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

Testing UK-EU Friendship Post-Brexit

by Oui Wed Jan 27th, 2021 at 09:26:23 PM EST

AstraZeneca cannot play the Britain First card of nationalism ... the EU invested in production facilities in 4 locations ... included two UK factories.

More below the fold ...


EU health official blasts slow vaccine delivery, and is consulting with Canada

Vaccine maker AstraZeneca was the recipient of the scathing message from Stella Kyriakides, European commissioner for health and food safety, dring a briefing in Brussels.

Kyriakides said buying vaccines during a pandemic shouldn't be treated like a first-come, first-served trip to a neighbourhood butcher shop when people are dying in large numbers.

EU demands UK Covid vaccines from AstraZeneca to make up shortfall | FT |

The EU has said AstraZeneca must take coronavirus vaccines from UK factories to make up a shortfall in supplies to its member states, a demand that could unleash an explosive post-Brexit political fight.

AstraZeneca was contractually obliged to use vaccines produced at UK plants to fulfil its delivery obligations to EU states, the European Commission said, as Brussels called on the manufacturer to agree to publish its EU supply contract.

Early agreement between Oxford/AstraZeneca and four EU countries ...

Four European nations to pay $843 million for AstraZeneca's coronavirus vaccine

The news comes two days after AstraZeneca announced on Saturday it had agreed with the four countries to supply up to 400 million doses of the vaccine, with deliveries set to start by the end of 2020. The pharmaceutical giant said it was building a number of supply chains in parallel across the world and is seeking to expand manufacturing capacity further.

AstraZeneca has recently completed similar agreements with the U.K. and U.S. and the Coalition for Epidemic Preparedness Innovations and vaccine alliance Gavi for 700 million doses.  It added on Saturday that it had agreed a license with the Serum Institute of India for the supply of an additional 1 billion doses, principally for low and middle-income countries. Total manufacturing capacity currently stands at 2 billion doses, the company said.

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This is all as clear as mud. It seems quite possible the EU was slower to sign an actual contract rather than the UK/US who appear to have taken a more nationalistic/competitive approach.

However it appears the EU is claiming AstraZeneca is reneging on the specific delivery schedule contained in it's contract, and there is no indication that that is being caused by production problems.

So why the delay? Did AstraZeneca sign up to over-optimistic production targets? Has it diverted supplies elsewhere? It seems quite reasonable to assume that producing billions of doses to an ambitious schedule is no easy task and unforeseen difficulties could arise.

The situation is not helped by the hubristic and nationalistic tone of UK government communications and the way this is being played into existing narratives of the EU Commission being a bureaucratic morass unable or unwilling to respond decisively to a crisis.

However it should be no more controversial for AstraZeneca supplies to be exported from Britain to the EU  than for Pfizer supplies to be exported from Belgium to the UK.

What makes the whole controversy even more unedifying is the way it portrays rich countries fighting each other over preferential treatment with no one caring about leaving poorer countries at the back of the queue.

When you add in the fact that Israel managed to vaccinate over half their total population by securing huge early supplies by paying more for their doses but then restricted access to Israeli settlers in Palestinian territories and making none available to the local Palestinian population - the elitist and racist dimensions of the scandal come into sharp relief.

Given that both Israel and the UK have had very severe outbreaks, an objective case could have been made for supplying those health systems early in the process. But that is not how it looks, with both governments taking a Britain first or Israelis first propaganda approach to their vaccination programmes.

If Brexit wasn't enough to poison EU/UK relations, this controversy could make it ten times worse. But I suspect it is too late for even the adults in the room to limit the damage now. This has become deeply personal for many citizens and they will not let their leaders forget it.

Index of Frank's Diaries

by Frank Schnittger (mail Frankschnittger at hot male dotty communists) on Thu Jan 28th, 2021 at 01:34:14 AM EST


'Sapere aude'
by Oui (Oui) on Thu Jan 28th, 2021 at 03:57:06 PM EST
[ Parent ]

Bahrain takes delivery of AstraZeneca vaccine from India

WEF: Indian Prime Minister Narendra Modi said the country would introduce more locally made COVID-19 vaccines as New Delhi continues to save lives of people in other countries by exporting medicines and vaccines.

On Monday, SII Chief Executive Adar Poonawalla told Reuters the firm, the world's biggest vaccine manufacturer, would supply Saudi Arabia with 3 million AstraZeneca vaccine doses priced at $5.25 each in about a week.

Part of the Abrahams Business Accords

'Sapere aude'

by Oui (Oui) on Thu Jan 28th, 2021 at 02:25:54 PM EST
Speedy Donor Lane (>$10k)

The Seattle Times reports Overland Medical Center & Clinics  emailed about 110 donors last week who gave more than $10,000 to the hospital system, telling them that vaccine slots were available.

The email gave the donors an access code to register for appointments "by invite" only. At the same time the public-facing Overlake registration site was fully booked through March.



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by Oui (Oui) on Thu Jan 28th, 2021 at 08:36:42 PM EST
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by Oui (Oui) on Thu Jan 28th, 2021 at 03:05:06 PM EST

Political Animal In Downing Street

EU seeks access to AstraZeneca's Covid-19 vaccines produced at UK plants | France24 |

British Prime Minister Boris Johnson said it would have been a "great pity" if the United Kingdom had stayed in the European Union's vaccine programme rather than set up its own plan.

"I do think that we've been able to do things differently, and better, in some ways," he said in parliament.

PM Mark Rutte had tied the Dutch to the science of Boris Johnson and Oxford ... even hired Dr. Levi as personal advisor to tackle the SARS Cov-2 pandemic ...

Still not approved by the FDA in the US although $1.2bn was poured into the development with BIG publicity in Operation Warp Speed ...

Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner |  NY Times - Dec. 8, 2020 |

The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused it to fall behind in the U.S.

'Sapere aude'

by Oui (Oui) on Thu Jan 28th, 2021 at 03:48:09 PM EST
EU could block millions of Covid vaccine doses from entering UK | The Guardian |

The criteria for blocking exports will be published on Friday, with adoption of the mechanism expected within the coming days.

