation Center for Genomics, told AFP that the drug has been successful at the animal testing stage.
“When we injected neutralizing antibodies into infected mice, after five days the viral load was reduced by a factor of 2,500,” said Xie.
This picture taken on May 14, 2020, shows
Sunney Xie, director of Peking University’s Beijing Advanced Innovation
Center for Genomics, during an interview at his laboratory in Beijing.
(Wang Zhao/AFP)
The drug uses neutralizing antibodies — produced by the human immune system to prevent the virus infecting cells — which Xie’s team isolated from the blood of 60 recovered patients.
A study on the team’s research, published Sunday in the scientific journal Cell, suggests that using the antibodies provides a potential “cure” for the disease and shortens recovery time.
Xie said his team had been working “day and night” searching for the antibody.
“Our expertise is single-cell
genomics rather than immunology or virology. When we realized that the
single-cell genomic approach can effectively find the neutralizing
antibody we were thrilled.”
He
said he hopes that the drug will be ready for use later this year and
in time for any potential winter outbreak of the virus, which has
infected 4.8 million people around the world and killed more than
315,000.
A medical worker takes a swab sample from
a woman to be tested for the COVID-19 coronavirus in Wuhan, in China’s
central Hubei province on May 19, 2020. (Hector Retamal/AFP)
“The hope is these neutralizing antibodies can become a specialized drug that would stop the pandemic,” he said.
China already has five potential coronavirus vaccines at the human trial stage, a health official said last week.
But the World Health Organization has warned that developing a vaccine could take 12 to 18 months.
Scientists have also pointed to the
potential benefits of plasma — a blood fluid — from recovered
individuals who have developed antibodies to the virus enabling the
body’s defenses to attack it.
Pedestrians wearing face masks walk along a business street in Beijing on May 19, 2020. (Wang Zhao/AFP)
“However, it (plasma) is limited in supply,” Xie said, noting that the 14 neutralizing antibodies used in their drug could be put into mass production quickly.
Prevention and cure
Using antibodies in drug treatments is not a new approach, and it has been successful in treating several other viruses such as HIV, Ebola and Middle East Respiratory Syndrome (MERS).
Xie said his researchers had “an early start” since the outbreak started in China before spreading to other countries.
Ebola drug Remdesivir was considered a
hopeful early treatment for COVID-19 — clinical trials in the US showed
it shortened the recovery time in some patients by a third — but the
difference in mortality rate was not significant.
This picture taken on May 14, 2020 shows a
researcher at Peking University’s Beijing Advanced Innovation Center
for Genomics conducting tests at their laboratory in Beijing. (Wang
Zhao/AFP)
The study showed that if the neutralizing antibody was injected before the mice were infected with the virus, the mice stayed free of infection and no virus was detected.
This may offer temporary protection for
medical workers for a few weeks, which Xie said they are hoping to
“extend to a few months.”
More than 100 vaccines for COVID-19 are in
the works globally, but as the process of vaccine development is more
demanding, Xie is hoping that the new drug could be a faster and more
efficient way to stop the global march of the coronavirus.
“We would be able to stop the pandemic with an effective drug, even without a vaccine,” he said.
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