Tag Archives: European Commission

Exclusive: Some EU nations still want Valneva COVID-19 vaccine deal – sources

By Matthias Blamont

PARIS (Reuters) – Some EU countries still want Brussels to strike a deal to buy Valneva’s COVID-19 vaccine candidate despite a recent setback in talks, as the bloc aim to shore up and diversify supplies, sources familiar with the talks told Reuters.

A spokesman for the European Commission said last week the French vaccine maker had not met conditions required to reach an agreement, two days after the company said it would now give priority to a country by country approach.

The EU concluded exploratory talks with Valneva in January for the supply of up to 60 million doses of its vaccine, which uses inactivated whole virus particles and is derived from the technology behind its licensed Japanese encephalitis shot.

Two sources familiar with the bloc’s plans said some EU members, including France and Germany, were still pushing for a deal to help diversify supplies as Europe tries to secure vaccines for the next two years.

“There are around 10 countries interested in a deal with Valneva. The contract is written, but the two sides still need to agree on a few structuring parameters. Once this is cleared, things could rapidly move forward,” one of the sources said.

The sources declined to be identified because of the confidential nature of the talks.

Valneva and the European Commission declined to comment.

So far, the EU has bought COVID-19 vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Johnson & Johnson, CureVac, and Sanofi/GlaxoSmithKline/GSK.

It is currently in negotiations for a third contract with Pfizer and BioNTech, which would mark the world’s biggest vaccine supply deal.

The vaccines have different approaches, ranging from the use of recombinant proteins to so-called messenger RNA.

Valneva, which started a late-stage human trial for its shot last week, has signed a deal with Britain for up to 190 million doses by 2025 in a transaction worth potentially up to 1.4 billion euros ($1.7 billion).

The company’s vaccine will be produced in Scotland, with an estimated capacity of 200 million doses next year. It will use an adjuvant made by U.S. company Dynavax.

This single location is a concern for the EU, which wants to ensure vaccines are produced on its soil and avoid a scenario where the company could be tempted to prioritize deliveries to Britain to the detriment of the continent, the sources said.

It has embarked on a legal battle against AstraZeneca, which it accuses of holding back doses made in Britain from its supplies to the region.

Germany wants Valneva to agree first that it would not prioritize Britain in deliveries, one of the sources said.

In February, Valneva’s chief financial officer David Lawrence told Reuters the group was open to production partnerships in other regions, should its vaccine candidate secure approval and generate enough interest beyond Britain and the EU.

($1 = 0.8269 euros)

(Reporting by Matthias Blamont. Additional reporting by Andreas Rinke in Berlin. Editing by Josephine Mason and Mark Potter)

EU warns it could block vaccine exports, wields legal threat at drugmakers

By John Chalmers and Philip Blenkinsop

BRUSSELS (Reuters) – Europe’s fight to secure COVID-19 vaccine supplies intensified on Thursday when the European Union warned drug companies such as AstraZeneca that it would use all legal means or even block exports unless they agreed to deliver shots as promised.

The EU, whose member states are far behind Israel, the United Kingdom and the United States in rolling out vaccines, is scrambling to get supplies just as the West’s biggest drugmakers slow deliveries to the bloc due to production problems.

As vaccination centers in Germany, France and Spain cancelled or delayed appointments, the EU publicly rebuked Anglo-Swedish drugmaker AstraZeneca for failing to deliver and even asked if it could divert supplies from Britain.

European Council President Charles Michel said in a letter to four EU leaders that the EU should explore legal means to ensure supplies of COVID-19 vaccines it contracted to buy if negotiations with companies over delayed deliveries are unsuccessful.

“If no satisfactory solution can be found, I believe we should explore all options and make use of all legal means and enforcement measures at our disposal under the Treaties,” Michel said in the Jan. 27 letter.

EU rules on monitoring and authorizing exports of COVID-19 vaccines in the 27-nation bloc could lead to exports being blocked if they violated existing contracts between the vaccine maker and the EU, an EU official said.

The European Commission is to lay out the criteria under which such exports would be evaluated on Friday.

VACCINE CRUNCH

The swiftest mass vaccination drive in history is stoking tensions across the world as big powers buy up doses in bulk and poorer nations try to navigate a financial and diplomatic minefield to collect whatever supplies are left.

