The EU said on Tuesday that it was considering emergency approvals for Covid-19 vaccines just weeks after criticising the UK for fast-tracking jabs.
In response, the European Commission said member states were free to strike separate deals should they wish to. ‘It’s not that the strategy unravelled or it goes against the strategy, not at all,’ spokesman Stefan de Keersmaecker said.
Fast tracking jabs would mark a big shift in the EU’s approach to vaccine approvals, as it would entail using a procedure that the bloc had considered dangerous, and would represent another U-turn after it was critical of the UK’s approval process.
On December 2, the EU criticised the UK’s ‘hasty’ approval of the Pfizer and BioNTech’s COVID-19 vaccine, and on February 2 Ursula von der Leyen, the European commission chief,
Mette Frederiksen, Denmark’s prime minister (left) and Sebastian Kurz, Austria’s leader, will meet with Israeli officials this week to discuss producing a second generation of coronavirus vaccines without EU help
Before the COVID-19 pandemic fast approvals in the EU have been reserved for exceptional authorisation at national level of drugs for terminally ill patients.
The potential change comes as the EU executive and the bloc’s drug regulator come under increasing pressure for what some consider slow vaccine approvals.
This has contributed to a slower rollout of COVID-19 shots in the 27-nation union, compared to the United States and former EU member Britain.
‘We are ready to reflect with the member states on all possible avenues to indeed accelerate the approval of the vaccines,’ an EU Commission spokesman told a news conference on Tuesday.
One option could be ‘an emergency authorisation of vaccines at EU level with shared liability among member states’, the spokesman said, adding that work on this could start very quickly if EU governments supported the idea.
It was not clear whether an EU-wide emergency authorisation procedure, if agreed upon, would entail the same conditions as emergency approvals granted at national level, the commission spokesman told Reuters.
Meanwhile, Sebastian Kurz, Austria’s prime minister, and Danish leader Mette Frederiksen announced today that they will travel to Israel to discuss development of a second generation of coronavirus vaccines with health authorities there.
Kurz said in a statement that while the EU’s common procurement and licensing policy for vaccines was ‘right in principle’, the European Medicines Agency (EMA) ‘is too slow in approving vaccines and there have been supply bottlenecks at manufacturers’.
‘We must prepare for further mutations and should no longer be dependent solely on the EU in the production of second-generation vaccines,’ Kurz said.
Danish Prime Minister Frederiksen was also critical of the EU’s vaccine programme.
‘I don’t think it can stand alone, because we need to increase capacity. That is why we are now fortunate to start a partnership with Israel,’ she told reporters Monday.
When asked whether Denmark and Austria wanted to take unilateral action in obtaining vaccines, Frederiksen said: ‘You can call it that.’
Israel’s Prime Minister Benjamin Netanyahu, who has made the campaign a showcase of his bid for re-election on March 23, has spoken of ‘an international corporation for manufacturing vaccines’.
None of the three countries has significant vaccine making capacity, however, raising questions over how realistic their ambitions are to gain greater self-sufficiency.
Israel is running the world’s fastest vaccine programme, giving over 90 per cent of its population at least one dose, with over 50 percent now fully vaccinated.
By contrast, in EU nations, an average of just five per cent of people have been given the first dose.
A graph showing the total number of vaccines administered in European countries per 100 people, up to March 2. The UK has vaccinated around 30 per cent of its population, while the European average is only around 7 per cent
The European Medicines Agency (EMA) cannot currently issue emergency approvals but in exceptional circumstances has recommended the compassionate use of drugs before marketing authorisation.
This procedure was used in April to initially authorise doctors to use Gilead’s antiviral drug remdesivir as a treatment against COVID-19. The drug was later given conditional approval by EMA.
National emergency approvals are allowed under EU laws, but they force countries to take full responsibility if something goes wrong with a vaccine, whereas under the more rigorous marketing authorisation, pharmaceutical companies remain liable for their vaccines.
The EU Commission had said that national emergency authorisations should not be used for COVID-19 vaccines, because faster approvals could reduce regulators’ ability to check efficacy and safety data.
This could also boost vaccine hesitancy, which is already high in some countries, EU officials had said.
