Up to 19 volunteers at a time will take part in the tests, to be held at the Royal Free Hospital in London, which houses a Biosafety Level 3 ward. They will be run by hVIVO, a medical research company that specializes in running challenge trials, in partnership with Imperial College London. These clinical trials will be a little different from most.For the current Covid-19 vaccine candidates that are in Phase 3 — the final stage of testing — tens of thousands of volunteers are given an experimental vaccine and then released to live their everyday lives; researchers assume that a certain percentage of them will be exposed to the virus naturally.In a challenge trial, by contrast, participants are deliberately dosed with virus.Proponents of challenge trials say that they are more efficient, requiring far fewer volunteers — likely in the hundreds — because researchers know for certain that everyone will be exposed to the virus, and that they can deliver scientific data more quickly. Critics worry about exposing people to a virus for which there is no fail-safe treatment, and say that the young, healthy volunteers are not representative of the wider population. "We are doing everything we can to fight coronavirus, including backing our best and brightest scientists and researchers in their hunt for a safe and effective vaccine," said Alok Sharma, the UK's Business Secretary. "The funding announced today for these ground-breaking but carefully controlled studies marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal life."
As a first step, hVIVO, a subsidiary of the Irish company Open Orphan, will conduct a characterization study at the beginning of 2021. That involves deliberately exposing a small number of healthy volunteers to the coronavirus, to determine the minimum dose that leads to symptomatic infection. "We want to find out right from the word go how the human body reacts to a dose of the virus," Dr. Martin Johnson, Senior Medical Director at hVIVO, told CNN.The company plans to be able to test the efficacy of up to three vaccine candidates sometime next year.A September article in the New England Journal of Medicine argued that challenge trials could "accelerate development of later rounds of vaccine candidates," as well as help researchers better see how the virus attacks the human body.Several potential vaccines are already nearing the end of traditional phase 3 trials using "natural" exposure to the virus, but simply showing that as vaccine has some effectiveness in preventing the onset of Covid-19 does not mean it is the best that scientists can do.The characterization study, and vaccine trials, will still need ethics approval from UK regulators. England's Health Research Authority tells CNN that it has already set up an ethics committee to assess any challenge trial proposals.Volunteers will be rigorously screened to ensure they are in good health, with no pre-existing conditions. They will need to be between the ages of 18 and 30, hVIVO says. They will be compensated for their participation, but regulators will want to ensure that the amount does not appear coercive.Volunteers will remain in residence at the Royal Free Hospital for the duration of the trial, which could last several weeks. hVIVO has isolated a strain of the virus taken from a British Covid-19 patient, and will expose the volunteers to the virus through the nose, using a pipette."We are actually going to take the very smallest dose," Dr. Johnson said. "What we're trying to do is we're trying to get the minimum number of symptoms that are safe."As soon as a patient has displayed symptoms of Covid-19, he said, doctors will administer the antiviral remdesivir. Scientists at hVIVO point out that unlike coronavirus patients who are admitted to the hospital, challenge trial volunteers will be treated at the first sign of infection. However, there are no treatments shown to help patients early on in the course of the virus.
Once the characterization study is complete, hVIVO will ready itself for testing up to three vaccine candidates, as determined by the UK's government-led Vaccine Taskforce. Those candidates could be vaccines that are not yet in Phase 3 trials, or field-tested vaccines for whiRead More – Source
Aliku Ogorchukwu: Wife of Nigerian killed in Italy demands justice
The wife of a Nigerian street trader who was killed in Italy has told the BBC she is seeking justice following his “painful death”.
Aliku Ogorchukwu, 39, was reportedly selling handkerchiefs in the seaside town of Civitanova Marche on Friday when he was chased and beaten to death.
A 32-year-old Italian has been arrested on suspicion of murder and robbery.
A video circulating online shows a man on top of Ogorchukwu, punching him with his bare hands.
None of those who witnessed the broad daylight attack appeared to intervene.
“This is a form of wickedness I don’t know,” Ogorchukwu’s wife, Charity Oriachi, told the BBC’s Focus on Africa.
Ms Oriachi said she had received help in coming to terms with her husband’s death but was tired of “talk”. Now, she was only interested in justice, she insisted.
Her family had lived in Italy for a long time, she said, stressing that her husband had never sought any trouble.
The killing has sparked outrage in the local community, including Nigerians, who took to the streets over the weekend and are planning another demonstration soon.