The extraordinary development came as Belgian regulators were sent in to AstraZeneca's coronavirus vaccine production site near Brussels at the request of the Ecommission. A first visit by officials from the Belgian federal medicines agency was completed on Wednesday at the site in Seneffe, Hainaut, the health ministry in Belgium said. Samples and records were taken from the plant, and a further inspection of the facility is expected in the coming days.

...
On Thursday the Cabinet Office minister, Michael Gove, said the UK would only help the EU with doses if there were spare vials. "We will want to talk to and with our friends in Europe to see how we can help," he said. "But the really important thing is to make sure our own vaccination programme proceeds precisely as planned."



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by Oui (Oui) on Thu Jan 28th, 2021 at 04:22:27 PM EST


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by Oui (Oui) on Thu Jan 28th, 2021 at 05:52:12 PM EST


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by Oui (Oui) on Thu Jan 28th, 2021 at 06:12:49 PM EST


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by Oui (Oui) on Thu Jan 28th, 2021 at 06:49:08 PM EST


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by Oui (Oui) on Thu Jan 28th, 2021 at 06:57:36 PM EST
Oxford/AstraZeneca Incapable to Meet Contract Targets

Serum Institute of India obtains emergency use authorisation in India for AstraZeneca's COVID-19 vaccine | Jan. 6, 2021 |

AstraZeneca is working with its global partners to continue building manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals.

New production sites

AstraZeneca aims to produce a billion doses at the Serum Institute of India, which is the world's largest vaccine manufacturer.

Establishing manufacturing facilities worldwide is seen as crucial for enabling fair global access to vaccines.

Deadly fire at massive Indian plant cranking out Oxford's COVID vaccine | CBS News - Jan. 22, 2021  |

Five people were killed by a fire that erupted at the sprawling complex of the Serum Institute of India, one of the world's biggest vaccine-making facilities which is currently producing millions of doses of the Oxford/AstraZeneca COVID-19 vaccine.

Several middle- and low-income nations are relying on the Serum Institute to supply their coronavirus vaccine stocks through the global, WHO-backed COVAX plan.  

...
India exported first batches of the Oxford-formulated vaccine from Serum to Bhutan and the Maldives on Wednesday.

The U.K.'s mass-vaccination plan is also relying heavily on the Oxford/AstraZeneca drug, but that stock is being produced in Britain.

Infographic - Countries Making Covid-19 Vaccines



'Sapere aude'
by Oui (Oui) on Thu Jan 28th, 2021 at 09:58:38 PM EST
I'm not sure this pretty chart tells us anything really. If we click through the sources we learn that Pfizer gives no public information about its production capabilities. And as far as I understand it the Pfizer vaccine is produced in a three stage process and only the the second stage, ( the lipid nanoparticle binding? Can't find the article, only stuff about Bill Gates' mind control nano chip) is done in Germany, the bottling in Belgium. Not sure if they get their mrna from the US. So where would you even count that production capacity?
by generic on Fri Jan 29th, 2021 at 09:30:52 AM EST
[ Parent ]
They Pledged to Donate Rights to Their COVID Vaccine, Then Sold Them to Pharma

The idea was to provide medicines preventing or treating COVID-19 at a low cost or free of charge, the British university said. That made sense to people seeking change. The coronavirus was raging. Many agreed that traditional vaccine development, characterized by long lead times, manufacturing monopolies and weak investment, was broken.

"We actually thought they were going to do that," James Love, director of Knowledge Ecology International, a nonprofit that works to expand access to medical technology, said of Oxford's pledge. "Why wouldn't people agree to let everyone have access to the best vaccines possible?"

A few weeks later, Oxford--urged on by the Bill & Melinda Gates Foundation--reversed course. It signed an exclusive vaccine deal with AstraZeneca that gave the pharmaceutical giant sole rights and no guarantee of low prices--with the less-publicized potential for Oxford to eventually make millions from the deal and win plenty of prestige.

by fjallstrom on Fri Jan 29th, 2021 at 08:27:36 AM EST
Wouldn't want to miss that level of professionalism we've seen in the clinical trials and the fast production ramp up. Imagine this had been in the hands of rank amateurs.
by generic on Fri Jan 29th, 2021 at 09:13:31 AM EST
[ Parent ]
You mean if the vaccine had been at the level of the first release of MS-DOS?
by gk (gk (gk quattro due due sette @gmail.com)) on Fri Jan 29th, 2021 at 09:17:45 AM EST
[ Parent ]
I don't know, did they accidentally install only half of MS-DOS on their test systems to then claim it works better that way?
by generic on Fri Jan 29th, 2021 at 09:29:20 AM EST
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by Oui (Oui) on Fri Jan 29th, 2021 at 03:12:45 PM EST


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by Oui (Oui) on Fri Jan 29th, 2021 at 03:14:53 PM EST
[ Parent ]

AstraZeneca must deliver vaccine doses from UK to EU, says Von der Leyen | The Guardian |

BREAKING NEWS: Coronavirus: EU confirms export controls on vaccines | BBC News |

'Sapere aude'

by Oui (Oui) on Fri Jan 29th, 2021 at 03:25:21 PM EST
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by Oui (Oui) on Fri Jan 29th, 2021 at 05:01:13 PM EST
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by Oui (Oui) on Fri Jan 29th, 2021 at 04:57:54 PM EST
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by Oui (Oui) on Fri Jan 29th, 2021 at 08:37:02 PM EST


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by Oui (Oui) on Fri Jan 29th, 2021 at 08:56:11 PM EST
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by Oui (Oui) on Fri Jan 29th, 2021 at 08:57:15 PM EST
[ Parent ]

In a further passage, AstraZeneca guarantees that it has no obligations towards other contractual partners that would be an obstacle to the full performance of the contract with the EU. That seems to contradict the company's argument that it has to deliver less because the British ordered first.

