Just before Fauci became a household name.
As massive Zika vaccine trial struggles, researchers revive plan to intentionally infect humans.
Intentionally infect. Do no harm.
By Jon CohenSep. 12, 2018 , 12:30 PM
In 2016, as the mosquito-borne Zika virus spread through the Americas and cases of infected women having brain-damaged babies mounted, investigators raced to develop a vaccine. Now, a $110 million vaccine trial is underway at 17 sites in nine countries, but it faces an unexpected, and ironic, challenge. Cases of Zika have plummeted to levels so low that most people vaccinated in the trial likely will never be exposed to the virus, which could make it impossible to tell whether the vaccine works.
"Right now, there are no infections, and certainly not enough to even think about an efficacy signal at this point," says Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, which launched the trial. Human trials of other Zika vaccine candidates at earlier stages are also in limbo, and last year one large vaccinemaker pulled the plug on development of its candidate. But NIAID and others are pressing ahead, saying a vaccine might someday be needed. To make up for the lack of new cases, other investigators are turning to an unusual, and ethically complex, strategy. Starting next year, Science has learned, they plan to test a vaccine by deliberately infecting people with Zika.
Launched in March 2017, NIAID's placebo-controlled vaccine trial includes two sites in Brazil, where Zika hit hardest and where the brain damage known as microcephaly first surfaced. From the beginning of the outbreak in 2015 until the start of this year, Brazil had about half of all 800,000 suspected and confirmed Zika cases in the Americas, according to the Pan American Health Organization in Washington, D.C. But from January through June, Brazil's Ministry of Health reported fewer than 7000 probable cases, in a nation of 200 million people. "It's a good dilemma because we don't have Zika anymore," says Esper Kallás of the University of São Paulo in São Paulo, Brazil, principal investigator for the local NIAID site. "But it's a dilemma. Everybody is concerned about it. It's a lot of investment!”
To date, 1380 participants have enrolled in the trial, which tests a vaccine containing a small circular piece of DNA that holds two Zika genes. From the outset, the researchers had planned to open new trial sites at infection hot spots, if needed. But new cases have dropped to a trickle throughout the Americas.
If they're careful, we have no problems supporting it," Fauci says. Durbin plans to submit her new protocol for review in about a month, and in early 2019 hopes to start injecting Zika virus into people immunized with a vaccine containing live, but weakened Zika virus made by NIAID's Stephen Whitehead. As a precaution, she plans to enroll only women at first, to avoid semen transmission from infected males. The volunteers will receive a low dose of Zika virus, and they will remain in clinics for the 2 weeks it typically takes to clear the infection. Any vaccine that works in the challenge study theoretically could then be evaluated in a real-world outbreak—just as is occurring now with an unlicensed but promising Ebola vaccine.
But regardless of whether the trial leads to an approved vaccine, he has no regrets about launching it. "Zika was a very ominous threat just a couple of years ago, and there is certainly the possibility that it is going to come back," Fauci says. "It's a risk that you'll spend this money and never use the vaccine, but balancing the importance of this infection and the impact it could have, we felt it was a good decision to move ahead. And I would be happy to defend that anywhere” so we will spread this virus.
FEBRUARY 16, 2016
by
Katie Worth
RECIFE, Brazil – As scientists have tried to solve the medical mystery behind the surge of babies being born with devastating birth defects in Brazil, they’ve pieced together evidence that the mosquito-borne Zika virus may be to blame. But in northeast Brazil, many residents have fashioned a rival theory: That the defects are caused by vaccines dispensed by the government.
Among the skeptics are 23-year-old sisters Luana Silva dos Santos, six months pregnant with her first child, and Luciana Silva dos Santos, who has a six-month old daughter.
“The Ministry of Health says it wasn’t the vaccines,” said Luana.
“I think it’s lies,” said Luciana. “It’s not the mosquitos. The mosquitos have always been here and we’ve never had this problem.”
The twin sisters said there are reasons many doubt the Zika-microcephaly connection: Some pregnant women, for example, come down with Zika but their babies are born just fine. Other mothers never have any symptoms, yet their babies have the defect anyway.
But Luciana said it can be hard to trust anything government specialists say.
“They’re pushing this story about the mosquitos because they’re worried about indemnity — they don’t want to have to pay everyone for the damage their vaccines are causing, it would be too expensive to tell the truth. So they say it’s mosquitos causing microcephaly.”
“Shhh! You’re going to get us arrested by the federal police,” joked Luana.
Ederlanha, an 18-year-old mother of a child recently diagnosed with microcephaly, is inclined to believe vaccines may be the problem. She says she never had symptoms of Zika, but she did receive a shot from her public health clinic every month of her pregnancy. As she waited for an appointment at the public hospital in Recife, she tried to soother her fussing baby, but said she couldn’t recall exactly what the shots were for.
“Maybe I got one that was out of date,” said Ederlanha, who declined to provide her last name. “I don’t believe it’s a mosquito that causes [microcephaly]. That’s an invention of the government … Everybody I know is saying that it’s an out-of-date vaccine.”
