vrijdag 3 juli 2020

'I'm cautiously optimistic': Imperial's Robin Shattock on his coronavirus vaccine




'I'm cautiously optimistic': Imperial's Robin Shattock on his coronavirus vaccine

Team is using new approach that could be cheap and scalable and become the norm within five years


Prof Robin Shattock Prof Robin Shattock: ‘I’m cautiously optimistic that it will work as well as anything else that is being developed.’ Photograph: Thomas Angus/Imperial College London/PA
 Health editor


Fri 3 Jul 2020 


P
rof Robin Shattock would have liked slightly longer to develop the revolutionary approach to vaccines that he is pretty sure will not only save lives in the Covid-19 pandemic but become the norm for vaccine development within five years.

His team at Imperial College were working on Ebola and Lassa fever vaccines using new technology but had not got as far as human trials when a novel coronavirus started to kill thousands of people in Wuhan, China.
Animal data told them they were on the right track, but it is now Covid-19 that will prove or disprove whether the approach, using what they call self-amplifying RNA, is a breakthrough.
He is careful not to over-promise, but it is clear he backs his own horse over 120 other contenders in the effort to develop a coronavirus vaccine. “Of course, or I wouldn’t be doing it,” Shattock told the Guardian.
“I’m cautiously optimistic that it will work as well as anything else that is being developed because it induces good immune responses in animal models, and we predict it will be the same in humans and it will be very safe because we are using such low doses.
“What we don’t know is what level of immunity is required to prevent infection. If we only need a tiny bit, the majority of vaccines out there will probably work. That will be fantastic for the world.
“If we need a certain level of immune response that is high then we may see some vaccines are more successful than others. I would hope ours will be one of the successful ones, but there is no guarantee until we get the data that shows it works.”
The Imperial vaccine is based on bits of genetic code, rather than bits of the virus itself. The code is inserted in fat droplets into the muscle of the arm, which then makes the spike protein for which the Sars-CoV-2 virus is famous. This induces the immune system to go into action, producing antibodies to fight it and hopefully creating a memory of the virus as an enemy invader to be repelled in case of genuine infection.
Shattock is aiming for a vaccine that will treat all the billions of people on the planet, however small their country’s GDP. That’s the real beauty of this approach, he believes: it’s very safe, uses very little material and can be scaled up very quickly.

And it’s going to be cheap, around £2 to £3 a dose, he thinks, which is chips for a brand-new vaccine. The first vaccines for human papillomavirus (HPV), which can cause types of cancer, cost around £300 per course.
Imperial has philanthropic funding from Morningside Ventures, founded by the Chan family of Hong Kong, and has formed a social enterprise called VacEquity Global Health to bring the vaccine to the world. Royalties will be waived for low-income countries. Shattock says they may charge higher prices for wealthy countries in order to give the vaccine to the poorest at no cost.
If it’s a race, Imperial will not win it. “We are not going to be first unless others fail,” he said. If that matters, it is because all the demand and funding will focus on the first vaccine that works, though there will be issues around affordability and scaling up.
The vaccines being developed in the US are likely to stay there, with the Trump administration securing every dose that can be produced to protect Americans first. “I suspect if they work, they will be so busy meeting US demand that there are always going to be parts of the world that can’t access them,” Shattock said. “The idea that a single vaccine will be rolled out in a timely fashion around the world I think is very naive.”
The UK government has put significant funding into Oxford University and Imperial’s attempts. The US has also invested in Oxford, but Shattock is not sorry it hasn’t offered anything to him. “In some ways it makes life easier. They have so much money that it also comes with a kind of pull. I think we would get very distracted if we were in that huge race in the US,” he said.
It’s unlikely the first vaccines will be 100% effective, and the protection they give may wear off after a time. Shattock said it was quite possible that the Oxford University/Astra Zeneca prototype, which is ahead of the field as the first in large human trials, and the Imperial vaccine could be used together.
“That’s not a surprise. If you use two different approaches – one to prime the immune system, and change to another to boost it, it often gives you a better response. One of the uncertainties about the AstraZeneca vaccine is whether it could be used for reboosting the immune system if you need an annual or five-yearly booster,” he said.
Oxford is using a traditional approach, delivering the vaccine through a mild cold virus called an adenovirus. That should teach the immune system to fight the coronavirus, but it’s possible the antibodies may next time reject the cold virus as well, so extra booster doses won’t work so well. The Imperial vaccine, on the other hand, which is two shots to begin with, one month apart, can be given as often as needed.
So is Shattock’s vaccine better? “I think that’s a difficult judgment call to make,” he said. “If what we see in animals translates to humans, we will have a different quality of immune response. That’s probably because we can give two doses. I think we will see higher levels of antibodies. Whether that makes a difference in protection or not, again, is an unknown.”
Imperial will start its efficacy trials in humans in October. “We should know whether the vaccine works by the end of the year,” he said. “We have put in place the ability to make 85m doses for the UK.” At two doses each, that could cover 42.5 million adults. “We can make more, but we know we can guarantee we can make that many doses. We can cover the UK without any problem at all.”
He thinks the more vaccines there are that work, the better, because that will give more coverage around the world. Imperial’s can be produced in very large quantities so quickly because it uses very little material, but Shattock said: “We need to partner with manufacturers around the world to do that.” That could be a huge pharma company such as AstraZeneca, but more likely, he thinks, it will be a variety of smaller companies that currently work on small margins based in different parts of the world, producing it in South America, India, Australia and so on to get global spread.
The success rate of vaccines at this stage of development is 10%, Shattock says, and there are already probably 10 vaccines in clinical trials, “so that means we will definitely have one”.
Other vaccines getting big support in the US are Johnson and Johnson’s, which uses an adenovirus like Oxford’s, and Moderna’s, which uses an RNA approach like Imperial’s but with a dose that is 100 times bigger. “I suspect their vaccine and ours will look quite similar in terms of immune response, but we are just using much less material. And they won’t be interested in developing world markets because they are a billion-dollar enterprise and need to make big returns on their investment.” BioNTech in Germany is testing several RNA candidates, one of which looks similar to Imperial’s.
While Shattock hopes the Imperial vaccine works against Covid-19, his team see it very much as the future. “The next time there is a pandemic, we hope this technology will be ready to be produced in many parts of the world much, much more rapidly. We are at a transition point. In five years’ time probably everybody will be using this sort of technology for outbreak pathogens.”
It’s fast and it’s cheap. If it works, it may mean vaccines not only against viral outbreaks but also against the endemic neglected diseases that afflict low-income countries, where there has been little incentive in the past for companies to get involved.

