No10 slaps down Ursula von der Leyen over vaccine criticism

Downing Street today slapped down Ursula von der Leyen after she accused Britain of compromising on coronavirus vaccine safety and claimed the EU’s slower approval process was the ‘right decision’.

Number 10 said experts at the Medicines and Healthcare products Regulatory Agency (MHRA) had been ‘very clear that no corners were cut, no stones were left unturned’ when they decided to give the green light to a number of jabs. 

The Prime Minister’s Official Spokesman said ‘the public should be confident of the safety and effectiveness of the vaccines’.

Mrs von der Leyen made the original comments after she pinned the blame for the bloc’s vaccine supply shambles, which saw Brussels threaten Britain with a vaccine export ban, on her deputy Valdis Dombrovskis, the European Commissioner for Trade. 

Speaking on Monday, the under-fire European Commission president said she was committed to her role, and that she should be judged at the end of her term in 2024.

She also refused to apologise for the coronavirus vaccines row last week that saw Brussels threaten to introduce a hard Irish border to block vaccine exports to the UK.

But pressure is mounting on the former German defence minister, particularly from her home country where MPs are planning to call her in for questioning over her handling of the EU’s slow vaccination programme.

A European source said on Monday that Berlin was putting ‘tremendous’ pressure on the Commission to improve the vaccine rollout, adding that Mrs von der Leyen’s position had been ‘severely weakened’.

European Commission president Ursula von der Leyen, pictured in Brussels on Sunday, has come under pressure over the EU’s slow jab rollout and her attempt to control vaccine exports

Speaking on Monday, Mrs von der Leyen defended the EU’s slower vaccine approvals policy, while criticising Britain’s for compromising on ‘safety and efficacy’.

‘Some countries started to vaccinate a little before Europe, it is true,’ she said in an interview with French newspaper Le Monde when asked about Britain. 

‘But they resorted to emergency, 24-hour marketing authorisation procedures. The commission and the member states agreed not to compromise with the safety and efficacy requirements linked to the authorisation of a vaccine,’ she said.

‘Time had to be taken to analyse the data, which, even minimised, takes three to four weeks. So, yes, Europe left it later, but it was the right decision. I remind you that a vaccine is the injection of an active biological substance into a healthy body. We are talking about mass vaccination here, it is a gigantic responsibility.’

Through her spokesman, Mrs von der Leyen also threw her deputy leader under the bus over the EU vaccine shambles, that saw Brussels decide to trigger Article 16 before performing a later U-turn. 

Brussels accused pharmaceutical firm AstraZeneca of breaching its contract with the EU, amid suspicion that the company had supplied the UK with stock that was meant to go to countries in the bloc.

Britain used emergency procedures to grant market approval to the AstraZeneca vaccine, developed with Oxford University, and signed a contract three months earlier than the EU, which used a slower approval process. 

Mrs von der Leyen said she did not take personal responsibility for the decision to trigger Article 16 of the Brexit treaty, which would have seen a hard ‘vaccine border’ in Ireland to stop vaccines from being smuggled through a back door, but she did admit the decision was an error. 

Instead, the European commission president said that the responsibility lay with Valdis Dombrovskis, the European Commissioner for Trade.  

‘This regulation falls under the responsibility of Mr Dombrovskis,’ Eric Mamer, the European Commission’s chief spokesman, said on Monday of the former prime minister of Latvia.

‘In my country we have a saying, ‘Only the Pope is infallible,” Mr Mamer said. ‘Mistakes can happen along the way the important thing is that you recognise them early on.’  

Speaking herself during the newspaper interview, von der Leyen said: ‘I know how sensitive the Irish subject is. But when you take urgent decisions – in this year of crisis, the Commission has taken almost 900 – there is always a risk of missing something. I am relieved that we were able to find a solution.’ 

The legislation was met with a fierce backlash, and was amended after British Prime Minister Boris Johnson and the Irish prime minister called Mrs von der Leyen. 

After years of Brexit negotiations between Britain and the EU to avoid a hard border on the island, the move would have created a ‘vaccine border’. It was announced without notifying either Ireland or Britain.  

