UK to infect healthy volunteers in vaccine research trial

In this Wednesday, Aug. 5, 2020 file photo, senior Clinical Research Nurse Ajithkumar Sukumaran prepares the COVID-19 vaccine to administer to a volunteer, at a clinic in London. (AP)
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Updated 20 October 2020
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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

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.”


Austin: No indication Hamas planning attack on US troops

Updated 5 sec ago
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Austin: No indication Hamas planning attack on US troops

  • Israel has killed more than 34,000 Palestinians, according to Gaza’s Health Ministry

WASHINGTON: US Defense Secretary Lloyd Austin said he did not see any indication Hamas was planning any attack on US troops in Gaza but added adequate measures were being put in place for the safety of military personnel.
“I don’t discuss intelligence information at the podium. But I don’t see any indications currently that there is an active intent to do that,” Austin said during a press briefing.
“Having said that ... this is a combat zone and a number of things can happen, and a number of things will happen.”
Austin’s remarks came as the US military said it was temporarily pausing the offshore construction of a maritime pier because of weather conditions and instead would continue building it at the Israeli Port of Ashdod.

FASTFACT

The US military says it is temporarily pausing the offshore construction of a maritime pier because of weather conditions.

The maritime pier, once built, will be placed off the coast of Gaza in a bid to speed the flow of humanitarian aid into the enclave.
“Forecasted high winds and high sea swells caused unsafe conditions for soldiers working on the surface of the partially constructed pier,” the US military said in a statement.
“The partially built pier and military vessels involved in its construction have moved to the Port of Ashdod, where assembly will continue,” it added.
Earlier this week, the Pentagon said about 50 percent of the pier had been constructed.
Israel has sought to demonstrate it is not blocking aid to Gaza, especially since President Joe Biden issued a stark warning to Prime Minister Benjamin Netanyahu, saying Washington’s policy could shift if Israel fails to take steps to address civilian harm, humanitarian suffering, and the safety of aid workers.
US officials and aid groups say some progress has been made but warn it is insufficient, amid stark warnings of imminent famine among Gaza’s 2.3 million people.
The humanitarian situation in Gaza — which has been devastated by more than six months of Israeli operations against Hamas — remains dire, with a senior US administration official saying last week that the territory’s entire population of 2.2 million people is facing food insecurity.

 


Canada police charge three with murder of Sikh leader Nijjar

Updated 5 min 24 sec ago
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Canada police charge three with murder of Sikh leader Nijjar

  • Nijjar was a Canadian citizen campaigning for the creation of Khalistan, an independent Sikh homeland

OTTAWA: Canadian police said on Friday they had arrested and charged three Indian nationals with the murder of Sikh separatist leader Hardeep Singh Nijjar in June 2023 and said they were probing possible links to the Indian government.

Nijjar, 45, was shot dead outside a Sikh temple in Surrey, a Vancouver suburb with a large Sikh population. Canadian Prime Minister Justin Trudeau has cited evidence of Indian government involvement, prompting a diplomatic crisis with New Delhi.

Assistant Commissioner David Teboul said the matter was still under investigation and other probes were being carried out. These “include investigating connections to the government of India,” he told a televised news conference.

Nijjar was a Canadian citizen campaigning for the creation of Khalistan, an independent Sikh homeland carved out of India. The presence of Sikh separatist groups in Canada has long frustrated New Delhi, which had labeled Nijjar a “terrorist.”

Last week the White House expressed concern about the reported role of the Indian intelligence service in assassination plots in Canada and the United States.


India’s Rahul Gandhi to contest elections from family borough

Updated 37 min 37 sec ago
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India’s Rahul Gandhi to contest elections from family borough

  • Gandhi contests polls from second seat in family bastion
  • Emotional moment to contest from Raebareli, Gandhi says

NEW DELHI: Indian opposition leader Rahul Gandhi will contest the general election from the family bastion in the north, his Congress Party announced on Friday, a move that will challenge Prime Minister Narendra Modi in a region he dominates.