The Nigerian government has asked Italian authorities to quickly “bring the perpetrator of the heinous act” to justice.
Suspect not released
The suspect – a white man named as Filippo Claudio Giuseppe Ferlazzo – has been ordered to remain in jail as the investigation continues.
His defence lawyer told the media the suspect had said he was sorry and that there was “no racial element” involved.
A police investigator said Ogorchukwu was attacked after the trader’s “insistent” requests to the suspect and his partner for spare change.
The partner, identified as Elena D, told Italian newspaper Corriere della Sera that Ogorchukwu had touched her arm, but that did not bother her.
Ms Oriachi now wants to see the suspect “face to face”, to understand why he killed her husband, the family’s lawyer told the Associated Press.
Ukrainian widow confronts Russian soldier accused of killing her husband
In the very first days of this invasion a 62-year-old unarmed civilian was shot dead on a village street outside his Ukrainian home. His name was Oleksandr Shelipov.
Three months later and the captured Russian soldier accused of killing him is in Kyiv being tried for a war crime.
Standing up in court to confront the 21-year-old defendant on Thursday was Kateryna Shelipova, the widow of the man killed.
Did he repent his crime, she asked?
The Russian tank commander, Vadim Shishimarin, replied that he admitted his guilt and asked for her forgiveness. “But I understand you won’t be able to forgive me,” he added.
Kateryna Shelipova hadn’t finished. “Tell me please, why did you [Russians] come here? To protect us?” she asked, citing Vladimir Putin’s justification for the invasion of Ukraine.
“Protect us from whom? Did you protect me from my husband, whom you killed?”
The soldier had no answer to that.
This landmark trial marks the first time a Russian serviceman has been put on the stand for war crimes since the invasion of Ukraine was launched in February.
And perhaps such raw encounters are what such trials are about, at least in part. Forcing a soldier – who ignored all the rules of war – to face up to exactly what he has done and the suffering he has caused.
Sgt Shishimarin has pleaded guilty and Ukrainian prosecutors are asking for him to be sentenced to life imprisonment.
On Wednesday, Ms Shelipova told me she actually felt sorry for the soldier, but she could not forgive him for this crime.
She heard the shots that killed her husband, then saw Sgt Shishimarin through her gate – holding his weapon.
Five minutes later she says she saw her husband’s body: “He was dead with a shot in his head. I started screaming very loudly.”
“The loss of my husband is everything for me,” Ms Shelipova said, adding: “He was my protector.”
‘It killed him’
Recalling the events of 28 February, Vadim Shishimarin said he and a small group of other Russian soldiers had become separated from their unit and hijacked a car in order to return to it.
“As we were driving, we saw a man. He was talking on the phone,” the defendant said.
He claimed that he hadn’t wanted to fire the fatal shots, that he was following orders – threatened by another soldier if he refused to do as he was told.
“He said I would be putting us in danger if I didn’t. I shot him at short range. It killed him,” the 21-year-old tank commander told the court.
Interestingly, his defence lawyer – appointed by the state – told me that no Russian official has been in touch with him, including from its defence ministry.
There is no Russian embassy in Kyiv these days, so no contact from there either.
President Vladimir Putin’s spokesman yesterday told the BBC that the Kremlin has “no information” about this case.
All in all, it feels rather like the young soldier has been abandoned to his fate by the commanders who sent him to war and continue to deny that their forces commit crimes here.
We also heard from a second Russian soldier who witnessed the killing in February and later surrendered to Ukrainian forces.
Ivan Maltysev, another slight and young-looking 21-year-old, told the court how the Russian soldiers spotted Oleksandr Shelipov while they were driving the stolen car.
Mr Maltysev claimed that Vadim Shishimarin was then ordered to shoot the victim because he was on the phone.
“Vadim didn’t do it. So the soldier, whose name I don’t know, turned round in the car and shouted that Vadim had to carry out the order, or we would be informed on.
“At this point, we were almost alongside the civilian and, under pressure, Vadim fired. He fired three or four rounds.”
Ukraine has so far identified more than 11,000 possible war crimes committed by Russia.
Moscow has denied its troops have targeted civilians, but investigators have been collecting evidence of possible war crimes to bring before the International Criminal Court (ICC) in The Hague.
This trial is Ukraine’s chance to prove, beyond doubt, that a Russian soldier killed a civilian with no regard for the rules of war.