Israel is by far the world leader on vaccine rollout per head of population, followed by the United Arab Emirates, the United Kingdom, Bahrain and the United States. Behind them are Italy, Germany, France, China and Russia.

The African Union (AU) has secured another 400 million doses of the AstraZeneca COVID-19 vaccine, a regional health leader said on Thursday, in a push to immunize 60% of the continent’s population over three years.

Under fire from the EU, AstraZeneca CEO Pascal Soriot said the EU was late to strike a supply contract so the company did not have enough time to iron out production problems at a vaccine factory run by a partner in Belgium.

Tensions have risen as both New York-based Pfizer and AstraZeneca, headquartered in Cambridge, England, have had production problems.

Britain, which has repeatedly touted its lead in the vaccine rollout race since leaving the EU’s orbit on Jan. 1, said its deliveries must be honored.

“I think we need to make sure that the vaccine supply that has been bought and paid for, procured for those in the UK, is delivered,” Minister for the Cabinet Office Michael Gove told LBC Radio.

Just a day ahead of a decision by European regulators on whether to approve the drugmaker’s shot, Germany’s vaccine committee said AstraZeneca’s vaccine should only be given to people aged between 18 and 64.

“There are currently insufficient data available to assess the vaccine efficacy from 65 years of age,” the committee, also known as Stiko, said in a draft resolution made available by the health ministry on Thursday.

Britain’s Johnson said health authorities in Britain believed the vaccine was safe and worked across all age groups.

APPOINTMENTS CANCELLED

In the northern French region of Hauts-de-France, France’s second-most-densely-populated region, several vaccination centers were no longer taking appointments for a first jab. In several other French regions, some online appointment platforms closed booking options.

Spain’s Madrid region has ceased first vaccinations for at least this week and next and was using the few doses it has to administer second shots to those who have had the first one, said deputy regional government chief Ignacio Aguado.

Germany’s most populous state, North Rhine-Westphalia, last week postponed opening its vaccination centers until Feb. 8, while the state of Brandenburg has also had to push back vaccination appointments originally scheduled for the end of January due to delivery delays.

AstraZeneca is prepared to publish the delivery contract it has with the European Union and aims on Friday to make proposals to the European Commission on which sensitive parts to black out, the Frankfurter Allgemeine reported.

The newspaper quoted an EU source as saying that while AstraZeneca would not be able to deliver the 80 million doses expected for the first quarter, volumes should significantly exceed the 31 million doses that had earlier been reported.

(Reporting by Emma Thomasson and Paul Carrel in Berlin and Matthias Blamont in Paris and Kate Holton, Paul Sandle and Alistair Smout in London; writing by Guy Faulconbridge; editing by Keith Weir and Nick Macfie)

WHO’s Tedros says ‘vaccine nationalism’ would prolong pandemic

By Stephanie Nebehay and Emma Farge

GENEVA (Reuters) – WHO Director-General Tedros Adhanom Ghebreyesus said on Friday that “vaccine nationalism” would only slow the effort to quash the pandemic and called for vaccines to be used fairly and effectively.

Tedros said 78 high-income countries had now joined the “COVAX” global vaccine allocation plan, bringing the total to 170 countries, and the “number is growing”. He urged others to join by the Sept. 18 deadline for binding commitments.

Joining the plan guaranteed those countries access to the world’s largest portfolio of vaccines, with nine candidates currently in the pipeline, he said, adding that a further four were “promising”.

The WHO and the GAVI vaccine alliance are leading the COVAX facility, aimed at helping buy and distribute vaccination shots fairly around the world.

But some countries that have secured their own supplies through bilateral deals, including the United States, have said they will not join COVAX.

“Vaccine nationalism will prolong the pandemic, not shorten it,” Tedros told a WHO briefing in Geneva, without mentioning any specific countries.

“If and when we have an effective vaccine, we must also use it effectively … In other words, the first priority must be to vaccinate some people in all countries, rather than all people in some countries,” he said, adding that priority should be given to healthcare workers, the elderly and those with underlying conditions.

Tedros thanked Germany, Japan, Norway and the European Commission for joining COVAX during the last week.

“Certainly by the middle of 2021 we should start to see some vaccines actually moving into countries and populations,” said WHO chief scientist Soumya Swaminathan, reiterating earlier comments.

Noting that there were 13 experimental vaccines currently in clinical trails, Swaminathan called it an “optimistic scenario” since the typical success rate of 10% could mean several vaccines are approved.