The European Commission president pinned the fiasco - that saw Brussels threaten to implement a hard Irish border - on Valdis Dombrovskis, the European Commissioner for Trade (pictured in Brussels on January 29)

The European Commission president pinned the fiasco – that saw Brussels threaten to implement a hard Irish border – on Valdis Dombrovskis, the European Commissioner for Trade (pictured in Brussels on January 29)

Von der Leyen’s initial comments attempting to avoid blame were met with scathing criticism from Alexander Stubb, the former prime minister of Finland, who campaigned to be appointed European Commission president himself.

‘Number one rule of any leader: if your organisation screws up; never, ever blame your team publicly,’ he said in response. 

To add to her woes, von der Leyen’s predecessor Jean-Claude Juncker said he was ‘very much opposed’ to her export restriction measures during a speech in Stuttgart on Sunday.

The Brussels-imposed export controls were introduced last week to supervise vaccines leaving the bloc for other countries, after AstraZeneca said it was cutting supplies to the EU in the first quarter of 2021.

‘It all went too slow, it all should have been done more transparently, even though that would have been difficult,’ Juncker said. 

Mr Mamer said the regulation to create an ‘export transparency mechanism’, which included the Article 16 measure, was passed provisionally and hurriedly by the College of Commissioners on Friday.

‘We believe that we are on the right track since the beginning of this pandemic in ensuring there is as cohesive and as effective a European response as possible,’ he told The Daily Telegraph.

The Brussels-imposed export controls were introduced last week to supervise vaccines leaving the bloc for other countries, after AstraZeneca said it was cutting supplies to the EU in the first quarter of 2021. Pictured: health worker draws a dose of the AstraZeneca's coronavirus disease (COVID-19) vaccine in Newcastle upon Tyne, Britain, January 30

The Brussels-imposed export controls were introduced last week to supervise vaccines leaving the bloc for other countries, after AstraZeneca said it was cutting supplies to the EU in the first quarter of 2021. Pictured: health worker draws a dose of the AstraZeneca’s coronavirus disease (COVID-19) vaccine in Newcastle upon Tyne, Britain, January 30

But Mrs Von der Leyen attempt to pass the blame on to her deputy has led to suggestions from EU diplomats that she has gone rogue, and to German MPs in Berlin planning to summon her in for questioning.

To make matters worse for her, the move by German MPs was led by legislators from her own party, Angela Merkel’s Christian Democrats (CDU).

Thus far, Mrs von der Leyen has refused calls for a public debate on the fiasco in the European Parliament, and she will instead hold closed-door meetings with MEPs on Tuesday with parties who approved her appointment.

In an interview on German television, she denied that the EU was losing a vaccine race against Britain, insisting that the only race was against the virus and time.

She also gave an assurance that neither the EU or Britain would block each other’s vaccine supplies. 

The EU and many of its 27 members have faced criticism over their sluggish rollout, with fewer than 10million people getting a dose so far across the entire bloc. 

Von der Leyen’s European Commission has invested 2.7 billion euros ($3.3 billion) to secure 2.3 billion doses from companies making potential vaccines, mostly using European factories.

Three vaccines are so far authorised for use across the EU’s 27 member countries: one by German outfit BioNTech with US giant Pfizer; one by US company Moderna; and most recently one by Anglo-Swedish group AstraZeneca.

All three firms are undershooting on delivery schedules for the January-March first-quarter period.   

While excessive bureaucracy in countries such as France and Germany has been one reason for the slow start, the EU has also struggled to get hold of enough supplies.  

Pictured: German Chancellor Angela Merkel speaking after a vaccine 'summit' that brought together key players. She renewed a promise to offer every German citizen a vaccine by the end of September

Pictured: German Chancellor Angela Merkel speaking after a vaccine ‘summit’ that brought together key players. She renewed a promise to offer every German citizen a vaccine by the end of September

German Chancellor Angela Merkel on Monday defended the European Union’s troubled vaccine drive, saying there were ‘good reasons’ the rollout had got off to a slower start than in some other countries.

Speaking after a vaccine ‘summit’ that brought together key players, Merkel renewed a promise to offer every German citizen a vaccine by the end of September.

