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.”


Prosecutors seek up to 14-year terms for French rape trial defendants

Updated 10 sec ago
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Prosecutors seek up to 14-year terms for French rape trial defendants

The case has sparked horror, protests and a debate about male violence in France
Until Wednesday, or latest Thursday morning, prosecutors are outlining their sentencing demands for all the defendants

AVIGNON, France: French prosecutors on Tuesday demanded sentences of up to 14 years for some of the remaining co-defendants of a man charged with enlisting dozens of strangers to rape his wife while she was drugged and unconscious.
On Monday, prosecutors requested a maximum 20-year jail term for Dominique Pelicot, who has been on trial in the southern city of Avignon since September with 49 other men for organizing the rapes and sexual abuse of Gisele Pelicot, now his former wife.
One man is being tried in absentia.
The case has sparked horror, protests and a debate about male violence in France, with tens of thousands of protesters staging demonstrations across the country on Saturday against violence targeting women.
The decade-long abuse of Gisele Pelicot by Dominque Pelicot was only uncovered when he was arrested for a separate upskirting offense, leading investigators to discover his meticulously-kept records of the visitors to the family home in the town Mazan.
Until Wednesday, or latest Thursday morning, prosecutors are outlining their sentencing demands for all the defendants, most of whom come from ordinary professions ranging from the fire brigade to the media.
On Tuesday, public prosecutor Laure Chabaud asked for a 14-year sentence for Karim S., 38, who was one of the few defendants whose messaging with Dominique Pelicot was discovered by investigators.
For Florian R., 32, who did not admit “intent” and Gregory S., 31, who was “aware of Gisele Pelicot’s altered state,” Chabaud demanded thirteen years in prison.
Some defense lawyers have described the sentencing demands as “staggering” and “out of proportion,” alleging the public prosecutor’s office was under pressure from “public opinion.”
“I fear what will happen next,” said Louis-Alain Lemaire, a lawyer for four defendants.
But public prosecutors say the trial should herald a fundamental change in society.
“In 2024, we can no longer say ‘she didn’t say anything, she agreed,’ that’s from another era,” Chabaud said on Monday.
Prosecutors asked for a 12-year sentence for nine of the remaining defendants, including Boris M., 37, who claimed during the hearings that he, too, was a victim.
“He says he was a victim of Dominique Pelicot, like Gisele Pelicot,” prosecutor Jean-Francois Mayet said.
But “at no time did he seek or obtain Gisele Pelicot’s consent,” he said, adding, “in reality, he was pleased with the situation presented to him” by the main defendant.
Prosecutors sought a 12-year sentence for Mahdi D., 36, who also claimed to be a victim of Dominique Pelicot’s actions.
Chabaud also asked for 12-years for Lionel R., 44, who said he was taking “part in a couple’s fantasy.”
Many of the accused argued in court that they believed Pelicot’s claim that they were participating in a libertine fantasy, in which his wife had consented to sexual contact and was only pretending to be asleep.
Among them, 33 have also claimed they were not in their right minds when they abused or raped Gisele Pelicot, a defense not backed by any of the psychological reports compiled by court-appointed experts.


Prosecutors also sought a 12-year jail term for Cyril B., 47, who “was well aware Gisele Pelicot should not be woken up,” and for Thierry P., 54, who said Dominique Pelicot was “solely responsible,” the public prosecutor said.
Mayet demanded the same prison sentence for Omar D., 36, who argued “the husband’s consent and presence seemed to be sufficient,” and Ahmed T., 54, who “denies any responsibility.”
Two other defendants, Redouane A., 40, who said he came to Mazan to “please the couple” and Jean T., 52, who claimed without evidence he was also drugged by the main defendant, are also facing a 12-year jail-term.
On Monday, prosecutors requested a 17-year prison sentence for one defendant, Jean-Pierre M., 63, who applied Pelicot’s practices against his own wife to rape her a dozen times, sometimes in Pelicot’s presence.
The trial has made Gisele Pelicot, who insisted the hearings be held in public, a feminist icon in the fight of women against sexual abuse.
Prosecutor Mayet praised her “courage” and “dignity,” thanking her for allowing the hearings to be held in public.
The verdicts and sentencing are expected by December 20.

