The EU coronavirus vaccine blame game. Why so slow? – POLITICO

When it comes to getting people vaccinated, the EU lags behind the UK, US and Israel – and a growing number of critics blame the European Commission.

Over the weekend, Markus Söder, head of the German Christian Social Union, and BioNTech CEO Uğur Şahin criticized the Commission for not purchasing enough BioNTech / Pfizer vaccine, the first to be approved by European regulators.

The Commission hit back on Monday, saying it had obtained more than 2 billion doses of vaccine from seven producers with member states participating throughout the process.

“I don’t think the problem is really the number of vaccines, it’s the fact that we are at the start of a deployment,” Commission chief spokesperson Eric Mamer said. “We all judge it as if this campaign is over; in fact, the campaign is only just beginning. “

It was certainly a slow start. EU countries have vaccinated hundreds of thousands of people collectively, but the numbers differ significantly from country to country.

Even Germany, which had vaccinated 265,000 people – more than any other EU country – as of Jan. 4, is still a long way from the 1.3 million doses it has available.

Meanwhile, the UK has beaten around a million people and the US over 4 million. Both countries are ahead of a week and face their own issues (the US has 13.2 million doses available, for example), but the EU’s slow deployment is due to delays in vaccine production, a more substantial but bureaucratic approval process, and poor planning in many EU countries.

Why didn’t the Commission buy enough BioNTech / Pfizer jabs to vaccinate everyone in the EU?

In June, when the Commission started purchasing vaccines, no one was sure which would be successful let alone which would be available first.

BioNTech / Pfizer, along with Moderna, Oxford / AstraZeneca, and Johnson & Johnson, were among the fastest to launch large-scale human trials and boasted ambitious timelines. But each of these vaccines had different hurdles to overcome, and no one expected any of them to be more than 90% effective – certainly not those based on mRNA technology, which didn’t. had never been approved by regulators before.

The Commission has therefore diversified its vaccine portfolio, obtaining more than 2 billion doses of vaccine from six producers. It is close to an agreement to purchase 200 million additional doses of Novavax jab.

Shouldn’t the EU have agreed to buy more?

Since BioNTech / Pfizer was the first to come out with a hit, everyone wants as much vaccine as possible, but it will almost certainly be a problem in the short term.

Compared to other vaccines, the BioNTech / Pfizer jab is difficult to dispense because it has to be stored in dry ice at -70 ° C (it can be stored in normal refrigerators for only five days) and it is expensive, at around € 12 a shot compared to Oxford / AstraZeneca which is less than € 2 a dose, according to a leaked price list.

Still, the Commission secured 200 million doses of the German-American vaccine with the possibility of purchasing an additional 100 million (the biggest contract for BioNTech / Pfizer vaccines at the time).

For comparison, the United States bought 100 million doses of the vaccine with the possibility of purchasing 500 million more in July. After criticism, the US government bought an additional 100 million on December 23 – even less than the EU’s initial purchase.

But even if the EU had bought more vaccines, it probably wouldn’t have made a difference at this point. Much of the problem now is with manufacturing bottlenecks and countries unprepared to roll out jabs quickly.

Should countries just buy and approve vaccines themselves?

The argument for teaming up is that EU countries would get better deals by negotiating en bloc.

They learned from past experience: During the 2009 swine flu pandemic, drug companies played EU countries against each other to charge more money for vaccines, with some states left with too much of doses and selling them to their neighbors.

This time the EU countries have agreed to let the Commission manage the negotiations. EU countries are still part of the process, however, with seven countries participating in the negotiations and all countries approve agreements before they are signed.

The EU could technically have bought 1 billion doses of each vaccine, but money was a constraint. It is not known to what extent, as almost all information in EU vaccination contracts is secret. We know that the Commission used around EUR 2.1 billion in down payments on vaccines and asked EU countries for an additional EUR 750 million in the autumn. Each EU country pays per dose when submitting vaccine orders. Yet they have amassed one of the largest vaccine portfolios in the world.

Some countries have decided to buy other vaccines or more vaccines in addition to the EU agreements. In the fall, Germany bought an additional 30 million doses of BioNTech / Pfizer and CureVac vaccines, even though this goes against EU strategy.