One senior EU official said the emergency procedure had so far usually been used at national level for terminally ill patients and the EU had instead chosen the lengthier conditional marketing authorisation because with vaccines ‘we inject healthy people’ and the risk was disproportionate.
Israel is running the world’s fastest vaccine programme, giving over 90 per cent of its population at least one dose, with over 50 percent now fully vaccinated. By contrast, in EU nations, an average of just five per cent of people have been given the first dose. Pictured: Vials of the Pfizer-BioNtech COVID-19 vaccine in the Israeli-annexed east Jerusalem
The change of tack would come after Eastern European countries, including Hungary, Slovakia and the Czech Republic, approved Russian and Chinese vaccines with national emergency procedures.
Slovakia said on Monday it had ordered 2 million doses of Russia’s Sputnik V vaccine and expects half to arrive this month to help it end a surge in infections.
The neighbouring Czech Republic – tackling the worst COVID-19 outbreak of any EU country – is also considering ordering Russia’s Sputnik V.
Hungary, meanwhile, has taken delivery of a vaccine developed by China’s Sinopharm, with Prime Minister Viktor Orban announcing on Sunday that he had received the shot.
The three vaccines so far cleared for use in the EU, made by Pfizer and German partner BioNTech, Moderna and AstraZeneca, rely on production in countries including Germany, Britain, Switzerland, Belgium and the Netherlands.
Kurz said Austria and Denmark would work with Israel on vaccine production against mutations of the coronavirus and jointly research treatment options in an alliance called the First Movers Group.
The initiative, which seeks greater protection against future pandemics in addition to joint EU vaccine supply, follows Germany’s decision last month to set up a task force to address supply bottlenecks and boost local manufacturing.
Kurz invited pharmaceutical companies with a local presence including Pfizer, Valneva, Novartis, Polymun and Boehringer Ingelheim on Tuesday to discuss the new initiative.
Pfizer, which declined comment for this story, has said it will make 2 billion doses this year – 70% of them in the EU – and has conducted extensive research into their effectiveness against coronavirus variants.
A spokesman for Boehringer Ingelheim said its focus was not on human vaccines ‘but if we receive requests we will of course look into them.’
On December 2, the EU criticised the UK’s ‘hasty’ approval of the Pfizer and BioNTech’s COVID-19 vaccine, and on February 2 Ursula von der Leyen, the European commission chief, said the UK had compromised on vaccine ‘safety and efficacy’
Europe has mounted one of the world’s slowest vaccine roll-outs, plagued by bureaucratic red tape, supply issues and meddling by regulators that means it is unlikely to see an end to lockdowns any time soon.
A row with Britain over jabs that saw some European leaders warn people off the AstraZeneca jab has further hampered its efforts – with politicians and regulators now rowing back their initial skepticism.
The latest to announce a U-turn on the AstraZeneca jab was Olivier Veran, the French health minister, who said on Monday that the country will allow those aged 50 to 75 and with underlying health conditions to have the Astra jab – having previously blocked anyone over the age of 65 from having it.
Mr Veran said the move is intended as a ‘first step’ towards making the vaccine available to all over-65s when the country’s vaccines agency publishes a new report on the jab, due some time this week.
The decision will pile pressure on other European countries which defied global health bodies by restricting the jab’s use in older people – including the likes of Germany and Sweden – to reverse their own policies.
It comes after a slew of real-world data showed the AstraZeneca jab reduces hospitalisations in over-65s by more than 80 per cent and it may be slightly more effective than the European
The data flies in the face of remarks Macron made last month, when he said the vaccine was ‘quasi-ineffective’ in older people.
A graph showing the average number of vaccines administered to 100 people in major European nations per day, up to March 2. The UK is well ahead of other countries and has one of the world’s fastest jab roll-outs
France had previously restricted use of the AstraZeneca jab to those aged under 50 and healthcare workers.
However, the law allowed those aged 50 to 65 who had an underlying condition to get the Astra jab. All those aged over 75 had to be vaccinated using the Pfizer jab, even if they were in perfect health.
That created an ambiguous group, aged 65-75, who were too old to get the Astra jab but were not in the mandatory Pfizer group.
Mr Veran cleared up the ambiguity on Monday night by confirming that all those aged 50 to 75 with an underlying condition could have the Astra jab.
