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Europe's drug regulator said on Tuesday it had started a real-time review of the COVID-19 vaccine developed by French drugmaker Sanofi and Britain's GlaxoSmithKline, the fifth shot under such a review currently.

The decision to start the "rolling review" of the vaccine, Vidprevtyn, was based on preliminary results from lab studies and early stage clinical trials in adults, the European Medicines Agency (EMA) said https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-vidprevtyn.

Late-stage global trials for the protein-based coronavirus vaccine candidate began in May.

Sanofi and GSK hope to get approvals by the end of 2021 after early stage results showed the vaccine produces a robust immune response.

"EMA will assess the compliance of Vidprevtyn with the usual EU standards for effectiveness, safety and quality," the regulator said, without giving details on data it had received so far and an expected timeline for approval.

EMA's rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is available.

Vidprevtyn uses the same technology as one of Sanofi's seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the shot, made by GSK.

Other COVID-19 vaccine candidates in EU's rolling review are those from CureVac, Novavax, Sinovac

and Russia's Sputnik V.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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European Union begins real-time review of Sanofi-GSK Covid vaccine - Business Standard

A surprising ruling from a top EU court means that the UK may be able to discriminate against EU nationals who have been granted the right to live and work in the UK after Brexit.

This decision has huge implications for millions of EU nationals in the UK, some of whom have been resident (and working) in the UK for years, and also raises questions about the meaning of equal treatment throughout the EU.

The Court of Justice of the European Union (CJEU) has upheld a UK rule that bars some EU citizens in the country from accessing benefits. The rule applies to those who have pre-settled status, which is one of two new statuses created under the EU Settlement Scheme allowing EU/EEA nationals (and their family members) to remain in the UK post-Brexit. Broadly, those who can show they had lived the UK for five years or more are entitled to settled status, while those with a shorter period of residence get pre-settled status. So far, over 2.3 million people have been granted pre-settled status.

The rights of each status are largely the same, but with one vital difference. In 2019, the UK government introduced regulations requiring those with pre-settled status to show another right to reside (typically meaning they are in work) before they can claim welfare benefits.

The case in question concerns CG, an EU national woman with pre-settled status, who came to Northern Ireland in 2018. She subsequently fled a domestic violence situation and has been living in a refuge with her two children. She applied for and was refused universal credit on the grounds that her pre-settled status did not entitle her to access benefits in the UK.

Law Centre Northern Ireland persuaded a first-tier benefit tribunal to take the unusual step of referring the case to the CJEU, to ask whether this restriction was discriminatory, and whether EU nationals with pre-settled status should therefore have the same access to benefits as UK nationals.

Without much explanation, the court ruled that people in the UK with pre-settled status cannot rely on the right enshrined in the treaty on the functioning of the EU to equal treatment on the grounds of nationality. The court also considered whether EU nationals could challenge being denied benefits as discriminatory within the meaning of the Free Movement Directive, which lays down residence rights and conditions for some EU migrants. The view was that these people first had to meet certain conditions, usually being in work.

However, the court suggested that while the UK was entitled to withhold benefits from CG, it must check whether doing so would violate her fundamental rights as contained in the Charter of Fundamental Rights of the EU. These include the right to live in dignity, the right to private and family life, and the best interests of the child.

What is particularly interesting about this case is CGs position as a woman and a mother. The Free Movement Directive, like other EU free movement laws, is biased in favour of men taking no account of periods of childcare, care for disabled or elderly relatives, or of periods of instability caused by fleeing from domestic abuse. These social-security risks all disproportionately affect women.

The court of appeal of England and Wales faced exactly the same questions in the case of Fratila in October 2020, but reached a dramatically different conclusion. It ruled that people with pre-settled status were entitled to the protection of EU law from discrimination on the ground of nationality, and should be entitled to claim benefits in the UK.

The UK government appealed to the supreme court, but the case was put on hold pending the CJEUs judgment in the case of CG. As the CJEUs ruling has not unequivocally endorsed or prohibited the UK rules, it seems likely that there will now be further hearings. Many claims will be put on hold while we wait for these cases to be resolved.

Beyond its implications for EU citizens with pre-settled status, the CG case is a good example of how, even after Brexit, EU law remains relevant in the UK. The facts of the case arose before the transition period ended, when EU law still applied, and the courts judgment is binding throughout the UK.

This case now presents a peculiar possibility. The UK government will probably argue, in a counterintuitive about-face, that EU law should be applicable in the UK, and that the supreme court should disregard UK national courts in favour of listening to the wisdom of the CJEU.

But if the UK government is allowed to maintain its exclusion of pre-settled status as a route to benefits, that exclusion is unlikely to be a blanket one. Individuals may have scope to argue, on a case-by-case basis, that a refusal of benefits would violate their fundamental rights.

