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UK government signs contract for first coronavirus human challenge studies

Up to 19 volunteers at a time will take part in the tests, to be held at the Royal Free Hospital in ..

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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. The trials will be held at the Royal Free hospital in London."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."

Characterization study

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.

Vaccine trials

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

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EU vaccine delays dog effort to speed up COVID inoculations

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AstraZeneca’s EU vaccine shipments will be delayed, the EU’s health commissioner said, in yet another obstacle to the bloc’s COVID-19 vaccination rollout.

“The EU Commission and Member States expressed deep dissatisfaction with this,” Stella Kyriakides tweeted on Friday after member states heard from AstraZeneca representatives.

The AstraZeneca/Oxford vaccine is expected to receive approval from the European Medicines Agency this week, and any delay or shortage of doses could be a significant speed bump as member states race to vaccinate their populations amid a worsening COVID-19 crisis.

The emergence of more transmissible variants of coronavirus has caused significant concern in Europe with the UK reporting record daily hospitalisations and deaths due to the virus mutations.

Johnson warned on Friday that early evidence showed the new variant could be more deadly as well.

Countries are racing against the clock to vaccinate as many people as possible before the variants spread further.

But Pfizer said just last week that fewer doses would be available in the EU in late January and early February due to quality tests at the manufacturing plant in Belgium.

Some EU countries have since had to cut vaccinations amid the delays, prompting criticism of the pharmaceutical companies behind the vaccines.

Domenico Arcuri, Italy’s coronavirus commissioner, said that vaccinations had been cut from 80,000 a day to 28,000 a day, Italian media reported. He said Italian authorities were considering taking legal action against Pfizer, AP reported.

Authorities in Germany’s most populous state said that due to delays in delivery of the Pfizer/BioNtech vaccine they would halt first vaccinations. North Rhine Westphalia had received 100,000 vaccine doses less than originally planned, the state said.

Germany’s health minister Jens Spahn said that “we are currently in a phase in which the worldwide demand for corona vaccines is very high.”

Member states agreed on Thursday that vaccine deliveries should be coordinated and distributed at the same time after the bloc’s most recent Steering Committee meeting, where vaccinations are discussed.

“We are determined to provide more predictability and stability to the delivery process, and we look forward to more vaccines and more doses coming on stream soon,” Commission President Ursula Von der Leyen said on Thursday.

She also called for more testing and increases in sequencing amid the more transmissible mutations of the virus.

It comes as the bloc urged member states to speed up vaccinations, setting an ambitious goal to vaccinate 70% of the EU population by summer 2021. By March, the EU commission says they hope that 80% of vulnerable individuals and healthcare workers can be vaccinated.

In order to speed things along, countries have in some cases delayed second doses as much as possible and begun pulling sixth doses from a vaccine dial instead of five, in accordance with the EU regulator’s recommendation.

Some EU member states secure vaccines outside of bloc

However, some EU states appeared to also go rogue recently in terms of vaccine procurement, a move EU officials said was unnecessary as the bloc had secured enough vaccines for the entire EU population.

Hungary’s foreign minister said the country had procured two million doses of the Russian coronavirus vaccine.

They are the only EU country to approve the vaccine, Sputnik V, which has not been approved by the European Medicines Agency.

Foreign minister Peter Szijjarto said the vaccines will arrive in three stages, with the first doses delivered within a month.

A Commission spokesperson told Euronews prior to Hungary’s announcement that “member states may have a separate negotiation if it’s about a vaccine that’s not covered by the portfolio if it’s with a company that we are not having negotiations with.”

Germany’s government, meanwhile, said in a statement to Euronews that it had bilateral negotiations with some pharmaceutical companies that would not impact the EU vaccine agreement.

It remains unclear, however, if vaccine doses secured bilaterally by the country would arrive before or after doses as part of EU contracts and whether those negotiations were outside the joint member state negotiations.

Read from source: https://www.euronews.com/2021/01/23/eu-vaccine-delays-dog-effort-to-speed-up-covid-inoculations

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Economists revise eurozone growth for 2021 downwards amid second COVID wave

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Positive growth forecasts for the eurozone economy have been cut by economists as the ongoing coronavirus pandemic look set to slow down its post-COVID-19 recovery, according to a European Central Bank (ECB) survey.