How EU raised doubts over AstraZeneca jab… and what science says
French president Emmanuel Macron : Claimed that the jab was ‘quasi-ineffective’ among over-65s and said UK had taken a risk with quick approval
German vaccine committee: Was the first EU regulator to limit the jab to younger people, on January 28
Dutch Health Council: Refused to approve the vaccine for over-65s because ‘the immune system starts to function less well with increasing age’
Austrian health ministry: Said that ‘no confident statements are possible’ about efficacy in older people
French minister Clement Beaune : Said there were ‘doubts about the efficacy’ in over-65s
German newspaper Handelsblatt: Published a sensational but widely-debunked report claiming the jab had just 8% efficacy among older people
Sweden, Norway, Denmark, Spain and Poland: Also refused to approve the vaccine for over-65s
Italy and Belgium: Would not even give it to over-55s
And what the science says:
- Real-world data from Scotland shows one dose of AstraZeneca reducing hospitalisation risk by 94 per cent among the mainly older people who have had it
- Clinical trials last year showed 100 per cent of older adults generating the necessary antibodies
- Only 1 out of 341 volunteers aged over 65 caught Covid-19 after receiving the jab, and four separate trials showed the vaccine to be safe
- A separate Oxford study showed 76 per cent protection in the three months between the first and second doses
- The same study also shows a possible 67 per cent cut in transmission of the virus
It comes as health bodies across the continent move to softening their stance on the AstraZeneca jab which has been widely-used in neighbouring Britain – where Covid cases and deaths are now falling rapidly.
Thomas Mertens, the head of Germany’s vaccine committee, said on Sunday that it would would ‘very soon’ update its recommendation on the AstraZeneca jab.
In a frank admission on German television station ZDF, he said: ‘The whole thing has somehow gone wrong.’
Meanwhile, Alain Fischer, chairman of France’s vaccine strategy orientation council, said the country would also ‘re-adjust our vaccine strategy’.
England’s Deputy Chief Medical Officer last night took a swipe at EU efforts to rubbish the Oxford/AstraZeneca coronavirus vaccine and said a new study showing just one shot offers dramatic protection against severe disease in older people ‘vindicated’ Britain’s approach.
Professor Jonathan Van-Tam suggested that ‘non-adoption’ by ‘many countries’ in the over-65s of their populations was not scientific as he claimed that it was ‘not immunologically plausible’ that the life-saving jab would work in the 18-55 bracket and then not work in older age groups.
He told a Downing Street press conference that the data by Public Health England (PHE) published yesterday, which found the vaccine more than 80 per cent effective at preventing hospital admission up to four weeks after the first dose, ‘clearly vindicated’ Britain’s approach to mass inoculation.
Asked about EU vaccine scepticism by Guardian health editor Sarah Boseley, Professor Van-Tam said: ‘That was driven by the fact that there were relatively small amounts of data on the over-65s in the clinical trials available at that point in time for the AZ vaccine.
‘Our technical advisory committee – the JCVI – took a view which I share that it was not immunologically plausible that the vaccine would work in the age range 18 to 55 years of age, which is a lot of where the data ran out, and then not work in those older age groups.’
He added: ‘We took a view that it almost certainly would work. The PHE data have clearly vindicated that approach today and I’m not here to criticise other countries but to say that in time the data emerging from our programme will speak for itself and that other countries will doubtless be very interested in it.’
Responding to his remarks, Health Secretary Matt Hancock quipped: ‘Very diplomatic’ as he told the public: ‘I hope that right round the world people study this data and understand what it means – getting the AstraZeneca jab and Pfizer jab could save your life’.
The most-recent vaccine data compiled by the European Center for Disease Control shows the UK vaccinated an average of 0.57 people our of every 100 per day last week – well ahead of the European average of 0.19 and France’s average of 0.18.
Britain’s fast-paced jabs roll-out means that 30 per cent of its population have now had at least one dose of vaccine – compared to a European average of 7.4 per cent.
Germany is lagging slightly behind that average with 7.3 per cent of its population jabbed, but France is much further behind with just 6.7 per cent inoculated.
After initially scaremongering about the AstraZeneca jab, both France and Germany were forced to launch a PR campaign to convince people to take the vaccine last week amid news that millions of doses are sitting un-used.