But Swaminathan said that no vaccine should be approved for a worldwide rollout until it had undergone sufficient scrutiny.

“No vaccine is going to be mass-deployed until regulators are confident, governments are confident, and the WHO is confident it has met the minimum standard of safety and efficacy,” she said.

Results were expected from some of the candidates already in phase 3 trials, each involving thousands of participants, by the end of the year or early 2021, Swaminathan said.

“We are not going to have enough for the whole world right at the beginning,” she said adding that scaling up of manufacturing would take time.

“Eventually there will be enough for everyone but it will mean prioritization,” she said.

(Reporting by Stephanie Nebehay and Emma Farge; Editing by Alison Williams and Giles Elgood)

It’s not for me: speed of COVID-19 vaccine race raises safety concerns

By Francesco Guarascio and Josephine Mason

BRUSSELS/LONDON (Reuters) – The frenetic race to develop a COVID-19 vaccine has intensified safety concerns about an inoculation, prompting governments and drugmakers to raise awareness to ensure their efforts to beat the coronavirus aren’t derailed by public distrust.

There are more than 200 COVID-19 vaccine candidates in development globally, including more than 20 in human clinical trials. U.S. President Donald Trump has vowed to have a shot ready before year’s end, although they typically take 10 years or longer to develop and test for safety and effectiveness.

In the drive to find a potential COVID-19 vaccine “fast is good for politicians,” said Heidi Larson, who leads the Vaccine Confidence Project (VCP), a global surveillance program on vaccine trust. “But from the public perspective, the general sentiment is: ‘too fast can’t be safe'”, she told Reuters.

Regulators around the world have repeatedly said speed will not compromise safety, as quicker results would stem from conducting in parallel trials that are usually done in sequence.

However, these reassurances have failed to convince many, including in Western countries where skepticism about vaccinations was already growing before the pandemic.

Preliminary results of a survey conducted over the last three months in 19 countries showed that only about 70% of British and U.S. respondents would take a COVID-19 vaccine if available, Scott Ratzan, co-leader of ‘Business Partners to CONVINCE’, told Reuters.

Business Partners to CONVINCE, a U.S./UK initiative that is partly government funded, conducted the survey jointly with VCP and the results were broadly in line with a Reuters/Ipsos poll of the U.S. public in May.

“We just see this distrust growing against science and government,” said Ratzan.

“We need to address legitimate concerns about the rapid pace of development, political over-promises and the risks of vaccination.”

The VCP/Business Partners’ survey, expected to be published in a few weeks, will also show that Chinese participants were the most trusting of vaccines, while Russians were the least so, Ratzan said.

Drugmakers and governments had hoped the scale of the COVID-19 crisis would allay concerns about vaccines, which they see as crucial to defeating the pandemic and enabling economies to fully recover from its impact.

Vaccine hesitancy – or the reluctance or refusal to be vaccinated – is also known as “anti-vax,” a term that is sometimes associated with conspiracy theories when often it simply reflects many people’s concerns about side-effects or industry ethics.

In January 2019 the World Health Organisation named vaccine hesitancy as one of the top 10 global health threats for that year.

TAILORED MESSAGES

In Europe, skepticism among the public was high before the pandemic due to a range of factors including negative coverage of pharmaceutical companies as well as false theories including suggested links between childhood immunizations and autism.

Only 70% of French people considered vaccines safe in a 2018 survey commissioned by the European Union executive. The EU average was 82%, but trust fell to 68% for the shot against seasonal flu.

The VCP project on vaccine trust, funded by the European Commission and pharmaceutical companies among others, aims to identify early signs and causes of public mistrust and tackle them with information campaigns before it is too late.

Larson said headlines referring to Warp Speed – the name of the U.S. operation aimed at delivering a COVID-19 vaccine to the U.S. population by next year – could increase vaccine hesitancy even more than perceptions that the disease could become less lethal.

“One of the most frequent things that comes up in people’s conversations is concerns about how quick it is. If I have to pick one theme that is more recurrent than others it is this one,” Larson said.

Data collected by VCP from social media show that by the end of June about 40% of Britons’ posts concerning a COVID-19 vaccine, for example, were negative, with many distrusting any coronavirus vaccine and the medical establishment.

