quarta-feira, 27 de janeiro de 2021

‘Solidarity Is Failing’: E.U. and U.K. Fight Over Scarce Vaccines // AstraZeneca CEO: EU vaccine contract is ‘not a commitment’

 


‘Solidarity Is Failing’: E.U. and U.K. Fight Over Scarce Vaccines

 

As vaccine production falls behind schedule, and the European Union lags in inoculating people, Brussels and London are lobbing threats and accusations at each other.

 

Benjamin MuellerMatina Stevis-Gridneff

By Benjamin Mueller and Matina Stevis-Gridneff

Jan. 27, 2021, 12:15 a.m. ET

https://www.nytimes.com/2021/01/27/world/europe/EU-UK-vaccine-fight.html

 

LONDON — The vaccine wars have come to Europe.

 

For months now, wealthy countries have been clearing the world’s shelves of coronavirus vaccines, leaving poorer nations with little hope of exiting the pandemic in 2021. But a fresh skirmish this week has pitted the rich against the rich — Britain versus the European Union — in the scramble for vials, opening a new and unabashedly nationalist competition that could poison relations and set back collective efforts to end the pandemic.

 

The European Union, stung by its slow progress on vaccinations, threatened this week to tighten rules on the shipment of Belgian-made shots to Britain.

 

British lawmakers, in turn, have accused their European counterparts of a blackmail campaign that could embitter relations for a generation.

 

And poorer countries, already at the back of the line for vaccines, could face even longer waits if the intense squabbling among rich countries drives up prices for everyone else.

 

The feuding in Europe holds echoes of the dark, early days of the pandemic, when scores of countries banned or restricted the export of protective equipment and medical devices. Nearly a year later, far from abating, that spirit of protectionism has been exacerbated: Not only are vaccine supplies too scarce for many poorer countries to begin inoculations, but wealthy countries cannot figure out how to share the available doses among themselves.

 

 

“Science is succeeding, and solidarity is failing,” said Robert Yates, the director of the global health program at Chatham House, the London-based policy institute. “The world’s political leaders are letting down the scientists, and everyone else.”

 

At the core of the problem are production delays at separate factories in Belgium that make the Pfizer-BioNTech vaccine and the one developed by AstraZeneca and the University of Oxford. With a new and more contagious coronavirus variant fueling a surge of cases in several European countries, those delays have undermined efforts to get shots into millions of people’s arms, ratcheting up the global competition for doses.

 

But the notoriously tricky manufacturing of vaccines is only part of the problem. Public health experts say the entire global system of buying doses, pitting one country against another with little regard for equity, is unfit to the task of ending a pandemic that respects no borders.

 

For the European Union, problems with its vaccination campaigns have reinforced criticism of the bloc’s occasionally unwieldy, slow bureaucracy. Unable to speed up vaccine makers, the bloc’s leaders have instead resorted to threats about the export process, a sign of the severe pressure facing them as the European Union falls far behind Britain and the United States, which made advanced purchases of vaccines earlier, and have been quicker to authorize the shots and get people inoculated.

 

“The prestige of the European Union is founded on a perception of competence, particularly when you go to different peripheries of the continent, where people think that Brussels is going to be more competent than the national authorities,” said Bruno Maçães, an author and a former politician in Portugal. “You can see a sense of desperation in the last couple days.”

 

Many European countries, rich and poor, have been hoping that the arrival of the AstraZeneca-Oxford vaccine would hasten the pace of vaccinations, owing to its lower price and simpler storage requirements, compared to those from Pfizer and Moderna. The bloc’s drug regulators are expected to authorize the vaccine on Friday, a month after Britain did.

 

But AstraZeneca told the European Union at a teleconference last week that it was going to slash its scheduled deliveries to 31 million doses by the end of March, less than half of the 80 million doses the bloc had been expecting.

 

E.U. officials were aghast. The news came on top of an announcement from Pfizer that it had to slow its own vaccine deliveries so that it could upgrade its Belgian factory.