"AstraZeneca therefore cannot cite problems in a single plant in Belgium as a reason to break its commitments to the EU," said the SPD MEP and former Federal Minister of Justice Katarina Barley. Other legal experts see it similarly. "In the contract there is no mandatory connection between the delivery obligation and the place of production," states the Passau law professor and contract law expert Thomas Riehm. So it is »not so that AstraZeneca can say that we cannot produce enough in the EU, so you get less«.

His Marburg colleague Wolfgang Voit also explains: "In my opinion, production in the United Kingdom is on an equal footing with production in the EU." Another paragraph explicitly states that the vaccine doses that AstraZeneca should deliver to the EU are also in Great Britain can be made to meet the obligation.

When it comes to #AstraZeneca, the facts have to be on the table. And the company has to secure production capacities from other pharmaceutical companies if it has failures itself. BioNTech recently proved that this is possible and brought Sanofi on board. [Katarina Barley]

'Sapere aude'

by Oui (Oui) on Fri Jan 29th, 2021 at 09:42:56 PM EST
by Oui (Oui) on Fri Jan 29th, 2021 at 10:33:35 PM EST


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by Oui (Oui) on Fri Jan 29th, 2021 at 10:52:31 PM EST

EU drops Irish border move in plan to curb vaccine exports  - Politico.eu
The swift about-face came after Irish Prime Minister Micheál Martin and U.K. Prime Minister Boris Johnson separately phoned Commission President Ursula von der Leyen to express deep concerns. Johnson and Martin also held a conversation on the issue.

In a tweet late Friday night, von der Leyen said she spoke to Martin "to agree on a satisfactory way to introduce an export mechanism for COVID vaccines." But that only raised a question of why she hadn't consulted the Irish leader before the Commission published its export regulations earlier in the day.

Irish Foreign Minister Simon Coveney welcomed the Commission's statement but added pointedly that "lessons should be learned; the Protocol is not something to be tampered with lightly, it's an essential, hard won compromise, protecting peace & trade for many."

by Bernard (bernard) on Sat Jan 30th, 2021 at 01:22:51 PM EST
[ Parent ]
Invoke article 16 for a few hours until the EU Commission backtracked.

An illustration how hard the non-compliance of Oxford / AstraZeneca hit the countries of the EU-27. Due to globalization almost all pharmaceutical manufacturing relies on imports. The Brexit deficit playing out in number of Covid-19 deaths.

Catastrophic errors in the handling of coronavirus | The Guardian - Opinion |

'Sapere aude'

by Oui (Oui) on Sat Jan 30th, 2021 at 06:27:53 AM EST
Brexit and EU Von der Leyen



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by Oui (Oui) on Sun Jan 31st, 2021 at 06:00:12 PM EST
[ Parent ]
GISAID

GESS: a database of global evaluation of SARS-CoV-2/hCoV-19 sequences | Oxford Academic |

'Sapere aude'

by Oui (Oui) on Sat Jan 30th, 2021 at 08:30:44 AM EST


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by Oui (Oui) on Sat Jan 30th, 2021 at 09:32:54 AM EST
It's always Macron, of course, even when he's repeating what the German experts said the day before.

Reminder: Macron is not a scientist but a politician.

by Bernard (bernard) on Sat Jan 30th, 2021 at 01:11:37 PM EST
[ Parent ]
Most likely based on the experts of Robert Koch Institute telling journalists the data is not there. A disputed newspaper article followed and a faulty assumption became a political tool to fight off the British. EMA did not follow the German concerns!

EU regulator authorizes AstraZeneca vaccine for all adults

'Sapere aude'

by Oui (Oui) on Sat Jan 30th, 2021 at 02:13:42 PM EST
[ Parent ]
RKI experts just say that there is not enough data for the 65+ age group. Nothing more.

Politicians then spin this into whatever their political agenda is.

Some suspect that Macron wants to divert attention from a lackluster vaccination campaign. They may have a point: last year, the French government kept pushing the line that face masks "were not recommended" throughout the spring, while the country was facing an acute shortage of masks provoked in part by the same government having decided not to replenish the stocks.

On the efficacy itself, there is a mass experiment going on now: millions have been inoculated by the AstraZeneca  vaccine in the UK, including a lot of people 65 and above; so there will be more data in the future; in the meanwhile, it's all speculation.

by Bernard (bernard) on Sat Jan 30th, 2021 at 03:02:20 PM EST
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by Oui (Oui) on Sat Jan 30th, 2021 at 02:19:56 PM EST
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'Sapere aude'
by Oui (Oui) on Sat Jan 30th, 2021 at 01:22:11 PM EST
The EU that keeps on giving ... where's Michel Barnier?

 

EU vaccine row 'political penalty kick for unionists' | BBC News |

Whatever the sequencing and the hard conversation between Dublin and Brussels, political parties in Northern Ireland are already picking through the wreckage to salvage what they can.

For Sinn Féin, the SDLP and Alliance, it is all about damage limitation and ensuring Brussels has learned lessons from its costly political blunder.

But for the DUP and Ulster Unionists, it has supercharged their onslaught on the Northern Ireland protocol.

They can say that, at the first sign of trouble, Brussels effectively advocated for the same hard land border it had fought years to prevent.

It was a political penalty kick for unionists into an open goal.

Now the glass is broken they want London to push the same emergency Article 16 button.

Nationalism and the global SARS CoV-2 pandemic ... getting it wrong most of the time! From herd immunity to economic favors to failing to protect the frontline workers and vulnerable persons in society. Guardianship and responsibility in leadership.

Hoarding Covid-19 vaccines `keeps the pandemic burning', says WHO | Irish Times |

'Sapere aude'

by Oui (Oui) on Sat Jan 30th, 2021 at 01:52:07 PM EST
Free vaccines and India's humanitarian diplomacy

More than 5 million Indian-made vaccines were airlifted last week to countries extending from Myanmar and Bangladesh to Mauritius and the Seychelles. And millions of more free vaccines are on their way this week.