Merkel had convened the online talks in response to growing anger in the 27-member bloc over the sluggish rollout of Covid-19 jabs, which has been beset with delivery delays and piled political pressure on EU leaders.

‘It is true that in some areas, the pace became slower, but there were good reasons for it to be slower,’ Merkel told reporters in Berlin.

Merkel, the leader of Europe’s largest economy, acknowledged that the United States, Israel and Britain were further along with their inoculations.

But she said the EU had deliberately avoided rushed emergency approvals, as seen in the UK, to bolster public ‘confidence’ in the jabs.

The EU had also at times negotiated ‘for a very long time’ to ensure pharma companies took on enough liability, she said.

And the bloc chose not to sacrifice data protection, Merkel added, in a nod to Israel’s deal with Pfizer/BioNTech to offer data on its inoculation campaign in exchange for doses.

German media has been scathing about the EU’s troubled vaccine drive, with the topselling Bild daily calling it a ‘disaster’. 

Mrs Von der Leyen did not join Merkel’s meeting with top German politicians, but the EU commissioners for health and the internal market did.

A string of vaccine makers also took part, including Pfizer, BioNTech, AstraZeneca, Moderna, Johnson & Johnson and CureVac.

‘The months ahead will be challenging. We must all continue working together in solidarity to find solutions,’ said Health Commissioner Stella Kyriakides. 

Like other EU leaders, Merkel has come under fire for the decision to pursue an EU-wide rather than a national strategy on inoculations.

She has said a go-it-alone drive would have inflated prices, left pockets of the continent more vulnerable to the pandemic and poisoned political unity in the bloc.

The German debate has been supercharged by the start of a general election year to choose a successor to Merkel, who has led the country since 2005.

The Social Democrats (SPD), junior partners in Merkel’s loveless ‘grand coalition’ government, at the weekend demanded she produce a ‘roadmap’ toward the September vaccinations goal. 

The UK committed £1.67billion on Covid vaccines before it was known whether they would be effective - more than the £1.57billion the EU put forward for its 448million people, with Britain spending £25.00 per capita compared to £3.51 for Brussels. The US government spent £7.9billion in total, according to the figures from science analytics firm Airfinity, an outlay of £24.02 for each of its 330million people

The UK committed £1.67billion on Covid vaccines before it was known whether they would be effective – more than the £1.57billion the EU put forward for its 448million people, with Britain spending £25.00 per capita compared to £3.51 for Brussels. The US government spent £7.9billion in total, according to the figures from science analytics firm Airfinity, an outlay of £24.02 for each of its 330million people

EU Vaccine approval: State of play 

Approved for the EU

BioNTech/Pfizer (German/US, mRNA vaccine, 95-percent efficacy according the European Medicines Agency): 600 million doses. Its first-quarter deliveries to EU member states were cut by as much as half, but the company vows they will be back to normal by mid-February.

Moderna: (US, mRNA vaccine, 94-percent efficacy): 160 million doses.

AstraZeneca (Anglo-Swedish, adenovirus, 60-percent efficacy): 400 million doses. It was meant to have delivered more than 100 million doses in the first quarter, but on December 22 said that would be cut to 31 million. Von der Leyen announced on Sunday that would now be boosted to 40 million.

Pending approval

Johnson & Johnson (US, adenovirus, efficacy unknown): 400 million doses. The Commission says 100 million should be delivered by June if this single-shot vaccine is approved.

CureVac (Germany/US, mRNA, efficacy unknown): 405 million doses.

Sanofi/GSK (France/UK, recombinant spike protein, efficacy unknown): 300 million doses. After a disappointing Phase 2 trial, the companies are trying a different antigen formulation and are now aiming for production late this year.

The Commission is also in exploratory talks with Novavax (US, recombinant spike protein, efficacy unknown) for up to 200 million doses and with Valneva (French, inactivated virus vaccine, efficacy unknown) for up to 60 million doses. 

Pfizer and BioNTech have slowed down production to make manufacturing changes, while AstraZeneca said it was cutting supplies to the EU in the first quarter of 2021. 

That prompted outrage from Brussels, which imposed export controls last week to supervise vaccines leaving the bloc for other countries. 

