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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 ..

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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Covid: Thousands protest in France against proposed new vaccine pass

A new draft law would in effect ban unvaccinated people from public life.

Demonstrators in the capital, Paris, held placards emblazoned with phrases like “no to vaccine passes”.

Interior Ministry officials said 34 people were arrested and some 10 police officers were injured after the protests turned violent in some places.

The bill, which passed its first reading in the lower house of France’s parliament on Thursday, would remove the option of showing a negative Covid-19 test to gain access to a host of public venues.

Instead, people would have to be fully vaccinated to visit a range of spaces, including bars and restaurants.

The government says it expects the new rules to come into force on 15 January, although the opposition-dominated Senate could delay the process.

But demonstrators on Saturday accused the government of trampling on their freedoms and treating citizens unequally.

Others targeted their anger at the president, Emmanuel Macron, over comments he made earlier this week in relation to unvaccinated citizens, telling Le Parisian newspaper that he wanted to “piss them off”.

One protester, hospital administrator Virginie Houget, told the Reuters news agency that Mr Macron’s remarks were “the last straw”.

And in Paris, where some 18,000 people marched against the new law, demonstrators responded to his coarse language by chanting: “We’ll piss you off”.

TV images showed altercations between protesters and police turning violent in some places. In Montpellier officers used teargas during clashes with the demonstrators.

Turnout for the protests was estimated to be about four times higher than the last major demonstrations on 18 December, when some 25,500 people marched across the country.

But despite the vocal protests, opposition to the new measures is not widespread and recent polling suggests the vast majority of people back the vaccine pass.

France is one of the most highly vaccinated countries in Europe, with more than 90% of over-12s eligible for the shot fully vaccinated.

Meanwhile, new coronavirus infections are rising rapidly across France as the new Omicron variant takes hold.

The country recorded more than 300,000 new cases for the second time in a week on Friday and admissions to intensive care wards are rising steadily, putting healthcare systems under strain.

Some hospitals have reported that some 85% of ICU patients are not vaccinated against Covid-19.

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Covid-19: ‘There is no choice between lives and livelihoods,’ OECD chief Gurría says

Issued on: 13/11/2020 – 17:26

As European countries move into their second Covid-19 lockdowns of t..

Issued on: 13/11/2020 – 17:26

As European countries move into their second Covid-19 lockdowns of the year, the head of the Organisation for Economic Co-operation and Development backs measures seen by many as tough. Ángel Gurría tells FRANCE 24: "If you win the battle against the virus first, you will have less economic consequences." He adds that "there is no choice between lives and livelihoods; it's a false dilemma".

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Mexican economist Ángel Gurría has been Secretary-General of the OECD since 2006 – throughout the global financial crash and subsequent recovery.

With hopes now high for viable vaccines against Covid-19, he's telling world leaders that the solutions to health and economic crises must carry the elements of our solutions to the environmental crisis too: "The single most important inter-generational responsibility is with the planet. That means the recovery, where we are going to make investments that have an impact for the next 30, 40 years, must absolutely have the sustainability of the planet in mind".

On the recently announced Pfizer vaccine, Gurría says: "It is a game changer […] The possibility of a vaccine being close is of enormous consequence. We still have to wait for it to be finalised, approved and distributed in sufficient amounts that it can get everywhere, so we are calculating that we are going to spend most of 2021 still living with the virus. But it changes expectations; the whole mood has improved considerably since the announcement."

On the refusal of Donald Trump, leader of the OECD's biggest single funder, to concede defeat in the US presidential election, Gurría sounds an upbeat note: "I believe that we will have an orderly transition of power in the United States come 20th January 2021. I believe in the institutions in the United States, I believe that the political forces in the United States will eventually align."

Finally, as talks drag on over a new Brexit deal on the future relationship between the EU and the United Kingdom, Gurría says he still expects a deal to be struck: "I believe that the common interest will lead to a deal […] The impact in Europe is going to be limited to the trade with the UK. The impact in the UK is going to be very serious, not only because of the flows of trade and flows of investment, but also because the overall business mood will be affected. So I am still counting on a deal."

Produced by Mathilde Bénézet

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Attacks in France and Austria: Europe’s response to extremism

Issued on: 13/11/2020 – 17:40Modified: 13/11/2020 – 17:42

TALKING EUROPE © FRANCE 24
This Friday..

Issued on: 13/11/2020 – 17:40Modified: 13/11/2020 – 17:42

TALKING EUROPE
TALKING EUROPE © FRANCE 24

This Friday marks the fifth anniversary of the Paris terror attacks, in which 130 people were killed. The last few weeks have seen more bloodshed, with attacks in the Paris region, in Nice and in the Austrian capital Vienna. European leaders are looking for solutions: ways to stop hate being preached, broadcast and acted upon, while defending individual freedoms of speech and of conscience. In our debate we ask two leading members of the European Parliament, from France and from Austria, what they believe should be done.

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Produced by Yi Song and Perrine Desplats

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Our guests

  • Andreas SCHIEDER, Austrian MEP, Socialists & Democrats
  • Nathalie LOISEAU, French MEP, Renew Europe

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