All of this complexity only concerns benefits claims made before December 31 2020, but EU law has not stopped being relevant as of January 1 2021 either. The Brexit Withdrawal Agreement provides similar rights to EU and UK nationals who are covered by the agreement for the rest of their lives - and to their future children. So we may see separate disputes emerging on exactly what rights that confers on people with pre-settled status. The CJEU will continue to have a say on citizens rights contained in the Withdrawal Agreement until December 31 2028, by which time pre-settled status will probably be a thing of the past.

It is disappointing that the CJEU has shown itself less inclined than the court of appeal of England and Wales to guard the rights of EU nationals cast adrift in the UK, and that it has done so in a judgment that could seriously disrupt the interpretation of equal treatment rights throughout the rest of the EU, long after the UK has gone.

See the rest here:
Over 2 million EU nationals are at risk of discrimination in UK after shock EU court ruling here's what happens next - The Conversation UK

European Union leaders requested on Sunday that the bloc's starred flag fly at the opening ceremony of the Tokyo Olympic Games.

In a letter sent to International Olympic Committee President Thomas Bach, EU Commission Vice President Margaritis Schinas and Slovenia's Prime Minister Janez Jansa asked that Slovenian athletes be allowed to bear the EU flag alongside their national flag for the games' kick-off.

Slovenia is currently holding the rotating presidency of the EU.

"This will render Slovenian athletes ambassadors for European Unity and the values underpinning our Union, which match those of the Olympic movement," the two EU officials wrote.

"We will fully support you in any way you see appropriate in introducing this special and historical gesture," the pair added.

"The EU flag needs to show in the Tokyo 2020 opening ceremony as a symbol of peaceful coexistence, tolerance and solidarity," wrote Schinas as he posted the letter on his Twitter account.

France expressed its "full support" for the idea. French Deputy-Minister for European affairs Clment Beaune tweeted that it would be "a beautiful symbol, complementing our national flag."

The IOC was yet to respond to the request.

The 2020 Tokyo Olympic Games, which were postponed due to the pandemic, are set to kick off on Friday.

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'Symbol of tolerance': EU pushes for its flag to fly at Tokyo Olympics opening ceremony - Euronews

EVIA, Greece, July 21 (Reuters) - Climber Tassos Baltas points up at a 22-metre high mast which is monitoring wind speeds on the summit of a rocky hillside on the Greek island of Evia and declares, "This mast which has been installed next to us is an omen of catastrophe."

The mountaineer's views are one of a host of obstacles to efforts to boost wind power across the European Union.

As parts of Europe reel from devastating flooding and Germany's Chancellor Angela Merkel says governments must redouble their efforts to tackle the impact of climate change, developers and governments are racing to capture green power investment. They are running into local opposition, bureaucratic red tape and legal tangles in the permitting process - to the point where the EU is veering off track for its emissions-cutting goals, wind industry data show.

The EU has unveiled ambitious plans to cut carbon dioxide emissions by 55% by 2030, which will mean renewable sources in its energy generation should increase to 40%. For that, it needs 27 GW of new wind capacity - enough to meet almost one third of European electricity demand - to be installed every year.

That's nearly double the 15 GW currently put in place annually, according to WindEurope, an association that represents the industry in Europe.

The drive to speed up renewable energy is pitting greens against each other. Theodota Nantsou, policy director for the World Wide Fund for Nature in Greece, said the country decided belatedly to shut down its coal plants and is now racing to build up renewables at the risk of hurting its biodiversity.

Last year, WindEurope says, the EU and Britain invested 43 billion euros ($51 billion) in new wind farms - the second highest annual amount on record after 2016. Banks lent over 21 billion euros for the construction of new wind farms - the most ever.

"The problem is not money: there is lots of money available," said Giles Dickson, the association's chief executive. "The problem is the projects: we are not getting enough new permitted projects coming through."

The EU Commission has recognised that. The EU's renewable energy directive says it should not take more than two years to grant a permit for a power plant, or three in extraordinary circumstances.

But these timelines have yet to be fully implemented.

The Commission says it is trying to speed things up. However, some of its plans need to be negotiated by 27 EU countries and the European Parliament. That itself can take around two years.

Worldwide, according to the Global Wind Energy Council, new wind capacity needs to be installed at about twice the current rate if the globe is to meet a goal in the Paris Agreement climate pact of limiting temperature rise to below 2 degrees Celsius this century.

"I think (permitting) is one of the key factors that could potentially slow down the energy transition," Miguel Stilwell de Andrade, chief executive of Portuguese energy company Energias de Portugal (EDP) SA (EDP.LS) which develops renewable energy, such as wind and solar, told Reuters.

