50 million doses of vaccines infected with HIV?

50 MILLION doses of 'vaccine recalled as they triggered 'false
positives' in HIV tests. The magnitude of this is beyond wrong.
This is channel 7 news (https://bit.ly/3rJaVCh).
A group of scientists have been warning us since 2020, that
certain COVID-19 vaccine candidates could increase susceptibility
to HIV.
The same researchers in 2007 learned that an experimental HIV
vaccine had raised in some people the risk for infection with the
AIDS virus. These concerns have percolated in the background of
the race for a vaccine to stem the coronavirus pandemic, but now
the researchers have gone public with a “cautionary tale,” in part
because trials of those candidates may soon begin in locales that
have pronounced HIV epidemics, such as South Africa.
Some approved and experimental vaccines have as a backbone a
variety of adenoviruses, which can cause the common cold but are
often harmless. The ill-fated HIV vaccine trial used an engineered
strain known as adenovirus 5 (Ad5) to shuttle into the body the gene
for the surface protein of the AIDS virus. In four candidate
COVID-19 vaccines now in clinical trials in several countries,
including the United States, Ad5 similarly serves as the “vector”
to carry in the surface protein gene of SARS-CoV-2, the viral cause
of the pandemic; two of these have advanced to large-scale, phase III
efficacy studies in Russia and Pakistan.
In today’s issue of The Lancet, four veteran researchers raise a
warning flag (https://bit.ly/3sCs3cd) about those COVID-19 vaccine
candidates by recounting their experience running a placebo-
controlled AIDS vaccine trial dubbed STEP. An interim analysis of
STEP found that uncircumcised men who had been naturally infected
with Ad5 before receiving the vaccine became especially vulnerable
to the AIDS virus. The vaccine, made by Merck, had been the leading
hope for what was then a 20-year search for a shot that could thwart
HIV. But after the STEP results appeared, the field went into
a tailspin. “It took a decade to recover,” says one of the co-authors
of the Lancet correspondence, Lawrence Corey of the Fred
Hutchinson Cancer Research Center.
Corey, who now co-leads the COVID-19 prevention network in the
United States that is testing vaccines at the behest of the National
Institutes of Health, says he and his co-authors went public because
Ad5-based COVID-19 vaccines may soon be tested in populations
with high HIV prevalence and thus a greater risk of accidental
infection during a clinical trial. “If I were in a sub-Saharan African
country and making a decision as to what I would want for my country
for a general population use of a SARS-CoV-2 vaccine, I don’t see
why I would pick an Ad5 vector [vaccine] when there are many other
alternative choices,” Corey says.
The backfire in STEP — which evaluated the efficacy of the Merck
vaccine in people at high risk of HIV infection in the Americas and
Australia — also appeared in a second study, dubbed Phambili, of
the same vaccine. It was taking place simultaneously in South Africa
and was stopped early because of the STEP data.
Precisely how Merck’s Ad5 vaccine increased the risk of HIV
transmission in STEP and Phambili remains murky. The Lancet
editorial spells out several possibilities, including dampening of
HIV immunity, enhancing replication of the AIDS virus, or setting
up more target cells for it.
In addition to the Ad5 COVID-19 vaccine candidates, several other
leading vaccines, including ones made by Johnson & Johnson and
AstraZeneca/the University of Oxford, use different adenoviruses
as vectors. There’s no evidence that any of those adenoviruses
increases the risks of an HIV infection.
Of the Ad5-based COVID-19 vaccine candidates, from China-based
CanSino Biologics, has developed the furthest. In a Lancet report
in May, researchers from the company recognized the “controversial”
possibility of their vector increasing the risk of HIV infection and
said they would watch for it in the candidate’s trials. CanSino’s
COVID-19 vaccine is being tested in efficacy trials in Russia and
Pakistan that together hope to enroll more than 40,000 people, and
the company is discussing starting studies in Saudi Arabia, Brazil,
Chile, and Mexico.
China has already approved a CanSino vaccine against Ebola that
uses the Ad5 vector. Yu Xuefeng, CanSino’s CEO, tells Science
the risk of increased HIV susceptibility may be limited to Ad5
vaccines that produce an AIDS virus protein. “There’s no clear answer
yet,” Yu says. “We certainly haven’t seen anything with the Ebola
vaccine.” The company’s Ebola vaccine was tested in a population
in Sierra Leone that, he notes, had a relatively high HIV prevalence,
making it more likely to have detected the problem if it existed.
Russia’s Gamaleya Research Institute has a COVID-19 vaccine
candidate that uses a combination of Ad5 and Ad26 vectors; it’s now
in an efficacy trial in that country.
Last week, ImmunityBio received approval from the U.S. Food and
Drug Administration to begin human trials of its COVID-19 vaccine,
which uses Ad5 as a vector. The first trial will take place in
Newport Beach, California, but Patrick Soon-Shiong, the company’s
CEO, says he also hopes to test it in South Africa, where he grew up
and went to medical school.
He calls the STEP study results “very, very fuzzy” and stresses that
ImmunityBio’s Ad5 has four deleted genes that reduce the immune
responses it triggers. “It’s 90% muted,” he says.
ImmunityBio is discussing the risks with scientists and regulators in
South Africa of a trial there to test its modified Ad5 COVID-19
vaccine. The informed consent process for that proposed study would
tell participants about potential risks given the previous STEP and
Phambili results.
Soon-Shiong emphasizes that his company’s experimental COVID-19
vaccine, unlike every other candidate that uses an adenovirus vector,
presents two different SARS-CoV-2 genes and might therefore offer
more protection from infection or disease. Why only test this in
wealthy enclaves of Southern California, he asks? “Why not South
Africa? Why not for the underserved people of the world?”
Pediatrician Glenda Gray, who heads the South African Medical
Research Council and was the protocol chair of Phambili, has taken
part in several discussions with the ImmunoBio team. “When
[Soon-Shiong] contacted South Africa, we were obviously quite
concerned,” Gray says. “All of us who were in Phambili and quite
traumatized by what happened asked whether there was an appetite
to do something in South Africa.”
But after several months of deliberations, the South Africans
concluded that regulators should consider a small trial of the vaccine
there in people at low risk of HIV infection, Gray says. “We decided
not to throw the baby out with the bath water just yet,” she adds.
“If it does go ahead in South Africa, there has to be huge
consultation with communities, and we have to make doubly sure
that the participants understand what happened in the past.”
Gray says South Africa appreciates ImmunoBio’s offer to allow the
country to manufacture the product. “We’re in the middle of a
COVID-19 epidemic in South Africa, and we don’t know if we’ll
ever get access to the current suite of vaccines” produced elsewhere,
she says.
The decision to move forward, she insists, has to be left to South
African scientists, regulators, and ethics committees.
“It’s incredibly patronizing for people to determine what science
is good or bad for other countries,” she says. “Everyone knows
about Phambili and STEP, and the scientists understand that there’s
an important need to be cautious.”
Gray, who has co-authored papers about HIV vaccines with Corey
and the other three authors of the Lancet correspondence, says there
are no easy answers. “What if this vaccine is the most effective
vaccine?” she asks. “If this works out to be an important vaccine,
we’ll have some experience with it.”
More Information: Susan P Buchbinder, M Juliana McElrath, et al,
Use of adenovirus type-5 vectored vaccines: a cautionary tale, The
Lancet, October 19, 2020 (https://bit.ly/34SbAs7).
Are these really false-positive HIV results or is this another
gevernmental cover-up? At least there is always more articles about
HIV in MSM (https://bit.ly/3v4dyRt)