India's free-vaccine diplomacy, however, has been driven by more than altruism. There are geopolitical considerations at play, including building goodwill and influence and countering China's growing strategic footprint in the Indian Ocean region.

...
India already has agreed to supply more than one billion coronavirus vaccines to various countries and to the World Health Organization-backed Covax initiative aimed at poorer countries. India is currently manufacturing two vaccines -- the AstraZeneca-Oxford vaccine, known in India as Covishield, and Covaxin, developed by the Indian pharmaceutical firm Bharat Biotech. Three other Indian companies are close to wrapping up development of their own vaccines.

Before India granted emergency approval to Covishield and Covaxin in early January, the privately-owned Serum Institute of India (SII) -- the world's largest maker of vaccines by volume and the leading production partner of AstraZeneca-Oxford -- had already manufactured and stocked between 70 to 80 million Covishield doses. This large stockpile has meant that India has enough vaccines to share with other countries.

AstraZeneca to supply Europe with up to 400 million doses of Oxford University's vaccine at no profit | Press statement June 13, 2020 |

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by Oui (Oui) on Sat Jan 30th, 2021 at 07:14:52 PM EST


'Sapere aude'
by Oui (Oui) on Wed Feb 3rd, 2021 at 06:15:50 AM EST
[ Parent ]
Using the wrecking ball and the tabloids will propagate the nonsense ... Britain First!

From my diary of March 17, 2020:

CureVac In Germany: Trump's Failed Takeover Bid

In a moment of global crisis, the worst of human kind outs itself ... or society can come together to fight a common enemy. The ultra-narcist in the leader of America came to the forefront: buy the German vaccine and we'll market as ::

FOR AMERICA ONLY!

"We've got the BEST doctors, scientists, hospitals ... we're doing a great job. Very early I closed to borders to China ... saved thousands of lives!"

Donald Trump greift nach deutscher Impfstoff-Firma | Die Welt - 5 Marz 2020 |

The EU Commission took the route of multilateralism ...

'Vaccine nationalism' delays WHO's struggling Covax scheme | FT - Sept. 2, 2020 |

The European Commission said this week it would offer €400m in guarantees to Covax to help supply vaccines to low and middle income countries. Both the commission and the WHO said the exact terms of the EU's relationship with Covax were still being worked out. The WHO also said Germany had joined Covax.

Covax has struggled to convince high income countries to use the facility for their own domestic vaccine procurement. Rich nations including the US, Japan and the UK have done their own private deals to secure doses instead.

...
The WHO has warned countries about the long-term risks of relying on bilateral procurement.

"We have two choices: vaccine nationalism, where a lot of people are vaccinated in a handful of countries, leaving the world's majority unprotected; or vaccine multilateralism, where we protect at-risk populations in all countries and keep our economies working," Mariângela Simão, the WHO's assistant director-general for access to medicines, told the FT.



'Sapere aude'
by Oui (Oui) on Sat Jan 30th, 2021 at 08:49:52 PM EST
Once again the leading nations in deaths are hoarding PPE supplies, vaccines and basic substances.

COVID-19 and the cost of vaccine nationalism | Rand Europe |

...
Vaccine nationalism adversely affects how well the public health crisis can be managed

Vaccine nationalism can have several negative implications for the production and equitable distribution of potential vaccines across the world.

Firstly, the race observed between superpowers such as the US, China and Russia for who is going to develop a vaccine first could help to drive the successful development of potential vaccines. However, the geopolitical competition could also induce countries to speed up their trials and, to satisfy public demand, push for quicker and riskier regulatory approvals. If it transpires that some of these vaccines are not effective or have severe side-effects, that could further erode public trust in vaccines and complicate national vaccination plans.

Secondly, the current public focus is on the development of the vaccine. However, once there are safe and effective vaccine candidates available, they need to be produced and administered at scale. Vaccine manufacturing is a complex process. The infrastructure needed will depend on the type of vaccine developed and there is also the challenge that poorer countries may not have adequate systems to deliver and administer doses that have been manufactured in different environments, mostly found in the wealthier countries. Moreover, components for a vaccine usually come from different geographical locations that specialize in specific stages of the production process. A 'nationalistic' approach to vaccine production could lead to global vaccine supply chains being interrupted if some countries hoard the key inputs, causing production delays.

Thirdly, in order to secure access to a vaccine, many governments, mostly from wealthier countries, have signed direct bilateral deals with producers of vaccine candidates in order to secure a stock for their own population. This patchwork of bilateral agreements could adversely affect pricing and availability of potential vaccines as wealthier countries bid for limited vaccine supplies. A 'my nation first' approach could lead to an inefficient allocation of early available vaccines, potentially favouring individuals at less risk in high-income countries over high-risk individuals in poorer countries.



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by Oui (Oui) on Sat Jan 30th, 2021 at 09:05:07 PM EST
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by Oui (Oui) on Sun Jan 31st, 2021 at 09:18:36 AM EST
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Covid vaccines to be recorded in Dublin in compromise deal | The Guardian |

Vaccine doses crossing the border between the Republic and Northern Ireland will have to be recorded in Dublin but they will not be at risk of being blocked under an EU regulation in force to avoid shortages in the bloc.

Brussels wants to ensure that pharmaceutical companies producing in the EU supply the member states with the doses committed to in their contracts.

Vaccines distributed to the UK from Belgian and German plants

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Officials on Saturday said they remained determined to hold the pharmaceutical companies to account, with vaccine shortages being reported across the block.

"We have a serious issue with a company that has signed a contract with us saying that it was to put at our disposal vaccines from two factories from the UK - and has not delivered a single dose from those factories," an EU official said. "And it was clearly saying, supported by the British government, that those factories will not be delivering vaccines to the EU until the UK has got the 100m doses it is supposed to get. This is a serious issue for us."



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by Oui (Oui) on Sat Jan 30th, 2021 at 09:33:21 PM EST
Australia to receive first batch of AstraZeneca COVID-19 vaccine in Jan 2021 - PM to say | Reuters - Sept. 5, 2020 |

Australia said in August it had signed a preliminary agreement with AstraZeneca for enough doses for its population of nearly 26 million, which would be manufactured locally by pharmaceutical company CSL.

