Welcome to European Tribune. It's gone a bit quiet around here these days, but it's still going.

EU Threatens to Stop Export Oxford AZ Vaccines

by Oui Sat Mar 20th, 2021 at 01:05:49 PM EST

The European Union could stop AstraZeneca from exporting its COVID-19 vaccine from the bloc if the British-Swedish pharma company does not meet its supply obligations, European Commission President Ursula von der Leyen said in comments published on Saturday.

"We have the possibility to forbid planned exports. That is the message to AstraZeneca: You fulfill your contract with Europe before you start delivering to other countries," von der Leyen told newspapers from the Funke Media Group.

She said the company had delivered only 30% of the doses promised in the first quarter of 2021. She also pointed out that although the contract with AstraZeneca had stipulated that the EU would receive vaccines from factories in the EU and Britain, "we have received nothing from the Britons, while we deliver vaccines to them."

Von der Leyen referred to statistics showing that at least 41 million doses of coronavirus vaccine had been exported from the EU to 33 countries, despite a shortfall in vaccine supplies in the bloc itself. According to the commission, 9 million doses have gone from the EU to the UK and a million to the US.

"I cannot justify to European citizens why we export millions of vaccine doses to countries that produce vaccines themselves -- and from whom nothing comes back," von der Leyen said. "And I can barely justify exports to countries that have a much higher vaccination rate and far fewer infections than the EU."


Biden's War on Vaccines - a New Form of Multilateralism Western cowboy style: Bush - Obama - Biden ...

Defense Production Act Speeds Up Vaccine Production

In the run-up to President Biden's promise on March 2 that there would be enough COVID-19 vaccines for every adult in the United States by the end of May, he talked up a Korean War era law called the Defense Production Act.

Biden mentioned it in his first presidential remarks about the pandemic fight from the White House State Dining Room on Jan. 26. He brought it up again during a Feb. 19 trip to a Pfizer vaccine factory in Kalamazoo, Mich., while he stood in front of gleaming stainless steel production equipment. He brought the law up on Feb. 25 after watching a Washington, D.C., resident get vaccinated in front of cameras at the Eisenhower Executive Office Building for an event to celebrate the 50-millionth shot. Less than two hours later, he talked about the law in the National Governors Association's winter meeting.

So perhaps it was no surprise Biden brought up the Defense Production Act yet again in his announcement this month that his administration brokered a deal between two pharmaceutical rivals -- Merck and Johnson & Johnson -- to increase the vaccine supply and help deliver doses earlier than expected.

USA and UK have designated all vaccines, substances and manufacturing part of cut-throat Capitalism .. Me1st insanity - Southern Africa needs the right COVID-19 vaccines, at the right price - right now | MSF |.

The U.S. Needs to Stop Hoarding Vaccines Immediately | Slate |

The only method is to confront the bully, not turning the other cheek ... the latter is for religious persons or social democrats counting on solidarity.

Here's how to get billions of COVID-19 vaccine doses to the world | Economic Policy of a Pandemic Age |

The unprecedented development of several effective COVID-19 vaccines in less than a year is an historic achievement in the annals of scientific research. No less impressive, however, is the work of the US government in organizing and subsidizing a complex supply chain for manufacturing and distributing the COVID-19 vaccine. American policymakers made large advance purchases of potential vaccines and supported some sponsors--such as Moderna and Johnson & Johnson--carrying out clinical trials, while simultaneously working with myriad far-flung and lesser-known contract manufacturers and suppliers of equipment and ingredients (from cellular material to glass tubing to syringes), to actually produce the vaccines and related supplies. The crash effort that went from science labs to vaccine distribution began under the Trump administration's Operation Warp Speed and has continued and expanded under the Biden administration.

As Americans prepare to emerge from the pandemic, however, much of the world is still living a nightmare. Global demand for vaccine doses dwarfs the supply. Only a handful of countries are able to manufacture these vaccines at the scale needed to overcome infections and deaths that are still growing--and shifting due to the emergence of viral variants. It is certainly problematic that the United States and some other countries are hoarding doses and critical vaccine supplies for their own domestic populations. But a focus on hoarding alone threatens to miss one crucial point. There is much that the United States can do to help replicate the success of Operation Warp Speed on a worldwide scale to get billions of doses to a global population.

Waiting for a pandemic to happen after SARS Cov-1 over a decade ago ... vaccine research and production was never profitable enough for BIG Pharma ... the few government entities in Europe which produced vaccines were forced to sell their pharmaceuticals off to the private sector. Today after the pandemic hit hard, Covid-19 Relief Fund for business large and middle, but a handout to the little men and employees of Main Street. Wall Street stocks flying high. This can't endure!

From the diaries ...

BIG Pharma and Corona Profits

Display:
by Oui on Sat Mar 20th, 2021 at 01:06:26 PM EST
What is the "European Region"?

51 countries from Nuuk, Greenland to Vladivostok, Russia?

The EU-27 has 550k deaths - 448M pop.
The USA with 535k deaths - 332M pop.
The UK tops 126k deaths -  68M pop.

Per capita is the EU-27 performance clearly better.

Tory PM Johnson Covid deaths inquiry ...

by Oui on Sat Mar 20th, 2021 at 03:51:57 PM EST
Why threaten to block exports?Either do ot or shut up. Just talking shows weakness.

Index of Frank's Diaries
by Frank Schnittger (mail Frankschnittger at hot male dotty communists) on Sat Mar 20th, 2021 at 08:31:30 PM EST
Ursula learned a wise lesson from the hasty Art. 16 and NI Protocol.

Get full backing of EU-27, assess repercussions, media backlash, legal advice ... how will Uncle Joe react? More sanctions on Europe?

PS Uncle Sam was the WWII version of Uncle Joe.

by Oui on Sun Mar 21st, 2021 at 12:38:57 PM EST
[ Parent ]
Yea, but a lot of that consultation could have been done before she said anything. Don't say it publicly, unless you mean to follow through on it. You get all the flack, and none of the actual benefits of taking the decision.