Steffen Seibert, Angela Merkel’s chief spokesman, said last week that the British-made jab is ‘both safe and highly effective’ and will ‘save lives’ as he joined the country’s health minister urging people to take it.
France will recommend AstraZeneca to those aged 50 to 75 with underlying health conditions despite Macron’s warning that it is ‘quasi-ineffective’ in older people. Jonathan Van Tam, the UK’s deputy chief medical officer, has said infection data has vindicated Britain’s approach
This graph shows infection rates in six European countries. The UK (in red) was the problem child of Europe at the start of 2021 but has since seen cases plummet and is leading the continent in terms of vaccinations
He spoke after it emerged Germans have been skipping vaccination appointments when they learned they would be given the jab.
Meanwhile Health Minister Jens Spahn suggesting drafting in the army to give the shots to soldiers and police officers in an attempt to drive inoculation rates up.
In France, health workers have also been refusing the vaccine after President Macron’s comments during the heated row over its effectiveness.
The European Medicines Agency approved the vaccine for all adults, but both France and Germany ruled that it should not be given to the over-65s.
After initially questioning its effectiveness, President Macron later said he would take the vaccine.
Angela Merkel caused further confusion when in an interview with Frankfurter Allgemeine Zeitung, the German chancellor said last week: ‘I am 66 years old and I do not belong to the group recommended for AstraZeneca.’
Though some interpreted this as a rejection of the vaccine, other commentators claim the chancellor was merely suggesting that others should get the vaccine first.
France has used only half its doses while 1.2million AstraZeneca shots are unused in Germany
France has used only around half the doses it has received since the EU roll-out began in late December, according to the website
More than 7.7million doses have been delivered since December 26, but only 3.97 million have found their way to patients, of which half are second doses.
It means that only 2.66million people have received any kind of injection at all, compared to 18.69million in the UK where second doses are being delayed.
Only 126,000 AstraZeneca doses have been handed out since the jab was approved last month.
Meanwhile in Germany, vaccine committee chair Prof Thomas Mertens said the country had a stockpile of 1.2million AstraZeneca jabs it was struggling to use up.
‘It is a problem, no doubt at the moment. We have about 1.4million doses of AstraZeneca vaccine in store and only about 240,000 have been given to people,’ he said.
Asked on BBC Radio 4’s Today programme whether his committee’s decision not to recommend the jab for under-65s was to blame for this, he admitted: ‘It may be part of the problem.’
He added: ‘Although we always stated that it had nothing to do with the safety of the vaccine – we never criticised the vaccine to be unsafe – we stated, and it’s correct, that the amount of data on this group of elderly people was not really great.
‘But I don’t think that was a major problem. The major problem was all the news that had been spread about the efficacy of the vaccine being much lower than the efficacy of the mRNA vaccines [Pfizer and Moderna].’
Meanwhile EU chief Ursula von der Leyen said that she herself would take it – despite her furious row with the drugmaker last month over missing shipments to the EU.
That struggle is set to continue into the spring with as many as 90million doses missing from AstraZeneca shipments in the second quarter of 2021.
An EU official involved in talks with the firm says AstraZeneca has warned that it may deliver only half of its promised 180million doses from April to June, having slowed supplies in January because of delays at a Belgian factory.
The new shortage could hamper the EU’s ability to meet its target of vaccinating 70 per cent of adults by summer – with Britain promising to offer one dose to 100 per cent by July 31.
The EU supply shortage is seen as one of the main reasons for a widely-criticised vaccine roll-out which is lagging far behind that in Britain.
While the UK has handed out 27.0 doses per 100 people, the EU is lagging behind on 6.2 and has not significantly sped up its progress in recent weeks.
Von der Leyen defended her policies by pointing out that the EU had handed out 27milion doses in total compared to 17million in Britain – but the bloc of 27 countries has a population more than six times larger.
She also noted that Italy had given double-doses to more people than Britain, but it has handed out far fewer doses overall.
Catching up to Britain will be made even harder if AstraZeneca shortfalls continue into the early summer, as an EU official told Reuters.
Von der Leyen told the Augsburger Allgemeine that ‘I would take the AstraZeneca vaccine without a second thought, just like Moderna’s and BioNTech/Pfizer’s products,’
But she also continued to voice doubts about the UK’s strategy of delaying second doses – a move approved by Britain’s chief medical officers – as she claimed that the EU was ‘catching up’ in the vaccine race.