That deal appeared in some doubt when CSL said its priority was manufacturing an alternative potential vaccine developed with the University of Queensland (UQ).

Agreeing a deal to overcome the potential roadblock, Australia will now also buy 51 million doses of the UQ vaccine.

It will take possession of the first 3.8 million doses of the AstraZeneca vaccine in January and February 2021, and then receive a further 30 million doses.

Is PM Morrison of Australia getting priority to fill the gap left by domestic UQ failure? Negative, Australia and New Zealand have managed to mitigate the Coronavirus and are in a much better position to delay vaccinations. The UK and EU countries truly screwed up in wavering between health and opening up the economy ... a lose-lose choice.

CSL, University of Queensland quit COVID-19 vaccine trials due to HIV antibody response | BioWorld - Dec. 11, 2020 |

Australia's vaccine agreements

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by Oui (Oui) on Sun Jan 31st, 2021 at 08:42:30 AM EST
Australia vows not to rush vaccine rollout, citing UK 'problems' | AFP - Jan. 5, 2021 |

Sydney: Under mounting pressure to speed up coronavirus vaccinations, Australian Prime Minister Scott Morrison  said he would not take "unnecessary risks" and emulate Britain's emergency drug approval.

While vaccinations are already well underway in many countries, Australia's pharmaceutical authority is not expected to rule on candidate drugs for around another month, and is aiming to administer the first doses by the end of March.

Australia approves Pfizer vaccine, warns of limited global AstraZeneca supply | CNBC - Jan. 25, 2021 |

Australia approved the Pfizer-BioNTech Covid-19 vaccine for use but warned AstraZeneca's international production problems mean the country would need to distribute a locally manufactured shot earlier than planned.

Vaccination of priority groups with the Pfizer vaccine is expected to begin in late February at 80,000 doses per week, Health Minister Greg Hunt told reporters.

Hunt said AstraZeneca had advised Australia the company has "had a significant supply shock and so that means we won't have as much of that AstraZeneca international in March as they had previously promised."

The AstraZeneca vaccine is yet to be approved by Australia, which expects to start CSL's domestic supply of the AstraZeneca vaccine in March, earlier than planned, at 1 million doses a week, he said.

"The decision to pay a premium for an onshore, secure, sovereign vaccine manufacturing capacity via CSL, that puts Australia in a vastly more secure position than almost any other country in the world," Hunt said.

Australia has set a target of 4 million vaccine doses by April. It has also committed to supplying vaccines to Pacific Island nations on a later timetable.



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by Oui (Oui) on Sun Jan 31st, 2021 at 08:45:10 AM EST
[ Parent ]
Australia  Morrison invests extra in vaccine rollout to save the economy ...

... so what do you know ... Et Tu Morrison... a salto, BIG flip-flop:

AUSTRALIA FIRST!

'Sapere aude'

by Oui (Oui) on Sun Jan 31st, 2021 at 06:06:23 PM EST
[ Parent ]
Coronavirus: Germany threatens legal action over vaccine delays; Brazil to receive millions of AstraZeneca doses | SCMP |

Brazil will receive between 10 million and 14 million doses of AstraZeneca's coronavirus vaccine starting in mid-February through the World Health Organization's Covax programme, according to the country's health ministry.

Brazilian health regulator Anvisa said that AstraZeneca had applied for full regulatory approval, a positive note for the country's difficult vaccine roll-out.

The submission, the first of its kind in Brazil, was made by the federally funded Fiocruz Institute, which will manufacture the British vaccine locally.

'Sapere aude'

by Oui (Oui) on Sun Jan 31st, 2021 at 11:46:46 AM EST

Post-Brexit England drifts farther apart from the Continent ... looking towards joining Asian-Pacific trade pact. Confronting CCP China with one modern aircraft carrier ... and the nuclear subs still in design phase.

'Sapere aude'

by Oui (Oui) on Sun Jan 31st, 2021 at 05:58:47 PM EST
[ Parent ]
Get rid of protection intellectual property rights of private companies funded by governments to develop coronavirus vaccines. Three of the four largest pharmaceutical groups are not participating in the COVID-19 pandemic.

Panel discussion about role Big Pharma and role of states to secure necessary vaccines.

Will 'vaccine nationalism' prolong the pandemic? | Al Jazeera |

Germany sends medical experts to Portugal as hospitals face COVID-19 crisis

𝗙𝗼𝗿𝗮𝗺 𝘃𝗮𝗰𝗶𝗻𝗮𝗱𝗮𝘀 𝟭𝟰.𝟰𝟵𝟲 𝗽𝗲𝘀𝘀𝗼𝗮𝘀 𝗻𝗮𝘀 𝘂́𝗹𝘁𝗶𝗺𝗮𝘀 𝟮𝟰 𝗵𝗼𝗿𝗮𝘀

Hungary:

Gulyás: EU's vaccine procurement is "sluggish"



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by Oui (Oui) on Sun Jan 31st, 2021 at 01:43:28 PM EST

Deutschland droht mit rechtlichen Schritten wegen Verzögerungen bei der Impfstoffabgabe |Welt am Sonntag |

"Under no circumstances should you give preference to another country over the EU." He welcomed the fact that the EU Commission had published the contract with the manufacturer AstraZeneca. "If it turns out that individual companies are not complying with their obligations, a decision must be made about legal consequences," said Altmaier.

He sees "no obvious serious mistakes" in the procurement of vaccines for the EU and Germany. Altmaier is also a member of the Federal Cabinet's vaccination working group. It was right to wait for proper approvals for the vaccines, even if other countries like Great Britain could start vaccinating earlier thanks to emergency approvals.

Serbia Becomes First European Country to Use Chinese COVID Vaccine for Mass Rollout

As the West competes for vaccines, China exports jabs and expands soft power

'Sapere aude'

by Oui (Oui) on Sun Jan 31st, 2021 at 03:37:28 PM EST
[ Parent ]

Angela Merkel says 'every vaccine is welcome' after Sputnik V results | DW - yesterday |

To get in front of the queue ... perhaps a deal for finishing Nord Stream 2?