Economists polled in the ECB’s annual Survey of Professional Forecasters (SPF) published on Friday predicted real GDP growth would fall to 4.4 per cent this year amid further lockdowns and pandemic-related restrictions, down from 5.3 per cent in the previous quarter’s predictions.

Speaking to journalists on Thursday, the president of the ECB Christine Lagarde said the pandemic posed “downside risks” to the prospects for a rapid return to growth in the eurozone.

“The intensification of the pandemic poses risks to short-term economic prospects,” said Lagarde after the institution’s governing council left its monetary support programme for the coronavirus-hit economy unaltered.

Forecasts for 2020 fared better than previously predicted, rising to 3.7 per cent compared to forecasts of 2.6 per cent in the last survey published in October.

The long-term forecast showed the eurozone economy expanding by just 1.4 per cent in 2025.

Mentioning “serious risks” and “risks of deterioration” for the eurozone economy, the ECB chief nevertheless considered the latest forecasts by the Frankfurt institution to remain “largely valid”.

“The start of vaccination campaigns in the euro area is an important step in the resolution of the current health crisis. But the pandemic continues to pose serious risks to public health and to the economies of the eurozone and the world,” she said.

Lagarde had previously warned in an interview with the French newspaper Le Monde in October last year that Europe’s economic recovery risked “running out of steam” as a second wave of coronavirus gripped the continent.

“The second wave of the epidemic in Europe, particularly in France, and the new restrictive measures that accompany it add to uncertainty and weigh on the recovery,” she said.

Of particular concern, she said, was job losses due to the pandemic. The EU unemployment rate in October hovered around 7.6 per cent, one per cent higher than at the same time the previous year.

Read from source: https://www.euronews.com/2021/01/22/economists-revise-eurozone-growth-for-2021-downwards-amid-second-covid-wave

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Steinmetz Swiss trial: Jail for tycoon in Guinea mine corruption trial

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Israeli businessman Beny Steinmetz has been given a five-year jail sentence by a court in Geneva, in a trial described as the mining sector’s biggest-ever corruption case.

The trial threw a spotlight on an often murky struggle for control of Africa’s natural resources.

Steinmetz, a former diamond magnate who also holds French citizenship, was convicted of bribing public officials in Guinea, in order to gain control of the country’s iron ore deposits.

The court also ordered him to pay compensation of 50m Swiss francs (£41m; $56m) to the state of Geneva.

“It is clear from what has been presented… that the rights were obtained through corruption and that Steinmetz co-operated with others,” to obtain them, Chief Justice Alexandra Banna told the court, according to AFP news agency.

Steinmetz, who has always denied bribery, condemned the verdict as a “big injustice”. He plans to challenge the verdict and will not go to jail pending the appeal, his lawyer said.

The Simandou mines, in south-eastern Guinea, are estimated to be the most valuable untapped iron ore deposits in the world.

The case dates back to 2006 when, according to the prosecution, the businessman, working for a company called Beny Steinmetz Resources Group (BSGR), paid bribes so that BSGR could acquire mining rights in Simandou. These had originally been held by mining giant Rio Tinto.

The trial took place in Switzerland because Mr Steinmetz lived in Geneva until 2016, and ran businesses there. Some of the bribes, the prosecution said, were paid through Swiss banks.

Key witnesses and hot shot lawyers

Steinmetz now lives in Israel, but travelled to Geneva to appear in court in person, hiring one of Geneva’s most high-profile lawyers, Marc Bonnant, to defend him.

The court found that Steinmetz, 64, and his two co-defendants had paid $8,5m (£6,2m) in bribes to a wife of Guinea’s late president Lansana Conté, who died in 2008. They were found guilty of setting up elaborate schemes to hide the link between BSGR and Conté’s fourth wife, Mamadie Touré. She had been scheduled to appear in court herself but did not turn up. She now lives in the United States.

Defence lawyer Mr Bonnant told the trial that Steinmetz had never “paid a cent” to Ms Touré, and that anyway she was never actually legally married to President Conté, and therefore under Swiss law did not qualify as a bribable public official.

What’s more, Mr Bonnant said, some of the alleged bribes were paid after President Conté’s death, which made no sense at all: “How do you bribe a ghost?” he asked the court.

