A Blog by Jonathan Low

 

Jan 31, 2021

The Reason Europe's Vaccine Roll-out Has Been So Problematic

As the US experience reveals, getting agreement in one country is hard enough. Getting 27 member countries to agree is maddening. 

Aside from the chaos of competing health regimens, philosophies and budgets, the EU hoped for a European vaccine, which has yet to materialize and its investment in the AstraZeneca model created problems due, in part, to Brexit. The Union was also cautious about how much money to invest and was late to agreements with those companies that were clearly leaders even though it could be argued the Pfizer/BioNTech vaccine was primarily European. Such small-minded regional thinking is dangerous when facing a global problem. JL 

Lauren Chadwick reports in EuroNews:

The European Union was slower to approve the first coronavirus vaccines than the UK and the US. The European regulator requires input from every member state (and) under the EU process, the drugmaker will be held liable if anything with the vaccine goes wrong. (Plus) "We wanted to invest in a diversified portfolio of different companies using different technologies because we were not sure which vaccine would be successful. The right thing to do was to throw money at the problem and make sure that we got enough of the vaccines that were actually useable in the time frame that they were needed. And that wasn’t done,"

As other rich countries have surged ahead in vaccinating against COVID-19, the European Union has been left lagging behind.

It's not that the EU doesn't recognise the urgency: the European Commission has already signed contracts for more than two billion vaccine doses from six companies. It wants countries to vaccinate 70% of their populations by this summer.

But whereas the UK has administered 11 doses per 100 people and the US 7.9 doses per 100 people, Germany has given 2.6 doses per 100 people, Italy 2.8 doses per 100 people and France 1.8 per 100 people, according to Our World in Data.

The EU now faces heightened criticism as delivery delays from pharmaceutical companies have prompted many to ask what the bloc could have done better in its initial rollout.

EU's vaccine approval process slower than other countries

The European Union was slower to approve the first coronavirus vaccines than the UK and the US

The UK approved the Pfizer/BioNTech vaccine on December 2, marking the first coronavirus vaccine to be approved in a Western country. A little over a week later, that vaccine was approved by the US Food and Drug Administration for emergency use.

The European Medicines Agency, meanwhile, did not give approval for the Pfizer/BioNTech vaccine until December 21 and vaccinations did not start until a week later.

That's in part because the European regulator requires input from every member state and issues a conditional marketing authorisation which is closer to the standard process for vaccine approval.

Under the EU process, the drugmaker will be held liable if anything with the vaccine goes wrong.

"We don’t want to skip any security routines that we have and the reason for that is that in the end we don’t want the boomerang effect that we have vaccines but then we get problems later on," said Swedish MEP Jytte Guteland, who sits on the European Parliament's public health and environment committee.

"We don't want people to be afraid of the vaccines," she added.

EU slower than others to secure vaccine contracts

Some of the blame could be placed on late vaccine contracts, experts say.

The European Commission reached its first agreement on doses of a potential coronavirus vaccine in mid-August with pharmaceutical company AstraZeneca, months behind the company's May deal with the UK.

The EU's contract with Pfizer, meanwhile, was not secured until November whereas the UK and US had deals by July with the company.

The US confirmed its first 100 million doses with Moderna in August and invested heavily in vaccine development starting in the spring.

Israel, a country that has vaccinated more than 30% of its population, had an agreement with Moderna by June and signed a contract with Pfizer in November, with an agreement that the country would share COVID-19 data with the drugmaker, according to Reuters.

"We wanted to invest in a diversified portfolio of different companies using different technologies because we were not sure which vaccine would be successful," said European Commission spokesman Stefan de Keersmaecker.

The Pfizer and Moderna vaccines use new mRNA technology, which he said are more "complex technologies... so that explains that you need a little bit more time to agree on contracts."

AstraZeneca CEO Pascal Soriot has said the reason for delays to vaccine dose deliveries was in part due to the EU's contract coming months after the UK.

In an interview with Die Welt, he also claimed that the company was not contractually obligated to give the promised doses, amid rising tensions as the drugmaker said they could not fulfil all of the first quarter doses to the EU.

"We said we are going to make our best effort. The reason why we said that is because Europe at the time wanted to be supplied more or less at the same time as the UK, even though the contract was signed three months later," Soriot said.

This raised questions about the contractual obligations of drug companies and prompted the EU to release a redacted version of the contract on Friday.

"I don’t know exactly what was promised and that is also part of this that we don’t have all the facts about why this happened," said Guteland, before the Commission released the contract. She said the AstraZeneca vaccine news came as a "shock" this week.

Von der Leyen told German radio on Friday the agreements were "binding orders and the contract is crystal clear".

The contract states that AstraZeneca should use its "best reasonable efforts" to manufacture initial European doses "within the EU for distribution" and deliver them following the marketing authorisation, but later on states that manufacturing sites could include the UK.