France President Macron succumbs to US pressure ...

U.S. Senator Warns France's Macron over Gas Exports Deal Delay | Pipeline & Gas Journal - Nov. 2020 |

'Sapere aude'

by Oui (Oui) on Wed Feb 3rd, 2021 at 11:16:25 AM EST
[ Parent ]
Quite promising, single jab and low-cost ... 85% efficacy to reduce severe symptoms, short stay in hospital and great reduction in deaths.



'Sapere aude'
by Oui (Oui) on Sun Jan 31st, 2021 at 04:25:13 PM EST
Covid-19 vaccine candidate: Novasep signs a Master Supply and Development Agreement with AstraZeneca | Novasep - Nov. 12, 2020 |

Novasep, a leading supplier of services and technologies for the life sciences industry, is pleased to announce that it has now signed a multi-year Master Supply and Development Agreement with AstraZeneca to support large-scale production of the active substance of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222.

This new contract follows the initial agreement signed between AstraZeneca and Novasep Belgium on June 14th in the context of the Inclusive Alliance for Vaccines (IAV), whose members are France, Germany, Italy and the Netherlands.  [Who was late at the table BoJo? ... honor British commitments]

The production of the vaccine candidate active substance under this supply agreement will be carried out at Novasep's site located in Seneffe, Belgium which expects to increase its workforce from 280 to close to 400 by 2021 to support this project.

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.

Halix - Excellence in GMP Manufacturing

The 6,700 m2 BSL2 GMP facility, recently approved by the Dutch authorities and located on the Leiden Bio Science Park in the Netherlands, provides both clinical and commercial scale manufacturing capabilities in fully independent, self-contained Grade B and C cleanrooms for virus products.

'Sapere aude'

by Oui (Oui) on Sun Jan 31st, 2021 at 07:42:41 PM EST
Expansion Facilities Halix bv Leiden

Press Release: HALIX and Leiden University sign agreement | Dec. 31, 2017 |

HALIX B.V. and the Leiden University signed an agreement for a plot of land at the Leiden Bio Science Park. This represents the kick-off for the final designing phase and start of the constructing phase of HALIX's brand-new GMP facilities.

HALIX is expanding the scope of its services, requiring additional capacity which will be created in a new, approx. 6.500 m2 facility located centrally in the Leiden Bio Science Park, the Netherlands. These new facilities will be designed for state of the art GMP manufacturing projects.

...
The Leiden Bio Science Park is the largest science cluster in the Netherlands and brings together Leiden University, Leiden University Medical Center (LUMC), and approximately 150 companies in close proximity. There is a lot of energy and expertise moving around between companies in the Bio Science Park. Being part of that is a great benefit for HALIX.

HALIX Opened New cGMP Facility at Leiden Bio Science Park | GMP News - Nov. 26, 2019 |

'Sapere aude'

by Oui (Oui) on Sun Jan 31st, 2021 at 08:25:52 PM EST
[ Parent ]
AstraZeneca COVID vaccine's complex EU supply chain | DW News |

The production of AstraZeneca's vaccine broadly involves two steps: one is producing the actual vaccine or drug substance, and the other is putting the vaccine into vials. Those two steps can take up to 60 days each.

AstraZeneca has said while it's facing no issues with the second step, it's struggling to produce high quantities of the vaccine at an EU production plant.

AstraZeneca's European supply chain

AstraZeneca has partnered with several contract manufacturers across the EU to scale up the production of its COVID-19 vaccine. The vaccine, or the drug substance, is currently being produced at two facilities in the Netherlands and Belgium. It's the company's Belgian partner, Novasep, which has struggled with low yields.

The vaccine is then filled into vials and packaged in Dessau in eastern Germany by IDT Biologika and by Catalent in Anagni, Italy. Spanish pharmaceutical group Insud Pharma will also undertake vial filling and packaging services for the vaccine in Spain's Castilla-La Mancha region.



'Sapere aude'
by Oui (Oui) on Tue Feb 2nd, 2021 at 10:00:12 PM EST
[ Parent ]


'Sapere aude'
by Oui (Oui) on Sun Jan 31st, 2021 at 08:50:07 PM EST



'Sapere aude'
by Oui (Oui) on Sun Jan 31st, 2021 at 08:51:55 PM EST

Apparently the delivery of the existing order is pulled forward...

EU secures nearly half of Pfizer's 2021 global output of COVID-19 shots | Reuters - Jan. 8, 2021 |

'Sapere aude'

by Oui (Oui) on Mon Feb 1st, 2021 at 07:18:22 AM EST
Pfizer and BioNTech boost target for 2021 Covid-19 vaccine output to 2.0bn doses | Jan. 11, 2021 |

US drug giant Pfizer and German partner BioNTech have boosted their target for producing Covid-19 vaccine doses in 2021 by more than half.

In response to the exceedingly strong and urgent demand for the shot, the two companies said they were now aiming to supply as many as 2.0bn doses, up from plans for 1.3bn previously.

That increase includes a label change which will allow doctors to extract six doses instead of five from each vaccine vial.

...
Brussels had inked a deal with the two firms to purchase as many as 600m doses.

With that an aim in mind, a new production site in Marburg, Germany, with an expected annual production capacity of as many as 750m shots was expected to come online by the end of February.

BioNTech was also pushing to add suppliers and contract manufacturers to improve production processes.

COVID vaccine: BioNTech plans 2 billion doses this year | DW |

The Brexit avengers from Downing Street ...

Can you believe it? While demand and manufacturing doubled, the British aligned AstraZeneca cut the planning for the EU by nearly 70% ... intolerable ⁉️

'Sapere aude'

by Oui (Oui) on Mon Feb 1st, 2021 at 10:46:25 AM EST
Unbelievable, the headline doesn't do justice to the underlying problems ...