The EU has to learn that the first duty of any state or wannabe state is to look after the health and security of its people. Prime Ministers know that well enough: Van Der Leyen needs to learn that lesson.

The EU will not gain any respect from friend and foe alike until it learns that lesson. Even just the appearance of doing so is important. The practicalities can be dealt with later. Why should citizens give their loyalty to the EU if it doesn't go all out o protect them?

Index of Frank's Diaries

by Frank Schnittger (mail Frankschnittger at hot male dotty communists) on Tue Mar 23rd, 2021 at 04:11:17 PM EST
[ Parent ]
The United States has been ignoring the health and security of the bulk of its citizenry for nearly 240 years.
by rifek on Mon Mar 29th, 2021 at 07:59:26 PM EST
[ Parent ]
Sky News interview with Ben Wallace - Minister of Defence and Wellbeing

UK warns EU attempts to block vaccine exports would be 'counterproductive'

In the latest exchange of barbs between Britain and the EU, Defence Secretary Ben Wallace has said the European Commission would suffer "severe reputational damage" if it blocked vaccine exports to the UK.

There has been an ongoing row between the EU and the drugmaker after the bloc accused AstraZeneca of failing to meet its supply contract.

Commission president Ursula von der Leyen had ramped up the rhetoric over the weekend by saying the EU had the power to "forbid" exports, adding: "That is the message to AstraZeneca."

But Mr Wallace hit back this morning while speaking to Sky News' Sophy Ridge on Sunday programme, saying: "If contracts and undertakings get broken that is a very damaging thing to happen for a trading bloc which prides itself on the rule of law.

"It would be counterproductive because the one thing we know about vaccine production and manufacturing is that it is collaborative.

"If we start to unpick that, if the commission were to start to do that, I think they would undermine not only their citizens' chances of having a proper vaccine programme, but also many other countries around the world with the reputational damage to the EU, I think, they would find very hard to change over the short-term."

by Oui on Sun Mar 21st, 2021 at 12:31:26 PM EST
by Oui on Sun Mar 21st, 2021 at 12:32:18 PM EST
[ Parent ]
So now the UK is worried about preserving the EU's reputation? That would be a first.

Index of Frank's Diaries
by Frank Schnittger (mail Frankschnittger at hot male dotty communists) on Tue Mar 23rd, 2021 at 04:13:00 PM EST
[ Parent ]
In conversation with Rajiv Nath, MD, Hindustan Syringes & Medical Devices Ltd. | Hindustan Times |

HMD is one of the largest suppliers to UN Agencies for KOJAK Auto Disable Syringes for immunization.

One of the organisations that need a special mention is Hindustan Syringes & Medical Devices Ltd. However, these achievements would not be possible without the support and unwavering contribution of Mr. Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd. in his additional role as a Forum Coordination of AiMeD (Association of Indian Medical Device Industry). In an exclusive interview, Mr. Rajiv Nath speaks on the recent pandemic and the future of the healthcare industry.

We have scaled up the production of KOJAK AD syringes and already supplied 140 million auto disposable syringes KOJAK AD 0.5ml Syringes to COVAX-the WHO facility to maintain the supply chain of vaccine & syringes for developed countries. To ensure continuous supply, HMD has ordered multi cavity molds, high speed assembly & packaging lines and expects to achieve 800 million capacity p.a. in Qtr1 and 1000 million by end of Qtr 2 of 2021. HMD will also make a total of 177.6 million KOJAK AD 0.5ml Syringe for Govt. of India by March 2021.

AiMeD was initiated a decade ago by 3-4 of like-minded Manufacturers at the side-lines of an international Conference on Regulation. It was established as an Umbrella Association of Indian Manufacturers of Medical Devices to cover all types of Medical Devices including Consumables, Disposables, Equipment, Instruments, Electronics, Diagnostics, and Implants. Today, more than 350 Manufacturers and additionally of over 200 Associate Members are a part of the AiMeD family. The association also represents the interest of over 1200 Manufacturers of Medical Devices. However, with over 2000 products AiMeD should have more than 7000 factories and bigger than Pharma to address the manufacturer's problems.

by Oui on Sun Mar 21st, 2021 at 01:40:53 PM EST
by Oui on Sun Mar 21st, 2021 at 01:42:23 PM EST
[ Parent ]

Towards the end of 2020, it was reported that ministers had tried to put the flag on packs of the Covid vaccine manufactured by AstraZeneca (which, contrary to the recent impression that is somehow a branch of Her Majesty's government, is actually an Anglo-Swedish company with a French chief executive). Labour, too, has got the bug, as evidenced by Keir Starmer's recent appearances in front of his own union jack, and February's news of internal documents pushing the idea that his party should make as much use of the flag as possible.

Simply just as silly as Donald Trump requiring the Covid-19 .... ehh Chinavirus Relief Bill with his own signature and not of the Treasurer on the cheques to American voters.

by Oui on Sun Mar 21st, 2021 at 04:29:46 PM EST
by Oui on Sun Mar 21st, 2021 at 05:21:05 PM EST
[ Parent ]
EU export ban would delay UK Covid vaccine drive by two months | The Guardian |

The 27 heads of state and government will discuss the next steps on Thursday via video conference, amid growing concerns over a third wave of coronavirus infections on the continent. Plans to meet in person were cancelled on Sunday in light of a rise in infections.

France and Germany have privately spoken in support of activating article 122 of the EU's treaty, last used in the 1970s oil crisis, allowing the bloc to take emergency measures to control the distribution of essential goods.

The EU commissioner for financial services, Mairead McGuinness, said on Sunday: "European citizens are growing angry and upset at the fact that the vaccine rollout has not happened as rapidly as we had anticipated."

The EU member states had administered 10.4 vaccine doses per 100 people as of Saturday, compared with the 42.7 jabs administered per 100 in the UK.

...
The UK government was until the last fortnight on course to beat its target of delivering a first vaccine dose to every adult in the UK by the end of July by over six weeks, according to Airfinity.