Announcements about fast progress in COVID vaccines in Russia and China in particular could also contribute to rising skepticism. “We don’t have transparency and don’t know how accurate or valid their data are,” Ratzan said, adding that errors there could boost skepticism elsewhere.

Key for any information campaign to be successful is to tailor it to different audiences as there is no uniform profile of anti-vaxxers, said Kate Elder of Doctors Without Borders, a non-governmental organisation.

“They go from the highly educated to those who don’t believe in science,” she said, urging politicians to be more careful in their messages on vaccines and to better explain the reasons behind potentially fast results against COVID-19.

“We are exploring the idea of a chatbot that will speak in different languages,” said Ratzan, adding it could be something similar to Smokey Bear, the U.S. Forest Service’s campaign to educate about preventing wildfires.

“Different parts of the world will require different strategies. We know we need to tailor it and to be specific,” he said.

Risks are high if hesitancy is not addressed quickly.

During the 2009 swine flu pandemic, growing skepticism about the vaccine led to a failure of the vaccination campaign in France, where only 8% of the population got a shot against the virus which is estimated to have killed around 280,000 people across the world.

A study published in May in the Lancet by a group of French scientists warned of similar risks now in the country where vaccine hesitancy went up from 18% in mid-March when a lockdown was imposed on the French to 26% by the end of that month.

“Distrust is likely to become an issue when the vaccine will be made available,” the scientists concluded.

(Reporting by Francesco Guarascio @fraguarascio in Brussels and Josephine Mason in London; Editing by Susan Fenton)

Google’s $2.1 billion Fitbit deal hits roadblock as EU opens probe

By Foo Yun Chee

BRUSSELS (Reuters) – Alphabet unit Google’s bid to take on Apple and Samsung in the wearable technology market by buying Fitbit hit a hurdle on Tuesday as EU antitrust regulators launched an investigation into the $2.1 billion deal.

The move by the European Commission on Tuesday came despite Google’s pledge last month not to use the fitness tracker’s data for advertising purposes in a bid to address competition concerns.

The EU antitrust enforcer said the data pledge was insufficient to allay its worries.

“The proposed transaction would further entrench Google’s market position in the online advertising markets by increasing the already vast amount of data that Google could use for personalization of the ads it serves and displays,” the Commission said.

It singled out online search and display advertising services and ad tech services, where analytics and digital tools are used in digital advertising, as two areas that would be affected by the deal.

It said data collected via wrist-worn wearable devices appeared to be an important advantage in online advertising, and the deal would give Google an edge in personalizing search engine ads and making it difficult for rivals to compete.

Ultimately this would result in higher prices for advertisers and publishers.

The investigation will also focus on digital healthcare and whether Google would make it difficult for rival wearables to function with its Android smartphone operating system.

The Commission will decide by Dec. 9 whether to clear or block the deal.

Google said the combination of its and Fitbit’s hardware would increase competition in the sector where players include Apple, Samsung, Xiaomi, Huawei and others.

“This deal is about devices, not data. We’ve been clear from the beginning that we will not use Fitbit health and wellness data for Google ads,” Rick Osterloh, senior vice president for devices and services, said in a statement.

“As we do with all our products, we will give Fitbit users the choice to review, move or delete their data.”

The deal has drawn criticism from healthcare providers, wearables rivals and privacy advocates.

Fitbit has a 3% share of the global wearables market as of the first quarter of 2020, far behind Apple’s 29.3% share, and also trailing Xiaomi, Samsung and Huawei, data from market research firm International Data Corp showed.

(Reporting by Foo Yun Chee; Editing by Jan Harvey)

AI must be accountable, EU says as it sets ethical guidelines

FILE PHOTO: An activist from the Campaign to Stop Killer Robots, a coalition of non-governmental organisations opposing lethal autonomous weapons or so-called 'killer robots', protests at Brandenburg Gate in Berlin, Germany, March, 21, 2019. REUTERS/Annegret Hilse/File Photo

By Foo Yun Chee

BRUSSELS (Reuters) – Companies working with artificial intelligence need to install accountability mechanisms to prevent its being misused, the European Commission said on Monday, under new ethical guidelines for a technology open to abuse.

AI projects should be transparent, have human oversight and secure and reliable algorithms, and they must be subject to privacy and data protection rules, the commission said, among other recommendations.