AstraZeneca says it will boost vaccine production to 2M a week | Politico - Jan. 15, 2021 |

Health authorities in the UK have decided to change their distribution strategy, prioritizing giving as many people a first shot as possible.

British drugmaker AstraZeneca says it will boost production of the coronavirus vaccine it developed with Oxford University to two million doses a week by the middle of January.

According to the Times, an unnamed member of the Oxford/AstraZeneca team said production was expected to reach a total of 1 million doses by the end of next week.

"The plan is then to build it up fairly rapidly -- by the third week of January we should get to two million a week," they added.

...

Meanwhile, a senior scientist from Oxford University has complained that the country's pharmaceutical manufacturing base is not prepared to handle the roll-out of the jab.

"The government has been completely disinterested in building onshore manufacturing capacity for any of the life-sciences products," said John Bell, professor of medicine at Oxford.

Simple math ... manufacturing rate of 52 million per year to double to 104 million 🚱 ... cutting corners to please the Brexiteers in the City.



'Sapere aude'
by Oui (Oui) on Mon Feb 1st, 2021 at 11:31:55 AM EST
Big Pharma Outsourcing Manufacturing

Global Contract Manufacturing Companies: Pharmaceutical and Biotechnology

As manufacturing processes become more complex and regulatory requirements become more burdensome, pharmaceutical companies are developing longer-term, more beneficial strategic deals. This process often results in pharmaceutical companies dealing with fewer partners, but these providers need to be able to deliver a full-service offering to compete for business. For a pharmaceutical entity to strategically outsource, the company must reinvent this relationship via persistent discussions with its preferred partners on planning, common objectives, and the responsibility of operating more effectively versus key metrics.

During recent years pricing pressures have driven manufacturing contractors to form operations in emerging markets. Offshoring has resulted in companies establishing facilities in India, China, Singapore, South Korea, and more recently Malaysia. Significant investment continues to flow into Asia with many western CMOs expanding operations there, especially in China. As the marketplace becomes more price competitive, the option to outsource certain projects to lower-cost Asian regions - particularly for producing large-volume products - will become a valuable option. This trend should have a strong impact on the worldwide CMO arena.



'Sapere aude'
by Oui (Oui) on Mon Feb 1st, 2021 at 12:10:23 PM EST
[ Parent ]
!Had turned down Pfizer offer of 70 million doses.

Brazil's Bolsonaro says COVID-19 vaccinations won't be mandatory | NBC News - Sept. 4, 2020 |

Brazil last month signed an agreement with AstraZeneca to buy 30 million doses of the vaccine it is developing with Oxford University, with an option for 70 million more doses if the vaccine works.

Latin America's most populous country has become a key testing ground for a COVID-19 vaccines and has approved phase 3 clinical trials for four that are under development, by Oxford University/AstraZeneca, China's Sinovac Biotech, and Pfizer Inc in partnership with BioNTech and Johnson & Johnson's pharmaceutical subsidiary Janssen.

Bolsonaro entered a vaccine deal with a single supplier ... the British AstraZeneca ... rollout planning unknown and not sufficient to prevent harm for the Brazilian people.

'Sapere aude'

by Oui (Oui) on Mon Feb 1st, 2021 at 02:33:48 PM EST


'Sapere aude'
by Oui (Oui) on Mon Feb 1st, 2021 at 05:54:17 PM EST
[ Parent ]
EU contract did not leave time to fix vaccine hiccups -AstraZeneca CEO

AstraZeneca's Chief Executive on Tuesday said the European Union's late decision to strike a contract with the drugmaker to supply COVID-19 vaccines, months after Britain, meant the company did not have enough time to iron out glitches in setting up production lines with external partners.

"We are basically two months behind where we wanted to be," Pascal Soriot told German daily Die Welt in an interview, when asked about delayed deliveries in Europe.

"And the issue here is we've had also teething issues like.this in the UK supply chain," he added. "As for Europe, we are three months behind in fixing those glitches."

...

In August last year, the EU agreed to purchase 300 million doses of AstraZeneca's vaccine for 750 million euros, with an option for an additional 100 million.

That was after Britain in May secured 100 million doses for 84 million pounds and the United States, also that month, secured 300 million doses for up to $1.2 billion.

Soriot, however, said the volumes agreed with the EU were not binding.

Never ever read so many much Bull in a short article ... ‼️

That's best effort??

Purchase price
EU €2.50
UK £0.84
US $4.-
I'm sure the above doesn't tell the whole story of the contract. AstraZeneca has excellent outsource partners in Europe ... it seems more likely the vaccine didn't perform or met FDA Standards ... yet ... thus no build-up of stock.

FDA: COVID-19 vaccines in development - Jan. 15, 2021

'Sapere aude'

by Oui (Oui) on Mon Feb 1st, 2021 at 02:37:27 PM EST
Are you saying that the UK has negotiated a much better price (one third) than what the EU negotiated? And this based solely on Soriot/Reuters reported figures?
by Bernard (bernard) on Mon Feb 1st, 2021 at 07:14:30 PM EST
[ Parent ]
South Africa to pay $5.25 a dose for AstraZeneca vaccine from India's SII | Reuters |



'Sapere aude'
by Oui (Oui) on Tue Feb 2nd, 2021 at 09:00:59 AM EST
[ Parent ]
Of course strongly backed by BoJo after Brexit ... getting even with Brussels by starting a trade war ... carving out the home turf.

Trump Administration's Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October

'Sapere aude'

by Oui (Oui) on Wed Feb 3rd, 2021 at 06:26:29 AM EST
[ Parent ]


'Sapere aude'
by Oui (Oui) on Wed Feb 3rd, 2021 at 06:44:32 AM EST
[ Parent ]
Covid news - live: Oxford vaccine may cut transmission by two thirds as antibodies `last for six months' | The Independent |

Health secretary Matt Hancock said a study showing a single dose of the Oxford vaccine may reduce transmission of coronavirus by two-thirds "categorically" supported the government's strategy of delaying rollout of the second jab.