A recent supply problem with AstraZeneca's facility in India is expected to set back the pace of vaccination by two weeks, from 10 June to 23 June.

But the imposition of an export ban on doses of the Pfizer/BioNTech vaccine produced in Belgium and Germany, by far the largest export to the UK, would delay every adult receiving a first jab until 5 August, according to Airfinity.

A ban on all exports of vaccines due for distribution, including those from Moderna and Johnson & Johnson, would delay reaching that target to 27 August, the analysis commissioned by the Guardian further suggests.

Rasmus Bech Hansen, the chief executive of Airfinity, said: "Export bans are a lose-lose situation and threaten the global production scale-up.

by Oui on Sun Mar 21st, 2021 at 11:07:01 PM EST
by Oui on Sun Mar 21st, 2021 at 11:07:23 PM EST
[ Parent ]
A ban, due to be debated by leaders of the 27 EU member states on Thursday, would badly stall the UK vaccination effort, and would be likely to force the government to extend restrictions on people's lives.

It would not, however, provide a significant boost to EU member states' troubled programmes, according to a report by the data analytics company Airfinity.

The comparatively small number of doses that would be kept within the bloc would speed up the full vaccination of every adult in the EU by "just over a week", the research suggests.

Sounds terrible,
... except the same number of people get vaccinated either way (or perhaps only half as many if the EU countries stick to the recommended two dose schedule while the UK continues to prioritize the first dose).

Now given the reported percentages of people having received a shot in the UK and the EU, it seems clear that more of the high risk categories have by now have been vaccinated in the UK than in the EU. Therefore an insistence by the UK that they continue to receive AZ doses ahead of the EU is actually an insistence that more EU citizens die so that the UK can get back to its normal life more quickly.

The idea that there would not be much benefit to the EU only holds if all people are equally at risk of serious illness or death. We know this is not the case and getting the most at risk vaccinated as quickly as possible should be an absolute priority.

by det on Mon Mar 22nd, 2021 at 09:38:13 AM EST
[ Parent ]
A long read ...

Waging war over vaccines can only end in tragedy for Britain and the EU | The Guardian - Opinion |

My conversations with people inside government suggest that many ministers appreciate that gloating is unedifying and self-defeating. At the same time, a Brexiter cabinet finds it hard to resist the temptation to exploit the EU's distress for partisan advantage. The NHS-delivered distribution of the vaccine is the only aspect of the handling of the crisis in which this government can claim to have a record that is impressive. Brexiters want to claim that success, however bogusly, as a justification for their experiment. There are also Tories who believe that a steady drumbeat of cross-Channel conflict serves their electoral interests by keeping the Brexit vote aroused and distracted from the punishing damage the rupture is inflicting on the economy.

A government with an enlightened perspective on the long-term interests of Britain would see value in offering expressions of sympathy and gestures of solidarity with the EU at its time of severe trial. That could generate a lot of goodwill among European voters and leaders. It might be the more effective in winning friends for Britain for being so unexpected from a Brexiter government. Dominic Raab, the foreign secretary, instead prefers to play tit for tat. He responded to Ms von der Leyen by accusing her of the "kind of brinkmanship" usually practised by dictatorships, an echo of those Brexiter tropes which insultingly compared the EU with Nazi Europe or the Soviet bloc.

Other cabinet members huff and puff that threats to curtail vaccine exports show that the EU can't be trusted to honour contracts.

There is a problem with this attempt by ministers to seize the title deeds to the moral high ground. Their behaviour has robbed them of any claims on it. No one is worse qualified to lecture others about contract-breaking than a member of Mr Johnson's government. It is not so long ago that he was brazenly threatening to break international law by tearing up clauses of the withdrawal agreement that he signed. More recently, the government abandoned attempts to renegotiate aspects of the agreement which are working badly in Northern Ireland and announced a reneging on previous commitments. "My word is my bond" has not exactly been the motto by which Boris Johnson has lived his life. Sylvie Bermann concluded her time as French ambassador in London with a valedictory assessment of Mr Johnson which described him as "an unrepentant and inveterate liar", a view widely held among European leaders. The chances of avoiding a mutually destructive struggle with the EU over vaccine supplies would be much better had Britain a prime minister who was regarded as a trustworthy international partner by his peer group.

by Oui on Mon Mar 22nd, 2021 at 08:46:26 AM EST
by Oui on Mon Mar 22nd, 2021 at 08:47:02 AM EST
[ Parent ]
Europe's third [BWAH!] COVID wave could hit Britain, warns Johnson, brushing aside n+1 UK "lockdowns"
Asked about the risk to Britain's vaccine programme from European Union threats to ban exports of the vaccine to the UK, Johnson said he did not think that that would happen.

"I'm reassured by talking to EU partners over the last few months, they don't want to see blockades, I think that's very very important," the Prime Minister said.

Britain would be continuing with its vaccination programme, he said, confirming that the plan to ease restrictions in line with the roadmap was on track.


by Cat on Mon Mar 22nd, 2021 at 03:34:34 PM EST
[ Parent ]
India to Prioritize Domestic Vaccinations

Boris Johnson's envoy calls for India's vaccine trade to alleviate Britain's shortage

Boris Johnson's fixer and close ally, Sir Edward Lister, visited India as part of an effort to secure millions of AstraZeneca vaccines essential to the fight against the British coronavirus.

According to Indian reports, Lister and International Adviser David Kwaley met with Indian Foreign Minister Hirsch Schlingla in New Delhi on Monday to discuss Johnson's planned visit to the country in April, "Bilateral Relations and Results discuss".

Lister, a fellow conservative and British Prime Minister's Gulf Special Envoy, will move from there to Pune to visit the Serum Institute of India, the world's largest vaccine manufacturer and producer of AstraZeneca jabs. .. With knowledge of talks.