"If we want to meet the Paris Agreement targets we really need to find a way of making sure that permitting is efficient, transparent."

FAST-TRACK

On Evia, Baltas and other Greek campaigners object to eight new wind farms, planned to span 80 km (50 miles) over an area which encompasses a pristine fir forest overlooking the Aegean. They say it will ruin acres of ancient forests, and turn a largely agricultural region into an industrial zone.

They are also fighting the fact that the Greek government, trying to avoid the delays that hobble some developments, fast-tracked the application to build 100 turbines, adding to 600 already in place on the island.

Greece, aiming for renewables to help transform the country's economy, wants to shorten its permitting process to about two to three years, the government says. That's down from the eight years more typical for such schemes in Greece, according to the Hellenic Wind Energy Association, which represents the industry.

As falling costs have made wind power attractive, there's an incentive to move fast. According to the International Renewable Energy Agency, an intergovernmental organisation that supports countries in their transition to sustainable energy, the overall cost of new projects both onshore and offshore roughly halved in the decade to 2020 read more .

This is visible in places like Evia, which has high winds from the Caucasus and Aegean Sea and is only about 80 km from the mainland power grid.

"There is a very strong interest in renewable energy sources," said Greece's Secretary General for Energy Alexandra Sdoukou. Greece hopes renewable energy will help secure power ahead of a shutdown of coal-fired plants by 2025.

Other countries are also trying to streamline procedures to help win access to some of the EU's 750 billion euro post-pandemic recovery fund - which will only be disbursed if projects move ahead.

Greece's fast-track process is no guarantee of a license, the government's investment agency said. An environmental impact assessment will happen later.

OBSOLETE EQUIPMENT

Elsewhere in the EU, it can take as long as a decade for wind projects on land to be greenlighted, case studies provided by the industry show. In at least one country, Sweden, the Wind Energy Association says it's not unusual for the process to take even longer, because municipalities can vote on projects and there is no legal deadline for appeals processes to end.

For offshore projects, negotiations with businesses such as fishing, tourism and shipping mean the permitting processes can take up to six years, said Jonathan Cole, head of offshore wind at Spanish energy company Iberdrola SA (IBE.MC). For projects on land, problems range from rules that require turbines to be certain distances away from buildings to local disputes.

In one case in Germany, WindEurope said, permissioning was so slow that by the time the farm was greenlighted, the turbine model in the plans was obsolete. Updated height restrictions meant the developer had to dismantle part-built foundations, as well as persuading the manufacturer to revive an old model.

In another German example, renewables developer Abo Wind AG (AB9.DE) applied to build a wind project south of Frankfurt in 2016. The plan was initially rejected due to a risk to black stork habitats. After back-and-forth legal actions and appeals with the local authority, the company says the wind farm will be built next year.

"This project is a prime example of why wind power expansion in Germany suffers," said ABO Wind executive Kristof Frank. "Courts are overburdened and there's not enough personnel to quickly handle the numerous processes."

A spokeswoman for Germany's economic affairs ministry said almost half Germany's electricity is supplied by renewable sources, but that Germany must accelerate the implementation of green energy. This will be the task of the next government, she added. The current government has pushed four laws to speed up new infrastructure through parliament, but nothing major has changed.

Germany does not have enough qualified experts in local administration, people in the industry say. And when its strong environmental laws slow down new wind farms, they divide the green movement.

ABANDONED PLANS

Italy is the biggest recipient of the EU's recovery resources. To meet targets agreed under the EU's Green Deal plan to become the first climate-neutral continent, it needs to add at least 7 GW of renewable capacity every year, compared with a recent average of less than 1 GW per year. It has identified almost 60 billion euros of projects for that funding.

But a group of European renewable energy associations says almost half of all renewables projects are abandoned in the country, and the other half subject to six years of permitting delays.

Italy's energy transition minister Roberto Cingolani said the consequences of delays will be far-reaching.

"If we don't get the permits, we'll be late in reaching the goal of having 72% of our electricity generated from renewables by 2030," Cingolani told Reuters.

"So we won't be able to press ahead with plans to replace furnaces, produce green hydrogen, and generate electricity for electric cars."

DETERRENT

Spending on the permitting process can run into tens of millions of euros, people in the industry say.

Delays are starting to deter investment.

"We could invest more in certain countries in Europe if we had better visibility on the permitting timeline," said Carlo Zorzoli, head of business development for the green power unit of Italy-based utility Enel SpA (ENEI.MI), which has the biggest capacity for renewable energy of any listed company worldwide. He declined to name the countries he was referring to.