 

With member states incensed, the European Commission reacted on Monday by saying that all coronavirus vaccines made within the bloc would require special paperwork to be shipped elsewhere. That put Britain’s supply of Pfizer-BioNTech vaccines at risk: Unlike its supply of the AstraZeneca vaccine, which is being produced in British plants, its shipments of the Pfizer-BioNTech vaccine come entirely from a factory in Puurs, Belgium.

 

European lawmakers justified the move by saying it would allow them to monitor how companies were distributing vaccines, and hold them accountable.

 

“This isn’t about E.U. first,” said the German health minister, Jens Spahn, in a televised interview Tuesday, “but Europe’s fair share.”

 

European officials have implied that AstraZeneca, headquartered in Britain, sent vaccines to Britain that were meant for the continent instead. They said suggestions by AstraZeneca that the company had been hit by manufacturing problems at its Belgian factory could not explain the steep drop in delivery volume.

 

AstraZeneca, for its part, has said that Britain’s supply of vaccines has come from the country’s own plants, and not Europe. “We have not diverted any supply from the Europe supply chain to countries outside the E.U.,” a company spokesman said on Tuesday.

 

Relations between Britain and the European Union were already testy after more than four years of wrangling over Brexit, which was finalized just weeks ago, and British lawmakers reacted with fury to being blamed for the bloc’s vaccine problems. David Jones, a Conservative lawmaker, told a British newspaper that “this looks awfully like blackmail,” saying it “shows why we were right to leave the E.U.”

 

Analysts said the spat was indicative of rising tensions over the large lead Britain has in inoculation, having given vaccines to 10 percent of its people so far, compared to about 2 percent in the European Union. Britain was the first country to authorize a fully tested coronavirus vaccine, and the government of Prime Minister Boris Johnson has trumpeted its successes.

 

“I think there are elements within the government, and within the pro-Brexit community, who are actually quite relishing this,” said Mr. Yates of Chatham House. “In this case, we are seeing perhaps a bit of retaliation now from our European neighbors who are fed up with this.”

 

The conflict between the European Union and AstraZeneca took a particularly damaging turn on Monday night when two German newspapers published claims — errantly, it turned out — that the AstraZeneca-Oxford vaccine was completely ineffective in older people.

 

While low numbers of older people were enrolled in AstraZeneca’s completed clinical trials, making it difficult to assess the vaccine’s efficacy in that group, the newspaper claims were false, the German health ministry later said. But they played into the anger among some Germans about the slow vaccine rollout, particularly given that Britain has been inoculating people since Dec. 8 with the vaccine that was originally developed by BioNTech, a German company.

 

“How Germany Became a Vaccination Snail,” read a headline in the mass-circulation Bild on Tuesday, over an article detailing the country’s missteps that have led it to fall behind in the race to vaccinate its population.

 

Concerns about the paucity of data in older people could further limit the use of the AstraZeneca shot: European regulators are considering authorizing it only for people under 65 years old, two E.U. officials said.

 

For AstraZeneca, which is being relied upon by much of the world to supply affordable and easy-to-store shots, the production delays in Europe have been a sign of snags in its ambitious plans, analysts said. While other vaccine makers, like Pfizer, are relying on only a few facilities, AstraZeneca has contracted its manufacturing to plants all over the world.

 

The European Commission is now demanding that AstraZeneca open up its production plans to scrutiny. In an internal document seen by The New York Times, the commission said that the European Union wants to know “which factory produced what and when,” a question that the bloc believes its contract entitles it to have answered.

 

Britain reached an agreement with AstraZeneca last May to buy tens of millions of doses of the vaccine, when it was still in clinical trials — three months before the European Union arranged its purchases.

 

Even so, the bloc made the vaccine a centerpiece of its plans, ordering 300 million doses that it planned to distribute to member states based on population size. Several member states eschewed parts of their shares of the Pfizer and Moderna vaccines, which are more expensive and harder to store and administer, to plan their strategies around AstraZeneca deliveries.

 

To ensure it would not be at a disadvantage to other countries in securing orders, European Union officials said that they also agreed in mid-October to pay more than 300 million euros ($360 million) so that AstraZeneca could scale up production capacity.