"Eddie Lister is on a personal trip on his way to Pune to solve this," he said. "he [Lister] The Indian government is at a standstill because it wants to be given, but is questioning why Congress is exporting the vaccine. "

Whitehall insiders confirmed that Lister will visit the Serum Institute this week to mediate a deal on the delivery of AstraZeneca doses in the United Kingdom.

by Oui on Mon Mar 22nd, 2021 at 07:45:19 PM EST

Developer paid Boris Johnson's aide Sir Edward Lister £480,000

by Oui on Mon Mar 22nd, 2021 at 07:46:29 PM EST
[ Parent ]

by Oui on Tue Mar 23rd, 2021 at 10:03:21 AM EST
There goes the $1.2bn investment of Trump's Operation Warp Speed (OWS) ...

AstraZeneca's vaccine has reached Phase 3 clinical trials in US: Trump | Health World - Sept. 1, 2020 |

"I am pleased to announce that AstraZeneca's vaccine has reached Phase 3 clinical trials and has joined various vaccines that are very close to the end. In the United States, we are doing things that people thought were not possible," Trump said in a press conference.

US agency questions AstraZeneca's Covid vaccine trial data | The Guardian |

AstraZeneca may have provided an incomplete view of efficacy data on its Covid-19 vaccine from a large-scale trial in the United States, a US health agency has said, in a fresh setback for the drug.

The concerns throw into question whether the British pharmaceutical firm can seek US emergency use authorisation for the vaccine in the coming weeks as planned, and come just one day after interim data from the trial had shown better-than-expected results.

    The vaccine developed with Oxford University was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalisation and posed no increased risk of blood clots.

The Data and Safety Monitoring Board (DSMB), an independent committee overseeing the trial, has "expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data", the USNational Institute of Allergy and Infectious Diseases (NIAID) said in a statement.

    Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

    Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.

NIAID is headed by the US infectious diseases expert Dr Anthony Fauci and is part of the National Institutes of Health.

If this pans out to be true, it surely pours tonnes of cold water on the EU-UK AstraZeneca dispute. Shipping 20 million doses in US stockpiles to the US Army dump sales.

AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis | AstraZeneca Press statement

    79% vaccine efficacy at preventing symptomatic COVID-19

    100% efficacy against severe or critical disease and hospitalisation

    Comparable efficacy result across ethnicity and age,
    with 80% efficacy in participants aged 65 years and over

    Favourable reactogenicity and overall safety profile

by Oui on Tue Mar 23rd, 2021 at 10:10:24 AM EST
by Oui on Tue Mar 23rd, 2021 at 10:57:30 AM EST

Go Dutch? UK and EU may share Netherlands Covid vaccine supplies to ease tensions

Ministers will seek to calm tensions over a potential EU ban on vaccine exports to the UK in a diplomacy blitz this week as sources raised the possibility of sharing jab supplies from a Dutch plant.

Sources said the UK government was keen to offer support and expertise at the AstraZeneca vaccine production plant in the Netherlands, run by the subcontractor Halix, to help scale up production.

...
Sir Tim Barrow, the former ambassador to the EU, is among the senior advisors trying to negotiate a solution to the dispute.

by Oui on Tue Mar 23rd, 2021 at 12:12:46 PM EST
This day will be remembered as a failure of mankind to one another ... many lives needlessly lost due to lack of leadership, vision in the Age of Narcissism. The year of Trump and how he missed out on the Nobel Peace Prize, stolen!

    So much of our focus today is rightly on the huge loss of life the pandemic has caused.

    Our thoughts are with all the families who are mourning the loss of a loved one - just as our thoughts have been with all the people whose lives lie behind the numbers reported every day.

    They will be remembered in the hearts and minds of all those who knew and loved them. And today we remember them too.

    Over the last year, we have heard too many sad stories. But we have also heard inspiring tales of resilience, bravery and determination from every part of Wales as communities support each other. And our everyday heroes - from bus drivers and shop workers to intensive care nurses and teachers - keep on keeping us safe.

    In the darkest of times, we have come together as a country. Today, we mark this anniversary with a sense of hope. Our fantastic vaccine programme is protecting thousands of people every day and we're relaxing the restrictions we have lived with for so long.

    As the first shoots of spring appear, we can all have real hope that this year will be so much better than the last.

    [Mark Drakeford - Cardiff City]

UK Covid live: minute's silence to honour victims ... England and Wales no longer recording excess deaths.

After a year the nursing and care homes were ravished by the pandemic ... an award for Boris? How utter stupidity reigns!

by Oui on Tue Mar 23rd, 2021 at 01:34:31 PM EST
EU to widen criteria for possible Covid vaccine export bans

"You have to be very careful now about imposing general export bans - you have to take a very close look at the supply chains."

"We will make our decision in a responsible manner, and at the same time we will keep talking to the British government, as Boris Johnson has already spoken with us and Emmanuel Macron on Sunday - and he is, by the way, in constant contact with the European commission. And we will certainly make our decision on Thursday, or at least hold a discussion about it."

The decision to revise the current export authorisation mechanism comes as UK and EU officials are seeking to avoid more damaging fallout from the row between Brussels and the Anglo-Swedish pharmaceutical company AstraZeneca.

by Oui on Tue Mar 23rd, 2021 at 05:47:46 PM EST
My earlier post ...

AstraZeneca Contract Manufacturing In Leiden

AstraZeneca COVID-19 Vaccine (AZD1222) Distribution

On December 8, 2020, Halix B.V.  announced it would provide commercial manufacturing of drug substance at its state-of-the-art cGMP facility at the Leiden Bio Science Park in the Netherlands. HALIX expands with 2 additional viral vector production lines to meet the increased demand.

by Oui on Tue Mar 23rd, 2021 at 06:23:01 PM EST
[ Parent ]
by Oui on Wed Mar 24th, 2021 at 04:38:41 AM EST
by Oui on Wed Mar 24th, 2021 at 05:00:58 AM EST
by Bernard on Wed Mar 24th, 2021 at 10:02:06 AM EST
[ Parent ]
Laura Kuensberg's BBC article ...