Intentionally infect. Do no harm.
By Jon CohenSep. 12, 2018 , 12:30 PM
In 2016, as the mosquito-borne Zika virus spread through the Americas and cases of infected women having brain-damaged babies mounted, investigators raced to develop a vaccine. Now, a $110 million vaccine trial is underway at 17 sites in nine countries, but it faces an unexpected, and ironic, challenge. Cases of Zika have plummeted to levels so low that most people vaccinated in the trial likely will never be exposed to the virus, which could make it impossible to tell whether the vaccine works.
"Right now, there are no infections, and certainly not enough to even think about an efficacy signal at this point," says Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, which launched the trial. Human trials of other Zika vaccine candidates at earlier stages are also in limbo, and last year one large vaccinemaker pulled the plug on development of its candidate. But NIAID and others are pressing ahead, saying a vaccine might someday be needed. To make up for the lack of new cases, other investigators are turning to an unusual, and ethically complex, strategy. Starting next year, Science has learned, they plan to test a vaccine by deliberately infecting people with Zika.
Launched in March 2017, NIAID's placebo-controlled vaccine trial includes two sites in Brazil, where Zika hit hardest and where the brain damage known as microcephaly first surfaced. From the beginning of the outbreak in 2015 until the start of this year, Brazil had about half of all 800,000 suspected and confirmed Zika cases in the Americas, according to the Pan American Health Organization in Washington, D.C. But from January through June, Brazil's Ministry of Health reported fewer than 7000 probable cases, in a nation of 200 million people. "It's a good dilemma because we don't have Zika anymore," says Esper Kallás of the University of São Paulo in São Paulo, Brazil, principal investigator for the local NIAID site. "But it's a dilemma. Everybody is concerned about it. It's a lot of investment!”
To date, 1380 participants have enrolled in the trial, which tests a vaccine containing a small circular piece of DNA that holds two Zika genes. From the outset, the researchers had planned to open new trial sites at infection hot spots, if needed. But new cases have dropped to a trickle throughout the Americas.
If they're careful, we have no problems supporting it," Fauci says. Durbin plans to submit her new protocol for review in about a month, and in early 2019 hopes to start injecting Zika virus into people immunized with a vaccine containing live, but weakened Zika virus made by NIAID's Stephen Whitehead. As a precaution, she plans to enroll only women at first, to avoid semen transmission from infected males. The volunteers will receive a low dose of Zika virus, and they will remain in clinics for the 2 weeks it typically takes to clear the infection. Any vaccine that works in the challenge study theoretically could then be evaluated in a real-world outbreak—just as is occurring now with an unlicensed but promising Ebola vaccine.
But regardless of whether the trial leads to an approved vaccine, he has no regrets about launching it. "Zika was a very ominous threat just a couple of years ago, and there is certainly the possibility that it is going to come back," Fauci says. "It's a risk that you'll spend this money and never use the vaccine, but balancing the importance of this infection and the impact it could have, we felt it was a good decision to move ahead. And I would be happy to defend that anywhere” so we will spread this virus.
FEBRUARY 16, 2016
by
Katie Worth
RECIFE, Brazil – As scientists have tried to solve the medical mystery behind the surge of babies being born with devastating birth defects in Brazil, they’ve pieced together evidence that the mosquito-borne Zika virus may be to blame. But in northeast Brazil, many residents have fashioned a rival theory: That the defects are caused by vaccines dispensed by the government.
Among the skeptics are 23-year-old sisters Luana Silva dos Santos, six months pregnant with her first child, and Luciana Silva dos Santos, who has a six-month old daughter.
“The Ministry of Health says it wasn’t the vaccines,” said Luana.
“I think it’s lies,” said Luciana. “It’s not the mosquitos. The mosquitos have always been here and we’ve never had this problem.”
The twin sisters said there are reasons many doubt the Zika-microcephaly connection: Some pregnant women, for example, come down with Zika but their babies are born just fine. Other mothers never have any symptoms, yet their babies have the defect anyway.
But Luciana said it can be hard to trust anything government specialists say.
“They’re pushing this story about the mosquitos because they’re worried about indemnity — they don’t want to have to pay everyone for the damage their vaccines are causing, it would be too expensive to tell the truth. So they say it’s mosquitos causing microcephaly.”
“Shhh! You’re going to get us arrested by the federal police,” joked Luana.
Ederlanha, an 18-year-old mother of a child recently diagnosed with microcephaly, is inclined to believe vaccines may be the problem. She says she never had symptoms of Zika, but she did receive a shot from her public health clinic every month of her pregnancy. As she waited for an appointment at the public hospital in Recife, she tried to soother her fussing baby, but said she couldn’t recall exactly what the shots were for.
“Maybe I got one that was out of date,” said Ederlanha, who declined to provide her last name. “I don’t believe it’s a mosquito that causes [microcephaly]. That’s an invention of the government … Everybody I know is saying that it’s an out-of-date vaccine.”
Interesting to find out that they are purposefully infecting people I order to test their vaccine.
It appears that humans are just the lab rats for big Pharma and governments.