AstraZeneca is producing vaccines at two plants in the UK, one in Belgium and one in the Netherlands, but is not exporting its British-made jabs under its contract with UK ministers – although it has offered the EU doses made in India and the US.
The official said AstraZeneca planned to deliver about 40million doses in the first quarter, less than half the 90million shots it was supposed to supply.
It was also due to deliver 30 million doses in the last quarter of 2020 but did not supply any shots last year as its vaccine had yet to be approved by the EU.
All told, AstraZeneca’s total supply to the EU could be about 130 million doses by the end of June, well below the 300 million it committed to deliver to the bloc by then.
AstraZeneca did not deny the EU official’s claims, but said it was striving to increase productivity in order to meet its 180million target.
‘We are hopeful that we will be able to bring our deliveries closer in line with the advance purchase agreement,’ an AstraZeneca spokesman said.
Later in the day, the firm added that its ‘most recent Q2 forecast… aims to deliver in line with its contract with the European Commission’.
‘At this stage AstraZeneca is working to increase productivity in its EU supply chain and to continue to make use of its global capability in order to achieve delivery of 180 million doses to the EU in the second quarter,’ it said.
A European Commission spokesman declined to comment on confidential talks but said the EU should have enough shots even if the AstraZeneca targets are not met.
An EU regulator approved the AstraZeneca jab in late January but the ruling was overshadowed by a furious political row over the delayed shipments.
After AstraZeneca warned of shortfalls but continued to supply Britain in full, the EU published its contract with the firm and claimed to have cast-iron commitments.
Brussels also imposed export controls on jab shipments leaving the bloc, but was forced into retreat after initially saying they would apply to Northern Ireland.
But AstraZeneca’s CEO blamed the delays on the fact that the EU had not signed a contract until three months after Britain had tied up a deal last year.
AstraZeneca is not exporting vaccines made in the UK, in line with its separate contract with the British government.
But AstraZeneca has told the EU it could provide more doses from its global supply chain, including from India and the United States, an EU official said last week.
AstraZeneca is now forecast to make up its shortfalls by the end of September, according to a German health ministry document.
German officials expect to receive 34million doses in the third quarter, taking the country to its full entitlement of 56million out of the EU’s 300million doses.
Germany’s health minister and top public health official beg citizens to take Oxford vaccine – after Merkel said she won’t have it
Lothar Wieler, the head of Germany’s top diseases institute, welcomed the findings by Edinburgh-based researchers that one dose of the Oxford/
Health minister Jens Spahn said that ‘this vaccine is safe and effective, it protects’ as more than a million AstraZeneca doses delivered to Germany lie unused in storage after top EU figures questioned the efficacy of the shot.
German health minister Jens Spahn, pictured, said the AstraZeneca jab was ‘strongly recommended’ – but it is still not available to the most vulnerable
Spahn said the vaccine drive was gathering pace with record numbers of doses handed out on Wednesday and Thursday, but it is still moving far more slowly than in Britain which has handed out three times as many jabs to a smaller population.
And despite the findings in Scotland, German regulators have yet to open up the jab to over-65s – with Angela Merkel saying she could not take it as an example to the country because she is too old at 66.
Germany’s 16 states have taken delivery of more than 1.4million AstraZeneca doses, but only 315,000 of these have been given to patients so far with some essential workers refusing to take the jab.
By contrast, 5.3million shots of the Pfizer/BioNTech jab – co-developed by a German firm – have been deployed out of 6.7million doses delivered so far.
The reluctance to take AstraZeneca shots piles further pressure on health officials already struggling to ramp up jabs because of the EU’s chaotic procurement.
Health minister Spahn acknowledged that ‘too much vaccine is sitting in the fridge’, after Merkel said the AstraZeneca vaccine had an ‘acceptance problem’.
There have also been reports of side-effects leading hospital staff and other front-line workers to call in sick. Regulators and scientists say the vaccine is safe.
‘We strongly recommend it: this vaccine is safe and effective, it protects,’ Spahn told a news conference on Friday.
‘It protects oneself and others, like both other vaccines,’ he added, referring to the Pfizer and Moderna products.
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