Its prosecutors know they are in the spotlight, proceeding so quickly, and in the middle of a war.
That is why they are keen to be as transparent and thorough as possible – so that this is not seen as a show trial, but part of a vital quest for justice.
Stop matching lone female Ukraine refugees with single men, UK told
The UN refugee agency has called on the UK government to intervene to stop single British men from being matched up with lone Ukrainian women seeking refuge from war because of fears of sexual exploitation.
Following claims that predatory men are using the Homes for Ukraine scheme to target the vulnerable, the United Nations high commissioner for refugees (UNHCR) told the Guardian “a more appropriate matching process” could be put in place to ensure women and women with children are matched with families or couples.
The suggestion from the global refugee agency follows reports that Ukrainian refugees, predominantly women and sometimes accompanied by children, are at risk in the UK of sexual exploitation.
Under the government’s Homes for Ukraine scheme, British hosts must link up with Ukrainian refugees themselves, leaving tens of thousands of people to resort to unregulated social media groups to connect.
A government-backed matching service run by the charity Reset offers to match UK hosts with refugees but has been operating for just over a week. Those who want to move to the UK must have a sponsor before applying for a visa.
In a statement, the UNHCR said there was a need for adequate safeguards and vetting measures to be in place against exploitation, as well as adequate support for sponsors. “[The] UNHCR believes that a more appropriate matching process could be put in place by ensuring that women and women with children are matched with families or couples, rather than with single men.
“Matching done without the appropriate oversight may lead to increasing the risks women may face, in addition to the trauma of displacement, family separation and violence already experienced,” a spokesperson said.
Leading refugee charities raised their concerns about the Homes for Ukraine scheme in a letter to Michael Gove, the minister in charge of the scheme. Louise Calvey, the head of safeguarding at the charity Refugee Action, told the Observer it was at risk of being a “Tinder for sex traffickers”.
One 32-year-old woman from Bakhmut, Ukraine, who has been searching for an appropriate person to match in the UK, wrote that she had received suggestive messages from men on Facebook’s Messenger app. “I was approached by one older guy from London who said that I would have to share a bedroom with him, and was asked if I was OK with that,” she said in an email seen by the Guardian.
The Sunday Times reported this week that a journalist posing as a 22-year-old Ukrainian woman from Kyiv found that within minutes of posting a message on the largest Facebook group for UK hosts she was inundated with inappropriate messages.
Some men lied about having several bedrooms in their one-bed homes while another proposed sharing a bed, writing: “I have a large bed. We could sleep together.” Another sent a voice note that said: “I am ready to help you and maybe you can help me also.”
In its statement, the UNHCR also raised concerns about the repercussions should the original UK host prove a potential threat to the safety of the refugee, and the six-month minimum duration on the Homes for Ukraine scheme.
“UNHCR believes that appropriate training and information are needed to ensure that hosts make an informed decision when applying to become sponsors. Housing a stranger in an extra bedroom for an extended period is not, for some people, sustainable,” the spokesperson said.
There is growing public anger over the length of time that Ukrainians are being forced to wait before being given visas from the Home Office amid the biggest refugee crisis in Europe since the second world war.
Priti Patel, the home secretary, apologised on Friday for the time it had taken for Ukrainian refugees to arrive in the UK under two visa schemes, after figures showed only 12,000 had so far reached Britain.
Reports on Tuesday claimed Gove had been accused of bullying Home Office officials by Patel’s permanent secretary, Matthew Rycroft.
Asked to respond to the UNHCR’s request for an intervention on sexual exploitation of Ukrainian women, a government spokesperson said: “Attempts to exploit vulnerable people are truly despicable – this is why we have designed our Homes for Ukraine scheme to have specific safeguards in place, including robust security and background checks on all sponsors, both by the Home Office and local authorities.
“Councils must make at least one in-person visit to a sponsors property and following guests arrival, they have a duty to ensure the guest is safe and well.
“We have also partnered with the charity Reset Communities and Refugees to fund and provide a matching service for sponsors and refugees to ensure that matches made are suitable, safe and successful. This service will vet eligibility, assess needs, and provide training for sponsors to ensure they
ensure they can support the people they host.”
Asked to confirm or deny whether there had been a complaint that Gove had bullied staff, the spokesperson added: “Humanitarian schemes set up in record time by the Home Office and the Department for Levelling Up, Housing and Communities working closely together are helping thousands of Ukrainians find safety in the UK.”
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