Gandhi, the scion of the Nehru-Gandhi dynasty, will contest from Raebareli in politically crucial Uttar Pradesh state, Congress said, in addition to Wayanad in Kerala state in the south, which has already voted. India allows candidates to contest multiple constituencies but they can represent only one.
Uttar Pradesh is India’s most populous state and elects 80 lawmakers to the lower house of parliament, the most of any state. In the last election in 2019, Modi’s Bharatiya Janata Party and allies won 64 seats, including from Amethi, adjacent to Raebareli, where Gandhi was defeated.
His return to the area, albeit for a second constituency, will invigorate the party, Congress officials said.
Gandhi said being nominated from Raebareli was an “emotional moment” for him.
“My mother has entrusted me with the responsibility ... with great confidence and given me the opportunity to serve it,” he posted on X.
“In the ongoing battle for justice and against injustice, I seek the love and blessings of my loved ones. I am confident that all of you are standing with me in this battle to save the constitution and democracy,” he said.
Gandhi’s mother Sonia won from Raebareli in 2019, which has returned a Congress candidate in 17 of the 20 elections held there since 1952, mostly members of the Gandhi family. Sonia Gandhi is now a member of the upper house of parliament.
Modi is widely expected to win a rare third term in the general election that got underway on April 19 and concludes on June 1, with votes set to be counted on June 4.
However, analysts say a low voter turnout in the first two phases of the seven-phase election has dampened hopes of a huge majority for the party, although they said the BJP was still likely to retain power in the world’s most populous nation.
Soon after the announcement, Gandhi flew to Raebareli in a private aircraft, accompanied by his mother Sonia, sister Priyanka and senior Congress leaders, and filed his nomination papers.
Modi and the BJP attacked Gandhi for the decision.
“I had said that the prince will lose in Wayanad and in fear of his loss ... he will look for another seat,” Modi said on Friday, referring to Gandhi.
“I also want to tell them wholeheartedly, do not be afraid, do not run away,” Modi said.
Congress has ruled India for 54 of its 76 years since independence from Britain, and members of the Nehru-Gandhi family were prime ministers for more than 37 of those 54 years.
However, the party has floundered since it was swept out of power by Modi in 2014 and has been struggling to revive itself.
Gandhi contesting from Raebareli is good news for the opposition INDIA alliance of 27 parties that Congress leads, said Rasheed Kidwai, political analyst and visiting fellow at New Delhi’s Observer Research Foundation.
“The significance of Rahul contesting here is that it will boost the alliance with Samajwadi Party,” Kidwai said referring to the regional partner of Congress in Uttar Pradesh. “The opposition story is not all that bad and this will force a contest with BJP.”

 


Defense chiefs from US, Australia, Japan and Philippines vow to deepen cooperation

Updated 44 min 2 sec ago
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Defense chiefs from US, Australia, Japan and Philippines vow to deepen cooperation

  • Defense chiefs from the four nations held their first meeting in Singapore last year

HONOLULU: Defense chiefs from the US, Australia, Japan and the Philippines vowed to deepen their cooperation as they gathered Thursday in Hawaii for their second-ever joint meeting amid concerns about China’s operations in the South China Sea.
The meeting came after the four countries last month held their first joint naval exercises in the South China Sea, a major shipping route where Beijing has long-simmering territorial disputes with a number of Southeast Asian nations and has caused alarm with its recent assertiveness in the waters.
US Defense Secretary Lloyd Austin told reporters at a news conference after their discussion that the drills strengthened the ability of the nations to work together, build bonds among their forces and underscore their shared commitment to international law in the waterway.

HIGHLIGHT

The meeting came after the four countries last month held their first joint naval exercises in the South China Sea, a major shipping route where Beijing has long-simmering territorial disputes with a number of Southeast Asian nations and has caused alarm with its recent assertiveness in the waters.

