MESSAGE
| DATE | 2021-03-01 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout - NYLXS] J&J Vaccine is far less effetive that other
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J&J Vaccine is far less effetive that other vaccines and might present
new problems for safety - I can not understand how it was approved when
we have better current options.
wsj.com
Covid-19 Vaccines Yield Breakthroughs in Long-Term Fight Against
Infectious Disease
Peter Loftus
14-18 minutes
The pandemic has opened a new era for vaccines developed with gene-based
technologies, techniques that have long stumped scientists and
pharmaceutical companies, suggesting the possibility of future
protection against a range of infectious disease.
Johnson & Johnson’s Covid-19 vaccine, which was authorized Saturday for
use in the U.S., is at the vanguard of a class of shots designed to
mobilize a person’s immune defenses against the disease. It will be the
first Covid-19 vaccine administered in the U.S. that uses viral-vector
technology, which employs an engineered cold virus to ferry
coronavirus-fighting genetic code to the body’s cells.
J&J’s vaccine is the third to be authorized in the U.S. after ones from
Pfizer Inc. PFE -0.98% and its partner, BioNTech SE, BNTX -2.94% and
Moderna Inc. MRNA 4.33% In a late-stage trial, J&J’s single-shot vaccine
was 66% effective in preventing moderate to severe cases of the disease
that has killed more than 500,000 people in the U.S. and about 2.5
million world-wide.
“This is one of those giant leap moments for us. These are fundamental
shifts in how we will build vaccines for the future,” said C. Buddy
Creech, director of Vanderbilt University’s vaccine research program. “I
think this really ushers in a golden age of vaccinology.”
New vaccine technologies spurred by the pandemic are leading efforts to
combat Covid-19 and herald a new arsenal of weapons for fighting lethal
viruses in the future, infectious-disease researchers said, another
example of how the fight against Covid has supercharged technological
development.
First came messenger RNA vaccines from Pfizer and Moderna, efforts that
after years of trying figured out how to use fatty particles to deliver
synthesized genetic code to cells. J&J’s shot emerged after researchers
finally found the right virus for ferrying tweaked DNA to the body.
Viral-vector Covid-19 vaccines developed in China and Russia also have
been authorized for use in those and other countries. The Covid-19
vaccine developed by the University of Oxford and AstraZeneca PLC, which
has been authorized in the U.K. and other countries, also is a
viral-vector shot.
For years, vaccines for such infectious diseases as measles and polio
were made from the viruses they targeted, in versions scientists
rendered harmless. The shots rally the immune system by exposing people
to the targeted virus. Yet such vaccines could take a decade or longer
to develop, and manufacturing them took months.
The mRNA vaccines and J&J’s viral-vector shot—developed and tested in
months—were propelled by new insights into the immune system that opened
the door to engineering a better defense.
Almost like computer programmers, researchers wrote genetic instructions
to muster the immune system’s molecular soldiers to fight the
coronavirus. The vaccines deliver the programmed genetic code directly
to cells in the body. The engineered DNA or RNA serve as a kind of
genetic software, commanding the hardware of the human cell to wage battle.
Health authorities seeking to increase vaccinations have been looking
forward to the arrival of J&J’s shot because it requires only one dose
instead of two. Also, it can be kept at standard refrigerator
temperatures for longer periods compared with the two vaccines now
authorized for use in the U.S.
Covid-19 viral-vector vaccines are made by engineering a harmless type
of virus—such as an adenovirus that can cause the common cold—to carry a
gene from the coronavirus into the cell.
Share Your Thoughts
What long-term impact do you think the pandemic will have on the world
of vaccines? Join the conversation below.
The vaccine’s DNA payload instructs the body’s cells to begin making a
protein from the coronavirus. That production provokes an immune
response to protect a vaccinated person if they are later exposed.
“The beauty is that you use natural systems, which are optimized by
millions of years of evolution, to deliver what you want to have your
body respond to,” said Vincent Munster, chief of the virus ecology
section at the National Institute of Allergy and Infectious Disease,
which helped with the AstraZeneca-Oxford vaccine.