He told Sky News: "This Oxford report is very good news, it backs the strategy that we've taken and it shows the world that the Oxford vaccine works effectively.

"The really good news embedded in it is that it not just reduces hospitalisations - there were no people in this part of the trial who are hospitalised with Covid after getting the Oxford jab - but also it reduces the number of people who have Covid at all, even asymptomatically, by around two-thirds.

Certainly hope this pans out to be true ... trust in the Conservative government is near absolute zero. Genomic analysis is well funded and traces new mutations to the Coronavirus ... the US and Brazil are greatly lacking genomic tracing, thus the world is blindsighted by this virus and pandemic.

'Sapere aude'

by Oui (Oui) on Wed Feb 3rd, 2021 at 08:45:16 AM EST
[ Parent ]
In the Netherlands we count differently: the Rutte mathemagician ❗️⚠️

Health Minister de Jonge wants to investigate possible double count of vaccination

On Sunday, the corona dashboard, the government's official website showing the number of administered vaccines, estimated that 346,790 people have thus far been inoculated. However, only 226,298 injections were reported the day before. 

Some explanation from colleague Health Minister de Jonge:

... this is due to the new way in which the number of vaccinations is being calculated. "it takes a while before an injection is registered. We are now looking at how many vaccines have actually been administered, and we take an x percentage of that per day," said Minister de Jonge. 

On Sunday, he also said that figures were often incomplete because many general practitioners, hospitals, and long-term care institutions often only process their figures later. There would therefore be an under-reporting of the actual number of vaccinations. 

Really what Hugo meant to say, the official administrations of the RIVM and local GGDs are a complete ... ehh mess.

The percentage x is based an a higher calculus algorithm presupposed as a derivative of the undercount of the number of deaths due to SARS CoV-2 novel virus. One takes the inverse of 5O% undercount of deaths and multiply the result with the assumption of the number of jabs. This correction will look much better for Mark's PR as he approaches the next virtual meeting with leaders of the EU-27. The Dutch people still place their trust in him, Merkel and Macron can't wait to be rid of him ... either by self-imposed retirement or election loss to Le Pen.

'Sapere aude'

by Oui (Oui) on Mon Feb 1st, 2021 at 05:35:32 PM EST



'Sapere aude'
by Oui (Oui) on Tue Feb 2nd, 2021 at 02:44:37 PM EST


'Sapere aude'
by Oui (Oui) on Tue Feb 2nd, 2021 at 02:45:13 PM EST
[ Parent ]


'Sapere aude'
by Oui (Oui) on Tue Feb 2nd, 2021 at 03:42:11 PM EST
Coronavirus: 'Sombre day' as UK hits 10,000 deaths - Matt Hancock | BBC News - Apr. 13, 2020 |



'Sapere aude'
by Oui (Oui) on Tue Feb 2nd, 2021 at 09:30:06 PM EST


'Sapere aude'
by Oui (Oui) on Wed Feb 3rd, 2021 at 09:17:40 PM EST

... and Dutch PM Mark Rutte a step behind the policy set by BoJo and Trump ... so sad!

'Sapere aude'

by Oui (Oui) on Fri Feb 5th, 2021 at 08:27:26 AM EST
On equal level with the UAE and Israel ... healthcare is WAR! Winston Johnson taking the lead ... Ursula Von der Leyen left an empty sack. The EU AstrraZenica produced vaccines were safely inside the British Isles and sovereignty ...

The UK has vaccinated more than 10 million people - the third-highest rate behind Israel and the UAE - after assembling the biggest vaccine stockpile per capita last year.

The Tory method: cutting corners and cheating. 😎

'Sapere aude'

by Oui (Oui) on Sun Feb 7th, 2021 at 09:41:33 AM EST
The growing Brexit threat to Ireland

EU Commission's NI Border Blunder

One security source predicted it would take strong leadership to undo the damage caused by the commission's article 16 blunder. The source said the EU had always tried to occupy the moral high ground, insisting it would do every everything to protect the Good Friday agreement "and then they go and trigger 16, which blew everything out of the water.

"How do you get back to a position where the adults in the room are acting in a way that brings more stability and not undermining what little stability there is."

Btw the Dutch too don't get their British goods delivered ... one importer had a delivery of Scot's whiskey delayed by four weeks. In the end helping out to fill in the necessary forms ...

Nissan forced to shut UK production line owing to supply delays

British business leaders warn of 'substantial difficulties' at UK ports

'Sapere aude'

by Oui (Oui) on Sun Feb 7th, 2021 at 11:43:11 AM EST


'Sapere aude'
by Oui (Oui) on Sun Feb 7th, 2021 at 11:44:17 AM EST
[ Parent ]
Oxford/AstraZeneca Vaccine and the African Strain

Oxford/AstraZeneca jab fails to prevent mild and moderate Covid from S African strain, study shows

The Oxford/AstraZeneca Covid-19 vaccine does not appear to offer protection against mild and moderate disease caused by the viral variant first identified in South Africa, according to a study.
Although none of the more than 2,000 mainly healthy and young patients in the study died or was hospitalised, the findings, which have not yet been peer reviewed, could complicate the race to roll out vaccines as new strains emerge.

In both the human trials and tests on the blood of those vaccinated, the jab showed significantly reduced efficacy against the 501Y.V2 viral variant, which is dominant in South Africa, according to the randomised, double-blind study seen by the Financial Times.

Johnson & Johnson vaccine: Multi-continent Study Provides Clinical Data on Multiple Emerging Viral Mutations

'Sapere aude'

by Oui (Oui) on Sun Feb 7th, 2021 at 02:45:55 PM EST

China steals march on West in developing nations' vaccine rollout | Reuters - Jan. 14, 2021 |

The geopolitics of covid vaccines in Europe's eastern neighbourhood | ECFR |

'Sapere aude'

by Oui (Oui) on Sun Feb 7th, 2021 at 07:57:22 PM EST
[ Parent ]


'Sapere aude'
by Oui (Oui) on Wed Feb 10th, 2021 at 10:05:15 AM EST


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