Russia vows response to latest Ukraine ATACMS strikes

Updated 38 min 44 sec ago
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Russia vows response to latest Ukraine ATACMS strikes

  • Ukraine firing the long-range missiles into Russia for the first time last week prompted a furious reaction from Moscow
  • Russia’s defense ministry on Tuesday said Ukraine had carried out fresh strikes — on November 23 and 25 — using ATACMS

MOSCOW: Moscow’s military on Tuesday pledged a response to fresh Ukrainian air attacks inside Russia using US-supplied ATACMS missiles.
Ukraine firing the long-range missiles into Russia for the first time last week prompted a furious reaction from Moscow.
Russia’s defense ministry on Tuesday said Ukraine had carried out fresh strikes — on November 23 and 25 — using ATACMS.
“Retaliatory actions are being prepared,” it said in a post on Telegram, without elaborating.
The United States gave Ukraine permission to use the weapons to hit Russian territory earlier this month after months of requests from Kyiv.
In a rare admission, Russia said the fresh strikes had caused damage to military hardware and wounded some of its personnel on the ground.
A strike on the Kursk Vostochny air base wounded two servicemen, the defense ministry said, while a strike on an air defense battery damaged a radar system and also caused “casualties.”
It said three of the five missiles fired in the first strike were shot down, while seven of the eight used in the second were destroyed.
Moscow rarely provides such specific details on Ukrainian aerial attacks and almost never admits missiles have reached their intended target.
The defense ministry also posted photos of what it said were the missile fragments, showing large casings with English-language inscriptions on the side.
AFP was unable to immediately verify the images.
The strikes come with tensions having ratched up dramatically in the near three-year conflict over the last few weeks.
Putin last week signed a decree lowering the threshold for the use of nuclear weapons, days before launching the nuclear-capable hypersonic Oreshnik missile at Ukraine.


US Air Force in UK says a small number of drones spotted flying over bases in eastern England

Updated 47 min 50 sec ago
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US Air Force in UK says a small number of drones spotted flying over bases in eastern England

  • The Air Force hasn’t identified who is believed to be behind the incursions
  • Unspecified mitigation measures are underway

LONDON: The US Air Force says a number of small drones have been detected near three bases in eastern England that are used by American forces.
Tuesday’s ongoing incident comes just days after drones were spotted near RAF Lakenheath, RAF Mildenhall and RAF Feltwell. They were actively monitored after they were seen in the vicinity of and over the three bases, US Air Forces Europe said in a statement on Sunday.
The Air Force hasn’t identified who is believed to be behind the incursions. Unspecified mitigation measures are underway.
Lakenheath is home to the 48th Fighter Wing, which the US Air Force describes as the foundation of its combat capability in Europe. Mildenhall hosts the 100th Air Refueling Wing, and Feltwell is a hub for housing, schools and other services.
Lakenheath, Mildenhall and Feltwell, located close to one another in the counties of Suffolk and Norfolk, are Royal Air Force bases used primarily by the US Air Force


Death toll from Hindu-Muslim clashes sparked by mosque survey rises to six in India

Updated 26 November 2024
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Death toll from Hindu-Muslim clashes sparked by mosque survey rises to six in India

  • Street battles broke out in a bid to block a team of surveyors from the government from entering the Shahi Jama Masjid in Sambhal
  • Hindu activist groups have laid claim to several mosques they say were built over Hindu temples during Muslim Mughal rule 