The European Union initiative taps in to a global debate about when or whether companies should put ethical concerns before business interests, and how tough a line regulators can afford to take on new projects without risking killing off innovation.

“The ethical dimension of AI is not a luxury feature or an add-on. It is only with trust that our society can fully benefit from technologies,” the Commission digital chief, Andrus Ansip, said in a statement.

AI can help detect fraud and cybersecurity threats, improve healthcare and financial risk management and cope with climate change. But it can also be used to support unscrupulous business practices and authoritarian governments.

The EU executive last year enlisted the help of 52 experts from academia, industry bodies and companies including Google, SAP, Santander and Bayer to help it draft the principles.

Companies and organizations can sign up to a pilot phase in June, after which the experts will review the results and the Commission decide on the next steps.

IBM Europe Chairman Martin Jetter, who was part of the group of experts, said guidelines “set a global standard for efforts to advance AI that is ethical and responsible.”

The guidelines should not hold Europe back, said Achim Berg, president of BITKOM, Germany’s Federal Association of Information Technology, Telecommunications, and New Media.

“We must ensure in Germany and Europe that we do not only discuss AI but also make AI,” he said.

(Reporting by Foo Yun Chee, additional reporting by Georgina Prodhan in London; editing by John Stonestreet, Larry King)

Greek Finance Minister Resigns Ahead of Bailout Vote

Greece’s Finance Minister, Nadia Valavani, has resigned her position after telling Prime Minister Alexis Tsipras that she couldn’t support the bailout measures.

“Alexis, I am ready to serve in any capacity to the end during challenges. However, when our delegation returned with liabilities that are ‘stillborn measures’ and at such a price [by the creditors in fulfilling the reforms program], once again when the dilemma appears of retreating or Grexit, it will be impossible for me to remain a member of the government,” reads Valavani’s letter of resignation.

This ‘capitulation’ is so overwhelming that it will not allow a regrouping of forces. With your signature there will be a deterioration in the status of an already suffering population, and this will be a tombstone around their necks for many years with little potential of redemption,” she wrote.

Valavani was in charge of taxation and overseeing privatization in the nation.

The International Monetary Fund (IMF) expanded on initial criticisms offered Tuesday of the deal between Tsipras and EU officials, saying that Greece’s debts now exceed $300 billion and that creditors will have to write off some of the debt if there is any hope of Greece repaying what it owes.

The European Commission has been critical of giving more money to Greece than what is already being offered.

“Greece has already received more international financing than all of Europe did from the U.S. Marshall Plan after the Second World War,” Commission President Jean-Claude Juncker said.

Greece’s energy minister, Panagiotis Lafazanis, said Wednesday that even if the deal passes the Parliament, the country’s people will never accept it and unite against it.

Spain and Italy Warned Over Budget Plans

The European Commission is warning the Spanish and Italian governments that their draft budgets for 2014 do not comply with new debt and deficit rules. The Commission also said that France and the Netherlands barely qualified for the new standards.

According to the European Union’s charter, countries that do not comply will likely have to revise their tax and spending plans before they can be submitted to national parliaments. The warning marks the first time the EC has taken this step.

Eurozone members states are required to cut deficits until they reach a balanced budget. They also have to reduce levels of public debt. The Commission usually gives countries flexibility if their deficit is below the EU ceiling of 3% of the nation’s gross domestic product.

The Commission said that France, while just below the 3% threshold, was making only “limited progress” in reforms.

The Eurozone economy grew by .1% from July to September in data released Thursday, down from .3% growth in the previous quarter.

EU Warns Russia Against Threating Former Soviet States

European Commission officials are warning Russia to stop “unacceptable” threats against former Soviet states that have been looking to develop closer ties to the EU.

Russia banned imports of wine and spirits from Moldova in what’s believed to be a strike against the country for looking to work with the EU. Ukraine and Armenia have also said that Russia has taken action against them for looking into the EU. Continue reading →

EU Leaders Closer To “European Government”

The leaders of 11 European Union nations are putting plans in place to make the 27-nation bloc more of a “European government” that would direct elect it’s leader who then would appoint a continent-wide government.

The “Future of Europe Group” headed by German Foreign Minister Guido Westerwelle released a report that says the current Eurozone crisis has caused a “crisis of confidence” in the EU. A result of the crisis, the report states, is a necessity for a stronger European Commission and a directly elected head of the Commission. Continue reading →