donderdag 2 juli 2020

Jeffrey Epstein ex-girlfriend Ghislaine Maxwell arrested by FBI


BBC-News-LOGO | Reinhart Lab



Jeffrey Epstein ex-girlfriend Ghislaine Maxwell arrested by FBI




Jeffrey Epstein and Ghislaine Maxwell in New York in 2005Image copyrightGETTY IMAGES
Image captionJeffrey Epstein and Ghislaine Maxwell in New York in 2005

British socialite Ghislaine Maxwell, an ex-girlfriend of disgraced financier Jeffrey Epstein, is facing charges in the US after being arrested by the FBI.
The six charges include enticing a minor to travel to engage in illegal sex acts and two counts of perjury.
She was reportedly arrested in New Hampshire and is due in federal court later.
She has denied any involvement in or knowledge of Epstein's alleged sexual misconduct.
Epstein died in prison on 10 August as he awaited, without the chance of bail, his trial on sex trafficking charges.
He was arrested last year in New York following allegations that he was running a network of underage girls - some as young as 14 - for sex. His death was determined to be suicide.

What are the charges?

Four of the charges relate to the years 1994-97 when Ms Maxwell was, according to the indictment, among Epstein's closest associates and also in an "intimate relationship" with him. The other two charges are allegations of perjury in 2016.
The indictment says Ms Maxwell "assisted, facilitated, and contributed to Jeffrey Epstein's abuse minor girls by, among other things, helping Epstein to recruit, groom and ultimately abuse victims known to Maxwell and Epstein to be under the age of 18".
She is charged with conspiracy to entice minors to travel to engage in illegal sex acts; enticing a minor to travel to engage in illegal sex acts; conspiracy to transport minors with intent to engage in criminal sexual activity; and transporting a minor with intent to engage in criminal sexual activity.
During the same period she groomed multiple minor girls to engage in sex acts with Epstein, the indictment says. She attempted to befriend them by asking about their lives and families and then she and Epstein built the friendships by taking minor victims to the cinema or shopping.
Having built a rapport, Ms Maxwell would "try to normalise sexual abuse for a minor victim by... discussing sexual topics, undressing in front of the victim, being present when a minor victim was undressed, and/or being present for sex acts involving the minor victim and Epstein".
The perjury counts relate to depositions she gave to a New York court on 22 April and 22 July 2016.
The charge sheet says she "repeatedly lied when questioned about her conduct, including in relation to some of the minor victims".

What is the background?

Allegations against Epstein had dated back years before the parents of a 14-year-old girl said he had molested her in 2005. Under a legal deal, he avoided federal charges and since 2008 was listed as level three on the New York sex offenders register.
But he was arrested again in New York on 6 July 2019 and accused of sex trafficking of underage girls over a number of years.
Some of Epstein's alleged victims have accused Ms Maxwell of bringing them into his circle to be sexually abused by him and his friends.
One told the BBC's Panorama that Ms Maxwell "controlled the girls. She was like the Madam".
Ms Maxwell has denied any wrongdoing.
Earlier this year she sued Epstein's estate seeking reimbursement for legal fees and security costs. She "receives regular threats to her life and safety", court documents in that case said.
Another of Epstein's alleged victims, Virginia Giuffre, has accused Ms Maxwell of recruiting her as a masseuse to the financier at the age of 15.
Details of that allegation against Ms Maxwell emerged in documents unsealed by a US judge last August in a 2015 defamation case but are not part of the charges against Ms Maxwell unveiled in July 2020.