These vaccines offer several advantages over shots using older
technology. They seem to activate not just the antibodies that
neutralize a virus but also the memory and T-cells that keep the immune
defense alert for the long-term.
A healthcare worker fills a syringe from a vial with a dose of the
Johnson & Johnson Covid-19 vaccine in South Africa.
Photo: phill magakoe/Agence France-Presse/Getty Images
Viral-vector vaccines also can be designed and manufactured relatively
quickly, using the same basic building blocks, to fight an emerging
infectious-disease outbreak. Scientists say the technology could yield
approved vaccines against other infectious diseases, such as Zika and
influenza.
Two viral-vector Ebola vaccines have been cleared for use. And a related
technology uses the same technology for gene therapies to treat some
cancers and rare genetic diseases.
“The future for pandemic response is that we want something along the
lines of what J&J has done, a single shot able to induce immunity,” said
Deborah Fuller, a vaccine researcher and professor of microbiology at
the University of Washington School of Medicine.
The people problem
Scientists had chased viral-vector vaccines since the 1970s. One was
approved to protect poultry by the U.S. Department of Agriculture in the
1990s, but it took much longer to find one for humans.
A major setback was a 2007 study finding that an experimental Merck &
Co. viral-vector vaccine against HIV failed to protect people from the
virus that causes AIDS. The problem turned out to be the common-cold
virus that researchers used to deliver the genetic code.
Researchers found that those in the study with pre-existing immunity to
the vaccine’s adenovirus strain appeared to have a higher susceptibility
to HIV infection. Researchers suspected that vaccination on top of a
pre-existing immunity may have activated the very part of the immune
system that HIV tends to target, allowing the virus to spread in the
body rather than be kept at bay. A Merck spokesman said a firm cause was
never established.
Merck dropped the work, and there is still no effective HIV vaccine.
The company, however, later developed an Ebola vaccine, using a
different viral vector called vesicular stomatitis, a virus that infects
animals but rarely humans. In 2019, it became the first Ebola vaccine
approved by the FDA.
One concern about viral-vector technology is whether people could
develop an immunity to the vaccine itself, potentially making it less
effective against new variants of the coronavirus or another type of
outbreak.
“Over time, if you start routinely vaccinating people over and over with
the same vaccine platform, the viral vector, you build up that
immunity,” Dr. Fuller said. “It’s going to stop working after a while.”
A viral-vector Covid-19 vaccine developed in China didn’t perform as
well in some people during testing because subjects had pre-existing
immunity to the underlying virus that was used.
One way around the challenge is to use a virus from another species. The
viral-vector vaccine from AstraZeneca PLC and its partner University of
Oxford, which is being tested in the U.S., uses a chimpanzee adenovirus.
J&J took a chance on a different approach.
Eureka
The company bet on viral-vector vaccines in 2011 with a $2.3 billion
acquisition of the remaining stake it didn’t own in a Dutch
biotechnology company, Crucell NV.
Though the world’s largest health-products maker by sales, J&J was a
relative newcomer to vaccines. Crucell offered the New Brunswick, N.J.,
giant a chance to own a pipeline of hepatitis, influenza and cholera
vaccines—and tap a market free of the cutthroat generic competition in
drug sales.
Dan Barouch, a physician and immunologist at Beth Israel Deaconess
Medical Center in Boston and a professor at Harvard Medical School.
Photo: M. Scott Brauer for The Wall Street Journal
Crucell had been collaborating with Dan Barouch, a physician and
immunologist at Beth Israel Deaconess Medical Center in Boston and
professor at Harvard Medical School. He ran a lab exploring viral-vector
use.
The same year that Merck’s HIV vaccine failed, Dr. Barouch and
colleagues published work identifying types of adenoviruses different
from the one Merck had used in its HIV shot.
One of the strains, dubbed Ad26, was less common in humans, and few
people had a strong pre-existing immunity to it. That meant vaccines
using the strain were less likely to fail. It later became the basis for
J&J’s viral-vector vaccine research.