 

With deliveries now falling far short, Ursula von der Leyen, the president of the European Commission, on Tuesday demanded a return on the bloc’s investments.

 

“The companies must deliver,” she said. “They must honor their obligations.”

 

But Pascal Soriot, the chief executive of AstraZeneca, said in an interview with the Italian newspaper La Repubblica that his company had never promised to deliver the vaccine to the bloc as fast as it did to Britain.

 

“Europe at the time wanted to be supplied more or less at the same time as the U.K., even though the contract was signed three months later,” he said. “So we said, ‘OK, we’re going to do our best, we’re going to try, but we cannot commit contractually.’”

 

Benjamin Mueller reported from London, and Matina Stevis-Gridneff from Brussels. Monika Pronczuk contributed reporting from Brussels, and Melissa Eddy from Berlin.

 

Benjamin Mueller is a United Kingdom correspondent for The New York Times. Before that, he had been a police and law enforcement reporter on the Metro desk since 2014. @benjmueller

 

Matina Stevis-Gridneff is the Brussels correspondent for The New York Times, covering the European Union. She joined The Times after covering East Africa for The Wall Street Journal for five years. @MatinaStevis




AstraZeneca CEO: EU vaccine contract is ‘not a commitment’

 

‘Our commitment’ says Pascal Soriot, is to make ‘our best effort.’

 

BY HELEN COLLIS AND DAVID M. HERSZENHORN

January 27, 2021 6:30 am

https://www.politico.eu/article/astrazeneca-ceo-eu-vaccine-contract-is-not-a-commitment/?utm_medium=Social&utm_source=Facebook&fbclid=IwAR1leBuzOJHALh9s6BnIsbu6xeEkt4KuEl5iZ9EhLyxZiTumxL6Y3WaqMs8#Echobox=1611743634

 

AstraZeneca’s chief has defended the company’s shock admission that the EU’s first coronavirus vaccine deliveries will fall far short of expectations, claiming the number that will be delivered is “not so bad” and his company only committed to meet demand to its “best effort."

 

In setting out the company’s position, Pascal Soriot, the chief executive of the Anglo-Swedish firm, told Italy's la Repubblica newspaper in an interview published Tuesday that the EU’s deliveries were in large part delayed because the bloc was late signing a contract for the vaccine — three months behind the U.K. — and therefore EU manufacturing facilities were playing catch-up in ironing out glitches.

 

He also denied allegations that the company had been selling its vaccines beyond the EU to make a quick buck. Soriot said the company was not making a profit on the vaccine anywhere, with prices ranging between $3 and $4 a dose globally, dependent upon local supply chain costs.

 

Some European leaders had reacted with outrage to Friday’s news that AstraZeneca’s scheduled COVID-19 vaccine supplies to the EU would be significantly cut. European Health Commissioner Stella Kyriakides said Monday it was “not acceptable,” while Italy and Latvia said they want to sue the company.

 

Amid suspicions the pharma giant was selling jabs that ought to have been contracted to the EU elsewhere for a higher price, Kyriakides announced new export rules that would require companies to notify Brussels of any vaccines they intend to sell outside of the bloc. The Commission also wants to know exact manufacturing yields at each facility and where these doses are destined.

 

Soriot said the EU will receive 3 million doses once the vaccine is approved by the European Medicines Agency, and 17 million total by February. He downplayed the shortfall in orders, saying stress was causing EU leaders to react badly.

 

"Governments are under pressure," Soriot said. "Everybody is getting kind of a bit, you know, aggravated or emotional."

 

He said AstraZeneca will be making 100 million doses globally a month from February, noting “Europe is getting 17 percent of the global production … for a population that is 5 percent of the world population.”

 

The issues lie with difficulties in manufacturing high yields of the active ingredient, or drug substance, which are made at sites in the Netherlands and Belgium, he said. Once the active ingredient is ready, it’s shipped to Italy and Germany where it is diluted and put into vials — and there are “zero problems” with the latter process, Soriot said.

