LONDON : UK researchers are preparing to infect healthy young volunteers with the virus that causes COVID-19, becoming the first to announce plans to use the controversial technique to study the disease and potentially speed up development of a vaccine that could help end the pandemic.
This type of research, known as a human challenge study, is used infrequently because some consider the risk involved in infecting otherwise healthy individuals to be unethical. But researchers racing to combat COVID-19 say that risk is warranted because such studies have the potential to quickly identify the most effective vaccines and help control a disease that has killed more than 1.1 million people worldwide.
“Deliberately infecting volunteers with a known human pathogen is never undertaken lightly,″ said Professor Peter Openshaw, co-investigator on the study. “However, such studies are enormously informative about a disease, even one so well studied as COVID-19.”
Human challenge studies have been previously used to develop vaccines for diseases including typhoid, cholera and malaria.
Imperial College London said Tuesday that the study, involving volunteers aged 18 to 30, would be conducted in partnership with the government’s Department for Business, Energy and Industrial Strategy, the Royal Free London NHS Foundation Trust and hVIVO, a company that has experience conducting challenge studies. The government plans to invest 33.6 million pounds ($43.4 million) in the research.
Governments around the world are funding efforts to develop a vaccine in hopes of ending the pandemic that has pummeled the international economy, shutting businesses and putting millions of people out of work. Forty-six potential vaccines are already in human testing, with 11 of them in late-stage trials — several expected to report results later this year or in early 2021.
The Imperial College partnership expects to begin work in January, with results expected by May. Before any research begins, the study must be approved by ethics committees and regulators.
While one or more vaccines are likely to be approved before then, the study will still be relevant because the world may need multiple vaccines to adequately protect different groups within the population, as well as treatments for those who continue to get sick, said Dr. Michael Jacobs, a consultant in infectious diseases at the Royal Free London NHS Foundation Trust who will take part in the research.
“I don’t think many people think that what we’re doing as scientists is searching for a silver bullet,” Jacobs said. “We’re going to need a whole raft of interventions in order to control this pandemic.”
Tens of thousands of volunteers around the world have already signed up to participate in more traditional trials of COVID-19 vaccines. Critics of challenge studies question the need to expose healthy people to the virus when the disease remains widespread and vaccine development is moving quickly.
In the first phase of the UK challenge study, researchers will expose 90 paid volunteers to the virus using nasal drops in an effort to determine the smallest level of exposure needed to cause COVID-19. Ultimately, the same model will be used to test the effectiveness of potential vaccines by exposing volunteers to the virus after they’ve received one of the candidate vaccines.
The research will be conducted at the Royal Free Hospital in London, which has a specially designed area to contain the disease. Volunteers will be monitored for at least a year to ensure they don’t suffer any long-term effects.
Kate Bingham, chair of the government’s Vaccine Taskforce, which is tasked with promoting development of a vaccine for COVID-19, said the project will improve understanding of the virus and help scientists make decisions about research.
“There is much we can learn in terms of immunity, the length of vaccine protection and reinfection,” she said in a statement.
Challenge studies are typically used to test vaccines against mild infections to avoid exposing volunteers to a serious illness if the vaccine doesn’t work. While the coronavirus causes only mild or moderate symptoms in most people and seems to be especially mild in young, healthy individuals, the long-term effects of the disease aren’t well understood, and there have been reports of lingering problems in the heart and other organs even in those who don’t ever feel sick.
In the US, the National Institutes of Health has downplayed the need for challenge studies given the speed with which vaccines are being developed, but it has taken preliminary steps to prepare for such research in case the approach eventually is required. Those steps include examining the ethics of a challenge study, and funding research to create lab-grown virus strains that potentially could be used.
But even if they are needed, “human challenge trials would not replace Phase 3 trials” of COVID-19 vaccines, according to a September statement from NIH that called the standard, rigorous studies its priority.
In July, the NIH’s vaccine working group published a paper in The New England Journal of Medicine pointing out the risks of doing a challenge study with a virus that so far has no good treatment and is wildly unpredictable, occasionally killing even some young, otherwise healthy people.
But 1Day Sooner, which advocates for COVID-19 challenge trial volunteers, praised the decision and called on the government to build a testing center.
“We are glad the UK government is embracing the altruism of the thousands of our British volunteers who want these studies,” the group said in a statement. “Challenge trials will be key to making multiple safe and effective COVID-19 vaccines available for the whole world, including those in low-income countries bearing the brunt of this pandemic.”
Danica Marcos, 22, a recent university graduate now doing volunteer work with homeless people, is hoping to take part.
“So many people (are) struggling right now, and I want this pandemic to be over,” she told The Associated Press. “Every day that goes on, more cases are going on, more people are dying. And if this vaccine trial could mean that this period of trauma for the whole world will be over sooner, I want to help. I want to be a part of that.”
UK to infect healthy volunteers in vaccine research trial
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UK to infect healthy volunteers in vaccine research trial
- Human challenge studies have been previously used to develop vaccines for diseases including typhoid, cholera and malaria
War powers resolution fails in Senate as 2 Republicans bow to Trump pressure
WASHINGTON: Senate Republicans voted to dismiss a war powers resolution Wednesday that would have limited President Donald Trump’s ability to conduct further attacks on Venezuela after two GOP senators reversed course on supporting the legislation.