“On best effort, the CEO of AstraZeneca was right,” says Gustav Oertzen, a lecturer at Leuphana University in Germany.

“This is all about ‘best reasonable effort’. No clear commitments for delivery, no recognisable penalties, unless in the redacted part."

Oertzen added that he had "no idea what von der Leyen means by 'crystal clear commitments' based on this contract.”

In response to criticism about the timing of contracts, EU health commissioner Stella Kyriakides said the European Commission rejected the idea that “any country has a priority over the other because they signed an agreement before them”.

Experts say that two to three months can make a big difference in allowing the company to ramp up production.

The delay in securing contracts “is a big hindrance because you need something like two to three months to ramp up production if you look at for example BioNTech they have ramped up production in something like ten weeks but you need some time to do this, that is clear," said Oertzen.

It wasn't until January that the EU concluded an agreement to buy an additional 300 million Pfizer/BioNTech vaccines for a total of 600 million vaccines, nearly half of what the company is planning on producing in 2021.

Did the EU throw enough money at the problem?

"We didn’t order enough doses of the two excellent vaccines early enough," said J Scott Marcus, a senior fellow at the Brussels-based economics think tank Bruegel. He thinks the EU should have focussed on vaccines that were clearly frontrunners earlier.

"At that point the right thing to do was to throw some money at the problem and make sure that we got enough of the vaccines that were actually useable in the time frame that they were needed. And that wasn’t done," Marcus added.

The Emergency Support Instrument used to purchase vaccines was worth €2.7 billion, while the US has spent some $18 billion on vaccines, according to Bloomberg.

EU spokesman De Keersmaecker says the vaccine contracts do include investment in vaccine development.

"We knew that there was no certainty that these vaccines would be successful but nevertheless we insisted on that these companies would develop their production capacity, they would develop stocks of vaccines, so that as soon as the green light is given by EMA, they can start delivering a large quantity of vaccines," he told Euronews, stating that the financial risk is taken up by the European Commission.

But some are not convinced that all the resources were thrown at the problem and that it was truly a priority over the summer.

“We set up a [coronavirus] rescue and a recovery fund of €750 billion but we can’t mobilise a couple of billion that we need for the vaccine?” asked Bruegel senior fellow Uri Dadush in a recent podcast interview.

“There was a certain sense of complacency also last summer that you know the numbers were down, the COVID numbers were really down, and I think a lot of people had that feeling well we are sort of over it and we managed to contain the virus and so the top political attention wasn’t given in a certain period.”

But now it comes at a time that new variants are threatening to once again overflow EU hospitals and countries have been forced to impose strict and costly lockdowns.

"The cost of the pandemic to Europe is measured in trillions of euro. The amounts that were talking about here are single digit billions of euro. There's a difference of three orders of magnitude," said Marcus.

"We're talking about peanuts here really in comparison to the cost of the pandemic."

Slow rollout in member states

Some of the blame for the slow rollout fell on member states, especially early on, as bureaucratic difficulties hampered EU countries.

The Netherlands came under significant criticism after starting their vaccination campaign late because the Pfizer/BioNTech vaccine had to be stored at ultracold temperatures, and they hadn't adequately prepared for it, AP reported.

France also came under heavy criticism with the country vaccinating mere hundreds in the first week of the rollout in part because their strategy required patients to have a pre-vaccination consultation.

Italy meanwhile vaccinated citizens faster than most other member states but have focussed their campaign on healthcare workers instead of vulnerable adults, so many vulnerable people remain at risk.

Recently some EU states appeared to go rogue in terms of vaccine procurement, raising more questions about the speed at which vaccines are being delivered across the bloc.

Hungary's foreign minister said the country had procured two million doses of the Russian coronavirus vaccine because the EU scheme was too slow. On Friday, the country approved a Chinese coronavirus vaccine.

Germany's government, meanwhile, said in a statement to Euronews that it had bilateral negotiations with some pharmaceutical companies that would not impact the EU vaccine agreement but also drew further attention to the EU's vaccine strategy.

EU solidarity in vaccine rollout

The EU has touted, meanwhile, their effort to secure vaccines as 27 nations in solidarity and start the inoculation campaign together.

"That made it possible to make a single order for vaccines and all of the member states agreed not to go outside of that. Now that actually had very big implications because it meant that the member states weren’t competing for one another and bidding for the same vaccines," said Marcus at Bruegel.

"What we’ve seen in the United States where we’ve had a very fractured public health response is that for things like PPE, for masks, for ventilators, the states were competing against one another in periods where these were really scarce."

But it also meant the vaccination campaign started later.

Guteland says that "if you do everything 27 times it would take a longer time to get everyone vaccinated than if you do it one time with one voice."

But, she said, "we should try to defend that we did it together."




0 comments:

Post a Comment