Only a ‘spokesperson’

But the prosecution presented evidence which, it said, proved there was a trail of bribery and corruption stretching from Geneva, via Liechtenstein, to the Virgin Islands and back again.

Another high-flying Geneva lawyer, chief prosecutor Yves Bertossa, scored points questioning Beny Steinmetz. Since it was a fact that BSGR had acquired the mining rights for Simandou, he asked, how did Mr Steinmetz not know about the financial transactions that led to that acquisition?

Beny Steinmetz, who cut a subdued figure in court, and sometimes, speaking in French, stumbled over his responses, insisted he had only been an “adviser” or a “spokesperson” for the company that bears his name.

When confronted with details of the alleged bribery, as well as transcripts of conversations, his frequent response was: “I don’t know. I wasn’t involved and I don’t know the details.”

Mr Bertossa produced details of a conversation (recorded by the FBI in 2013) in which one of Steinmetz’s co-defendants appeared to try to persuade Ms Touré to get rid of evidence of corruption, mentioning a certain person “up there” at BSGR who made all the decisions. “Who’s ‘up there’?” asked the prosecution.

“I don’t know who is up there,” replied the businessman. “There may be God, but not me.”

Even when the prosecution produced evidence of meetings, emails, and money transfers that allegedly proved bribery had taken place, Steinmetz denied all knowledge of them, leading Mr Bertossa to scoff that it seemed highly odd that Beny Steinmetz knew nothing about the workings of a company called Beny Steinmetz Resources Group.

Beny Steinmetz is no stranger to investigations into his financial affairs. He has been questioned at least once by Israeli authorities, and was recently convicted of money laundering (in absentia) in Romania, in a case believed to be linked to the Guinea bribery scandal.

Historic trial

For observers of the trial, including non-governmental organisations that for years have followed the tangled web of BSGR’s finances, the trial has been historic.

Agathe Duparc of Swiss NGO Public Eye, which focuses on big Swiss businesses and multinationals based in Switzerland, said the case had “starkly revealed the inner workings of international corruption, against the backdrop of one of the poorest countries in the world”.

While the trial had sent a strong signal to the commodities sector, it also showed that Switzerland should tackle legal loopholes that allowed such “predatory practices,” she said.1px transparent line

In fact this very public trial took place against a backdrop of other moves aimed at cleaning up Switzerland’s financial sector, and proving the country has put some of its more questionable financial practices behind it.

In November a nationwide referendum, which would have made businesses domiciled in Switzerland legally responsible for human rights violations and environmental damage along their supply chains anywhere in the world, won the popular vote but not the required number of cantons.

Nevertheless, the Swiss government, mindful of public opinion, has introduced new legislation for Swiss businesses, requiring them to report on human rights and environmental standards and conduct due diligence when it comes to child labour and mineral sourcing from conflict areas.

At the same time, Switzerland’s Attorney General is conducting painstaking investigations into global financial scandals in which there may have been some Swiss involvement, including Malaysian state wealth fund 1MDB and Brazilian oil giant Petrobras.

Just last week Swiss prosecutors said they had opened an investigation into money laundering and embezzlement linked to Lebanon’s Central Bank.

Big implications for mining industry

This case has much wider implications than the fate of Beny Steinmetz.

When BSGR acquired the Simandou mining rights, it did not extract any iron ore. A few years later, BSGR sold the mining rights to Brazilian multinational Vale for an estimated $2.5bn. Vale has yet to show an interest in Simandou either.

Businesses and their shareholders in places far from Guinea have done extremely well trading those mining rights.

The people of Guinea themselves have got precisely nothing – and the iron ore deposits, described by Agathe Duparc as “fabulous” resources, lie untouched, the Simandou region undeveloped and lacking in investment.

It’s a story that NGOs such as Public Eye insist is repeated across Africa. In the fight for control of highly valuable mineral resources, unscrupulous businesses see ways to get rich quick, and there is little control of their financial practices.

The bribery in Guinea only came to light when, after the death of President Lansana Conté, his democratically elected successor Alpha Condé ordered an audit into the Simandou mines.

It has been seven years since the Steinmetz investigation was opened.

This trial is now likely to bring more pressure on Switzerland to prevent what Public Eye calls “predatory practices that deprive the populations of resource-rich countries of essential revenues”.

Read from source|: https://www.bbc.com/news/world-europe-55748674

 

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