PM's vaccines comments set tongues wagging

Discussing why the programme was doing so well, he told colleagues it was down to "greed" and "capitalism".

Several of those present have told me he quickly realised his words could be taken out of context and urged MPs to "remove that comment from your collective memory".

by Oui on Thu Mar 25th, 2021 at 06:18:06 AM EST
[ Parent ]
by Oui on Wed Mar 24th, 2021 at 01:31:48 PM EST
Covid-19 is an intelligence test.

Many are failing.


She believed in nothing; only her skepticism kept her from being an atheist. -- Jean-Paul Sartre

by ATinNM on Wed Mar 24th, 2021 at 03:20:24 PM EST
[ Parent ]
Plus, in this case, it's 17 people in a room who have to reach a consensus. Which means the slowest one will determine the speed and the weakest one will determine the overall intellectual caliber. Ahh what a shitshow. Happy Easter!

Schengen is toast!
by epochepoque on Wed Mar 24th, 2021 at 03:28:59 PM EST
[ Parent ]
Sorry, no Passover, Easter this year ...

Hoe bad can it get after lockdown for human kind.

by Oui on Wed Mar 24th, 2021 at 04:28:29 PM EST
[ Parent ]
Margaret Thatcher - Theresa May - Angela Merkel ... The Iron Ladies on leadership in Europe ... Succeeded by Ursula Von der Leyen ...

German Holidays ... The Return of Berlin's Ampelmann, the on-off traffic light (wo)man.

by Oui on Wed Mar 24th, 2021 at 05:23:23 PM EST
[ Parent ]
One of the more bizarre policy aspects during the entire pandemic. On the one hand, they say, please don't travel. We know this is how the virus and new variants are imported. And yet, due to the recommendation or data of the Robert Koch institute travel warnings to Mallorca are lifted!? Merkel says travel is dangerous. Yes, but it's the federal government --her government-- that has been lifting/reinstating all those warnings since the last summer. Why don't they simply keep the warnings for all countries with local transmission till the end of the crisis. That's one of the easiest levers to pull but she isn't doing it. WTF?

Schengen is toast!
by epochepoque on Wed Mar 24th, 2021 at 05:55:58 PM EST
[ Parent ]
How the EU's naivety led to its vaccine debacle - New Statesman - Dave Keating
The threatened EU export ban on vaccines is an overdue response to protectionism elsewhere, but it may come to late to speed up the bloc's own roll-out.

... the EU played by the normal rules of free trade. While much of the anglophone media's focus has centred on dubious claims about a fumbled EU procurement process, the real problem has gone largely undiscussed: the EU, perhaps naively, took vaccine decisions on an assumption of a free market and good faith from its international partners. The US and the UK instead manoeuvred to protect themselves.

... US plants are being used to supply the US, while EU plants are being used to supply the world.

... how have EU countries ended up in a situation where they are struggling with vaccine supply but exporting millions of doses to countries who are much more vaccinated, are not exporting anything, and whose media are antagonizing and ridiculing the EU for its slower performance?

... And it is especially galling coming from the new EU administration of Ursula von der Leyen, who has promised a more geopolitical Commission

But while an EU export ban could make the UK's vaccination campaign collapse, it would do little benefit to the EU's campaign ... The real thing that could make a difference is if the US were to end its export ban and allow companies to send US-made vaccines to countries such as Canada, Mexico and Japan. Then the EU plants would no longer have to supply these countries, and those doses could stay in Europe.

So my last critique of the procurement process was wrong. Nevertheless, Vdl again shows herself as a mediocre establishment figure. Back in the day public TV regularly sent smart children to interview members of the German parliament. They were not impressed by VdL. I think they said: "Some people just don't get it."

The EU currently only wants a possible export ban to countries who don't reciprocate, not to those who can't because they don't produce. So that doesn't help because US is producing only for itself and enough of it and Japan et al can't produce.

Instead of a blanket export ban, one could think about reducing exports to those third countries to the proportional level as if the US were exporting. Which would be somewhat fair. Not all or nothing but a play to redirect some of the "bad guy" pressure to the US and relieve supply problems.

Schengen is toast!

by epochepoque on Wed Mar 24th, 2021 at 02:59:12 PM EST
To defend the commission a bit, the error of not forcing an EU partner on Biontech for trials&manufacturing was made by the German government. They financed Biontech and had leverage but they missed this. Another lesson.

Schengen is toast!
by epochepoque on Wed Mar 24th, 2021 at 06:16:03 PM EST
[ Parent ]
True to character, Johnson and Tories won't fail you ...

Joe Biden to attend EU virtual vaccine summit this week

by Oui on Wed Mar 24th, 2021 at 04:04:49 PM EST
by Cat on Wed Mar 24th, 2021 at 04:16:02 PM EST
Collecting investment funds from large clients such as the US and EU ...

Nine months later ...

30 Million AstraZeneca Doses Found

Manufactured by Halix near Leiden and send to production for bottling near Rome, Italy. [Denial by AstraZeneca]

by Oui on Wed Mar 24th, 2021 at 06:30:07 PM EST
by Oui on Wed Mar 24th, 2021 at 06:32:01 PM EST
by Oui on Fri Mar 26th, 2021 at 07:35:27 AM EST
[ Parent ]
by Oui on Wed Mar 24th, 2021 at 06:34:01 PM EST

Earlier policy decision ...

Commission strengthens transparency and authorisation mechanism for exports of COVID-19 vaccines

A sign there was no unanimity of the EU-27 as Belgium and the Netherlands would veto an outright ban on exports. These countries have manufacturing facilities for main three Covid-19 vaccine brands. Reputation damage control ...

by Oui on Wed Mar 24th, 2021 at 07:02:27 PM EST
Third country to oppose a ban was Ireland ...
by Oui on Wed Mar 24th, 2021 at 07:06:49 PM EST
[ Parent ]

Remarks to EU threat of export ban ...

