The new coronavirus disease, COVID-19, that
originated in Wuhan, China, at the end of 2019, is poised to become a global
pandemic. As of February 19, 2020, more than 75,600 people around the world
have contracted the disease; 2,122 people, mostly in mainland China, have died.
Biotech companies like Moderna and pharma giants like Johnson & Johnson say
they’re pushing hard to find a vaccine—but the discovery won’t come quickly.
Here’s what we know.
When will there be a publicly available
vaccine for the new coronavirus?
Not for several months, and probably closer to
a year. On February 7, 2020, National Institute of Allergy and Infectious
Diseases director Anthony Fauci said that if research goes smoothly,
phase one clinical trials could begin in humans in less than three months.
“There have been no glitches so far,” he said. Phase one
trials are usually small studies to test the safety and efficacy of a vaccine.
Even if a phase one trial is successful, it could still take a long time for
the vaccine to be available to people outside of Wuhan, China. When the new
Ebola vaccine was being tested, researchers did a phase three trial in
Guinea, the epicenter of that outbreak. A new Covid-19 vaccine could take the
same approach, going first to people in the areas of China that are most
affected. Only after the completion of a phase three trial and FDA approval
would it be available to people in the U.S. who are at lower risk of being
exposed to the disease.
Why does it take so long to make
vaccines?
Normal vaccine development takes an average
of 10 to 15 years because
researchers and doctors want to make sure that they are giving people a
treatment that is safe. To get a vaccine approved in the United States, it must
go through several phases of
development, including preclinical research and animal testing,
human clinical trials and quality control. “Generally, we’re talking years if not
decades in most scenarios,” says Kathleen Neuzil, director at the Center for
Vaccine Development and Global Health at the University of Maryland School of
Medicine. Many factors can influence how long it takes to make a vaccine,
including the complexity of the disease, how the human immune system reacts to
a specific disease and where in the body a disease takes root. Respiratory
diseases, like Covid-19, “in general can be a little harder,” Neuzil says. This
is because the vaccine has to create enough of an immune response in the
bloodstream to activate antibodies in the respiratory tract.
Vaccines are also incredibly expensive to
develop. From beginning to end, it can cost hundreds of
millions of dollars to create a successful vaccine. (The key
word here being “successful”; companies regularly spend millions of dollars
developing vaccines that don’t work well, only to have to start all over
again.)
Luckily there are some systems in place for
fast-tracking vaccines, especially during a large disease outbreak. Several
vaccines have been given Fast Track status
by the U.S. Food and Drug Administration, including a vaccine for HPV, a virus
that can cause cervical cancer, and a vaccine for chikungunya, a painful
infectious disease spread by mosquitoes. But a big disease epidemic doesn’t
automatically mean a fast approval. The first Ebola vaccine was just
granted FDA approval in
December 2019, more than five years after the start of a deadly outbreak in
West Africa.
Who is working on a new vaccine for
Covid-19?
Johnson & Johnson, a large pharmaceutical
company based in New Jersey; Inovio, a public biotech company based in
Pennsylvania; Moderna, a biotech company based in Massachusetts; and a research
group at the University of Queensland in Australia are four outfits that have
disclosed they’re trying to find a vaccine.
Inovio just received a $9 million grant to
develop a new Covid-19 vaccine from the Coalition for Epidemic Preparedness
Innovations, on top of a previous $56 million grant to develop vaccines for
other diseases. J. Joseph Kim, Inovio’s CEO, says he wants to have a Covid-19
vaccine in human trials in less than seven months. “We’re trying to move very
rapidly into human testing in China,” Kim says.
Moderna said that
it completed a clinical batch of the vaccine as of February 7, 2020, and it
will soon move into phase one testing.
Johnson & Johnson, which is repurposing a
technology for the new coronavirus vaccine that was once successful for its
Ebola and Zika vaccines, is “looking at 8 to 12 months” before the vaccine is
publicly available, says the company’s chief scientific officer, Paul
Stoffels.
How are new scientific advances speeding up
the process?
Though the process will take time, drugmakers
still expect to move faster than they have with past outbreaks. One reason is
due to advances in genome sequencing technology. The process used to take
months, but Chinese scientists posted the genome of the virus publicly online
only a few weeks into the outbreak. “That piece of information, for us, is more
important than getting ahold of the virus,” Kim says, “that’s all we need.”
Inovio’s vaccines use
modified DNA sequences delivered into human cells that trigger an immune
response against specific pathogens.
Another new advance: mRNA vaccines. These
vaccines, made from messenger RNA, are faster and cheaper to
produce than traditional vaccines. Moderna will use an mRNA vaccine to target a
protein on the coronavirus surface that will also activate the immune
system.
If it takes so long to make a vaccine, could
it be “too late?”
There is a possibility that the current
outbreak could be contained or be over before a vaccine is publicly available.
In that case, will all the money and time spent creating a vaccine specifically
for Covid-19 be for nothing? Not necessarily, Stoffels says. “I hope it will be
over by then,” he says, and “if it is over in 12 months, then you know what, we
have the vaccine for the next outbreak.”
Coronaviruses are actually common viruses in
humans, and most cause nothing more than a common cold. But in recent history
there has been a rash of deadly outbreaks: Covid-19 is the third lethal
coronavirus epidemic in the past two decades. It seems likely that even if we
get this outbreak under control, another future outbreak will occur where a
vaccine would be useful.
What other treatments are available in the
meantime?
Because the illness is caused by a virus,
researchers are testing antiviral medications to see if they can help treat
sick patients. One drug, called remdesivir, manufactured by Gilead Sciences, is
currently being tested on
more than 700 sick patients in Wuhan. A drug called Kaletra, produced by AbbVie
to treat HIV, is also being used on
Covid-19 patients. Other patients are simply receiving supportive care,
like oxygen through ventilators and blood pressure monitoring, while the body
does its best to fight off the infection.
Stoffels says that Johnson & Johnson is
also looking at their other medications to see if they have a drug that could
potentially be used against the disease. The chance is slim, he says, because
most drugs are “extremely specific” to target the diseases that they were
intended for. But it’s worth a shot.
No comments:
Post a Comment