 

Water-tight contract

Reports of legal action against the company — potentially from Italy, as well as calls for a European-level lawsuit — for not meeting its contracted deliveries, didn't appear to faze Soriot, with the CEO insisting he was confident in the wording of the company's agreement.

 

The EU “contract is very clear: Our commitment is, I am quoting, ‘our best effort,’” he said. It was drawn up this way because AstraZeneca and its partner Oxford University had already signed a deal with the U.K. government for 100 million doses, and was committed to delivering them, while the EU deal for 400 million doses was signed three months later, with the bloc wanting them to be shipped concurrently.

 

“We said, ‘OK, we're going to do our best, we’re going to try, but we cannot commit contractually because we are three months behind U.K.,'” he said, adding the company knew it was a “super stretch goal."

 

At a news conference Tuesday, the European Commission’s chief spokesman, Eric Mamer, noted that AstraZeneca was fulfilling orders to other customers — a clear reference to the U.K., where the vaccine has been deployed for several weeks — and said the EU saw no reason why it should not receive its expected supply once the vaccine is formally approved, as is expected later this week.

 

“We see that doses are being delivered elsewhere and we know that we have signed an agreement with AstraZeneca in August, that member states placed their orders, I believe around October, and that we are now at the end of January,” he said. “Therefore, we believe that the doses should be basically available to be delivered if and when the conditional marketing authorization is recommended by the European Medicines Agency.”

 

But Soriot pointed out that the British agreement stipulates that supply coming out of the U.K. would go to the U.K. first. The EU agreement allows use of the U.K. manufacturing sites, “but only later,” Soriot said, once Britain reaches a “sufficient number of vaccinations.”

 

EU's 'really bad luck'

The British deal, facilitated by Oxford University's early talks with the U.K. government, allowed manufacturing to be expanded and fine-tuned early in the U.K., overcoming hurdles in scaling up a complex biological process, Soriot said, before the vaccine was approved.

 

The later deal with the EU meant all these processes were three months behind. The company had to train partners across Europe on how to manufacture the vaccine, and “some people are new to this process … They don't know how to make the vaccine and they're not as efficient as others," he said.

 

For this reason, the most-efficient U.K. facility yields three times the vaccine doses compared with the less-efficient factories elsewhere, and facilities with the lowest yields are those supplying the EU, according to Soriot.

 

"Unfortunately, it's really bad luck,” he said. “There’s nothing mysterious about it.”

 

In response to the remarks by Soriot, the European Commission’s Mamer reiterated the EU’s insistence that AstraZeneca fulfill its contractual obligations and better explain why it would not be able to deliver the promised quantities of vaccine. Earlier on Tuesday, at the Commission’s daily news conference, Mamer said he had been unable to answer reporters’ many questions about what had gone wrong because AstraZeneca had not provided sufficient explanation for the expected production shortfall.

 

EU officials have said previously that the bloc’s purchase agreements with the company were not tied to any particular production facility and that they sought out agreements with companies with a demonstrated capacity for the large-scale manufacturing required to make vast quantities of vaccine.

 

“When we signed the agreement, it was on the basis that these companies had production capacity, and we expected that there is flexibility,” Mamer said Tuesday night. “We are looking forward to continue the conversation during the steering board meeting tomorrow evening.”

 

Meanwhile, the U.K.’s approach to delay the second jab until 12 weeks to enable more people to get the first was “absolutely the right way to go, at least for our vaccine,” Soriot said. “You get a better efficiency if you get the second dose later than earlier." Denmark and the Netherlands are now also delaying second doses by six weeks.

 

Soriot denied that AstraZeneca was selling vaccines outside of the EU to make more money, underlining that the company was contractually obliged with Oxford University to make no profit. “We're certainly not taking vaccines away from the Europeans to sell it somewhere else at the profit,” he said. “It would not make sense.”

 

And Soriot said he was baffled as to why German media reported the vaccine has just 8 percent efficacy in over 65s. “It’s incorrect,” he said, adding: “Lots of very smart people” working for regulators in countries that have approved the vaccine accepted its efficacy in people 18 years old and above.

 

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