Boris Johnson warns EU not to ban Covid vaccine exports to UK | The Guardian - 20 minutes ago |

by Oui on Wed Mar 24th, 2021 at 07:20:52 PM EST

    "Meanwhile, the UK health secretary, Matt Hancock, warned the EU that the UK had contract law on its side. "I believe that free trading nations follow the law of contracts," he told the Financial Times. "They have a 'best efforts' contract and we have an exclusivity deal."

On the side of "greed" and "capitalism"

by Oui on Thu Mar 25th, 2021 at 04:50:39 PM EST
Has produced vaccines since December and could provide 5m doses per month ... however Oxford AstraZeneca UK has failed to request EMA approval for the manufacturing plant. Thus no vaccines could be distributed to the EU-27 countries but would be exported elsewhere.

Best Reasonable Efforts or non-compliance with its contract with Brussels!?

AstraZeneca's vaccine contract with the UK is based on 'best efforts,' just like its deal with a frustrated EU | CNN News - Feb. 17, 2021 |

AstraZeneca's contract to supply the UK with 100 million Covid-19 vaccine doses commits it to making "best reasonable efforts," the same language used in its deal with the European Union, which critics blamed for the bloc's faltering inoculation program.

The details of the contract are contained in a redacted version published online without fanfare months ago, long before the UK and the EU became embroiled in a bitter dispute over vaccine supply.

British officials had earlier declined to provide the contract to CNN, making no mention of the redacted version, and have repeatedly refused to give details on the country's vaccine supplies, citing "security reasons." A junior UK government minister said in a recent interview that publishing the contract would risk national security.

British clearly not acting in good faith ...

AstraZeneca's lower EU vaccine supply target hinges on factory approval - document | Reuters - March 13, 2021 |

AstraZeneca's new aim of supplying 30 million doses of its COVID-19 vaccine to the European Union by the end March hinges on the bloc's drug regulator approving supplies from a factory in the Netherlands, an internal document showed.

The Anglo-Swedish drugmaker said it would try to deliver 30 million doses to the EU by the end of March, down from a contractual obligation of 90 million and a previous pledge made last month to deliver 40 million doses.

The new lower target for March deliveries, which confirmed an earlier report from Reuters, depends on the regulatory approval of a vaccine factory in Leiden run by subcontractor Halix, the internal document dated March 10 showed.

AstraZeneca said in the document seen by Reuters that it is assuming the Halix factory will get the green light on March 25 and has pencilled in deliveries of nearly 10 million doses for the following week.

The European Medicines Agency (EMA) confirmed in a statement that the Halix factory had not yet been approved and declined to comment on when any authorisation might be granted.

AstraZeneca Contract Manufacturing In Leiden

by Oui on Thu Mar 25th, 2021 at 07:16:29 PM EST
EU rebuffs UK calls to ship AstraZeneca COVID vaccines from Europe | Reuters - March 21, 2021 |

AstraZeneca has not yet sought approval in the EU for Halix, but the official and a second EU source said the request was on its way. AstraZeneca has declined to comment on the amount of vaccines that are currently stockpiled at Halix.

The EU official said the factory had already produced shots, but was not able to quantify the output. Under the EU contract with AstraZeneca, vaccines must be produced before approval and be delivered immediately afterwards.

Two factories in Britain run by Oxford Biomedica and Cobra Biologics are also listed as suppliers to the EU in the contract with AstraZeneca, but no vaccine has so far been shipped from Britain to the EU, despite Brussels' earlier requests.

Officials have said that Cobra is not fully operational. AstraZeneca told EU officials that the UK is using a clause in its supply contract that prevents export of its vaccines until the British market is fully served, EU officials said.

The ancient Institution monetizing its research ...

COVID-19: The multi-billion pound business of the Oxford vaccine | Sky News |

Shooting for the stars ...

Biden sets new Covid vaccine goal of 200 million shots within his first 100 days: 'I believe we can do it' | CNBC - 3 hrs ago |

by Oui on Thu Mar 25th, 2021 at 07:17:45 PM EST
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Boris Thanking Our European Friends!

Two-thirds of vaccine doses delivered were produced inside the EU-27 🙏🏼

Thus total jabs is 31,766,669

Yesterday's numbers released, the EU delivered 21 million Pfizer/BioNTech doses and a million Oxford AstraZeneca.

Coronavirus vaccination: Live data tracker | Politico |

The EU Commission and program to inoculate 450 million ...

'Highly unfair' to accuse the EU of vaccine nationalism, trade chief says | CNBC |

In the next three months, the European Union is expecting 55 million doses of the Johnson & Johnson shot, 200 million doses of the Pfizer-BioNTech vaccine, 35 million from Moderna and 70 million more from AstraZeneca.

30 Countries EU/EEA vaccine rollout overview - 60 million doses

by Oui on Fri Mar 26th, 2021 at 07:31:20 AM EST
by Oui on Fri Mar 26th, 2021 at 07:32:59 AM EST
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by Oui on Fri Mar 26th, 2021 at 07:50:18 PM EST
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by Oui on Fri Mar 26th, 2021 at 07:56:48 PM EST
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Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna

EMA's human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

New manufacturing site for AstraZeneca's COVID-19 vaccine

A new manufacturing site has been approved for the production of AstraZeneca's COVID-19 vaccine active substance. The Halix site is located in Leiden, the Netherlands, and will bring the total number of manufacturing sites licensed for the production of the active substance of the vaccine to four.

New manufacturing site and more flexible storage conditions for BioNTech/Pfizer's COVID-19 vaccine

A new site has also been approved for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. The facility, which is in the German city of Marburg, will produce both active substance and the finished product. There are currently three active substance manufacturing sites supplying the EU included in the marketing authorisation.

In addition to the new manufacturing facility for this vaccine, the CHMP has also given a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks.

New manufacturing site and scaled-up processes for Moderna's COVID-19 vaccine

Already last week, the CHMP recommended approving the addition of a new manufacturing site for the production of active substance and finished product intermediates for Moderna's COVID-19 vaccine. The addition of the new manufacturing lines at the Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that were greenlighted by the Committee are intended to scale-up production capacity and increase supply of the vaccine for the EU market.