J&J began to deploy viral-vector technology, using AD26, against
infectious-disease outbreaks, first Ebola and then Zika.
In 2015, during a deadly Ebola outbreak in West Africa, the company
started studies of a two-vaccine Ebola regimen, shots given eight weeks
apart. The first dose used Ad26 vector technology and the second dose a
different design.
The studies showed the vaccines were safe and could provide an immune
response. More than 100,000 people, mostly in Africa, have since
received the J&J Ebola vaccine regimen under emergency-use approval.
A patient receiving a shot of the Johnson & Johnson vaccine for Ebola in
the city of Goma, Democratic Republic of Congo, in November 2019.
Photo: MSF/Agence France-Presse/Getty Images
After five years of development and testing, the European Commission in
July last year approved J&J’s two-vaccine regimen against Ebola, a
decision that validated the company’s viral-vector technology. Yet going
into 2020, J&J had only a limited body of evidence that its viral-vector
vaccines worked.
The Ebola studies, for instance, didn’t compare whether people receiving
the vaccine had lower rates of Ebola than unvaccinated people who got a
placebo. J&J had determined it wasn’t feasible to run that kind of
controlled trial during a deadly outbreak. Instead, the EU relied on the
evidence of positive immune-response results among those vaccinated
against the Ebola virus.
When the pandemic hit, J&J’s Chief Scientific Officer Paul Stoffels said
he asked his team members in January last year to explore making a
vaccine against the new coronavirus spreading in China.
“Hey boss, we’re already doing it,” Dr. Stoffels recalled them saying.
The researchers studied the genetic sequence of the new coronavirus soon
after it was published online by Chinese scientists. Then they sketched
designs of potential vaccines, focusing on the spike protein found on
the surface of the virus; Covid-19 uses it to attach and gain entry into
human cells.
The idea was to employ Ad26 to carry DNA into human cells to instruct
them make their own spike protein. That would trigger production of
immune-system antibodies to fight off the actual virus in a vaccinated
person, by binding to the spike protein and preventing it from entering
cells.
Paul Stoffels, the chief scientific officer of Johnson & Johnson, in
Leiden, Netherlands last year.
Photo: janssen vaccines/Reuters
By the end of January, Dr. Barouch got in touch with J&J researchers,
and within a few days, they came up with about a dozen vaccine designs.
Two months later, they landed on one candidate the company planned to
test in animal and human studies, said Hanneke Schuitemaker, head of
viral vaccine discovery at J&J.
In an early test, researchers at a contract laboratory in Maryland
vaccinated rhesus macaques with J&J’s experimental shot, and, six weeks
later, exposed them to the coronavirus.
After putting his children to bed on a Friday night in May, Dr. Barouch
settled into his home office and opened an email with the results: After
a single dose, there was no detectable virus in specimens from the lungs
of all of the monkeys tested. “It gave me hope that this actually might
work,” he said.
After Dr. Stoffels at J&J saw the monkey data, he said he, too,
concluded, “Yes, we can do this.”
A scientist working on the Johnson & Johnson Covid-19 vaccine in Leiden,
the Netherlands.
Photo: Johnson & Johnson/Associated Press
The results helped shape J&J’s decision to start a series of human
tests—and to see if a single dose provided enough protection for
widespread use during a pandemic emergency.
In July, J&J began testing its single-dose Covid-19 vaccine on more than
1,000 healthy adult volunteers. The company also ran parallel tests to
see whether giving two doses about two months apart would be more effective.
The single-dose shot kept proving itself. In an early study, it produced
antibodies to neutralize the coronavirus in people at levels that were
stable for at least 71 days after vaccination.
That prompted J&J to run a large clinical trial. The study began in
September and enrolled about 44,000 people in the U.S. and other
countries. The results formed the basis for the FDA’s authorization,
which, Dr. Stoffels said, capped “the work of 10 years of research.”
Write to Peter Loftus at peter.loftus-at-wsj.com
Copyright ©2020 Dow Jones & Company, Inc. All Rights Reserved.
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