Trump put intense pressure on five Republican senators who joined with Democrats to advance the resolution last week and ultimately prevailed in heading off passage of the legislation. Two of the Republicans — Sens. Josh Hawley of Missouri and Todd Young of Indiana — flipped under the pressure.
Vice President JD Vance had to break the 50-50 deadlock in the Senate on a Republican motion to dismiss the bill.
The outcome of the high-profile vote demonstrated how Trump still has command over much of the Republican conference, yet the razor-thin vote tally also showed the growing concern on Capitol Hill over the president’s aggressive foreign policy ambitions.
Democrats forced the debate after US troops captured Venezuelan leader Nicolás Maduro in a surprise nighttime raid earlier this month
“Here we have one of the most successful attacks ever and they find a way to be against it. It’s pretty amazing. And it’s a shame,” Trump said at a speech in Michigan Tuesday. He also hurled insults at several of the Republicans who advanced the legislation, calling Sen. Rand Paul of Kentucky a “stone cold loser” and Sens. Lisa Murkowski of Alaska and Susan Collins of Maine “disasters.” Those three Republicans stuck to their support for the legislation.
Trump’s latest comments followed earlier phone calls with the senators, which they described as terse. The president’s fury underscored how the war powers vote had taken on new political significance as Trump also threatens military action to accomplish his goal of possessing Greenland.
The legislation, even if it had cleared the Senate, had virtually no chance of becoming law because it would eventually need to be signed by Trump himself. But it represented both a test of GOP loyalty to the president and a marker for how much leeway the Republican-controlled Senate is willing to give Trump to use the military abroad. Republican angst over his recent foreign policy moves — especially threats of using military force to seize Greenland from a NATO ally — is still running high in Congress.
Two Republicans reconsider
Hawley, who helped advance the war powers resolution last week, said Trump’s message during a phone call was that the legislation “really ties my hands.” The senator said he had a follow-up phone call with Secretary of State Marco Rubio Monday and was told “point blank, we’re not going to do ground troops.”
The senator added that he also received assurances that the Trump administration will follow constitutional requirements if it becomes necessary to deploy troops again to the South American country.
“We’re getting along very well with Venezuela,” Trump told reporters at a ceremony for the signing of an unrelated bill Wednesday.
As senators went to the floor for the vote Wednesday evening, Young also told reporters he was no longer in support. He said that he had extensive conversations with Rubio and received assurances that the secretary of state will appear at a public hearing before the Senate Foreign Relations Committee.
Young also shared a letter from Rubio that stated the president will “seek congressional authorization in advance (circumstances permitting)” if he engaged in “major military operations” in Venezuela.
The senators also said his efforts were also instrumental in pushing the administration to release Wednesday a 22-page Justice Department memo laying out the legal justification for the snatch-and-grab operation against Maduro.
That memo, which was heavily redacted, indicates that the administration, for now, has no plans to ramp up military operations in Venezuela.
“We were assured that there is no contingency plan to engage in any substantial and sustained operation that would amount to a constitutional war,” according to the memo signed by Assistant Attorney General Elliot Gaiser.
Trump’s shifting rationale for military intervention
Trump has used a series of legal arguments for his campaign against Maduro.
As he built up a naval force in the Caribbean and destroyed vessels that were allegedly carrying drugs from Venezuela, the Trump administration tapped wartime powers under the global war on terror by designating drug cartels as terrorist organizations.
The administration has claimed the capture of Maduro himself was actually a law enforcement operation, essentially to extradite the Venezuelan president to stand trial for charges in the US that were filed in 2020.
Paul criticized the administration for first describing its military build-up in Caribbean as a counternarcotics operation but now floating Venezuela’s vast oil reserves as a reason for maintaining pressure.
“The bait and switch has already happened,” he said.
Trump’s foreign policy worries Congress
Lawmakers, including a significant number of Republicans, have been alarmed by Trump’s recent foreign policy talk. In recent weeks, he has pledged that the US will “run” Venezuela for years to come, threatened military action to take possession of Greenland and told Iranians protesting their government that ” help is on its way.”
Senior Republicans have tried to massage the relationship between Trump and Denmark, a NATO ally that holds Greenland as a semi-autonomous territory. But Danish officials emerged from a meeting with Vance and Rubio Wednesday saying a “fundamental disagreement” over Greenland remains.
“What happened tonight is a roadmap to another endless war,” Senate Democratic leader Chuck Schumer said at a news conference following the vote.
More than half of US adults believe President Donald Trump has “gone too far” in using the US military to intervene in other countries, according to a new AP-NORC poll.
House Democrats have also filed a similar war powers resolution and can force a vote on it as soon as next week.
How Republican leaders dismissed the bill
Last week’s procedural vote on the war powers resolution was supposed to set up hours of debate and a vote on final passage. But Republican leaders began searching for a way to defuse the conflict between their members and Trump as well as move on quickly to other business.
Once Hawley and Young changed their support for the bill, Republicans were able to successfully challenge whether it was appropriate when the Trump administration has said US troops are not currently deployed in Venezuela.
“We’re not currently conducting military operations there,” said Senate Majority Leader John Thune in a floor speech. “But Democrats are taking up this bill because their anti-Trump hysteria knows no bounds.”
Democratic Sen. Tim Kaine, who has brought a series of war powers resolutions this year, accused Republicans of burying a debate about the merits of an ongoing campaign of attacks and threats against Venezuela.
“If this cause and if this legal basis were so righteous, the administration and its supporters would not be afraid to have this debate before the public and the United States Senate,” he said in a floor speech.