Generally, wind industry groups say authorities are scrutinising projects more carefully, but permitting agencies have not been expanded enough: "The permitting agencies are often under-resourced and with the market growing faster than was ever expected it's going to be hard for them to keep up," said Iberdrola's Cole.

The EU Commission is proposing one body be made responsible for coordinating permits of some offshore projects. But that proposal needs to be negotiated by EU countries and the European Parliament.

Rather than wait, Greece plans to hire certified private evaluators, the country's energy ministry said in May.

Evia's opposition groups have rallied.

"To appeal against the project at the court, we have collected money by talking to local residents, shopkeepers, hotels, farmers with environmental concerns, beekeepers," said Baltas.

"And we did that rather fast."

($1 = 0.8499 euros)

Angeliki Koutantou reported from Evia, Nina Chestney reported from London, Stephen Jewkes from Milan; Additional reporting from Markus Wacket in Berlin, Christoph Steitz in Frankfurt, Kate Abnett in Brussels, Isla Binnie in Madrid and Tim Barsoe in Copenhagen; Edited by Veronica Brown and Sara Ledwith

Our Standards: The Thomson Reuters Trust Principles.

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Floods wreck towns, but Europe's wind power goals tangled in red tape - Reuters

Peter R.deVries, who specialised in covering crime, died of the gunshot injuries to the head that he received on 6 July. The Dutch police quickly arrested two suspected perpetrators after the shooting but have yet to identify who ordered it or discover the motive. Furthermore, a live broadcast of the RTL Boulevard programme in which de Vries participated immediately before the shooting had to be cancelled on 10 July because of a serious threat.

Aged 64 and much respected by fellow journalists and the Dutch public, de Vries took a close interest in both recent cases with organised crime links as well older ones, which would explain why he was targeted. A crime reporter for 40 years, he had won the trust of several victims and had served as their mouthpiece or adviser. He had, for example, advised the main prosecution witness in the case against Ridouan Taghi, the countrys most wanted criminal and suspected organised crime boss.

The murder of Peter R. de Vries is the latest in a series of murders of journalists in Europe, where organised crime now represents a major danger for the media profession, said Pavol Szalai, the head of RSFs EU and Balkans desk.

The mafia-style hit on this Dutch journalist follows three other murders in which organised crime is also suspected those of Daphne Caruana Galizia in Malta in 2017, Jan Kuciak in Slovakia in 2018 and Giorgos Karaivaz in Greece in April of this year. We therefore urge the Netherlands, which is ranked sixth in the World Press Freedom Index, to set an example in the way it identifies and prosecutes those responsible for this murder.

Threats from organised crime against Dutch journalists have increased in recent years. A live grenade was found outside the home of a crime reporter for the newspaper De Limburger in December 2020. In June 2018, three Dutch newspapers De Telegraaf, Panorama and Nieuwe Revu were the targets of attacks using an anti-tank missile and a van driven into the facade of their premises.

Organised crime is suspected of being behind the murders of three other journalists in the European Union in the past four years, in cases in which national authorities have struggled to render justice to the victims. The most recent previous victim, Greek crime reporter Giorgos Karaivaz, was gunned down in broad daylight in Athens on 9 April. Despite the government's promise to act in a swift and expedited manner, the investigation has not progressed.

The accused instigator of Slovak investigative journalist Jan Kuciaks murder in February 2018 has still not been convicted, the Slovak supreme court having only recently overturned businessman Marian Kocners acquittal on a charge of ordering the hit.

Several people are suspected of ordering and carrying out the 2017 car-bomb killing of Daphne Caruana Galizia, a reporter who was investigating corruption at the highest levels of the state in Malta. But only one of them has so far been convicted. Yorgen Fenech, a businessman accused of ordering her murder, is currently detained pending a trial that will not begin before this autumn.

Reporters are often organised crime targets in the south of the European Union. Around 20 journalists live under permanent police protection in Italy, although this does not prevent them from being regularly targeted. Journalist Fabio Buonofiglios car was destroyed by a fire in Calabria in April 2020, while reporter Michele Santagata was ambushed in the town of Cosenza in the same region in September 2020.

The situation is no better in Bulgaria, which has the lowest ranking of any EU country in the World Press Freedom Index. Journalists are often attacked there. Recent victims include Slavi Angelov, an investigative journalist who was badly beaten outside his home in March 2020. The perpetrator has still not been identified.

Slovakia, Italy, Malta and Bulgaria are ranked 35th, 41st, 56th and 81st respectively in RSF's 2021 World Press Freedom Index.

See the report entitled Journalists: bte noire of organised crime that RSF published in November 2018.

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Dutch crime reporter is fourth journalist murdered in as many years in the European Union | Reporters without borders - Reporters sans frontires