COVID vaccine: EMA approves new production sites in Germany, Netherlands, Switzerland | DW News |

by Oui on Fri Mar 26th, 2021 at 06:11:40 PM EST
Britain nearing vaccine deal with European Union - The Times (via Reuters)

Britain is close to striking a vaccine deal with the European Union as soon as this weekend that will remove the threat of the bloc cutting off supplies, The Times reported on Saturday.

...
Under the agreement the EU will remove its threat to ban the export of Pfizer-BioNTech vaccines to Britain, it added.

In return, the British government will garen to forgo some long-term supplies of the Oxford-AstraZeneca vaccine that had been due to be exported from a factory in Holland run by AstraZeneca's subcontractor Halix, the newspaper reported.

🤣🤣

"We are only at the start of discussions with the UK. There are no talks over the weekend," an EU Commission source said on Saturday, adding that sending vaccines produced at Halix was not part of the talks.

A second EU source had previously said that the EU has no intention of sharing with Britain the vaccine substance from Halix, which is estimated to have already produced enough for about 15-20 million doses, and can produce the equivalent of 5 million shots per month.

Of course Mark Rutte is in the Tory pocket and would prefer to deal with London and not Brussels. However, the Dutch and Halix are bound by an export permit from the EU. Transparency, not the Rutte Doctrine.

by Oui on Sat Mar 27th, 2021 at 04:47:38 PM EST
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Statement by President von der Leyen at the joint press conference with President Michel, following the videoconference of the members of the European Council

by Oui on Sun Mar 28th, 2021 at 06:16:37 PM EST
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EMA starts rolling review of CureVac's COVID-19 vaccine (CVnCoV)

12-02-2021 EMA's human medicines committee (CHMP) has started a rolling review of CVnCoV, a COVID‑19 vaccine being developed by CureVac AG.

The CHMP's decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID‑19.

The company is currently conducting trials in people to assess the vaccine's safety, immunogenicity (how well it triggers a response against the virus) and effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available.

CureVac on track to apply for COVID-19 vaccine market authorization in Q2 2021

CureVac In Germany: Trump's Failed Takeover Bid | March 17, 2020 |

by Oui on Fri Mar 26th, 2021 at 08:43:16 PM EST
Given CureVac record of failure, I wouldn't hold my breath. Now their stage 3 study has the problem that many (older) people are getting vaccinated and the virus is getting suppressed in other ways. Which means it's taking longer to show efficacy. Second half of the year if things turn out well. Long after it would have been major help.

Schengen is toast!
by epochepoque on Sat Mar 27th, 2021 at 11:53:31 AM EST
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Germany coronavirus: RKI chief says UK variant to dominate new infections

by Oui on Fri Mar 26th, 2021 at 09:15:26 PM EST
by Oui on Fri Mar 26th, 2021 at 09:17:28 PM EST
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Of course only now. These people...

Schengen is toast!
by epochepoque on Sat Mar 27th, 2021 at 11:54:09 AM EST
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And more ...

We stand by our partners in the Western Balkans

Except for Malta, Serbia with the highest vaccination rate on continental Europe ...

by Oui on Sun Mar 28th, 2021 at 07:53:27 AM EST
UK restricts COVID medicine exports amid AstraZeneca vaccine fight | Politico - Jan. 27, 2021 |

The U.K. placed a series of export restrictions last year on around 100 medicines that could be used to treat COVID-19 patients despite criticizing others for considering similar limits on vaccines.

...
While Johnson hit out at the EU for weighing export controls on vaccines, the British government itself has a list of 174 medicines that are currently banned from export from the U.K., because they "are needed for UK patients." Additions to the list in 2020 included around 100 medicines that have been suggested as possible treatments for COVID-19 patients or are being used to alleviate symptoms of COVID-19 patients in intensive care units.

In addition, the list includes flu vaccines, which while not directly used to treat COVID-19, are considered a critical public health tool in combating the virus, by reducing other pressures on the National Health Service.

Also on the list are a host of medicines associated with intensive care and long periods of intubation, while breathing is supported mechanically. While not solely used to treat specific COVID symptoms they were needed to prepare hospitals for an influx of intensive care patients suffering from severe cases of the disease.

by Oui on Sun Mar 28th, 2021 at 12:40:16 PM EST
The success of greed and capitalism once again ... did Boris refer to Labour and Brussels as Communists yet? Can't be far off ..

Coronavirus: UK `set to offer 3.7m vaccines to Ireland' amid EU exports row

by Oui on Sun Mar 28th, 2021 at 01:35:46 PM EST

Imposing DPA on the global vaccines and API market.

by Oui on Sun Mar 28th, 2021 at 08:45:48 PM EST
See methods thru Defense Production Act

Initiated by Harry Truman at the outbreak on the Korean War in 1950 ... those Asians again!

The DPA now defines "national defense" as "programs for military and energy production or construction, military or critical infrastructure assistance to any foreign nation, homeland security, stockpiling, space, and any directly related activity," including "emergency preparedness activities" (defined by the Robert T. Stafford Disaster Relief and Emergency Assistance Act [1988] as "all those activities and measures designed or undertaken to prepare for or minimize the effects of a hazard upon the civilian population").

Proposed Executive Order on "Buy American" and Defense Production Act Designation for Health-Related Goods Production

by Oui on Sun Mar 28th, 2021 at 08:46:56 PM EST
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WTO rules and Active Pharmaceutical Ingredients (API)

by Oui on Sun Mar 28th, 2021 at 08:48:35 PM EST
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As the US of Trump and UK under Johnson went for MeFirst! Nationalist legal policy and bullhorn "diplomacy".

UK-EU Vaccine War: the Good, Bad and Ugly

If relations between Britain and the EU before Brexit was finalised were frosty and since then have been distant, then in recent weeks they have become downright ugly.