Pharmaceutical companies have since made public pledges to make up for the shortfalls with additional doses later on – though none has pledged to speed up the initial delivery, meaning the EU’s Covid pain will drag on for some time.

BioNTech and Pfizer have promised to send up to 75 million extra doses to the bloc in the spring thanks to progress at key manufacturing sites.

Meanwhile Mrs von der Leyen, who signed the vaccine contracts on behalf of the bloc, said Sunday that AstraZeneca would deliver 40 million doses in total in the first quarter – 30 per cent more previously promised – but shipments will not start until the second week of February. 

And chemicals giant Bayer announced that from 2022 it would produce a coronavirus vaccine that fellow German pharmaceuticals company CureVac is developing.

CureVac CEO Franz-Werner Haas said his company would also produce several hundred million doses of its own vaccine by the end of 2021.

CureVac’s mRNA vaccine has yet to receive the green light from regulators, but German health minister Jens Spahn said it was ‘on its way to approval in the coming weeks’.

French pharma group Sanofi agreed last week to help produce 125 million doses of the Pfizer-BioNTech vaccine. 

A European source said on Monday that Germany was putting ‘tremendous’ pressure on the Commission to improve the vaccine rollout, adding that von der Leyen’s position had been ‘severely weakened’. 

While Brussels boasts of having a portfolio of 2.3billion doses, it has paid dearly for failing to sign its agreement with AstraZeneca until August last year.  

Meanwhile, the EU’s contract with Pfizer was not signed until November 2020, two days after the company had announced its successful trial results.  

The Pfizer rollout did not begin until the very end of December, and even a month later the daily vaccination rates in countries such as France, Germany, Italy and Spain are well below those in Britain and the US. 

Brussels did sign a deal with Moderna days before Britain, but again this was after the jab had already passed clinical trials. 

And the EU was again shown to be lagging when the Novavax trial results were published last week showing 89.3 per cent efficacy. 

While Britain has 60million doses ordered, the EU has only conducted ‘exploratory talks’ with the manufacturer, which were completed in December. 

Even then, the 200million doses envisaged in an ‘exploratory contract’ are a smaller stockpile when adjusted for population size than Britain has ordered.  

The EU also has other agreements in place with vaccines from Sanofi-GSK and CureVac, which have yet to conclude clinical trials. 

Each EU member state is responsible for its own rollout. Most are giving priority to the elderly and frontline health workers.

Almost all the vaccines require two jabs for a full vaccination. (Johnson & Johnson is aiming for a single-shot regimen, subject to trials and EMA approval.)

Collectively, the European Union as of Saturday had provided 2.4 doses per 100 people, according to official sources collated by the website Our World in Data.

EU country's vaccination programmes have been lagging behind other nations as the bloc continues to struggle with its rollout following the fiasco

EU country’s vaccination programmes have been lagging behind other nations as the bloc continues to struggle with its rollout following the fiasco

Top performers are Malta (6.08 doses per 100 people), Denmark (4.47), Slovenia (3.65) and Romania (3.50).

The bigger countries are trailing: Germany has given 2.8 doses per 100 people, France 2.34, Italy 3.16 and Spain 3.1.

The countries leading the world in giving jabs are Israel (54.7 per 100 people, with most of those over 70 already having been vaccinated with their two injections), the United Arab Emirates (33.7) and Britain (13.9).

Britain, which left the EU last year, is focused on giving the maximum number of people one injection and stretching out the time before they become completely vaccinated through their second injection.

France and other EU countries, in contrast, say they are maintaining stocks to give the second jab as recommended, even if that means a slowdown in their first jab programme. 

Some EU countries, particularly in the poorer east of the bloc, are sensitive to the cost of vaccinating their populations. The logistical challenge of the mRNA-type vaccines that require sub-Arctic temperatures is also a factor.

While the price of each vaccine has been kept secret in the European Commission’s contracts, a Belgian minister’s tweet in December – deleted afterwards – gave a breakdown.

The Moderna vaccine was listed as most expensive, with Brussels paying 14.70 euros a dose. The BioNTech/Pfizer one 12 euros. The AstraZeneca vaccine came in at 1.78 euros a dose.