Australian Defense Minister Richard Marles said the defense chiefs talked about increasing the tempo of their defense exercises.
“Today, the meetings that we have held represent a very significant message to the region and to the world about four democracies which are committed to the global rules-based order,” Marles said at the joint news conference with his counterparts.
Austin hosted the defense chiefs at the US military’s regional headquarters, US Indo-Pacific Command, at Camp H.M. Smith in the hills above Pearl Harbor. Earlier in the day, Austin had separate bilateral meetings with Australia and Japan followed by a trilateral meeting with Australia and Japan.
Defense chiefs from the four nations held their first meeting in Singapore last year.
The US has decades-old defense treaties with all three nations.
The US lays no claims to the South China Sea, but has deployed Navy ships and fighter jets in what it calls freedom of navigation operations that have challenged China’s claims to virtually the entire waterway. The US says freedom of navigation and overflight in the waters is in America’s national interest.
Aside from China and the Philippines, Vietnam, Malaysia, Taiwan and Brunei also have overlapping claims in the resource-rich sea. Beijing has refused to recognize a 2016 international arbitration ruling that invalidated its expansive claims on historical grounds.
Skirmishes between Beijing and Manila in particular have flared since last year. Earlier this week, Chinese coast guard ships fired water cannons at two Philippine patrol vessels off off Scarborough Shoal, damaging both.
The repeated high-seas confrontations have sparked fears of a larger conflict that could put China and the United States on a collision course.. The US has warned repeatedly that it’s obligated to defend the Philippines — its oldest treaty ally in Asia — if Filipino forces, ships or aircraft come under an armed attack, including in the South China Sea.
President Joe Biden’s administration has said it aims to build what it calls a “latticework” of alliances in the Indo-Pacific even as the US grapples with the Israel-Hamas war and Russia’s ongoing invasion of Ukraine.

Beijing says the strengthening of US alliances in Asia is aimed at containing China and threatens regional stability.

 


Senior Labour official admits Gaza has cost party votes in local elections

Updated 03 May 2024
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Senior Labour official admits Gaza has cost party votes in local elections

  • Pat McFadden says leadership’s stance on conflict has been ‘a factor in some places’
  • Prof. John Curtice says Labour has performed ‘quite badly’ among Muslim voters

LONDON: A senior Labour official has suggested the party’s stance on Gaza might have affected its performance in local elections in the UK.

A series of votes took place this week nationwide to elect new mayors in multiple major cities, as well as council members and police and crime commissioners.

Labour was expected to perform strongly, but Pat McFadden, Labour’s national campaign coordinator, told Sky News that Gaza had been “a factor in some places,” adding that with “so many innocent people being killed I’m not surprised people have strong feelings about that.”

Party sources suggested turnout in key areas was lower than anticipated, with many Muslim voters choosing not to vote, including in one key election in the West Midlands where lack of support saw Labour lose the local mayoralty to the Conservative incumbent Andy Street.

It comes weeks after former Labour MP George Galloway was elected to represent the formerly safe Labour constituency of Rochdale in Parliament, with Israel’s ongoing war in Gaza a key theme of the campaign.

Galloway has since said his Workers Party of Britain will seek to stand candidates in every constituency at the next UK general election.

An anonymous Labour source in the West Midlands told The Times: “We (would) have beaten him (Andy Street) as a general rule, but the Muslim vote has collapsed to the Galloway-backed independent.”

Another source quoted by the BBC caused controversy and was accused of racism by Conservative sources for saying: “It’s the Middle East, not West Midlands, that will have won Andy Street the mayoralty. Once again Hamas are the real villains.”

In a statement, Labour told ITV: “The Labour Party has strongly condemned this racist quote which has not come from anyone who is speaking on behalf of the party or whose values are welcome in the party.”

Labour lost its 13-year spell controlling the local council in Oldham, having seen its majority reduced in recent weeks ahead of the elections following defections by councilors opposed to Labour leader Keir Starmer’s stance on Gaza.

However, Arooj Shah, Labour’s council chief in Oldham, disputed that Gaza was the main issue, telling The Independent: “I don’t think that’s a fair statement to make, given that the issue of Gaza has been over the last year, but what we’ve seen in Oldham is a lot longer than that. We have had 13 years of austerity and that’s been really, really difficult.”

Elsewhere, Green Party candidates also claimed former Labour seats in Newcastle and Bolton.

Nick Peel, Labour’s council leader for Bolton, told The Independent: “As a direct result of the ongoing humanitarian crisis in Palestine, many South Asian voters have not supported Labour or Conservative.”

Chris Hopkins, political research director for market research company Savanta, told The Independent that Labour could lose more council seats in areas with significant Muslim populations, such as Bradford and Burnley, over the Gaza issue as results continued to be announced.

Leading pollster Prof. John Curtice told the paper that “Labour has actually done quite badly” in areas of the country with large Muslim communities, and warned that the trend could harm the party ahead of the next general election.

Starmer told the BBC: “I’m concerned wherever we lose votes and we intend to win back any votes we have lost.

“But there’s no denying that across the country, whether it’s Hartlepool in the north or Rushmoor in the south, or Redditch, a bellwether seat, we are winning votes across the country. And that, I think, reflects a changed Labour Party with a positive case to take to the country.”