... on a political level, the vaccine wars tell us much more than this. They are a picture of a world in which global problems are not dealt with through cooperation, but by dog-eat-dog tribalism. It shows how, in the post-Brexit era, even technical disagreements turn into a biblical war between opposing camps.

Our understanding of the AstraZeneca contracts are shrouded in a certain amount of mystery. There are earlier agreements on research funding which haven't been made public.

...
This won No.10 an influential role in the development process, so that UK supply was guaranteed.

But there is also a darker element. "As you could imagine," AstraZeneca CEO Pascal Soriot said, "the UK government said the supply coming out of the UK supply chain would go for the UK first. Basically, that's how it is." It's not clear what this is a reference to - it could be a clause in an unpublished early agreement or a general description of the UK's pressure in the development process. But either way: the UK's view was clearly that the vaccine should stay in the UK.

The EU followed a different course. Vaccines produced in Europe, including AstraZeneca and Pfizer, are finding their way across the world. More than nine million have gone to the UK, 3.9 million to Canada, 3.1 million to Mexico and 2.7 million to Japan. And that was not just about EU inadequacy in the contract process. It was about the principle that a global problem required a global solution and should operate according to free market principles.

No matter what anyone says, there is no national solution to coronavirus. You can be so successful that you bring your domestic infections down to nothing. But as soon as someone goes overseas, picks up a variant and brings it back, it will spread like wildfire - and we'll be right back where we started. The only permanent solution is global.

by Oui on Mon Mar 29th, 2021 at 01:34:45 PM EST

GSK to support manufacture of Novavax' COVID-19 vaccine

by Oui on Mon Mar 29th, 2021 at 08:29:52 PM EST
by Oui on Mon Mar 29th, 2021 at 08:31:52 PM EST
Is the point of this law to get more people to support abortion?
by gk (gk (gk quattro due due sette @gmail.com)) on Mon Mar 29th, 2021 at 08:45:37 PM EST
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by Oui on Tue Mar 30th, 2021 at 06:14:45 AM EST
The Orthodox Jewish mutant?

A tale of three SARS-CoV-2 variants with independently acquired P681H mutations in New York State

Those who profess to "let her rip" will be honoured with a name of a new mutant.

by Oui on Tue Mar 30th, 2021 at 02:37:18 PM EST
PM Rutte failed to judge value of investment opportunity after Golden tip from Pieter Omtzigt, member of Lower House.

Crazy hypothetical poll with Pieter Omtzigt (CDA)

by Oui on Tue Mar 30th, 2021 at 06:04:00 PM EST
by Oui on Tue Mar 30th, 2021 at 06:06:01 PM EST
April 19 is the target delivery date of Janssen vaccines for all the EU27.
by Bernard on Tue Mar 30th, 2021 at 06:10:54 PM EST
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by Oui on Wed Mar 31st, 2021 at 01:23:17 PM EST
by Oui on Wed Mar 31st, 2021 at 09:02:47 PM EST
Is German politics getting tired of Ms. Ursula Von der Leyen ... for the second time?

Germany considers break with EU on 2022 vaccine orders | DW News |

German Health Minister Jens Spahn says the country must secure booster vaccines for 2022 -- even if that means acting independently from the European Union.

...
Speaking as Germany prepares to ramp up its vaccination program at family doctor practices across the country, he said securing supplies for the next year was vital.

"We need to secure production capacity also for 3rd and 4th shots of COVID-19 vaccine," said Spahn. For now we don't know how long protection will last. Nobody has been immunized longer than 12 months according to the first clinical studies. And nobody know how long it will last -- 12, 24 months, 5 years, 10 years."

"Nobody can rule out the need for repeat shots for immune reinforcement. Therefore we should secure capacity within the European Union framework -- if not done urgently, then nationally."

by Oui on Thu Apr 1st, 2021 at 09:46:07 PM EST
Vaccine scarcity: how the EU's appeasement of Big Pharma damages COVID-19 response

The first legal assessments of the published contracts show that they suffer from major weaknesses, including ambiguous delivery dates and a lack of sanctions should the companies fail to comply. Investigative journalist Stefano Valentino, who consulted several legal experts, concludes that the EU used a "softball approach" in the negotiations and now "has its hands tied" when the pharma companies announce delays in delivery and is left to "rely on the goodwill" of the companies. "The only real certainty", Valentino argues, "is the weak position in which the EU and the member states have placed themselves, taking high-margin financial risks and a less demanding attitude toward suppliers".

As Viviana Galli of the European Alliance for Responsible R&D and Affordable Medicines told VoxEurop: "When negotiating the contracts, the European Commission and the Member States should have put much more care in protecting the public interests with specific clauses giving responsibility to the companies in case of non-compliance".

Global health before profits

While joint procurement by the 27 EU member states was clearly the right approach, it appears that the EU negotiators could have achieved far better results considering the strong negotiating position they had. They were negotiating on behalf of 27, mostly very wealthy, European countries, during a pandemic in which pharmaceutical companies had pledged to put global health before profits. The negotiators moreover had a very sizeable budget available for the pharmaceutical companies, in order to fund research and development and manufacturing capacity. The negotiators committed public money to remove financial risk and - to some extent - liability for the pharma companies working to develop COVID-19 vaccines. They should have at least insisted on very strong public interest conditions in return.

COVID-19 Vaccines: The EU is at the mercy of Big Pharma

    More than half of the subcontracted sites are located in Germany, France and Belgium, and 80 percent of the companies are German, French, Spanish, American or British (the latter are located only in the UK). The most active subcontracting unit is France's Fareva, which bottles Curevac's vaccine in three different facilities, while in another it creates the vaccine for Sanofi/GSK. With several commissions each, these are followed by their compatriots Delpharm and Recipharm, Austria's Polymun, Germany's Idt Biologika, Siegfried, Rentschler, as well as America's Baxter and Catalent.

Commission silent as Germany buys own vaccines

by Oui on Thu Apr 1st, 2021 at 09:47:00 PM EST
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