Who is Ghislaine Maxwell?

Ms Maxwell is the daughter of late British media mogul Robert Maxwell.
A well-connected socialite, she is said to have introduced Epstein to many of her wealthy and powerful friends, including Bill Clinton and the Duke of York (who was accused in the 2015 court papers of touching a woman at Jeffrey Epstein's US home, although the court subsequently struck out allegations against the duke).
Buckingham Palace has said that "any suggestion of impropriety with underage minors" by the duke was "categorically untrue".
Ms Maxwell has mostly been out of public view since 2016.







Media caption
In a BBC interview in 2019, Prince Andrew said he would testify under oath about Epstein

In a BBC interview last year, the Duke of York said he had met Ms Maxwell last year, before Epstein was arrested and charged. However they did not discuss Epstein, he said.
Last month a US prosecutor said Prince Andrew had "sought to falsely portray himself" as eager to co-operate with the inquiry into Epstein.
US attorney Geoffrey Berman said Prince Andrew had "repeatedly declined our request" to schedule an interview.
The duke's lawyers previously rejected claims he had not co-operated, saying he offered to help three times.
Prince Andrew stepped away from royal duties last year.

Ghislaine Maxwell arrested by FBI on charges related to Jeffrey Epstein



Ghislaine Maxwell arrested by FBI on charges related to Jeffrey Epstein

  • Maxwell arrested in New Hampshire early Thursday morning
  • 17-page FBI indictment charges Maxwell with several crimes

Ghislaine Maxwell with Epstein in New York in 2005. Epstein killed himself in his Manhattan jail cell last summer. Ghislaine Maxwell with Epstein in New York in 2005. Epstein killed himself in his Manhattan jail cell last summer. Photograph: Patrick McMullan/Patrick McMullan via Getty Images

* Ghislaine Maxwell, the British socialite and close friend of convicted sex offender Jeffrey Epstein, has been arrested, an FBI spokesman has said.
* Maxwell was accused by many women of recruiting them to give Epstein massages, during which they were pressured into sex. Those accusations, until now, never resulted in criminal charges.


Profile

Who is Ghislaine Maxwell?


Maxwell had kept a low profile, and her location was unknown since Epstein’s arrest last July on charges that he abused and trafficked in women and girls in Manhattan and Florida between 2002 and 2005. The search for Maxwell has been the subject of intense speculation, with reported sightings and rumors of her whereabouts popping up across the US and even abroad.
She was arrested in the small town of Bradford, New Hampshire at 8.30am.
Epstein, who pleaded not guilty, killed himself in his Manhattan jail cell in August last year.
The 17-page, six-count indictment filed by the FBI charges Maxwell with a host of crimes, including conspiracy to entice minors to travel to engage in illegal sex acts, enticement of a minor to travel to engage in illegal sex acts, conspiracy to transport minors with intent to engage in criminal sexual activity, transportation of a minor with intent to engage in criminal sexual activity, and perjury.
The indictment described Maxwell’s relationship to Epstein as “personal and professional” – and that she was “in an intimate relationship” with him from about 1994 to 1997.
Epstein paid Maxwell “to manage their various properties”, the document says.
The court paperwork provides chilling detail into how Maxwell allegedly lured minors into Epstein’s orbit.
According to charging documents, Maxwell “befriended” some of these victims, “including by asking the victims about their lives, their schools, and their families”. She and Epstein spent time forging relationships with these girls, by taking them shopping and to the movies. The alleged grooming happened, according to the documents, at Epstein’s manse on the Upper East Side neighborhood of Manhattan, his estate in Palm Beach, Florida, his ranch in Sante Fe, New Mexico, as well as Maxwell’s residence in London.
After developing a rapport, the documents allege, “Maxwell would try to normalize sexual abuse for a minor victim by, among other things, discussing sexual topics, undressing in front of the victim, being present when a minor victim was undressed, and/or being present for sex acts involving the minor victim and Epstein”.
Sometimes, Maxwell would give Epstein massages in front of victims whereas other times, she urged them to give him massages, “including sexualized massage during which a minor victim would be fully or partially nude.” These would often involve Epstein sexually abusing these minors.
On some occasions, Maxwell was “present for and participated in the abuse”.
Maxwell’s father was the British media baron Robert Maxwell. She was was a one-time girlfriend of Epstein’s and key presence at his side in his glittering social life, which often included rich, influential and powerful people from around the world in politics, the arts and science.

Virginia Giuffre, one of Epstein’s alleged victims, has said in a civil lawsuit that Maxwell recruited her into Epstein’s circle, where she claims Epstein forced her to have sex with him and friends including British royal Prince Andrew – who has strongly denied the allegations.
Maxwell has said Giuffre’s allegations are untrue. Giuffre in response filed a defamation suit against Maxwell in 2015.