Time - USA (2020-09-21)

(Antfer) #1

for the HPV and hepatitis-B vaccines that
were approved in 2006 and 1986, respec-
tively. It’s also the technology that Sanofi
uses to make Flublok, its influenza vac-
cine, which means that if its COVID-19
vaccine made with this method is safe
and effective, the company could ramp
up production quickly. The companies
began human testing in September and
anticipate providing up to 1 billion doses
annually if their vaccine is effective. Aus-
tralian scientists at Novavax are also using
an insect-cell-based system to deliver the
genetic code of the SARS-CoV-2 spike
protein in its vaccine, and reported en-
couraging results in September.
Meanwhile, at Inovio, based in Penn-
sylvania, researchers have conducted
studies on primates using an experi-
mental DNA-based vaccine for MERS,
and the results suggest that animals with
strong T-cell responses were better able
to neutralize the MERS virus. “I believe
that the level of T-cell response is going
to be very important in providing pro-
tection [against SARS-CoV-2],” says
Dr. J. Joseph Kim, president and CEO of
Inovio. The company vaccinated the first
of 40 volunteers in a Phase 1 trial for its
COVID-19 vaccine in April and reported
in June, without providing deeper details,
that 94% of participants generated an im-
mune response. Inovio plans to continue
testing its vaccine into the fall.


EvEn if vaccinE manufacturErs
are able to find just the right viral sparks
to catalyze an immune response against
SARS-CoV-2, they face another, equally
daunting task: manufacturing enough of
these vaccines in a short amount of time
to throw the brakes on the runaway pan-
demic. AstraZeneca’s CEO has pledged
to produce 2 billion doses of the vaccine
by year’s end—an ambitious timeline.
But even typically circumspect experts
note that there is a chance, however re-
mote, that ongoing tests of the vaccines
could show dramatic effectiveness and
be stopped early, by the end of the year.
Whether that’s possible will depend in
large part on how widespread COVID-19
is as more of the vaccines reach the last
stages of testing. Such studies are focused
more on efficacy than on safety and re-
quire tens of thousands of participants. If
there aren’t enough cases of COVID-19 still
circulating by the time these final trials


begin, scientists won’t have the statistical
power they need to compare, among those
exposed to the virus, the people who were
vaccinated with those receiving a placebo,
and quickly see if the vaccine is working.
Such was the fate of the SARS and
MERS vaccine programs governments
and pharmaceutical companies launched
in 2003 and 2012, respectively. As soon as
cases waned, the urgency for vaccines did
as well, along with investments in research
and testing. Some public- health experts
believe that if that work had continued,
what researchers would have learned about
corona viruses and how to protect against
them might have given scientists a jump
start on a vaccine against SARS-CoV-2.
To avoid losing that momentum
again, some epidemiologists have floated
the idea of intentionally infecting vol-
unteers for COVID-19 vaccine trials.
Known as “human-challenge” research,
it’s a controversial strategy and has been
done only with diseases like flu and ma-
laria for which there are good safety-net
treatments that people can
take if they get severely ill
after getting intentionally
exposed to the disease.
For now, the ethical ques-
tions such an approach
raises aren’t urgent, as
new hot spots continue to
emerge around the world.
The bigger and more
immediate problem, if
vaccines are authorized,
is how they will make it to
the people who need them
most. In the U.S., public-
health systems are already
overwhelmed with test-
ing for cases and tracking
the pandemic, and desper-
ately need guidance “yes-
terday,” according to one
state health official, on
how to plan for a massive
immunization campaign,
how many doses they can
expect and how they should decide who
gets those first doses. “Our public-health
system is highly fragmented, under-
resourced, overlooked and underappre-
ciated,” says Dr. Howard Koh, a profes-
sor at Harvard T.H. Chan School of Public
Health and former assistant secretary for
health and human services. “To make this

happen, the local and state public-health
infrastructure has got to be very strong,
and right now it’s not.” The situation is
similarly dire in lower-resource countries
like India, where a lack of hospital beds
and medical equipment amplifies the bur-
den and toll of the disease.
No matter which vaccines are suc-
cessful in trials, coverage will be key to
achieving herd immunity. A linchpin of
coverage is access, and access hinges on
price. Moderna has said its vaccine will
be priced depending on the volume of
doses ordered, with smaller volumes cost-
ing at most around $32 to $37 per dose,
while AstraZeneca says its collaborative
vaccine with Oxford will be developed
and distributed at cost to meet the needs
in lower-resource countries. Ahead of
final results from its trials, Astra Zeneca
signed agreements with companies in
South Korea, Japan and Brazil to manu-
facture and provide up to 3 billion doses
of its vaccine. “This isn’t about us win-
ning and somebody else losing. It’s about
us making a difference on
this disease,” says Pangalos
from AstraZeneca.
Even if the COVID-19
vaccines don’t provide
100% protection against in-
fection, they could provide
a huge boost toward that re-
turn to normality. But how
quickly that happens will
depend as much on the sci-
ence behind them as on the
humanity that determines
where those vaccines go.
What’s being tested is more
than the new technologies
and the latest virus- fighting
strategies encased in each
injection. It’s also our will-
ingness to be blind to the
physical as well as social
and economic borders that
divide us to combat a virus
that holds no such biases.
“With COVID-19, there is
a chronic fear,” says Kelly. “To be relieved
of that is so important. It’s so important
to trust that the vaccine is going to help
us have a healthier society that’s not fear-
based, so we can enjoy our lives again.”
—With reporting by ciara nugent/
london, leslie dickstein, Mariah
espada and siMMone shah 

179


NUMBER OF


VACCINES IN


DEVELOPMENT


GLOBALLY


144


NUMBER IN


PRECLINICAL


EVALUATION


35


NUMBER IN


CLINICAL PHASES


THAT INVOLVE


HUMAN TESTING


SOURCE: WHO 37

Free download pdf