When asked why by POLITICO, Health Minister Jens Spahn said Germany wanted to buy more, but “there was not really a greater need from member states at this point.”

Once those additional purchases become more public, Denmark has said it will follow suit and purchased an additional 2.6 million doses.

Has Germany been held back by the Commission?

Germany helped force the Commission in June by teaming up with France, Italy and the Netherlands to sign an agreement for up to 400 million Oxford / AstraZeneca vaccines for the entire EU so that the United States cannot get them all back.

Other countries, notably Belgium, criticized the initiative and the Commission stepped in to negotiate for the bloc. The four countries eventually transferred the Oxford / AstraZeneca agreement to the Commission.

This is now reported in the German media as the start of the “vaccine catastrophe”. Bild reported that Spahn had apologized for the four country alliance’s stance on a “humiliating tone” so that Commission President Ursula von der Leyen and German Chancellor Angela Merkel could make the “grand gesture. To let the EU take the lead.

Steffen Siebert, head of the German government’s press office, upheld the decision on Monday, saying he was convinced it was “the right way”.

“For a country in central Europe … dependent on the free movement of goods, with a vested interest in a functioning Schengen area, ‘every man for himself’ cannot be the way,” he said. .

So why is the EU taking so long to vaccinate people?

Did the EU, as some claim, make vaccine deals too late? Most of the deals were made in early August – the Commission simply did not get approval from EU countries until months later.

It is true that the UK and US were able to vaccinate hundreds of thousands of people before European regulators approved the first vaccine against the coronavirus. There are several reasons for this, including the fact that the European Medicines Agency has recommended a conditional marketing authorization, which has more conditions for drug manufacturers than the UK emergency authorization procedures. Accordingly, if there are unforeseen problems with the vaccines, the UK government will be held responsible; while in the EU, drug makers are said to be on the hook.

It also takes longer as it requires the participation of all EU countries. Countries have largely been strong supporters of this process throughout December, but seeing images of Britons and Americans getting vaccinated, countries like Hungary, Poland, Germany and Italy have pushed the ‘EU to go faster.

The EMA has brought forward its recommendation dates and the Commission has streamlined its authorization process from days to hours, but it seems likely that the EU process will continue to take longer as other countries issue emergency authorizations.

The next EMA decision will be on Moderna’s vaccine this week, though the US company has limited production capacity in the EU.

The EMA is also carrying out ongoing reviews of the Oxford / AstraZeneca and Johnson & Johnson vaccines (although the former has not formally submitted a conditional marketing authorization application, which could cause delays).

Shouldn’t a vaccine be good to use once it gets the green light?

Once the BioNTech / Pfizer vaccine received EU approval, companies had to release the vaccine and countries had to use it. This is largely where we see problems now.

BioNTech / Pfizer has been unable to deliver the 12.5 million vaccines it had promised the EU by the end of 2020, largely due to supply chain issues. BioNTech CEO Şahin told Der Spiegel that more vaccines need to be approved as the company increases its manufacturing capacity.

“It doesn’t look good – a hole appears because there is a lack of other approved vaccines and we have to fill the void with our own vaccine,” he said.

When it comes to the use of jabs, most countries started on December 27 with a demonstration of solidarity with the EU (Germany, Hungary and Slovakia jumped the gun and started a day earlier) . Other countries were just not prepared.

The Netherlands won’t start vaccinating until this week, with Health Minister Hugo De Jonge saying it was because they believed Oxford / AstraZeneca would be the first vaccine approved. “Maybe it could and should have been done differently,” he wrote in a letter to parliament on Monday.

Many others have just been incredibly slow, notably France, which had only vaccinated 138 people as of December 30.

Hans von der Burchard, Sarah Wheaton and Merlin Sugue contributed reporting.

This article is part of POLITICOPremium Police Service: Pro HealthCare. From drug pricing, EMA, vaccines, pharmacy and more, our specialist journalists keep you up to date on the topics that drive the health policy agenda. E-mail [email protected] for a free trial.