Lucknow, India: The death toll from violent protests in India sparked by a survey into whether a centuries-old mosque was built on a Hindu temple has risen to six, an official said Tuesday.
Around 20 police officers were also wounded during the violence on Sunday in Sambhal in India’s northern state of Uttar Pradesh, district magistrate Chirag Goyal told AFP.
Street battles broke out in a bid to block a team of surveyors from the government’s Archaeological Survey of India (ASI) from entering the Shahi Jama Masjid in Sambhal.
The six Muslim men were killed by gunfire — with Goyal saying they were shot by fellow protesters.
“The six killed were caught in crossfire by rioters using homemade pistols,” he said. “The police only fired tear gas and rubber bullets.”
Two people were initially reported dead on Sunday, but more details emerged later, while others later died of their wounds.
Goyal said 25 people had been arrested following the violence.
Hindu activist groups have laid claim to several mosques they say were built over Hindu temples during the Muslim Mughal empire centuries ago.
The survey in Sambhal was ordered by a local court, after a petition from a Hindu priest this month claimed it was built on the site of a Hindu temple.
Within hours the court ordered a survey of the mosque, a decision protested by local Muslim residents.
The first survey was undertaken on November 19. A second survey four days later, which included taking photos and video of the mosque’s features, triggered the violence.
The hilltop Shahi Jama Masjid was built in 1526 during the rule of Mughal emperors Babur and Humayun, according to historians, with renovations during the 17th century.
Hindu nationalist activists were emboldened earlier this year when Prime Minister Narendra Modi inaugurated a grand new Hindu temple in the northern city of Ayodhya, built on grounds once home to the centuries-old Babri mosque.
That mosque was torn down in 1992 in a campaign spearheaded by members of Modi’s party, sparking sectarian riots that killed 2,000 people nationwide, most of them Muslims.
Some Hindu campaigners see an ideological patron in Modi.
Calls for India to more closely align the country’s officially secular political system with its majority Hindu faith have rapidly grown louder since Modi was swept to office in 2014.
It has made the country’s roughly 210-million-strong Muslim minority increasingly anxious about their future.


Philippines, UAE pledge stronger economic ties as Marcos marks first visit

Updated 26 November 2024
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Philippines, UAE pledge stronger economic ties as Marcos marks first visit

  • Marcos is the first Philippine president to visit Abu Dhabi in more than 15 years
  • UAE president says he looks forward to talks on a free trade deal with the Philippines

Manila: The Philippines and the UAE on Tuesday committed to boosting economic relations as Philippine President Ferdinand Marcos Jr. marked his first official trip to Abu Dhabi.

On his one-day trip, Marcos was received by UAE President Sheikh Mohammed bin Zayed.

He is the first Philippine president to visit the UAE since Gloria Macapagal-Arroyo in 2008.

During the meeting, the two leaders committed “to deepening cooperation in various areas, including economy, trade and sustainability,” Marcos’ office said in a statement.

“The two leaders emphasized their dedication to strengthening bilateral ties and delivering lasting benefits to their peoples, coinciding with the 50th anniversary of friendship and collaboration between their nations.”

The Philippines and the UAE celebrated 50 years of diplomatic relations on Aug. 19.

Emirati state news agency WAM cited Sheikh Mohammed as saying that he hoped the visit “would herald a new and significant chapter” in UAE-Philippine ties and that the UAE “looks forward to continuing discussions toward reaching a Comprehensive Economic Partnership Agreement with the Philippines to elevate trade and investment relations to new heights of mutual economic growth.”

Negotiations on the free trade deal have been underway between Philippine and UAE officials since the beginning of this year.

The UAE is a key trading partner of the Philippines in the region and home to the second-largest Filipino diaspora after Saudi Arabia.

Some 700,000 overseas Filipino workers live and work in the UAE. Many are employed in the construction, healthcare and hospitality sectors.

Marcos was initially expected to meet representatives of the Filipino community, but his visit was shortened, with the Philippine Presidential Communications Office saying he would “immediately fly back to Manila to resume his personal supervision and inspection of the relief and reconstruction activities in communities devastated by six successive typhoons.”